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Sample records for acute decompensation randomized

  1. Aggressive fluid and sodium restriction in acute decompensated heart failure : a randomized clinical trial

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    Aliti,Graziella Badin; Silva, Eneida Rejane Rabelo da; Clausell, Nadine Oliveira; Rohde, Luis Eduardo Paim; Biolo, Andreia; Silva, Luis Beck da

    2013-01-01

    Importance: The benefits of fluid and sodium restriction in patients hospitalized with acute decompensated heart failure (ADHF) are unclear. Objective: To compare the effects of a fluid-restricted (maximum fluid intake, 800 mL/d) and sodiumrestricted (maximum dietary intake, 800 mg/d) diet (intervention group [IG]) vs a diet with no such restrictions (control group [CG]) on weight loss and clinical stability during a 3-day period in patients hospitalized with ADHF. Design: Randomized, paralle...

  2. Aggressive fluid and sodium restriction in acute decompensated heart failure: a randomized clinical trial.

    Science.gov (United States)

    Aliti, Graziella Badin; Rabelo, Eneida R; Clausell, Nadine; Rohde, Luís E; Biolo, Andreia; Beck-da-Silva, Luis

    2013-06-24

    The benefits of fluid and sodium restriction in patients hospitalized with acute decompensated heart failure (ADHF) are unclear. To compare the effects of a fluid-restricted (maximum fluid intake, 800 mL/d) and sodium-restricted (maximum dietary intake, 800 mg/d) diet (intervention group [IG]) vs a diet with no such restrictions (control group [CG]) on weight loss and clinical stability during a 3-day period in patients hospitalized with ADHF. Randomized, parallel-group clinical trial with blinded outcome assessments. Emergency room, wards, and intensive care unit. Adult inpatients with ADHF, systolic dysfunction, and a length of stay of 36 hours or less. Fluid restriction (maximum fluid intake, 800 mL/d) and additional sodium restriction (maximum dietary intake, 800 mg/d) were carried out until the seventh hospital day or, in patients whose length of stay was less than 7 days, until discharge. The CG received a standard hospital diet, with liberal fluid and sodium intake. Weight loss and clinical stability at 3-day assessment, daily perception of thirst, and readmissions within 30 days. Seventy-five patients were enrolled (IG, 38; CG, 37). Most were male; ischemic heart disease was the predominant cause of heart failure (17 patients [23%]), and the mean (SD) left ventricular ejection fraction was 26% (8.7%). The groups were homogeneous in terms of baseline characteristics. Weight loss was similar in both groups (between-group difference in variation of 0.25 kg [95% CI, -1.95 to 2.45]; P = .82) as well as change in clinical congestion score (between-group difference in variation of 0.59 points [95% CI, -2.21 to 1.03]; P = .47) at 3 days. Thirst was significantly worse in the IG (5.1 [2.9]) than the CG (3.44 [2.0]) at the end of the study period (between-group difference, 1.66 points; time × group interaction; P = .01). There were no significant between-group differences in the readmission rate at 30 days (IG, 11 patients [29%]; CG, 7 patients [19%]; P = .41

  3. Efficacy and safety of electroacupuncture in acute decompensated heart failure: a study protocol for a randomized, patient- and assessor-blinded, sham controlled trial.

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    Leem, Jungtae; Lee, Seung Min Kathy; Park, Jun Hyeong; Lee, Suji; Chung, Hyemoon; Lee, Jung Myung; Kim, Weon; Lee, Sanghoon; Woo, Jong Shin

    2017-07-11

    The purpose of this trial is to evaluate the effectiveness and safety of electroacupuncture in the treatment of acute decompensated heart failure compared with sham electroacupuncture. This protocol is for a randomized, sham controlled, patient- and assessor-blinded, parallel group, single center clinical trial that can overcome the limitations of previous trials examining acupuncture and heart failure. Forty-four acute decompensated heart failure patients admitted to the cardiology ward will be randomly assigned into the electroacupuncture treatment group (n = 22) or the sham electroacupuncture control group (n = 22). Participants will receive electroacupuncture treatment for 5 days of their hospital stay. The primary outcome of this study is the difference in total diuretic dose between the two groups during hospitalization. On the day of discharge, follow-up heart rate variability, routine blood tests, cardiac biomarkers, high-sensitivity C-reactive protein (hs-CRP) level, and N-terminal pro b-type natriuretic peptide (NT-pro BNP) level will be assessed. Four weeks after discharge, hs-CRP, NT-pro BNP, heart failure symptoms, quality of life, and a pattern identification questionnaire will be used for follow-up analysis. Six months after discharge, major cardiac adverse events and cardiac function measured by echocardiography will be assessed. Adverse events will be recorded during every visit. The result of this clinical trial will offer evidence of the effectiveness and safety of electroacupuncture for acute decompensated heart failure. Clinical Research Information Service: KCT0002249 .

  4. The dose-dependent effect of nesiritide on renal function in patients with acute decompensated heart failure: a systematic review and meta-analysis of randomized controlled trials.

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    Xiong, Bo; Wang, Chunbin; Yao, Yuanqing; Huang, Yuwen; Tan, Jie; Cao, Yin; Zou, Yanke; Huang, Jing

    2015-01-01

    Conflicting renal effects of nesiritide have been reported in patients with acute decompensated heart failure. To answer this controversy, we performed a meta-analysis of randomized controlled trials to evaluate the influence of nesiritide on renal function in patients with acute decompensated heart failure. Articles were obtained from PubMed, Medline, Cochrane Library and reference review. Randomized controlled studies that investigated the effects of continuous infusion of nesiritide on renal function in adult patients with acute decompensated heart failure were included and analyzed. Fixed-effect model was used to estimate relative risk (RR) and weight mean difference (WMD). The quality assessment of each study, subgroup, sensitivity, and publication bias analyses were performed. Fifteen randomized controlled trials were eligible for inclusion. Most of included studies had relatively high quality and no publication bias was found. Overall, compared to control therapies, nesiritide might increase the risk of worsening renal function in patients with acute decompensated heart failure (RR 1.08, 95% CI 1.01-1.15, P = 0.023). In subgroup analysis, high-dose nesiritide strongly associated with renal dysfunction (RR 1.54, 95% CI 1.19-2.00, P = 0.001), but no statistical differences were observed in standard-dose (RR 1.04, 95% CI 0.98-1.12, P = 0.213), low-dose groups (RR 1.01, 95% CI 0.74-1.37, P = 0.968) and same results were identified in the subgroup analysis of placebo controlled trials. Peak mean change of serum creatinine from baseline was no significant difference (WMD -2.54, 95% CI -5.76-0.67, P = 0.121). In our meta-analysis, nesiritide may have a dose-dependent effect on renal function in patients with acute decompensated heart failure. High-dose nesiritide is likely to increase the risk of worsening renal function, but standard-dose and low-dose nesiritide probably have no impact on renal function. These findings could be helpful to optimize the use of

  5. NT-proBNP-Guided Therapy in Acute Decompensated Heart Failure: The PRIMA II Randomized Controlled Trial.

    Science.gov (United States)

    Stienen, Susan; Salah, Khibar; Moons, Arno H; Bakx, Adrianus L; van Pol, Petra; Kortz, Mikael; Ferreira, João Pedro; Marques, Irene; Schroeder-Tanka, Jutta M; Keijer, Jan T; Bayés-Genis, Antoni; Tijssen, Jan G P; Pinto, Yigal M; Kok, Wouter E

    2017-12-14

    Background -The concept of natriuretic peptide guidance has been extensively studied in chronic heart failure (HF) patients, with only limited success. The effect of NT-proBNP-guided therapy in acute decompensated HF (ADHF) patients using a relative NT-proBNP target has not been investigated. The aim of this study was to assess whether NT-proBNP-guided therapy of ADHF patients using a relative NT-proBNP target would lead to improved outcome compared with conventional therapy. Methods -We conducted a prospective randomized, controlled trial to study the impact of in-hospital guidance for ADHF treatment by a predefined NT-proBNP target (>30% reduction from admission to discharge) versus conventional treatment. ADHF patients with NT-proBNP levels of > 1700 ng/L were eligible. After achieving clinical stability, 405 patients were randomized to either NT-proBNP-guided or conventional treatment (1:1). The primary endpoint was dual, i.e. a composite of all-cause mortality and HF readmissions in 180 days, and the number of days alive out of the hospital in 180 days. Secondary endpoints were all-cause mortality within 180 days, HF readmissions within 180 days, and a composite of all-cause mortality and HF readmissions within 90 days. Results -Significantly more patients in the NT-proBNP-guided therapy group were discharged with an NT-proBNP reduction of >30% (80% versus 64%, P=0.001). Nonetheless, NT-proBNP-guided therapy did not significantly improve the combined event rate for all-cause mortality and HF readmissions (HR for NT-proBNP-guided therapy, 0.96; 95% CI, 0.72 to 1.37; P=0.99), or the median number of days alive outside of the hospital (178 vs. 179 days for NT-proBNP vs. conventional patients, P=0.39). Guided therapy also did not significantly improve any of the secondary endpoints. Conclusions -The PRIMA II demonstrates that that guidance of HF therapy to reach an NT-proBNP reduction of >30% after clinical stabilization did not improve 6-months outcome. Clinical

  6. Pharmacologic strategies to preserve renal function in acute decompensated heart failure.

    Science.gov (United States)

    Kumar, Sachin; Taylor, David O

    2015-02-01

    Over a million patients get hospitalized with the diagnosis of acute decompensated heart failure which poses an insurmountable financial burden on the health care system. Heart failure alone incurs over 30 billion dollars with half the cost spent towards acute hospitalizations. Majority of the treatment strategies have focused towards decongesting patients which often comes with the cost of worsening renal function. Renal dysfunction in the setting of acute decompensated heart failure portends worse morbidity and mortality. Recently, there has been a change in the focus with shift towards therapies attempting to conserve renal function. In the past decade, we have witnessed several large randomized controlled trials testing the established as well as emerging therapies in this subset of population with mixed results. This review intends to provide a comprehensive overview of the pharmacologic therapies commonly utilized in the management of acute decompensated heart failure and the body of evidence supporting these strategies.

  7. Computational modeling to predict nitrogen balance during acute metabolic decompensation in patients with urea cycle disorders.

    Science.gov (United States)

    MacLeod, Erin L; Hall, Kevin D; McGuire, Peter J

    2016-01-01

    Nutritional management of acute metabolic decompensation in amino acid inborn errors of metabolism (AA IEM) aims to restore nitrogen balance. While nutritional recommendations have been published, they have never been rigorously evaluated. Furthermore, despite these recommendations, there is a wide variation in the nutritional strategies employed amongst providers, particularly regarding the inclusion of parenteral lipids for protein-free caloric support. Since randomized clinical trials during acute metabolic decompensation are difficult and potentially dangerous, mathematical modeling of metabolism can serve as a surrogate for the preclinical evaluation of nutritional interventions aimed at restoring nitrogen balance during acute decompensation in AA IEM. A validated computational model of human macronutrient metabolism was adapted to predict nitrogen balance in response to various nutritional interventions in a simulated patient with a urea cycle disorder (UCD) during acute metabolic decompensation due to dietary non-adherence or infection. The nutritional interventions were constructed from published recommendations as well as clinical anecdotes. Overall, dextrose alone (DEX) was predicted to be better at restoring nitrogen balance and limiting nitrogen excretion during dietary non-adherence and infection scenarios, suggesting that the published recommended nutritional strategy involving dextrose and parenteral lipids (ISO) may be suboptimal. The implications for patients with AA IEM are that the medical course during acute metabolic decompensation may be influenced by the choice of protein-free caloric support. These results are also applicable to intensive care patients undergoing catabolism (postoperative phase or sepsis), where parenteral nutritional support aimed at restoring nitrogen balance may be more tailored regarding metabolic fuel selection.

  8. Management of Patients Admitted with Acute Decompensated Heart Failure

    Science.gov (United States)

    Krim, Selim R.; Campbell, Patrick T.; Desai, Sapna; Mandras, Stacy; Patel, Hamang; Eiswirth, Clement; Ventura, Hector O.

    2015-01-01

    Background Hospital admission for the treatment of acute decompensated heart failure is an unfortunate certainty in the vast majority of patients with heart failure. Regardless of the etiology, inpatient treatment for acute decompensated heart failure portends a worsening prognosis. Methods This review identifies patients with heart failure who need inpatient therapy and provides an overview of recommended therapies and management of these patients in the hospital setting. Results Inpatient therapy for patients with acute decompensated heart failure should be directed at decongestion and symptom improvement. Clinicians should also treat possible precipitating events, identify comorbid conditions that may exacerbate heart failure, evaluate and update current guideline-directed medical therapy, and perform risk stratification for all patients. Finally, efforts should be made to educate patients about the importance of restricting salt and fluid, monitoring daily weights, and adhering to a graded exercise program. Conclusion Early discharge follow-up and continued optimization of guideline-directed medical therapy are key to preventing future heart failure readmissions. PMID:26413005

  9. Evaluating the safety and efficacy of sodium-restricted/Dietary Approaches to Stop Hypertension diet after acute decompensated heart failure hospitalization: design and rationale for the Geriatric OUt of hospital Randomized MEal Trial in Heart Failure (GOURMET-HF).

    Science.gov (United States)

    Wessler, Jeffrey D; Maurer, Mathew S; Hummel, Scott L

    2015-03-01

    Heart failure (HF) is a major public health problem affecting predominantly older adults. Nonadherence to diet remains a significant contributor to acute decompensated HF (ADHF). The sodium-restricted Dietary Approaches to Stop Hypertension (DASH/SRD) eating plan reduces cardiovascular dysfunction that can lead to ADHF and is consistent with current HF guidelines. We propose that an intervention that promotes adherence to the DASH/SRD by home-delivering meals will be safe and improve health-related quality of life (QOL) in older adults after hospitalization for ADHF. This is a 3-center, randomized, single-blind, controlled trial of 12-week duration designed to determine the safety and efficacy of home-delivered DASH/SRD-compliant meals in older adults after discharge from ADHF hospitalization. Sixty-six subjects will be randomized in a 1:1 stratified fashion by gender and left ventricular ejection fraction (<50% vs ≥50%). Study subjects will receive either preprepared, home-delivered DASH/SRD-compliant meals or usual dietary advice for 4weeks after hospital discharge. Investigators will be blinded to group assignment, food diaries, and urinary electrolyte measurements until study completion. The primary efficacy end point is the change in the Kansas City Cardiomyopathy Questionnaire summary scores for health-related QOL from study enrollment to 4weeks postdischarge. Safety evaluation will focus on hypotension, renal insufficiency, and hyperkalemia. Exploratory end points include echocardiography, noninvasive vascular testing, markers of oxidative stress, and salt taste sensitivity. This randomized controlled trial will test the efficacy, feasibility, and safety of 4weeks of DASH/SRD after ADHF hospitalization. By testing a novel dietary intervention supported by multiple levels of evidence including preliminary data in outpatients with stable HF, we will address a critical evidence gap in the care of older patients with ADHF. If effective and safe, this

  10. Significance of Sarcopenia Evaluation in Acute Decompensated Heart Failure.

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    Tsuchida, Keiichi; Fujihara, Yuki; Hiroki, Jiro; Hakamata, Takahiro; Sakai, Ryohei; Nishida, Kota; Sudo, Koji; Tanaka, Komei; Hosaka, Yukio; Takahashi, Kazuyoshi; Oda, Hirotaka

    2018-01-27

    In patients with chronic heart failure (HF), the clinical importance of sarcopenia has been recognized in relation to disease severity, reduced exercise capacity, and adverse clinical outcome. Nevertheless, its impact on acute decompensated heart failure (ADHF) is still poorly understood. Dual-energy X-ray absorptiometry (DXA) is a technique for quantitatively analyzing muscle mass and the degree of sarcopenia. Fat-free mass index (FFMI) is a noninvasive and easily applicable marker of muscle mass.This was a prospective observational cohort study comprising 38 consecutive patients hospitalized for ADHF. Sarcopenia, derived from DXA, was defined as a skeletal muscle mass index (SMI) two standard deviations below the mean for healthy young subjects. FFMI (kg/m 2 ) was calculated as 7.38 + 0.02908 × urinary creatinine (mg/day) divided by the square of height (m 2 ).Sarcopenia was present in 52.6% of study patients. B-type natriuretic peptide (BNP) levels were significantly higher in ADHF patients with sarcopenia than in those without sarcopenia (1666 versus 429 pg/mL, P sarcopenia as a predictor of higher BNP level (OR = 18.4; 95% CI, 1.86-181.27; P = 0.013).Sarcopenia is associated with increased disease severity in ADHF. SMI based on DXA is potentially superior to FFMI in terms of predicting the degree of severity, but FFMI is also associated with ADHF severity.

  11. Mechanisms of Diuresis for Acute Decompensated Heart Failure by Tolvaptan.

    Science.gov (United States)

    Nomoto, Hidetsugu; Satoh, Yasuhiro; Kamiyama, Mayu; Yabe, Kento; Masumura, Mayumi; Sakakibara, Atsushi; Yamashita, Shu; Suzuki, Masahito; Sugiyama, Tomoyo; Oumi, Tetsuo; Ohno, Masakazu; Takahashi, Yoshihide; Isobe, Mitsuaki

    2017-08-03

    Tolvaptan, a vasopressin type 2 receptor antagonist, does not affect kidney circulation or cause worsening of renal function (WRF) in patients with acute decompensated heart failure (ADHF). Bioelectrical impedance analysis (BIA) can be used to evaluate intravascular volume by calculating the ratio of extracellular water (ECW) to intracellular water (ICW). There have been no reports examining the mechanisms of tolvaptan-induced diuresis using BIA. We investigated whether tolvaptan decreases excess volume while maintaining intravascular volume in ADHF patients.Study patients included 29 ADHF patients (age 48-95, men 69%) diagnosed between April 2013 and May 2016 and who underwent BIA before and after treatment. Fifteen patients were treated with tolvaptan in addition to conventional diuresis therapy (tolvaptan group), and 14 patients were treated with conventional diuresis therapy only (control group). In the control group, the numerical value of serum creatinine (Cre) significantly increased from 0.89 ± 0.22 mg/ dL to 1.07 ± 0.29 mg/dL (P = 0.004), and the ECW/ICW significantly decreased from 0.696 ± 0.036 to 0.673 ± 0.032 (P = 0.004). These values were not significantly different from those obtained for the tolvaptan group. Furthermore, regression analysis showed a negative correlation between ΔCre and ΔECW/ICW, which are the differences between values before and after treatment (ΔCre = -0.002-5.668 × ΔECW/ICW, r2 = 0.306, P = 0.002).Our findings suggest that WRF is caused by a reduction in intravascular volume and that tolvaptan treatment can decrease the excess volume while maintaining intravascular volume.

  12. Effect of Nesiritide in Patients with Acute Decompensated Heart Failure

    NARCIS (Netherlands)

    O'Connor, C. M.; Starling, R. C.; Hernandez, A. F.; Armstrong, P. W.; Dickstein, K.; Hasselblad, V.; Heizer, G. M.; Komajda, M.; Massie, B. M.; McMurray, J. J. V.; Nieminen, M. S.; Reist, C. J.; Rouleau, J. L.; Swedberg, K.; Adams, K. F.; Anker, S. D.; Atar, D.; Battler, A.; Botero, R.; Bohidar, N. R.; Butler, J.; Clausell, N.; Corbalan, R.; Costanzo, M. R.; Dahlstrom, U.; Deckelbaum, L. I.; Diaz, R.; Dunlap, M. E.; Ezekowitz, J. A.; Feldman, D.; Felker, G. M.; Fonarow, G. C.; Gennevois, D.; Gottlieb, S. S.; Hollander, J. E.; Howlett, J. G.; Hudson, M. P.; Kociol, R. D.; Krum, H.; Laucevicius, A.; Levy, W. C.; Mendez, G. F.; Metra, M.; Mittal, S.; Oh, B. -H.; Pereira, N. L.; Ponikowski, P.; Wilson, W. H.; Tanomsup, S.; Teerlink, J. R.; Triposkiadis, F.; Troughton, R. W.; Voors, A. A.; Whellan, D. J.; Zannad, F.; Califf, R. M.; Hill, Joseph A.

    2011-01-01

    Background Nesiritide is approved in the United States for early relief of dyspnea in patients with acute heart failure. Previous meta-analyses have raised questions regarding renal toxicity and the mortality associated with this agent. Methods We randomly assigned 7141 patients who were

  13. Intensification of Medication Therapy for Cardiorenal Syndrome in Acute Decompensated Heart Failure.

    Science.gov (United States)

    Grodin, Justin L; Stevens, Susanna R; de Las Fuentes, Lisa; Kiernan, Michael; Birati, Edo Y; Gupta, Divya; Bart, Bradley A; Felker, G Michael; Chen, Horng H; Butler, Javed; Dávila-Román, Victor G; Margulies, Kenneth B; Hernandez, Adrian F; Anstrom, Kevin J; Tang, W H Wilson

    2016-01-01

    Worsening renal function in heart failure may be related to increased venous congestion, decreased cardiac output, or both. Diuretics are universally used in acute decompensated heart failure, but they may be ineffective and may lead to azotemia. We aimed to compare the decongestive properties of a urine output-guided diuretic adjustment and standard therapy for the management of cardiorenal syndrome in acute decompensated heart failure. Data were pooled from subjects randomized to the stepwise pharmacologic care algorithm (SPCA) in the CARRESS-HF trial and those who developed cardiorenal syndrome (rise in creatinine >0.3 mg/dL) in the DOSE-AHF and ROSE-AHF trials. Patients treated with SPCA (n = 94) were compared with patients treated with standard decongestive therapy (SDT) that included intravenous loop diuretic use (DOSE-AHF and ROSE-AHF; n = 107) at the time of cardiorenal syndrome and followed for net fluid balance, weight loss, and changing renal function. The SPCA group had higher degrees of jugular venous pressure (P cardiorenal syndrome. The group that received SPCA had more weight change (-3.4 ± 5.2 lb) and more net fluid loss (1.705 ± 1.417 L) after 24 hours than the SDT group (-0.8 ± 3.4 lb and 0.892 ± 1.395 L, respectively; P < .001 for both) with a slight improvement in renal function (creatinine change -0.1 ± 0.3 vs 0.0 ± 0.3 mg/dL, respectively; P = .03). Compared with SDT, patients who received an intensification of medication therapy for treating persisting congestion had greater net fluid and weight loss without being associated with renal compromise. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. AKI in patients with acute on chronic liver failure is different from acute decompensation of cirrhosis.

    Science.gov (United States)

    Maiwall, Rakhi; Kumar, Suman; Chandel, Shivendra Singh; Kumar, Guresh; Rastogi, Archana; Bihari, Chhagan; Sharma, Manoj Kumar; Thakur, Bhaskar; Jamwal, K; Nayak, Suman; Mathur, R P; Sarin, S K

    2015-10-01

    The current definitions of acute kidney injury (AKI) including HRS have been derived from patients with decompensated cirrhosis. No studies have carefully addressed AKI in patients with acute on chronic liver failure (ACLF). We evaluated the prevalence, spectrum, natural history and mortality of AKI at admission and new-onset AKI in hospitalized patients with ACLF and compared the results with patients with acute decompensation of cirrhosis (ADC). Consecutive patients with ACLF (n = 382) and ADC (n = 451) were prospectively studied. Serial renal and liver functions were recorded and correlated with the disease course and outcome. AKI at admission and new onset AKI in the hospital were not different in patients with ACLF and ADC (p > 0.05). However, a significant difference in the spectrum of AKI was noted; functional volume-responsive AKI was more common (p liver failure. Patients with ACLF with AKI have more structural AKI, greater potential for reversibility despite higher progression as well as higher mortality compared to patients with ADC. Prevention and early detection of AKI should be considered in patients with ACLF.

  15. Acute glyco-metabolic decompensation during septic shock

    Directory of Open Access Journals (Sweden)

    Maria Marta Cravino

    2010-09-01

    Full Text Available Hyper-glycemy is commonly described as a complication in patients affected by septic states, regardless of their having had diabetes. Numerous studies also record the presence of glyco-metabolic decompensations in patients affected by leukemia and lymphoma treated with chemotherapy. The case under study interesting and peculiar as there is no mention of glycemy levels so high to be not suitable for life. It is interesting also the patient's good therapeutical response, their marrow aplasia status and general poor health condition notwithstanding.

  16. Troponin I in acute decompensated heart failure : insights from the ASCEND-HF study

    NARCIS (Netherlands)

    Felker, G. Michael; Hasselblad, Vic; Tang, W. H. Wilson; Hernandez, Adrian F.; Armstrong, Paul W.; Fonarow, Gregg C.; Voors, Adriaan A.; Metra, Marco; McMurray, John J. V.; Butler, Javed; Heizer, Gretchen M.; Dickstein, Kenneth; Massie, Barry M.; Atar, Dan; Troughton, Richard W.; Anker, Stefan D.; Califf, Robert M.; Starling, Randall C.; O'Connor, Christopher M.

    2012-01-01

    We examined the prognostic importance of cardiac troponin I (cTnI) in a cohort of patients enrolled in the ASCEND-HF study of nesiritide in acute decompensated heart failure (ADHF). Circulating troponins are a prognostic marker in patients with ADHF. Contemporary assays with greater sensitivity

  17. Acute metabolic decompensation due to influenza in a mouse model of ornithine transcarbamylase deficiency

    Directory of Open Access Journals (Sweden)

    Peter J. McGuire

    2014-02-01

    Full Text Available The urea cycle functions to incorporate ammonia, generated by normal metabolism, into urea. Urea cycle disorders (UCDs are caused by loss of function in any of the enzymes responsible for ureagenesis, and are characterized by life-threatening episodes of acute metabolic decompensation with hyperammonemia (HA. A prospective analysis of interim HA events in a cohort of individuals with ornithine transcarbamylase (OTC deficiency, the most common UCD, revealed that intercurrent infection was the most common precipitant of acute HA and was associated with markers of increased morbidity when compared with other precipitants. To further understand these clinical observations, we developed a model system of metabolic decompensation with HA triggered by viral infection (PR8 influenza using spf-ash mice, a model of OTC deficiency. Both wild-type (WT and spf-ash mice displayed similar cytokine profiles and lung viral titers in response to PR8 influenza infection. During infection, spf-ash mice displayed an increase in liver transaminases, suggesting a hepatic sensitivity to the inflammatory response and an altered hepatic immune response. Despite having no visible pathological changes by histology, WT and spf-ash mice had reduced CPS1 and OTC enzyme activities, and, unlike WT, spf-ash mice failed to increase ureagenesis. Depression of urea cycle function was seen in liver amino acid analysis, with reductions seen in aspartate, ornithine and arginine during infection. In conclusion, we developed a model system of acute metabolic decompensation due to infection in a mouse model of a UCD. In addition, we have identified metabolic perturbations during infection in the spf-ash mice, including a reduction of urea cycle intermediates. This model of acute metabolic decompensation with HA due to infection in UCD serves as a platform for exploring biochemical perturbations and the efficacy of treatments, and could be adapted to explore acute decompensation in other

  18. Nesiritide, renal function, and associated outcomes during hospitalization for acute decompensated heart failure: results from the Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure (ASCEND-HF).

    Science.gov (United States)

    van Deursen, Vincent M; Hernandez, Adrian F; Stebbins, Amanda; Hasselblad, Vic; Ezekowitz, Justin A; Califf, Robert M; Gottlieb, Stephen S; O'Connor, Christopher M; Starling, Randall C; Tang, W H Wilson; McMurray, John J; Dickstein, Kenneth; Voors, Adriaan A

    2014-09-16

    Contradictory results have been reported on the effects of nesiritide on renal function in patients with acute decompensated heart failure. We studied the effects of nesiritide on renal function during hospitalization for acute decompensated heart failure and associated outcomes. A total of 7141 patients were randomized to receive either nesiritide or placebo and creatinine was recorded in 5702 patients at baseline, after infusion, discharge, peak/nadir levels until day 30. Worsening renal function was defined as an increase of serum creatinine >0.3 mg/dL and a change of ≥25%. Median (25(th)-75(th) percentile) baseline creatinine was 1.2 (1.0-1.6) mg/dL and median baseline blood urea nitrogen was 25 (18-39) mmol/L. Changes in both serum creatinine and blood urea nitrogen were similar in nesiritide-treated and placebo-treated patients (P=0.20 and P=0.41) from baseline to discharge. In a multivariable model, independent predictors of change from randomization to hospital discharge in serum creatinine were a lower baseline blood urea nitrogen, higher systolic blood pressure, lower diastolic blood pressure, previous weight gain, and lower baseline potassium (all Prenal function during hospitalization was similar in the nesiritide and placebo group (14.1% and 12.8%, respectively; odds ratio with nesiritide 1.12; confidence interval, 0.95-1.32; P=0.19) and was not associated with death alone and death or rehospitalization at 30 days. However, baseline, discharge, and change in creatinine were associated with death alone and death or rehospitalization for heart failure (all tests, Prenal function in patients with acute decompensated heart failure. Baseline, discharge, and change in renal function were associated with 30-day mortality or rehospitalization for heart failure. © 2014 American Heart Association, Inc.

  19. De novo acute heart failure and acutely decompensated chronic heart failure.

    Science.gov (United States)

    Hummel, Astrid; Empe, Klausn; Dörr, Marcus; Felix, Stephan B

    2015-04-24

    Heart failure is one of the most common diseases of adults in Europe, with an overall prevalence of 1-2%. Among persons aged 60 and above, its prevalence is above 10% in men and 8% in women. Acute heart failure has a poor prognosis; it is associated with a high rate of rehospitalization and a 1-year mortality of 20-30%. This review is based on pertinent literature, including guidelines, retrieved by a selective search in PubMed. There are different types of acute heart failure; the basic diagnostic assessment is performed at once and consists of ECG, echocardiography, and the measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) and troponin levels. The most common causes of decompensation are arrhythmia, valvular dysfunction, and acute cardiac ischemia, each of which accounts for 30% of cases. The potential indication for immediate revascularization should be carefully considered in cases where acute heart failure is due to coronary heart disease. The basic treatment of acute heart failure is symptomatic, with the administration of oxygen, diuretics, and vasodilators. Ino-tropic agents, vasopressors, and temporary mechanical support for the circulatory system are only used to treat cardiogenic shock. The treatment of acute heart failure is markedly less evidence-based than that of chronic heart failure. Newer treatment approaches that are intended to improve outcomes still need to be tested in multicenter trials.

  20. MR diffusion imaging and MR spectroscopy of maple syrup urine disease during acute metabolic decompensation

    Energy Technology Data Exchange (ETDEWEB)

    Jan, Wajanat; Wang, Zhiyue J. [Department of Radiology, University of Pennsylvania School of Medicine, Children' s Hospital of Philadelphia, Pennsylvania (United States); Zimmerman, Robert A. [Department of Radiology, University of Pennsylvania School of Medicine, Children' s Hospital of Philadelphia, Pennsylvania (United States); Department of Radiology, Children' s Hospital of Philadelphia, 34th Street and Civic Center Boulevard, PA 19104, Philadelphia (United States); Berry, Gerard T.; Kaplan, Paige B.; Kaye, Edward M. [Department of Pediatrics, University of Pennsylvania School of Medicine, The Children' s Hospital of Philadelphia, Philadelphia, Pennsylvania (United States)

    2003-06-01

    Maple syrup urine disease (MSUD) is an inborn error of amino acid metabolism, which affects the brain tissue resulting in impairment or death if untreated. Imaging studies have shown reversible brain edema during acute metabolic decompensation. The purpose of this paper is to describe the diffusion-weighted imaging (DWI) and spectroscopy findings during metabolic decompensation and to assess the value of these findings in the prediction of patient outcome. Six patients with the diagnosis of MSUD underwent conventional MR imaging with DWI during acute presentation with metabolic decompensation. Spectroscopy with long TE was performed in four of the six patients. Follow-up examinations were performed after clinical and metabolic recovery. DWI demonstrated marked restriction of proton diffusion compatible with cytotoxic or intramyelinic sheath edema in the brainstem, basal ganglia, thalami, cerebellar and periventricular white matter and the cerebral cortex. This was accompanied by the presence of an abnormal branched-chain amino acids (BCAA) and branched-chain alpha-keto acids (BCKA) peak at 0.9 ppm as well as elevated lactate on proton spectroscopy in all four patients. The changes in all six patients were reversed with treatment without evidence of volume loss or persistent tissue damage. The presence of cytotoxic or intramyelinic edema as evidenced by restricted water diffusion on DWI, with the presence of lactate on spectroscopy, could imply imminent cell death. However, in the context of metabolic decompensation in MSUD, it appears that changes in cell osmolarity and metabolism can reverse completely after metabolic correction. (orig.)

  1. Triple Diuretics and Aquaretic Strategy for Acute Decompensated Heart Failure due to Volume Overload

    Directory of Open Access Journals (Sweden)

    Rita Jermyn

    2013-01-01

    Full Text Available Diuretics, including furosemide, metolazone, and spironolactone, have historically been the mainstay of therapy for acute decompensated heart failure patients. The addition of an aquaretic-like vasopressin antagonist may enhance diuresis further. However, clinical experience with this quadruple combination is lacking in the acute setting. We present two hospitalized patients with acute decompensated heart failure due to massive fluid overload treated with a combination strategy of triple diuretics in conjunction with the aquaretic tolvaptan. The first patient lost 72.1 lbs. (32.7 kg with an average urine output of 3.5 to 7.5 L/day over eight days on combined therapy with furosemide, metolazone, spironolactone, and tolvaptan. The second patient similarly achieved a weight loss of 28.2 lbs. (12.8 kg over 4 days on the same treatment. Both patients maintained stable serum sodium, potassium, and creatinine over this period and remained out of the hospital for more than 30 days. Thus, patients hospitalized with acute decompensated heart failure due to volume overload can achieve euvolemia rapidly and without electrolytes disturbances using this regimen, while being under the close supervision of a team of cardiologists and nephrologists. Additionally, this therapy can potentially decrease the need for ultrafiltration and the length of hospital stay.

  2. Change of Exhaled Acetone Concentration in a Diabetic Patient with Acute Decompensated Heart Failure.

    Science.gov (United States)

    Yokokawa, Tetsuro; Ichijo, Yasuhiro; Houtsuki, Yu; Matsumoto, Yoshiyuki; Oikawa, Masayoshi; Yoshihisa, Akiomi; Sugimoto, Koichi; Nakazato, Kazuhiko; Suzuki, Hitoshi; Saitoh, Shu-Ichi; Shimouchi, Akito; Takeishi, Yasuchika

    2017-10-21

    In heart failure patients, exhaled acetone concentration, a noninvasive biomarker, is increased according to heart failure severity. Moreover, exhaled acetone concentration is also known to be affected by diabetes mellitus. However, there have been no reports on exhaled acetone concentration in heart failure patients with diabetes mellitus. A 77-year old man was admitted to our hospital with acute decompensated heart failure and atrioventricular block. He had controlled diabetes mellitus under insulin treatment with hemoglobin A1c of 6.5%. He underwent treatment of diuretics and permanent pacemaker implantation. His condition improved and he was discharged at Day 12. Due to the heart failure improvement, his levels of exhaled acetone concentration decreased from 1.623 ppm at admission to 0.664 ppm at discharge. This is the first report to reveal a change of exhaled acetone concentration in a diabetic patient with acute decompensated heart failure.

  3. Haemodialysis is an effective treatment in acute metabolic decompensation of maple syrup urine disease

    Directory of Open Access Journals (Sweden)

    P.S. Atwal

    2015-09-01

    Full Text Available Acute metabolic decompensation in maple syrup urine disease can occur during intercurrent illness and is a medical emergency. A handful of reports in the medical literature describe the use of peritoneal dialysis and haemodialysis as therapeutic inventions. We report the only patient from our centre to have haemodialysis performed in this setting. Combined with dietary BCAA restriction and calorific support, haemodialysis allows rapid reduction in plasma leucine concentrations considerably faster than conservative methods.

  4. Intravenous Furosemide for Acute Decompensated Congestive Heart Failure: What Is the Evidence?

    Science.gov (United States)

    Owen, D R J; MacAllister, R; Sofat, R

    2015-08-01

    Use of intravenous furosemide rather than oral administration in acute decompensated congestive cardiac failure is universally recommended in international guidelines. We argue that this recommendation is not supported by the existing evidence, and suggest that trials should be performed to determine whether larger doses of oral furosemide should be prescribed prior to an IV switch. This could reduce length of hospital admissions and allow for more patients to be managed in the primary care setting. © 2015 ASCPT.

  5. Hospital variation in noninvasive positive pressure ventilation for acute decompensated heart failure.

    Science.gov (United States)

    Kulkarni, Vivek T; Kim, Nancy; Dai, Ying; Dharmarajan, Kumar; Safavi, Kyan C; Bikdeli, Behnood; Lindenauer, Peter K; Testani, Jeffrey; Dries, Daniel L; Krumholz, Harlan M

    2014-05-01

    Although noninvasive positive pressure ventilation (NIPPV) for patients with acute decompensated heart failure was introduced almost 20 years ago, the variation in its use among hospitals remains unknown. We sought to define hospital practice patterns of NIPPV use for acute decompensated heart failure and their relationship with intubation and mortality. We conducted a cross-sectional study using a database maintained by Premier, Inc., that includes a date-stamped log of all billed items for hospitalizations at >400 hospitals. We examined hospitalizations for acute decompensated heart failure in this database from 2005 to 2010 and included hospitals with annual average volume of >25 such hospitalizations. We identified 384 hospitals that encompassed 524 430 hospitalizations (median annual average volume: 206). We used hierarchical logistic regression models to calculate hospital-level outcomes: risk-standardized NIPPV rate, risk-standardized intubation rate, and in-hospital risk-standardized mortality rate. We grouped hospitals into quartiles by risk-standardized NIPPV rate and compared risk-standardized mortality rates and risk-standardized intubation rates across quartiles. Median risk-standardized NIPPV rate was 6.2% (interquartile range, 2.8%-9.3%; 5th percentile, 0.2%; 95th percentile, 14.8%). There was no clear pattern of risk-standardized mortality rates across quartiles. The bottom quartile of hospitals had higher risk-standardized intubation rate (11.4%) than each of the other quartiles (9.0%, 9.7%, and 9.1%; Pvariation exists among hospitals in the use of NIPPV for acute decompensated heart failure without evidence for differences in mortality. There may be a threshold effect in relation to intubation rates, with the lowest users of NIPPV having higher intubation rates. © 2014 American Heart Association, Inc.

  6. Inferior vena cava diameter change after intravenous furosemide in patients diagnosed with acute decompensated heart failure.

    Science.gov (United States)

    Tchernodrinski, Stefan; Lucas, Brian P; Athavale, Ambarish; Candotti, Carolina; Margeta, Bosko; Katz, Ariel; Kumapley, Rudolf

    2015-03-01

    Measurement of the inferior vena cava (IVC) diameters may improve decision-making for patients hospitalized with acute decompensated heart failure. Nevertheless, little is known about how the IVC is affected by loop diuretics. We sought to determine if bolus infusions of intravenous furosemide affect IVC diameters measured by hand-carried ultrasonography. We conducted a prospective cohort study at a public teaching hospital from September 2009 through June 2010. Physician investigators performed IVC ultrasonography on a convenience sample of 70 hospitalized adults who were prescribed intravenous furosemide for the diagnosis of acute decompensated heart failure. Participants' median baseline IVC diameter was 2.38 cm (interquartile range, 1.91-2.55 cm). At 1-2 hours after furosemide, IVC diameters decreased an average of 0.21 cm (95% CI, 0.13-0.29 cm) and remained significantly below baseline at 2-3 hours after furosemide by an average of 0.15 cm (95% CI, 0.07-0.22 cm). IVC diameters of adults diagnosed with acute decompensated heart failure become measurably smaller after single doses of intravenous furosemide. Whether this represents a true change in volume status has not been studied. © 2014 Wiley Periodicals, Inc.

  7. Prognostic Value of Prothrombin Time International Normalized Ratio in Acute Decompensated Heart Failure – A Combined Marker of Hepatic Insufficiency and Hemostatic Abnormality

    National Research Council Canada - National Science Library

    Okada, Atsushi; Sugano, Yasuo; Nagai, Toshiyuki; Takashio, Seiji; Honda, Satoshi; Asaumi, Yasuhide; Aiba, Takeshi; Noguchi, Teruo; Kusano, Kengo F; Ogawa, Hisao; Yasuda, Satoshi; Anzai, Toshihisa

    2016-01-01

    .... The clinical significance of prothrombin time international normalized ratio (INR), a widely accepted marker assessing coagulation abnormalities, in acute decompensated heart failure (ADHF) remains unclear.Methods...

  8. Extracorporal hemodialysis with acute or decompensated chronical hepatic failure

    Science.gov (United States)

    Hessel, Franz; Grabein, Kristin; Schnell-Inderst, Petra; Siebert, Uwe; Caspary, Wolfgang; Wasem, Jürgen

    2006-01-01

    Background Conventional diagnostic procedures and therapy of acute liver failure (ALF) and acute-on-chronic liver failure (ACLF) focus on to identify triggering events of the acute deterioration of the liver function and to avoid them. Further objectives are to prevent the development respectively the progression of secondary organ dysfunctions or organ failure. Most of the times the endocrinological function of the liver can to a wide extent be compensated, but the removal of toxins can only marginally be substituted by conventional conservative therapy. To improve this component of the liver function is the main objective of extracorporal liver support systems. The following principles of liver support systems can be differentiated: Artificial systems, bioartifical systems and extracorporal liver perfusion systems. This HTA report focuses on artificial systems (e.g. BioLogic-DT/-DTPF, MARS, Prometheus), because only these approaches currently are relevant in the German health care system. In 2004 a category "Extracorporal liver assist device" was introduced in the list of "additional payments" in the German DRG-system, which makes reimbursement for hospitals using the technology in inpatient care possible, based on an hospital's individual contract with statutory sickness funds. Objectives To report the present evidence and future research need on medical efficacy and economic effectiveness of extracorporal liver support devices for treatment of patients with ALF or ACLF based on published literature data. Are artificial liver support systems efficient and effective in the treatment of ALF or ACLF? Methods An extensive, systematic literature search in medical, economic, and HTA literature data bases was performed. Relevant data were extracted and synthesised. Results Relevant controlled trials were detected for BioLogic-DT and MARS. No randomised controlled trial on Prometheus was found. None of the included studies on BioLogic-DT showed advantages of the

  9. Extracorporal hemodialysis with acute or decompensated chronical hepatic failure

    Directory of Open Access Journals (Sweden)

    Wasem, Jürgen

    2006-04-01

    Full Text Available Background: Conventional diagnostic procedures and therapy of acute liver failure (ALF and acute-on-chronic liver failure (ACLF focus on to identify triggering events of the acute deterioration of the liver function and to avoid them. Further objectives are to prevent the development respectively the progression of secondary organ dysfunctions or organ failure. Most of the times the endocrinological function of the liver can to a wide extent be compensated, but the removal of toxins can only marginally be substituted by conventional conservative therapy. To improve this component of the liver function is the main objective of extracorporal liver support systems. The following principles of liver support systems can be differentiated: Artificial systems, bioartifical systems and extracorporal liver perfusion systems. This HTA report focuses on artificial systems (e.g. BioLogic-DT/-DTPF, MARS, Prometheus, because only these approaches currently are relevant in the German health care system. In 2004 a category "Extracorporal liver assist device" was introduced in the list of "additional payments" in the German DRG-system, which makes reimbursement for hospitals using the technology in inpatient care possible, based on an hospital's individual contract with statutory sickness funds. Objectives: To report the present evidence and future research need on medical efficacy and economic effectiveness of extracorporal liver support devices for treatment of patients with ALF or ACLF based on published literature data. Are artificial liver support systems efficient and effective in the treatment of ALF or ACLF? Methods: An extensive, systematic literature search in medical, economic, and HTA literature data bases was performed. Relevant data were extracted and synthesised. Results: Relevant controlled trials were detected for BioLogic-DT and MARS. No randomised controlled trial on Prometheus was found. None of the included studies on BioLogic-DT showed

  10. Acutely decompensated heart failure: characteristics of hospitalized patients and opportunities to improve their care.

    Science.gov (United States)

    Sarmento, Pedro Moraes; Fonseca, Cândida; Marques, Filipa; Ceia, Fátima; Aleixo, Ana

    2006-01-01

    Heart failure (HF) remains a major public health problem in western countries, despite the enormous progress in its diagnosis and treatment. Acute and chronic decompensated HF are leading medical causes of hospitalization among people aged over 65 years in European countries, the USA, Australia and New Zealand. However, there have been few studies on acute and chronic decompensated HF and the European Society of Cardiology (ESC) guidelines on this subject have only just been published. To evaluate the overall prevalence of hospitalization due to HF according to its subtypes, comorbidities, and decompensating factors, in the Medical Department of a central teaching hospital in an urban area. We performed a retrospective observational study of patients admitted consecutively to the Medical Department via the emergency room between January and June 2001. Discharge casenotes on 1038 admissions were reviewed. Those with a diagnosis of HF or cardiovascular conditions associated with or precursors of HF were analyzed. Cases with a final diagnosis of HF according to the criteria of the ESC guidelines were included in the study. We evaluated the overall prevalence of HF and subtypes of cardiac dysfunction, etiological risk factors, patients' demographic characteristics, decompensating factors, comorbidity, mean length of hospital stay, and in-hospital mortality rate. We identified 180 patients with HF (17.4%), mean age 74.6 +/- 14; 87 were male (48%), aged 73.7 +/- 14.2, and 93 female (52%), aged 75.6 +/- 14. Left ventricular systolic dysfunction (LVSD) was present in 42.2% of cases, preserved left ventricular systolic function in 32.6%, and valvular heart disease in 10.6%. Hypertension and coronary artery disease were the main etiological risk factors (62.2% and 42.8% respectively). Atrial fibrillation was recorded in 43.4% of the patients, diabetes was diagnosed in 21.6%, and anemia and chronic obstructive pulmonary disease in about one third. Infection, predominantly

  11. Left Ventricular global longitudinal strain predicts heart failure readmission in acute decompensated heart failure.

    Science.gov (United States)

    Romano, Simone; Mansour, Ibrahim N; Kansal, Mayank; Gheith, Hana; Dowdy, Zachary; Dickens, Carolyn A; Buto-Colletti, Cassandra; Chae, June M; Saleh, Hussam H; Stamos, Thomas D

    2017-03-15

    The goal of this study was to determine if left ventricular (LV) global longitudinal strain (GLS) predicts heart failure (HF) readmission in patients with acute decompensated heart failure. Two hundred ninety one patients were enrolled at the time of admission for acute decompensated heart failure between January 2011 and September 2013. Left ventricle global longitudinal strain (LV GLS) by velocity vector imaging averaged from 2, 3 and 4-chamber views could be assessed in 204 out of 291 (70%) patients. Mean age was 63.8 ± 15.2 years, 42% of the patients were males and 78% were African American or Hispanic. Patients were followed until the first HF hospital readmission up to 44 months. Patients were grouped into quartiles on the basis of LV GLS. Kaplan-Meier curves showed significantly higher readmission rates in patients with worse LV GLS (log-rank p heart disease, dementia, New York Heart Association class, LV ejection fraction, use of angiotensin converting enzyme inhibitors or angiotensin receptor blockers, systolic and diastolic blood pressure on admission and sodium level on admission, worse LV GLS was the strongest predictor of recurrent HF readmission (p heart failure with a higher risk of readmission in case of progressive worsening of LV GLS, independent of the ejection fraction.

  12. Relief and Recurrence of Congestion During and After Hospitalization for Acute Heart Failure: Insights From Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure (DOSE-AHF) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARESS-HF).

    Science.gov (United States)

    Lala, Anuradha; McNulty, Steven E; Mentz, Robert J; Dunlay, Shannon M; Vader, Justin M; AbouEzzeddine, Omar F; DeVore, Adam D; Khazanie, Prateeti; Redfield, Margaret M; Goldsmith, Steven R; Bart, Bradley A; Anstrom, Kevin J; Felker, G Michael; Hernandez, Adrian F; Stevenson, Lynne W

    2015-07-01

    Congestion is the most frequent cause for hospitalization in acute decompensated heart failure. Although decongestion is a major goal of acute therapy, it is unclear how the clinical components of congestion (eg, peripheral edema, orthopnea) contribute to outcomes after discharge or how well decongestion is maintained. A post hoc analysis was performed of 496 patients enrolled in the Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure (DOSE-AHF) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARRESS-HF) trials during hospitalization with acute decompensated heart failure and clinical congestion. A simple orthodema congestion score was generated based on symptoms of orthopnea (≥2 pillows=2 points, <2 pillows=0 points) and peripheral edema (trace=0 points, moderate=1 point, severe=2 points) at baseline, discharge, and 60-day follow-up. Orthodema scores were classified as absent (score of 0), low-grade (score of 1-2), and high-grade (score of 3-4), and the association with death, rehospitalization, or unscheduled medical visits through 60 days was assessed. At baseline, 65% of patients had high-grade orthodema and 35% had low-grade orthodema. At discharge, 52% patients were free from orthodema at discharge (score=0) and these patients had lower 60-day rates of death, rehospitalization, or unscheduled visits (50%) compared with those with low-grade or high-grade orthodema (52% and 68%, respectively; P=0.038). Of the patients without orthodema at discharge, 27% relapsed to low-grade orthodema and 38% to high-grade orthodema at 60-day follow-up. Increased severity of congestion by a simple orthodema assessment is associated with increased morbidity and mortality. Despite intent to relieve congestion, current therapy often fails to relieve orthodema during hospitalization or to prevent recurrence after discharge. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00608491, NCT00577135. © 2015 American Heart

  13. Meta-Analysis of Ultrafiltration versus Diuretics Treatment Option for Overload Volume Reduction in Patients with Acute Decompensated Heart Failure.

    Science.gov (United States)

    Ebrahim, Barkoudah; Sindhura, Kodali; Okoroh, Juliet; Sethi, Rosh; Hulten, Edward; Suemoto, Claudia; Bittencourt, Marcio Sommer

    2015-05-01

    Although diuretics are mainly used for the treatment of acute decompensated heart failure (ADHF), inadequate responses and complications have led to the use of extracorporeal ultrafiltration (UF) as an alternative strategy for reducing volume overloads in patients with ADHF. The aim of our study is to perform meta-analysis of the results obtained from studies on extracorporeal venous ultrafiltration and compare them with those of standard diuretic treatment for overload volume reduction in acute decompensated heart failure. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases were systematically searched using a pre‑specified criterion. Pooled estimates of outcomes after 48 h (weight change, serum creatinine level, and all-cause mortality) were computed using random effect models. Pooled weighted mean differences were calculated for weight loss and change in creatinine level, whereas a pooled risk ratio was used for the analysis of binary all-cause mortality outcome. A total of nine studies, involving 613 patients, met the eligibility criteria. The mean weight loss in patients who underwent UF therapy was 1.78 kg [95% Confidence Interval (CI): -2.65 to -0.91 kg; p diuretic therapy. The post-intervention creatinine level, however, was not significantly different (mean change = -0.25 mg/dL; 95% CI: -0.56 to 0.06 mg/dL; p = 0.112). The risk of all-cause mortality persisted in patients treated with UF compared with patients treated with standard diuretics (Pooled RR = 1.00; 95% CI: 0.64-1.56; p = 0.993). Compared with standard diuretic therapy, UF treatment for overload volume reduction in individuals suffering from ADHF, resulted in significant reduction of body weight within 48 h. However, no significant decrease of serum creatinine level or reduction of all-cause mortality was observed.

  14. Submassive hepatic necrosis distinguishes HBV-associated acute on chronic liver failure from cirrhotic patients with acute decompensation.

    Science.gov (United States)

    Li, Hai; Xia, Qiang; Zeng, Bo; Li, Shu-Ting; Liu, Heng; Li, Qi; Li, Jun; Yang, Shu-Yin; Dong, Xiao-Jun; Gao, Ting; Munker, Stefan; Liu, Yan; Liebe, Roman; Xue, Feng; Li, Qi-Gen; Chen, Xiao-Song; Liu, Qiang; Zeng, Hui; Wang, Ji-Yao; Xie, Qing; Meng, Qin-Hua; Wang, Jie-Fei; Mertens, Peter R; Lammert, Frank; Singer, Manfred V; Dooley, Steven; Ebert, Matthias P A; Qiu, De-Kai; Wang, Tai-Ling; Weng, Hong-Lei

    2015-07-01

    Distinguishing between acute on chronic liver failure (ACLF) and decompensated liver cirrhosis is difficult due to a lack of pathological evidence. A prospective single-center study investigated 174 patients undergoing liver transplantation due to acute decompensation of hepatitis B virus (HBV)-associated liver cirrhosis. Two groups were distinguished by the presence or absence of submassive hepatic necrosis (SMHN, defined as necrosis of 15-90% of the entire liver on explant). Core clinical features of ACLF were compared between these groups. Disease severity scoring systems were applied to describe liver function and organ failure. Serum cytokine profile assays, gene expression microarrays and immunohistochemical analyzes were used to study systemic and local inflammatory responses. SMHN was identified in 69 of 174 patients proven to have cirrhosis by histological means. Characteristic features of SMHN were extensive necrosis along terminal hepatic veins and spanning multiple adjacent cirrhotic nodules accompanied by various degrees of liver progenitor cell-derived regeneration, cholestasis, and ductular bilirubinostasis. Patients with SMHN presented with more severely impaired hepatic function, a higher prevalence of multiple organ failure (as indicated by higher CLIF-SOFA and SOFA scores) and a shorter interval between acute decompensation and liver transplantation than those without SMHN (p<0.01 for all parameters). Further analyzes based on serum cytokine profile assays, gene expression microarrays and immunohistochemical analyzes revealed higher levels of anti-inflammatory cytokines in patients with SMHN. SMHN is a critical histological feature of HBV-associated ACLF. Identification of a characteristic pathological feature strongly supports that ACLF is a separate entity in end-stage liver disease. Copyright © 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

  15. Continuous ultrafiltration in acute decompensated heart failure: current issues and future directions.

    Science.gov (United States)

    Marenzi, Giancarlo; Morpurgo, Marco; Agostoni, Piergiuseppe

    2015-04-01

    Most patients hospitalized for acutely decompensated heart failure (ADHF) present with symptoms and signs of volume overload, which are also associated with high rates of death and re-hospitalization. Several studies have investigated the possible use of extracorporeal ultrafiltration in the management of ADHF, evaluating potential clinical benefits in terms of hospitalization and survival rates versus those of conventional diuretic therapy. Though ultrafiltration remains an extremely appealing therapeutic option for patients with AHDF, some of the most recent studies have reported conflicting results. Differences in the selection of study population, heterogeneity of the indications for the use of ultrafiltration, disparity in the ultrafiltration protocols, and high variability in the pharmacologic therapies used for the control group could explain some of these contradictory findings. The purpose of the present review is to provide an overview and an update on the mechanisms and clinical effects of ultrafiltration and on currently available evidence supporting its use in ADHF.

  16. Hyponatremia in acute decompensated heart failure: mechanisms, prognosis, and treatment options.

    Science.gov (United States)

    Jao, Geoffrey T; Chiong, Jun R

    2010-11-01

    Hyponatremia is common and is increasingly recognized as an independent prognostic marker that adversely affects morbidity and mortality in various disease states, including heart failure. In acute decompensated heart failure (ADHF), the degree of hyponatremia often parallels the severity of cardiac dysfunction and is further exacerbated by any reduction in glomerular filtration rate and arginine vasopressin dysregulation. A recent study showed that even modest improvement of hyponatremia may have survival benefits. Although management of hyponatremia in ADHF has traditionally focused on improving cardiac function and fluid restriction, the magnitude of improvement of serum sodium is fairly slow and unpredictable. In this article, we discuss the mechanisms of hyponatremia in ADHF, review its evolving prognostic significance, and evaluate the efficacy of various treatments for hyponatremia, including the recently approved vasopressin receptor antagonists for managing hyponatremia among patients hospitalized for ADHF. Copyright © 2008 Wiley Periodicals, Inc.

  17. Circulating Kidney Injury Molecule-1 Levels in Acute Heart Failure Insights From the ASCEND-HF Trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure)

    NARCIS (Netherlands)

    Grodin, Justin L.; Perez, Antonio L.; Wu, Yuping; Hernandez, Adrian F.; Butler, Javed; Metra, Marco; Felker, G. Michael; Voors, Adriaan A.; McMurray, John J.; Armstrong, Paul W.; Califf, Robert M.; Starling, Randall C.; O'Connor, Christopher M.; Tang, W. H. Wilson

    2015-01-01

    OBJECTIVES This study sought to determine the relationship of KIM-1 levels with adverse clinical outcomes in acute decompensated heart failure (ADHF). BACKGROUND Kidney injury molecule (KIM)-1 is a biomarker expressed by the nephron in acute tubular injury, and is a sensitive and specific marker for

  18. Galectin-3: A Link between Myocardial and Arterial Stiffening in Patients with Acute Decompensated Heart Failure?

    Directory of Open Access Journals (Sweden)

    Radu Ioan Lala

    2016-01-01

    Full Text Available Abstract Background: Heart failure is accompanied by abnormalities in ventricular-vascular interaction due to increased myocardial and arterial stiffness. Galectin-3 is a recently discovered biomarker that plays an important role in myocardial and vascular fibrosis and heart failure progression. Objectives: The aim of this study was to determine whether galectin-3 is correlated with arterial stiffening markers and impaired ventricular-arterial coupling in decompensated heart failure patients. Methods: A total of 79 inpatients with acute decompensated heart failure were evaluated. Serum galectin-3 was determined at baseline, and during admission, transthoracic echocardiography and measurements of vascular indices by Doppler ultrasonography were performed. Results: Elevated pulse wave velocity and low arterial carotid distensibility are associated with heart failure in patients with preserved ejection fraction (p = 0.04, p = 0.009. Pulse wave velocity, carotid distensibility and Young’s modulus did not correlate with serum galectin-3 levels. Conversely, raised galectin-3 levels correlated with an increased ventricular-arterial coupling ratio (Ea/Elv p = 0.047, OR = 1.9, 95% CI (1.0‑3.6. Increased galectin-3 levels were associated with lower rates of left ventricular pressure rise in early systole (dp/dt (p=0.018 and raised pulmonary artery pressure (p = 0.046. High galectin-3 levels (p = 0.038, HR = 3.07 and arterial pulmonary pressure (p = 0.007, HR = 1.06 were found to be independent risk factors for all-cause mortality and readmissions. Conclusions: This study showed no significant correlation between serum galectin-3 levels and arterial stiffening markers. Instead, high galectin-3 levels predicted impaired ventricular-arterial coupling. Galectin-3 may be predictive of raised pulmonary artery pressures. Elevated galectin-3 levels correlate with severe systolic dysfunction and together with pulmonary hypertension are independent markers of

  19. Galectin-3: A Link between Myocardial and Arterial Stiffening in Patients with Acute Decompensated Heart Failure?

    Science.gov (United States)

    Lala, Radu Ioan; Darabantiu, Dan; Pilat, Luminita; Puschita, Maria

    2016-02-01

    Heart failure is accompanied by abnormalities in ventricular-vascular interaction due to increased myocardial and arterial stiffness. Galectin-3 is a recently discovered biomarker that plays an important role in myocardial and vascular fibrosis and heart failure progression. The aim of this study was to determine whether galectin-3 is correlated with arterial stiffening markers and impaired ventricular-arterial coupling in decompensated heart failure patients. A total of 79 inpatients with acute decompensated heart failure were evaluated. Serum galectin-3 was determined at baseline, and during admission, transthoracic echocardiography and measurements of vascular indices by Doppler ultrasonography were performed. Elevated pulse wave velocity and low arterial carotid distensibility are associated with heart failure in patients with preserved ejection fraction (p = 0.04, p = 0.009). Pulse wave velocity, carotid distensibility and Young's modulus did not correlate with serum galectin-3 levels. Conversely, raised galectin-3 levels correlated with an increased ventricular-arterial coupling ratio (Ea/Elv) p = 0.047, OR = 1.9, 95% CI (1.0‑3.6). Increased galectin-3 levels were associated with lower rates of left ventricular pressure rise in early systole (dp/dt) (p=0.018) and raised pulmonary artery pressure (p = 0.046). High galectin-3 levels (p = 0.038, HR = 3.07) and arterial pulmonary pressure (p = 0.007, HR = 1.06) were found to be independent risk factors for all-cause mortality and readmissions. This study showed no significant correlation between serum galectin-3 levels and arterial stiffening markers. Instead, high galectin-3 levels predicted impaired ventricular-arterial coupling. Galectin-3 may be predictive of raised pulmonary artery pressures. Elevated galectin-3 levels correlate with severe systolic dysfunction and together with pulmonary hypertension are independent markers of outcome.

  20. Plasma Cystatin C is a predictor of renal dysfunction, ACLF and mortality in patients with acutely decompensated liver cirrhosis

    DEFF Research Database (Denmark)

    Markwardt, Daniel; Holdt, Lesca M; Steib, Christian

    2017-01-01

    BACKGROUND: The development of acute-on-chronic liver failure (ACLF) in patients with liver cirrhosis is associated with high mortality rates. Renal failure is the most significant organ dysfunction that occurs in ACLF. So far there are no biomarkers predicting ACLF. AIM: To investigate whether...... Cystatin C (CysC) and neutrophil gelatinase-associated lipocalin (NGAL) can predict development of renal dysfunction (RD), hepatorenal syndrome (HRS), ACLF and mortality, respectively. METHODS: We determined the plasma levels of CysC and NGAL of 429 patients hospitalized for acute decompensation....... CONCLUSIONS: Baseline CysC is a biomarker of renal dysfunction, HRS and ACLF and an independent predictor of mortality in patients with acutely decompensated liver cirrhosis. Determining CysC at day 3 did not provide any benefit. While NGAL is also associated with short-term mortality, it fails to predict...

  1. [Ultrafiltration versus intravenous diuretics in decompensated heart failure: a meta-analysis of randomized controlled trials].

    Science.gov (United States)

    Zhao, Yu-liang; Zhang, Ling; Yang, Ying-ying; Tang, Yi; Liu, Fang; Fu, Ping

    2013-08-13

    To explore whether ultrafiltration is superior to intravenous diuretics in ameliorating fluid overload and preserving renal functions in decompensated heart failure patients. By searching in Pubmed, Cochrane Library, Embase, Springer, WanFang, CQVIP, CNKI and CBM database as well as related Chinese journals, qualified randomized controlled trials (RCTs) were included for meta-analysis by Revman 5.0 and STATA 10.0. Six RCTs were included with 241 patients in ultrafiltration group and 240 patients in intravenous diuretics group. Pooled analyses demonstrated ultrafiltration was superior to intravenous diuretics in the aspects of weight loss (WMD = 1.44 kg, 95%CI:0.33-2.55 kg, P = 0.01) and fluid removal (WMD = 1.23 kg, 95%CI:0.63-1.82 kg, P diuretics in mitigating fluid overload. No intergroup difference was observed in renal function preservation, mortality or rehospitalization.

  2. Influence of Spironolactone on Matrix Metalloproteinase-2 in Acute Decompensated Heart Failure.

    Science.gov (United States)

    Ferreira, João Pedro; Santos, Mário; Oliveira, José Carlos; Marques, Irene; Bettencourt, Paulo; Carvalho, Henrique

    2015-01-23

    Background: Matrix metalloproteinases (MMPs) are a family of enzymes important for the resorption of extracellular matrices, control of vascular remodeling and repair. Increased activity of MMP2 has been demonstrated in heart failure, and in acutely decompensated heart failure (ADHF) a decrease in circulating MMPs has been demonstrated along with successful treatment. Objective: Our aim was to test the influence of spironolactone in MMP2 levels. Methods: Secondary analysis of a prospective, interventional study including 100 patients with ADHF. Fifty patients were non-randomly assigned to spironolactone (100 mg/day) plus standard ADHF therapy (spironolactone group) or standard ADHF therapy alone (control group). Results: Spironolactone group patients were younger and had lower creatinine and urea levels (all p enzimas importantes para a reabsorção da matriz extracelular e controle do remodelamento e da reparação vasculares. Demonstrou-se aumento da atividade de MMP2 na insuficiência cardíaca, e, na insuficiência cardíaca agudamente descompensada (ICAD), demonstrou-se uma diminuição nas MMPs circulantes juntamente com o tratamento bem-sucedido. Objetivos: Testar a influência da espironolactona nos níveis de MMP2. Métodos: Análise secundária de estudo prospectivo, intervencionista, incluindo 100 pacientes com ICAD, 50 designados não aleatoriamente para o uso de espironolactona (100 mg/dia) mais terapia padrão para ICAD (grupo espironolactona) e 50 para terapia padrão para ICAD apenas (grupo controle). Resultados: Os pacientes do grupo espironolactona eram mais jovens e tinham níveis mais baixos de creatinina e ureia (todos p < 0,05). Os valores basais de MMP2, NT-pro BNP e peso não diferiram entre os grupos espironolactona e controle. Observou-se tendência para uma redução mais pronunciada na MMP2 do basal para o dia 3 no grupo espironolactona (-21 [-50 a 19] vs 1,5 [-26 a 38] ng/ml, p = 0,06). Os valores de NT-pro BNP e peso tamb

  3. Decompensated liver disease complicated by acute stroke caused by multiple factors: a clinical analysis of 15 cases

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    GOU Chunyan

    2016-09-01

    Full Text Available Objective To investigate the clinical features of patients with decompensated liver disease complicated by acute stroke. Methods A retrospective analysis was performed for the clinical data of 15 patients who were hospitalized in Beijing You'an Hospital, Capital Medical University and diagnosed with decompensated liver disease complicated by acute stroke from January 2011 to December 2015, including medical history, neurological manifestations, treatment, and prognostic features. Results Among the 15 patients, 11 had acute hemorrhagic stroke (AHS, and 4 had acute ischemic stroke (AIS; among the 11 patients with AHS, 4 (36.36% had hemorrhage caused by brain metastatic tumor of liver cancer (tumor-associated stroke, and 3 (27.27% were complicated by liver failure. Among the 15 patients, 12 (80% had disturbance of consciousness as the early neurological manifestation, and the confirmed diagnosis was made based on head CT findings; the treatment mainly included symptomatic support and rehabilitation training. The patients with AHS had poor prognosis. Four (26.67% of the 15 AHS patients died, among these patients, 2 had liver failure complicated by AHS, 1 had liver cirrhosis complicated by AHS, and 1 had brain metastases complicated by AHS. Conclusion Patients with decompensated liver disease complicated by acute stroke tend to develop the manifestations of AHS, which may be related to a poor clotting mechanism and brain metastasis of liver cancer, and have poor prognosis. Head CT scan should be performed for patients with decompensated liver disease accompanied by neuropsychiatric abnormalities as early as possible to help with early diagnosis and timely treatment.

  4. Cardiology Consultation in the Emergency Department Reduces Re-hospitalizations for Low-Socioeconomic Patients with Acute Decompensated Heart Failure.

    Science.gov (United States)

    Tabit, Corey E; Coplan, Mitchell J; Spencer, Kirk T; Alcain, Charina F; Spiegel, Thomas; Vohra, Adam S; Adelman, Daniel; Liao, James K; Sanghani, Rupa Mehta

    2017-09-01

    Re-hospitalization after discharge for acute decompensated heart failure is a common problem. Low-socioeconomic urban patients suffer high rates of re-hospitalization and often over-utilize the emergency department (ED) for their care. We hypothesized that early consultation with a cardiologist in the ED can reduce re-hospitalization and health care costs for low-socioeconomic urban patients with acute decompensated heart failure. There were 392 patients treated at our center for acute decompensated heart failure who received standardized education and follow-up. Patients who returned to the ED received early consultation with a cardiologist; 392 patients who received usual care served as controls. Thirty- and 90-day re-hospitalization, ED re-visits, heart failure symptoms, mortality, and health care costs were recorded. Despite guideline-based education and follow-up, the rate of ED re-visits was not different between the groups. However, the rate of re-hospitalization was significantly lower in patients receiving the intervention compared with controls (odds ratio 0.592), driven by a reduction in the risk of readmission from the ED (0.56 vs 0.79, respectively). Patients receiving the intervention accumulated 14% fewer re-hospitalized days than controls and 57% lower 30-day total health care cost. Despite the reduction in health care resource consumption, mortality was unchanged. After accounting for the total cost of intervention delivery, the health care cost savings was substantially greater than the cost of intervention delivery. Early consultation with a cardiologist in the ED as an adjunct to guideline-based follow-up is associated with reduced re-hospitalization and health care cost for low-socioeconomic urban patients with acute decompensated heart failure. Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Clinical benefit of tolvaptan in patients with acute decompensated heart failure and chronic kidney disease.

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    Uemura, Yusuke; Shibata, Rei; Takemoto, Kenji; Uchikawa, Tomohiro; Koyasu, Masayoshi; Ishikawa, Shinji; Mitsuda, Takayuki; Miura, Ayako; Imai, Ryo; Iwamiya, Satoshi; Ozaki, Yuta; Kato, Tomohiro; Miura, Takanori; Watarai, Masato; Murohara, Toyoaki

    2016-10-01

    Tolvaptan, a vasopressin type 2 receptor antagonist, has an aquaretic effect without affecting renal function. The effects of long-term tolvaptan administration in heart failure patients with renal dysfunction have not been clarified. Here, we assessed the clinical benefit of tolvaptan during a 6-month follow-up in acute decompensated heart failure (ADHF) patients with severe chronic kidney disease (CKD; estimated glomerular filtration rate (eGFR) tolvaptan in addition to loop diuretics (TLV group), with 36 patients with ADHF and severe CKD who were administered high-dose loop diuretics (≥40 mg) alone (LD group). Alterations in serum creatinine and eGFR levels from the time of hospital discharge to 6-month follow-up were significantly different between the groups, with those in the TLV group being more favorable. Furthermore, Kaplan-Meier analysis revealed that rehospitalization for heart failure (HF) was significantly lower in the TLV group compared with the LD group. In ADHF patients with severe CKD, tolvaptan use for 6 months reduced worsening of renal function and rehospitalization rates for HF when compared with conventional diuretic therapy. In conclusion, tolvaptan could be a safe and effective agent for long-term management of HF and CKD.

  6. Rationale and Design of the "Safety and Efficacy of the Combination of Loop with Thiazide-type Diuretics in Patients with Decompensated Heart Failure (CLOROTIC) Trial:" A Double-Blind, Randomized, Placebo-Controlled Study to Determine the Effect of Combined Diuretic Therapy (Loop Diuretics With Thiazide-Type Diuretics) Among Patients With Decompensated Heart Failure.

    Science.gov (United States)

    Trullàs, Joan Carles; Morales-Rull, José Luís; Casado, Jesús; Freitas Ramírez, Adriana; Manzano, Luís; Formiga, Francesc

    2016-07-01

    Fluid overload refractory to loop diuretic therapy can complicate acute or chronic heart failure (HF) management. The Safety and Efficacy of the Combination of Loop with Thiazide-type Diuretics in Patients with Decompensated Heart Failure (CLOROTIC) trial (Clinicaltrials.gov identifier NCT01647932) will test the hypothesis that blocking distal tubule sodium reabsorption with hydrochlorothiazide can antagonize the renal adaptation to chronic loop diuretic therapy and improve diuretic resistance. CLOROTIC is a randomized, placebo-controlled, double-blind, multicenter study. Three hundred and four patients with decompensated HF will be randomly assigned to receive hydrochlorothiazide or placebo in addition to a furosemide regimen. The main inclusion criteria are: age ≥18 years, history of chronic HF (irrespective of etiology and/or ejection fraction), admission for acute decompensation, and previous treatment with an oral loop diuretic for at least 1 month before randomization. The 2 coprimary endpoints are changes in body weight and changes in patient-reported dyspnea during hospital admission. Morbidity, mortality, and safety aspects will also be addressed. CLOROTIC is the first large-scale trial to evaluate whether the addition of a thiazide diuretic (hydrochlorothiazide) to a loop diuretic (furosemide) is a safe and effective strategy for improving congestive symptoms resulting from HF. This trial will provide important information and will therefore have a major impact on treatment strategies and future trials in these patients. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Effects of Beta-Blocker Withdrawal in Acute Decompensated Heart Failure: A Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Prins, Kurt W; Neill, John M; Tyler, John O; Eckman, Peter M; Duval, Sue

    2015-08-01

    This study sought to evaluate the effects of beta-blocker withdrawal in acute decompensated heart failure (ADHF). Published reports showed trends for either no harm or increased risk of in-hospital mortality, short-term mortality, and rehospitalization rates in patients admitted for ADHF that discontinued beta-blockers; however, a comprehensive analysis has not been conducted. Relevant studies from January 2000 through January 2015 were identified in the PubMed, EMBASE, and COCHRANE electronic databases. Where appropriate data were available, weighted relative risks were estimated using random-effects meta-analysis techniques. Five observational studies and 1 randomized clinical trial (n = 2,704 patients who continued beta-blocker therapy and n = 439 patients who discontinued beta-blocker therapy) that reported the short-term effects of beta-blocker withdrawal in ADHF were included in the analyses. In 2 studies, beta-blocker withdrawal significantly increased risk of in-hospital mortality (risk ratio: 3.72; 95% confidence interval [CI]: 1.51 to 9.14). Short-term mortality (relative risk: 1.61; 95% CI: 1.04 to 2.49; 4 studies) and combined short-term rehospitalization or death (relative risk: 1.59; 95% CI: 1.03 to 2.45; 4 studies) were also significantly increased. Discontinuation of beta-blockers in patients admitted with ADHF was associated with significantly increased in-hospital mortality, short-term mortality, and the combined endpoint of short-term rehospitalization or mortality. These data suggest beta-blockers should be continued in ADHF patients if their clinical picture allows. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  8. Bedside lung ultrasound in the evaluation of acute decompensated heart failure.

    Science.gov (United States)

    Leidi, Federica; Casella, Francesco; Cogliati, Chiara

    2016-06-01

    Dyspnea is a common presenting complaint in the emergency department (ED) and a leading cause of hospitalization in intensive care unit (ICU) and medical wards. Ultrasound (US) has traditionally been considered inadequate to explore the aerated lung. However, in the past 15 years LUS gained broader application, at least in part thanks to the interpretation of the artefacts generated by the interaction of US and lung structures/content. The total reflection of US beam occurring at the pleural level determines the artefactual image of the aerated lung: an homogenous 'foggy-like' picture under the pleural line. As the air content of the lungs decreases due to interstitial imbibition, deposition of collagen or presence of blood, vertical artefacts -arising from the pleural line and moving synchronously with the respiration- called B-lines appear. Multiple and bilateral B-lines identify the alveolar-interstitial syndrome (AIS). The most common cause of AIS is the wet lung: the more the congestion burden, the more the extent of the B-lines, which become confluent until the so-called white lung in case of pulmonary edema. Many studies showed a higher accuracy of LUS in diagnosing acute decompensated heart failure (ADHF) as compared to chest X-ray As recently shown, the integration of LUS to clinical assessment allow to differentiate cardiogenic dyspnea with sensitivity and specificity greater than 95 %. Moreover, LUS can easily detect pleural effusion -frequently present in ADHF-appearing as an anechoic area in the recumbent area of the thorax, delimited inferiorly by the diaphragmatic dome and superiorly by the aerated lung.

  9. Impact of chronic kidney disease on the diuretic response of tolvaptan in acute decompensated heart failure.

    Science.gov (United States)

    Ikeda, Shuntaro; Ohshima, Kiyotaka; Miyazaki, Shigehiro; Kadota, Hisaki; Shimizu, Hideaki; Ogimoto, Akiyoshi; Hamada, Mareomi

    2017-11-01

    This study investigated the relationship between the initial diuretic response to tolvaptan and clinical predictors for tolvaptan responders in patients with acute decompensated heart failure (ADHF). Patients (153) with ADHF (clinical scenario 2 or 3 with signs of fluid retention) who were administered tolvaptan were enrolled. Tolvaptan (15 or 7.5 mg) was administered for at least 7 days to those patients in whom fluid retention was observed even after standard treatment. The maximum urine volume immediately after tolvaptan administration showed good correlations with the ejection fraction and estimated glomerular filtration rate that were independent predictors of the urine volume (UV) responders (≥1500 mL increase in urine volume). The diuretic response (in terms of maximum diuresis) diminished with advancing chronic kidney disease (CKD) stage and concomitant deterioration of the renal function. Furthermore, advanced CKD was a significant negative predictor for the body weight (BW) responders (2.0% decrease in the body weight within 1 week after starting tolvaptan). As compared with non-CKD, the presence of advanced CKD predicts poor diuretic response for both UV and BW responders. The diuretic response following tolvaptan administration gradually diminished with progressive deterioration of the CKD stage. Worsening renal function was not observed. Tolvaptan is effective in treating CS2 or CS3 ADHF patients who present fluid retention and congestion, suggesting its potential efficacy for fluid management in the ADHF patients with CKD without worsening the renal function. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

  10. Competing Risk of Cardiac Status and Renal Function During Hospitalization for Acute Decompensated Heart Failure.

    Science.gov (United States)

    Salah, Khibar; Kok, Wouter E; Eurlings, Luc W; Bettencourt, Paulo; Pimenta, Joana M; Metra, Marco; Verdiani, Valerio; Tijssen, Jan G; Pinto, Yigal M

    2015-10-01

    The aim of this study was to analyze the dynamic changes in renal function in combination with dynamic changes in N-terminal pro-B-type natriuretic peptide (NT-proBNP) in patients hospitalized for acute decompensated heart failure (ADHF). Treatment of ADHF improves cardiac parameters, as reflected by lower levels of NT-proBNP. However this often comes at the cost of worsening renal parameters (e.g., serum creatinine, estimated glomerular filtration rate [eGFR], or serum urea). Both the cardiac and renal markers are validated indicators of prognosis, but it is not yet clear whether the benefits of lowering NT-proBNP are outweighed by the concomitant worsening of renal parameters. This study was an individual patient data analysis assembled from 6 prospective cohorts consisting of 1,232 patients hospitalized for ADHF. Endpoints were all-cause mortality and the composite of all-cause mortality and/or readmission for a cardiovascular reason within 180 days after discharge. A significant reduction in NT-proBNP was not associated with worsening of renal function (WRF) or severe WRF (sWRF). A reduction of NT-proBNP of more than 30% during hospitalization determined prognosis (all-cause mortality hazard ratio [HR]: 1.81; 95% confidence Interval [CI]: 1.32 to 2.50; composite endpoint: HR: 1.36, 95% CI: 1.13 to 1.64), regardless of changes in renal function and other clinical variables. When we defined prognosis, NT-proBNP changes during hospitalization for treatment of ADHF prevailed over parameters for worsening renal function. Severe WRF is a measure of prognosis, but is of lesser value than, and independent of the prognostic changes induced by adequate NT-proBNP reduction. This suggests that in ADHF patients it may be warranted to strive for an optimal decrease in NT-proBNP, even if this induces WRF. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  11. Copeptin in acute decompensation of liver cirrhosis: relationship with acute-on-chronic liver failure and short-term survival.

    Science.gov (United States)

    Kerbert, Annarein J C; Verspaget, Hein W; Navarro, Àlex Amorós; Jalan, Rajiv; Solà, Elsa; Benten, Daniel; Durand, François; Ginès, Pere; van der Reijden, Johan J; van Hoek, Bart; Coenraad, Minneke J

    2017-12-21

    Acute-on-chronic liver failure (ACLF) is characterized by the presence of acute decompensation (AD) of cirrhosis, organ failure, and high short-term mortality rates. Hemodynamic dysfunction and activation of endogenous vasoconstrictor systems are thought to contribute to the pathogenesis of ACLF. We explored whether copeptin, a surrogate marker of arginine vasopressin, is a potential marker of outcome in patients admitted for AD or ACLF and whether it might be of additional value to conventional prognostic scoring systems in these patients. All 779 patients hospitalized for AD of cirrhosis from the CANONIC database with at least one serum sample available for copeptin measurement were included. Presence of ACLF was defined according to the CLIF-consortium organ failure (CLIF-C OF) score. Serum copeptin was measured in samples collected at days 0-2, 3-7, 8-14, 15-21, and 22-28 when available. Competing-risk regression analysis was applied to evaluate the impact of serum copeptin and laboratory and clinical data on short-term survival. Serum copeptin concentration was found to be significantly higher in patients with ACLF compared with those without ACLF at days 0-2 (33 (14-64) vs. 11 (4-26) pmol/L; p copeptin at admission was shown to be a predictor of mortality independently of MELD and CLIF-C OF scores. Moreover, baseline serum copeptin was found to be predictive of ACLF development within 28 days of follow-up. ACLF is associated with significantly higher serum copeptin concentrations at hospital admission compared with those with traditional AD. Copeptin is independently associated with short-term survival and ACLF development in patients admitted for AD or ACLF.

  12. Outcomes of de novo and acute decompensated heart failure patients according to ejection fraction.

    Science.gov (United States)

    Choi, Ki Hong; Lee, Ga Yeon; Choi, Jin-Oh; Jeon, Eun-Seok; Lee, Hae-Young; Cho, Hyun-Jai; Lee, Sang Eun; Kim, Min-Seok; Kim, Jae-Joong; Hwang, Kyung-Kuk; Chae, Shung Chull; Baek, Sang Hong; Kang, Seok-Min; Choi, Dong-Ju; Yoo, Byung-Su; Kim, Kye Hun; Park, Hyun-Young; Cho, Myeong-Chan; Oh, Byung-Hee

    2018-03-01

    There are conflicting results among previous studies regarding the prognosis of heart failure with preserved ejection fraction (HFpEF) compared with heart failure with reduced ejection fraction (HFrEF). This study aimed to compare the outcomes of patients with de novo acute heart failure (AHF) or acute decompensated HF (ADHF) according to HFpEF (EF≥50%), or HFrEF (EF<40%) and to define the prognosis of patients with HF with mid-range EF (HFmrEF, 40≤EF<50%). Between March 2011 and February 2014, 5625 consecutive patients with AHF were recruited from 10 university hospitals. A total of 5414 (96.2%) patients with EF data were enrolled, which consisted of 2867 (53.0%) patients with de novo and 2547 (47.0%) with ADHF. Each of the enrolled group was stratified by EF. In de novo, all-cause death rates were not significantly different between HFpEF and HFrEF (HFpEF vs HFrEF, 206/744 (27.7%) vs 438/1631 (26.9%), HR adj 1.15, 95% CI 0.96 to 1.38, p=0.14). However, among patients with ADHF, HFrEF had a significantly higher mortality rate compared with HFpEF (HFpEF vs HFrEF, 245/613 (40.0%) vs 694/1551 (44.7%), HR adj 1.25, 95% CI 1.06 to 1.47, p=0.007). Also, in ADHF, HFmrEF was associated with a significantly lower mortality rate within 1 year compared with HFrEF (HFmrEF vs HFrEF, 88/383 (23.0%) vs 430/1551 (27.7%), HR adj 1.31, 95% CI 1.03 to 1.65, p=0.03), but a significantly higher mortality rate after 1 year compared with HFpEF (HFmrEF vs HFpEF, 83/295 (28.1%) vs 101/469 (21.5%), HR adj 0.70, 95% CI 0.52 to 0.96, p=0.02). HFpEF may indicate a better prognosis compared with HFrEF in ADHF, but not in de novo AHF. For patients with ADHF, the prognosis associated with HFmrEF was similar to that of HFpEF within the first year following hospitalisation and similar to HFrEF 1  year after hospitalisation. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted

  13. Predictors of postdischarge outcomes from information acquired shortly after admission for acute heart failure: a report from the Placebo-Controlled Randomized Study of the Selective A1 Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized With Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function (PROTECT) Study.

    Science.gov (United States)

    Cleland, John G; Chiswell, Karen; Teerlink, John R; Stevens, Susanna; Fiuzat, Mona; Givertz, Michael M; Davison, Beth A; Mansoor, George A; Ponikowski, Piotr; Voors, Adriaan A; Cotter, Gad; Metra, Marco; Massie, Barry M; O'Connor, Christopher M

    2014-01-01

    Acute heart failure is a common reason for admission, and outcome is often poor. Improved prognostic risk stratification may assist in the design of future trials and in patient management. Using data from a large randomized trial, we explored the prognostic value of clinical variables, measured at hospital admission for acute heart failure, to determine whether a few selected variables were inferior to an extended data set. The prognostic model included 37 clinical characteristics collected at baseline in PROTECT, a study comparing rolofylline and placebo in 2033 patients admitted with acute heart failure. Prespecified outcomes at 30 days were death or rehospitalization for any reason; death or rehospitalization for cardiovascular or renal reasons; and, at both 30 and 180 days, all-cause mortality. No variable had a c-index>0.70, and few had values>0.60; c-indices were lower for composite outcomes than for mortality. Blood urea was generally the strongest single predictor. Eighteen variables contributed independent prognostic information, but a reduced model using only 8 items (age, previous heart failure hospitalization, peripheral edema, systolic blood pressure, serum sodium, urea, creatinine, and albumin) performed similarly. For prediction of all-cause mortality at 180 days, the model c-index using all variables was 0.72 and for the simplified model, also 0.72. A few simple clinical variables measured on admission in patients with acute heart failure predict a variety of adverse outcomes with accuracy similar to more complex models. However, predictive models were of only moderate accuracy, especially for outcomes that included nonfatal events. Better methods of risk stratification are required. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00328692 and NCT00354458.

  14. Autologous bone marrow mononuclear cell transplantation in patients with decompensated alcoholic liver disease: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Laurent Spahr

    Full Text Available OBJECTIVE: Impaired liver regeneration is associated with a poor outcome in patients with decompensated alcoholic liver disease (ALD. We assessed whether autologous bone marrow mononuclear cell transplantation (BMMCT improved liver function in decompensated ALD. DESIGN: 58 patients (mean age 54 yrs; mean MELD score 19, all with cirrhosis, 81% with alcoholic steatohepatitis at baseline liver biopsy were randomized early after hospital admission to standard medical therapy (SMT alone (n = 30, including steroids in patients with a Maddrey's score ≥32, or combined with G-CSF injections and autologous BMMCT into the hepatic artery (n = 28. Bone marrow cells were harvested, isolated and reinfused the same day. The primary endpoint was a ≥3 points decrease in the MELD score at 3 months, corresponding to a clinically relevant improvement in liver function. Liver biopsy was repeated at week 4 to assess changes in Ki67+/CK7+ hepatic progenitor cells (HPC compartment. RESULTS: Both study groups were comparable at baseline. After 3 months, 2 and 4 patients died in the BMMCT and SMT groups, respectively. Adverse events were equally distributed between groups. Moderate alcohol relapse occurred in 31% of patients. The MELD score improved in parallel in both groups during follow-up with 18 patients (64% from the BMMCT group and 18 patients (53% from the SMT group reaching the primary endpoint (p = 0.43 (OR 1.6, CI 0.49-5.4 in an intention to treat analysis. Comparing liver biopsy at 4 weeks to baseline, steatosis improved (p<0.001, and proliferating HPC tended to decrease in both groups (-35 and -33%, respectively. CONCLUSION: Autologous BMMCT, compared to SMT is a safe procedure but did not result in an expanded HPC compartment or improved liver function. These data suggest either insufficient regenerative stimulation after BMMCT or resistance to liver regenerative drive in patients with decompensated alcoholic cirrhosis. TRIAL REGISTRATION

  15. Association between Severity of Anemia and 30-Day Readmission Rate: Archival Data of 847 Patients with Acute Decompensated Heart Failure

    Directory of Open Access Journals (Sweden)

    Jorge C. Busse

    2014-01-01

    Full Text Available Hospitals today are facing adjustments to reimbursements from excessive readmission rates. One of the most common and expensive causes of readmissions is exacerbation of a heart failure condition. The objective of this paper was to determine if there was an association between the presence of anemia in patients with acute decompensated heart failure and their readmission rate. Using archival data of 4 hospitals in the Miami area, a sample of 847 inpatients with a diagnostic related group (DRG of HF at discharge was considered. There was a significant association between low hemoglobin values and a high rate of readmissions at 14 days and at 30 days in subjects with normal sodium and creatinine values. For subjects with low sodium and high creatinine values, a higher readmission rate was seen in men with low hemoglobin but not in women. These results support a prospective effort to measure the impact of anemia and its treatment on readmission rates.

  16. Aggressive salt and water restriction in acutely decompensated heart failure: is it worth its weight in salt?

    Science.gov (United States)

    Rami, Kahwash

    2013-09-01

    Acute decompensated heart failure (ADHF) is the leading cause of hospitalization worldwide, especially in the elderly, and is associated with a high readmission rate and increased first year mortality. Fluid overload manifested by pulmonary congestion is seen in the majority of patients with ADHF and is believed to be the reason behind most admissions. ADHF is commonly treated with intravenous diuretics aimed to alleviate congestion and restore euvolemia. In fact, current European and American guidelines for heart failure (HF) consider relief of congestion as the first-line therapy in ADHF. Following the same theme of reducing fluid retention, historical approaches have recommended water and salt restriction as an essential non-pharmacological therapy in the management of symptomatic HF. This 'common sense' dietary practice was mainly based on experts' opinions and has been challenged by recent data suggesting that salt or fluid restriction has neutral outcomes in achieving clinical stability and improving signs and symptoms of HF.

  17. When to increase or reduce sodium loading in the management of fluid volume status during acute decompensated heart failure.

    Science.gov (United States)

    Hirotani, Shinichi; Masuyama, Tohru

    2014-12-01

    Sodium restriction has been believed to be indispensible to manage fluid overload during acute decompensated heart failure (ADHF). However, recently, it was reported that a change in aggression of sodium and water restriction did not affect the outcome of ADHF. In contrast, current data suggest that small amount of hypertonic saline solution with high-dose furosemide produces an improvement in haemodynamic and clinical parameters without any severe adverse effects. In this perspective, first, we are going to describe the effects of sodium loading on neurohormonal activation, body's sodium balance, and renal function in chronic heart failure and the efficacy of loop diuretics in ADHF. Then, we are going to explain the possible mechanisms by which sodium loading enhances the efficacy of loop diuretics and about the clinical conditions during which sodium loading should be avoided. © 2014 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

  18. [Influence of nutritional status on development of nosocomial pneumonia in case of acute decompensation of chronic obstructive pulmonary diseases].

    Science.gov (United States)

    Bady, E; Rabbat, A; Kouchakji, B; Coignard, S; Laaban, J P

    2000-09-01

    The aim of this retrospective study was to assess the incidence of nutritional status on the development of nosocomial pneumonia in patients with chronic obstructive pulmonary disease (COPD) suffering an acute episode of respiratory failure requiring ventilatory assistance. The study included 48 patients with COPD who were hospitalized in an intensive care unit for acute respiratory failure requiring ventilatory assistance. Nutritional status was assessed within 24 hours of admission to the intensive care unit. Body weight, tricipital skin fold, brachial muscle circumference, creatinuria-waist index, plasma levels of albumin, transferrin, transthyretin and retinol-binding protein, the Multitest and lymphocyte counts were recorded. The diagnosis of nosocomial pneumonia was based on recognized criteria: occurrence more than 48 hours after admission, Andrews' criteria for bacterial pneumonia and bacteriological proof. Nineteen of the 48 patients developed nosocomial pneumonia. The nutritional parameters at admission to intensive care were not significantly different between patients who developed nosocomial pneumonia and those who remained free of lung infection. The duration of ventilatory assistance and total stay in the intensive care unit were significantly longer in patients who developed nosocomial pneumonia. This study showed that in patients with COPD who undergo ventilatory assistance for acute decompensation, the development of nosocomial pneumonia was not correlated with nutritional status admission.

  19. Impact on Clinical Outcomes of Periodic Leg Movements During Sleep in Hospitalized Patients Following Acute Decompensated Heart Failure.

    Science.gov (United States)

    Yatsu, Shoichiro; Kasai, Takatoshi; Suda, Shoko; Matsumoto, Hiroki; Shiroshita, Nanako; Kato, Mitsue; Kawana, Fusae; Murata, Azusa; Kato, Takao; Hiki, Masaru; Daida, Hiroyuki

    2017-03-24

    Periodic leg movements during sleep (PLM) are characterized by regularly recurring movement of the legs during sleep. Although PLM is common and a predictor of death in patients with chronic heart failure, the clinical significance of PLM in hospitalized patients with a reduced left ventricular ejection fraction (LVEF) following acute decompensated heart failure (ADHF) remains unknown.Methods and Results:After initial improvement of acute signs and symptoms of ADHF, 94 consecutive patients with reduced LVEF who underwent polysomnography were enrolled. They were divided into 2 groups based on the presence or absence of severe PLM defined as PLM index ≥30. The risks for clinical events, composite of all-cause death and rehospitalization, were assessed using a stepwise multivariable Cox proportional model including variables showing PPLM was observed in 21 patients (22%). At a median follow-up of 5.2 months, 30 patients experienced clinical events (32%). In the multivariable analysis, the presence of severe PLM was significantly associated with increasing clinical events (hazard ratio, 2.16; 95% confidence interval, 1.03-4.54; P=0.042) independent of hemoglobin level and the severity of sleep-disordered breathing. In hospitalized patients with systolic dysfunction following ADHF, severe PLM was prevalent and significantly associated with increased risk of death and/or rehospitalization.

  20. Ischemia-modified albumin levels in patients with acute decompensated heart failure treated with dobutamine or levosimendan: IMA-HF study.

    Science.gov (United States)

    Çavuşoğlu, Yüksel; Korkmaz, Şule; Demirtaş, Selda; Gencer, Erkan; Şaşmaz, Hatice; Mutlu, Fezan; Güneş, Hakan; Mert, Uğur Kadir; Özdemir, Sedat; Kalaycı, Süleyman; Yılmaz, Mehmet Birhan

    2015-08-01

    Ischemia-modified albumin (IMA) is a sensitive biomarker of myocardial ischemia. However, data on IMA levels in acute heart failure (HF) are still lacking. In this study, we aimed to evaluate serum IMA levels in acute decompensated HF and the effects of dobutamine and levosimendan treatments on IMA levels. This was a prospective, multicenter study that included 70 patients hospitalized with acute decompensated HF and left ventricular ejection fraction HF therapy. Twenty-nine patients were treated with standard HF therapy, 18 received levosimendan, and 23 received dobutamine in addition to standard of care. A single serum specimen was also collected from 32 healthy individuals each. IMA concentrations were measured by the albumin cobalt binding colorimetric assay, and the results were given in absorbance units (AU). Independent and paired sample t-tests, Mann-Whitney U test, and Wilcoxon signed-rank test were used for the analysis. In patients with acute decompensated HF, the serum concentration of IMA was significantly higher than those of healthy subjects (0.894 ± 0.23 AU vs. 0.379 ± 0.08 AU, p HF therapy (0.894 ± 0.23 AU and 0.832 ± 0.18 AU, p = 0.013). Furthermore, the IMA levels were also found to significantly decrease with standard HF therapy (1.041 ± 0.28 vs. 0.884 ± 0.15 AU, p = 0.041), with levosimendan (0.771 ± 0.18 vs. 0.728 ± 0.18 AU, p = 0.046) and also with dobutamine (0.892 ± 0.18 vs. 0.820 ± 0.13 AU, p = 0.035). Patients with acute decompensated HF had elevated IMA levels, and appropriate HF therapy significantly reduced the serum IMA levels. Dobutamine or levosimendan did not increase the IMA levels, suggesting a lower potential in inducing myocardial ischemia when used in recommended doses.

  1. Chronic liver failure-consortium acute-on-chronic liver failure and acute decompensation scores predict mortality in Brazilian cirrhotic patients.

    Science.gov (United States)

    Picon, Rafael Veiga; Bertol, Franciele Sabadin; Tovo, Cristiane Valle; de Mattos, Ângelo Zambam

    2017-07-28

    To validate prognostic scores for acute decompensation of cirrhosis and acute-on-chronic liver failure in Brazilian patients. This is a prospective cohort study designed to assess the prognostic performance of the chronic liver failure-consortium (CLIF-C) acute decompensation score (CLIF-C AD) and CLIF-C acute-on-chronic liver failure score (CLIF-C ACLF), regarding 28-d and 90-d mortality, as well as to compare them to other prognostic models, such as Model for End-Stage Liver Disease (MELD), MELD Sodium (MELD-Na), Child-Pugh (CP) score, and the CLIF-C Organ Failure score (CLIF-C OF). All participants were adults with acute decompensation of cirrhosis admitted to the Emergency Department of a tertiary hospital in southern Brazil. Prognostic performances were evaluated by means of the receiver operating characteristic (ROC) curves, area under the curves (AUC) and 95%CI. One hundred and thirteen cirrhotic patients were included. At admission, 18 patients had acute-on-chronic liver failure (ACLF) and 95 individuals had acute decompensation (AD) without ACLF, of which 24 eventually developed ACLF during the course of hospitalization (AD evolving to ACLF group). The AD group had significantly lower 28-d (9.0%) and 90-d (18.3%) mortality as compared to the AD evolving to ACLF group and to the ACLF group (both P < 0.001). On the other hand, 28-d and 90-d mortalities were not significantly different between AD evolving to ACLF group and ACLF group (P = 0.542 and P = 0.708, respectively). Among patients with ACLF, at 28 d from the diagnosis, CLIF-C ACLF was the only score able to predict mortality significantly better than the reference line, with an AUC (95%CI) of 0.71 (95%CI: 0.54-0.88, P = 0.021). Among patients with AD, all prognostic scores performed significantly better than the reference line regarding 28-d mortality, presenting with similar AUCs: CLIF-C AD score 0.75 (95%CI: 0.63-0.88), CP score 0.72 (95%CI: 0.59-0.85), MELD score 0.75 (95%CI: 0.61-0.90), MELD

  2. Efficacy and safety assessment of isolated ultrafiltration compared to intravenous diuretics for acutely decompensated heart failure: a systematic review with meta-analysis.

    Science.gov (United States)

    De Vecchis, R; Esposito, C; Ariano, C

    2014-04-01

    Intravenous diuretics at relatively high doses are currently used for treating acute decompensated heart failure (ADHF). However, the existence of harmful side effects diuretic-related, such as electrolyte abnormalities, symptomatic hypotension and marked neuro-hormonal activation have led researchers to implement alternative therapeutic tools such as isolated ultrafiltration (IUF). Our study aimed to compare intravenous diuretics vs. IUF as regards their respective efficacy and safety in ADHF patients through systematic review and meta-analysis of data derived from relevant randomized controlled trials. 6 studies grouping a total of 477 patients were included in the systematic review. By contrast, data from only three studies were pooled for the meta-analysis, because of different adopted outcomes or marked dissimilarities in the data presentation . Weight loss at 48 h was greater in IUF group compared to the diuretics group [weighted mean difference (WMD)=1.77 kg; 95%CI: 1.18-2.36 kg; Pdiuretics group (WMD=1.2 liters; 95%CI: 0.73-1.67 liters; P 0.3 mg/dl at 48 hours, was similar to the one found in the diuretics group (OR=1.33; 95% CI: 0.81-2.16 P=0.26). On the basis of this meta-analysis, IUF induced greater weight loss and larger fluid removal compared to iv diuretics in ADHF patients, whereas the probability of developing WRF was not significantly different in the comparison between iv diuretics and IUF.

  3. B29 A STATE OF UNREST: SLEEP/SDB IN THE ICU AND HOSPITAL: Sleep-Disordered Breathing Is Of High Prevalence In Patients With Acute Cardiac Decompensation

    National Research Council Canada - National Science Library

    H Fox; T Bitter; D Horstkotte; O Oldenburg

    2016-01-01

    ... after being admitted to our hospital for acute cardiac decompensation. None of the patients was treated with ventilation therapy and all patients were naïve to ventilation therapy. The prevalence of SDB (apnea-hypopnea index [AHI] > 5/h) was 59.1 % (AHI > 15/h was 51.3 % and AHI > 15/h was 32.2 %). Mean AHI was 35.3±23.9/h, mean ODI (3%) w...

  4. On admission serum sodium and uric acid levels predict 30 day rehospitalization or death in patients with acute decompensated heart failure.

    Science.gov (United States)

    Amin, Ahmad; Chitsazan, Mitra; Shiukhi Ahmad Abad, Fatemeh; Taghavi, Sepideh; Naderi, Nasim

    2017-05-01

    A considerable proportion of hospitalized patients for acute decompensated heart failure will be readmitted or die in short-term follow-up. In the present study, we aimed to assess the role of admission sodium (Na) and uric acid (UA) levels in the prediction of 30 day post-discharge heart failure readmission or all-cause mortality in advanced heart failure patients admitted with acute decompensation. One hundred and forty consecutive advanced heart failure patients who were admitted for a recent cardiac decompensation were enrolled in this prospective study. Serum Na and UA levels remained statistically unchanged during index admission (P = 0. 54 and 0.19, respectively). Within 30 days post-discharge, composite end point of heart failure rehospitalization or all-cause death occurred in 62 (44.3%) patients (event group). Length of stay was statistically similar between patients in the event and non-event groups (P = 0.38). No correlations were also found between length of stay and left ventricular ejection fraction, serum Na, UA, erythrocyte sedimentation rate (ESR), high-sensitivity C-reactive protein (hs-CRP), creatinine, and N-terminal pro b-type natriuretic peptide (NT-proBNP) levels (all P > 0.05). Lower left ventricular ejection fraction and Na and higher UA on admission were significantly associated with 30 day event both in univariate and multivariate analyses. Given the predictive role of baseline Na and UA for early post-discharge outcome and the absence of significant changes in their levels during initial hospitalization, admission Na and UA can be considered as prognosticators of acute decompensated heart failure, which their prognostic significance cannot be affected by routine acute heart failure therapy.

  5. Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure: Results from the CARRYING ON for HF Pilot Study.

    Science.gov (United States)

    Vanoli, Emilio; Mortara, Andrea; Diotallevi, Paolo; Gallone, Giuseppe; Mariconti, Barbara; Gronda, Edoardo; Gentili, Alessandra; Bisetti, Silvia; Botto, Giovanni Luca

    2016-04-26

    There's scarce evidence about cardiovascular events (CV) in patients with hospitalization for acute heart failure (HF) and no indication for immediate device implant. The CARdiac RhYthm monitorING after acute decompensatiON for Heart Failure study was designed to assess the incidence of prespecified clinical and arrhythmic events in this patient population. In this pilot study, 18 patients (12 (67%) male; age 72±10; 16 (89%) NYHA II-III), who were hospitalized for HF with low left ventricular ejection fraction (LVEF) (<40%) and no immediate indication for device implant received an implantable loop recorder (ILR) before hospital discharge. Follow-up visits were scheduled at 3 and 6 months, and at every 6 months until study closure; device data were remotely reviewed monthly. CV mortality, unplanned CV hospitalization, and major arrhythmic events during follow-up were analyzed. During a median follow-up of 593 days, major CV occurred in 13 patients (72%); of those, 7 patients had at least 1 cardiac arrhythmic event, 2 had at least a clinical event (CV hospitalization or CV death), and 4 had both an arrhythmic and a CV event. Six (33%) patients experienced 10 major clinical events, 5 of them (50%) were HF related. During follow-up, 2 (11%) patients died due to a CV cause and 3 (16%) patients received a permanent cardiac device. After an acute HF hospitalization, patients with LVEF<40% and who are not readily eligible for permanent cardiac device implant have a known high incidence of major CV event. In these patients, ILR allows early detection of major cardiac arrhythmias and the ability to react appropriately in a timely manner. ClinicalTrials.gov NCT01216670; https://clinicaltrials.gov/ct2/show/NCT01216670.

  6. Body mass index and mortality in acutely decompensated heart failure across the world: a global obesity paradox.

    Science.gov (United States)

    Shah, Ravi; Gayat, Etienne; Januzzi, James L; Sato, Naoki; Cohen-Solal, Alain; diSomma, Salvatore; Fairman, Enrique; Harjola, Veli-Pekka; Ishihara, Shiro; Lassus, Johan; Maggioni, Aldo; Metra, Marco; Mueller, Christian; Mueller, Thomas; Parenica, Jiri; Pascual-Figal, Domingo; Peacock, William Frank; Spinar, Jindrich; van Kimmenade, Roland; Mebazaa, Alexandre

    2014-03-04

    This study sought to define the relationship between body mass index (BMI) and mortality in heart failure (HF) across the world and to identify specific groups in whom BMI may differentially mediate risk. Obesity is associated with incident HF, but it is paradoxically associated with better prognosis during chronic HF. We studied 6,142 patients with acute decompensated HF from 12 prospective observational cohorts followed-up across 4 continents. Primary outcome was all-cause mortality. Cox proportional hazards models and net reclassification index described associations of BMI with all-cause mortality. Normal-weight patients (BMI 18.5 to 25 kg/m(2)) were older with more advanced HF and lower cardiometabolic risk. Despite worldwide heterogeneity in clinical features across obesity categories, a higher BMI remained associated with decreased 30-day and 1-year mortality (11% decrease at 30 days; 9% decrease at 1 year per 5 kg/m(2); p 75 years; hazard ratio [HR]: 0.82; p = 0.006), decreased cardiac function (ejection fraction obesity paradox" is confined to older persons, with decreased cardiac function, less cardiometabolic illness, and recent-onset HF, suggesting that aging, HF severity/chronicity, and metabolism may explain the obesity paradox. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  7. Baseline albumin is associated with worsening renal function in patients with acute decompensated heart failure receiving continuous infusion loop diuretics.

    Science.gov (United States)

    Clarke, Megan M; Dorsch, Michael P; Kim, Susie; Aaronson, Keith D; Koelling, Todd M; Bleske, Barry E

    2013-06-01

    To identify baseline predictors of worsening renal function (WRF) in an acute decompensated heart failure (ADHF) patient population receiving continuous infusion loop diuretics. Retrospective observational analysis. Academic tertiary medical center. A total of 177 patients with ADHF receiving continuous infusion loop diuretics from January 2006 through June 2009. The mean patient age was 61 years, 63% were male, ~45% were classified as New York Heart Association functional class III, and the median length of loop diuretic infusion was 4 days. Forty-eight patients (27%) developed WRF, and 34 patients (19%) died during hospitalization. Cox regression time-to-event analysis was used to determine the time to WRF based on different demographic and clinical variables. Baseline serum albumin 3 g/dl or less was the only significant predictor of WRF (hazard ratio [HR] 2.87, 95% confidence interval [CI] 1.60-5.16, p=0.0004), which remained significant despite adjustments for other covariates. Serum albumin 3 g/dl or less is a practical baseline characteristic associated with the development of WRF in patients with ADHF receiving continuous infusion loop diuretics. © 2013 Pharmacotherapy Publications, Inc.

  8. Insufficient natriuretic response to continuous intravenous furosemide is associated with poor long-term outcomes in acute decompensated heart failure.

    Science.gov (United States)

    Singh, Dhssraj; Shrestha, Kevin; Testani, Jeffrey M; Verbrugge, Frederik H; Dupont, Matthias; Mullens, Wilfried; Tang, W H Wilson

    2014-06-01

    Treatment of acute decompensated heart failure (ADHF) with loop diuretics, such as furosemide, is frequently complicated by insufficient urine sodium excretion. We hypothesize that insufficient natriuretic response to diuretic therapy, characterized by lower urine sodium (UNa) and urine furosemide, is associated with subsequent inadequate decongestion, worsening renal function, and adverse long term events. We enrolled 52 consecutive patients with ADHF and measured serum and urine sodium (UNa), urine creatinine (UCr), and urine furosemide (UFurosemide) levels on a spot sample taken after treatment with continuous intravenous furosemide, and followed clinical and renal variables as well as adverse long-term clinical outcomes (death, rehospitalizations, and cardiac transplantation). We observed similar correlations between UNa:UFurosemide ratio and UNa and fractional excretion of sodium (FENa) with 24-hour net urine output (r = 0.52-0.64, all P furosemide were observed when UNa:UFurosemide ratios were furosemide infusion, impaired natriuretic response to furosemide is associated with greater likelihood of worsening renal function and future adverse long-term outcomes, independently from and incrementally with decreasing intrinsic glomerular filtration. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Neutrophil Gelatinase-Associated Lipocalin (NGAL predicts renal injury in acute decompensated cardiac failure: a prospective observational study

    Directory of Open Access Journals (Sweden)

    Macdonald Stephen

    2012-02-01

    Full Text Available Abstract Background Acute Decompensated Cardiac Failure (ADCF is frequently associated with deterioration in renal function. Neutrophil gelatinase-associated lipocalin (NGAL is an early marker of kidney injury. We aimed to determine if NGAL measured at admission predicts in-hospital acute kidney injury (AKI in ADCF. Methods A prospective observational study measured NGAL and B-natriuretic peptide (BNP from patients with ADCF presenting to two tertiary hospitals. Patients received standard care and were followed up daily as inpatients. ADCF was defined by PRIDE score ≥ 6 and AKI by RIFLE criteria. Results One hundred and two patients (median age 80, IQR 69-84 years, 52% male were enrolled. AKI developed in 22 (25% of 90 for whom outcome data was available. Seven patients died. NGAL was significantly elevated in those who developed AKI versus those who did not (median 130 ng/ml vs 69 ng/ml, p = 0.002. NGAL was also higher in those who died (median 136 ng/ml vs 68 ng/ml, p = 0.005. AKI was significantly associated with risk of death (5/22 (23% vs 1/68 (1.5%, p = 0.001, but not length of hospital stay. NGAL significantly correlated with admission eGFR but not BNP. For prediction of AKI, NGAL > 89 ng/ml had sensitivity of 68% and specificity of 70% with area under the receiver operator characteristic (ROC curve of 0.71 (0.58-0.84. After adjustment for baseline renal function, the odds ratio (OR for AKI was 3.73 (1.26-11.01 if admission NGAL > 89 ng/ml. Conclusions Elevated NGAL at admission is associated with in-hospital AKI and mortality in patients with ADCF. However, it has only moderate diagnostic accuracy in this setting.

  10. BETAWIN-AHF study: effect of beta-blocker withdrawal during acute decompensation in patients with chronic heart failure.

    Science.gov (United States)

    Miró, Òscar; Müller, Christian; Martín-Sánchez, Francisco Javier; Bueno, Héctor; Mebazaa, Alexander; Herrero, Pablo; Jacob, Javier; Gil, Víctor; Escoda, Rosa; Llorens, Pere

    2016-12-01

    To evaluate the effects of discontinuing chronic beta-blocker (BB) treatment on short-term outcome in patients with chronic heart failure (CHF) during acute decompensation. We selected all the patients previously diagnosed with CHF and currently on BB and attended for acute heart failure (AHF) in one of the 35 Spanish emergency departments participating in the EAHFE registry. Patients were classified according to BB maintenance or withdrawal (BBM or BBW, respectively) during the episode. In-hospital mortality was the primary endpoint; and 30-day mortality, 30-day combined endpoint, and prolonged hospitalization were secondary. We used logistic regression for adjustment of results according to the differences between the BBM and BBW groups, and stratified analysis by age, sex, left ventricular ejection fraction, chronic obstructive pulmonary disease, heart rate (HR), and BB type (carvedilol/bisoprolol) was performed. Among 2058 patients receiving chronic BB treatment, 1990 were analyzed: BBM 530 (27 %), BBW 1460 (73 %). Compared to BBM, BBW had a higher in-hospital mortality (5.5 vs 3.0 %; p BBW and in-hospital mortality (OR 1.89; 95 % CI 1.09-3.26) and 30-day mortality (OR 2.01; 95 % CI 1.28-3.15). Stratified analysis indicated no interaction by all the subgroups analyzed, except for HR (p = 0.01 for interaction), which showed a greater negative impact of BBW in patients with HR >80 bpm (OR 2.74; 95 % CI 1.13-6.63). In the absence of clear contraindications, BB treatment should be maintained during AHF episodes in patients already receiving BB at home.

  11. Fat-free muscle mass in magnetic resonance imaging predicts acute-on-chronic liver failure and survival in decompensated cirrhosis

    DEFF Research Database (Denmark)

    Praktiknjo, Michael; Book, Marius; Luetkens, Julian

    2018-01-01

    of sarcopenia using magnetic resonance imaging (MRI) in decompensated cirrhotic patients with transjugular intrahepatic portosystemic shunt (TIPS). METHODS: The total erector spinae muscle area and the intramuscular fat tissue area were measured and subtracted to calculate the fat-free muscle area (FFMA) in 116...... in a validation cohort of 45 patients. RESULTS: FFMA correlated with follistatin and TPMT and showed slightly better association with survival than TPMT. Gender-specific cut-off values for FFMA were determined for sarcopenia. Decompensation (ascites, overt hepatic encephalopathy) persisted after TIPS...... in the sarcopenia group but resolved in the non-sarcopenia group. Sarcopenic patients showed no clinical improvement after TIPS as well as higher mortality, mainly due to development of acute-on-chronic liver failure (ACLF). FFMA was an independent predictor of survival in these patients. CONCLUSION: This study...

  12. Modification in CSF specific gravity in acutely decompensated cirrhosis and acute on chronic liver failure independent of encephalopathy, evidences for an early blood-CSF barrier dysfunction in cirrhosis.

    Science.gov (United States)

    Weiss, Nicolas; Rosselli, Matteo; Mouri, Sarah; Galanaud, Damien; Puybasset, Louis; Agarwal, Banwari; Thabut, Dominique; Jalan, Rajiv

    2017-04-01

    Although hepatic encephalopathy (HE) on the background of acute on chronic liver failure (ACLF) is associated with high mortality rates, it is unknown whether this is due to increased blood-brain barrier permeability. Specific gravity of cerebrospinal fluid measured by CT is able to estimate blood-cerebrospinal fluid-barrier permeability. This study aimed to assess cerebrospinal fluid specific gravity in acutely decompensated cirrhosis and to compare it in patients with or without ACLF and with or without hepatic encephalopathy. We identified all the patients admitted for acute decompensation of cirrhosis who underwent a brain CT-scan. Those patients could present acute decompensation with or without ACLF. The presence of hepatic encephalopathy was noted. They were compared to a group of stable cirrhotic patients and healthy controls. Quantitative brain CT analysis used the Brainview software that gives the weight, the volume and the specific gravity of each determined brain regions. Results are given as median and interquartile ranges and as relative variation compared to the control/baseline group. 36 patients presented an acute decompensation of cirrhosis. Among them, 25 presented with ACLF and 11 without ACLF; 20 presented with hepatic encephalopathy grade ≥ 2. They were compared to 31 stable cirrhosis patients and 61 healthy controls. Cirrhotic patients had increased cerebrospinal fluid specific gravity (CSF-SG) compared to healthy controls (+0.4 %, p encephalopathy did not modify CSF-SG (-0.09 %, p = 0.1757). Specific gravity did not differ between different brain regions according to the presence or absence of either ACLF or HE. In patients with acute decompensation of cirrhosis, and those with ACLF, CSF specific gravity is modified compared to both stable cirrhotic patients and healthy controls. This pattern is observed even in the absence of hepatic encephalopathy suggesting that blood-CSF barrier impairment is manifest even in absence of overt

  13. Plasma cystatin C is a predictor of renal dysfunction, acute-on-chronic liver failure, and mortality in patients with acutely decompensated liver cirrhosis.

    Science.gov (United States)

    Markwardt, Daniel; Holdt, Lesca; Steib, Christian; Benesic, Andreas; Bendtsen, Flemming; Bernardi, Mauro; Moreau, Richard; Teupser, Daniel; Wendon, Julia; Nevens, Frederik; Trebicka, Jonel; Garcia, Elisabet; Pavesi, Marco; Arroyo, Vicente; Gerbes, Alexander L

    2017-10-01

    The development of acute-on-chronic liver failure (ACLF) in patients with liver cirrhosis is associated with high mortality rates. Renal failure is the most significant organ dysfunction that occurs in ACLF. So far there are no biomarkers predicting ACLF. We investigated whether cystatin C (CysC) and neutrophil gelatinase-associated lipocalin (NGAL) can predict development of renal dysfunction (RD), hepatorenal syndrome (HRS), ACLF, and mortality. We determined the plasma levels of CysC and NGAL in 429 patients hospitalized for acute decompensation of cirrhosis in the EASL-CLIF Acute-on-Chronic Liver Failure in Cirrhosis (CANONIC) study. The patients were followed for 90 days. Patients without RD or ACLF at inclusion but with development of either had significantly higher baseline concentrations of CysC and NGAL compared to patients without. CysC, but not NGAL, was found to be predictive of RD (odds ratio, 9.4; 95% confidence interval [CI], 1.8-49.7), HRS (odds ratio, 4.2; 95% CI, 1.2-14.8), and ACLF (odds ratio, 5.9; 95% CI, 1.3-25.9). CysC at day 3 was not found to be a better predictor than baseline CysC. CysC and NGAL were both predictive of 90-day mortality, with hazard ratios for CysC of 3.1 (95% CI, 2.1-4.7) and for NGAL of 1.9 (95% CI, 1.5-2.4). Baseline CysC is a biomarker of RD, HRS, and ACLF and an independent predictor of mortality in patients with acutely decompensated liver cirrhosis, though determining CysC at day 3 did not provide any benefit; while NGAL is also associated with short-term mortality, it fails to predict development of RD, HRS, and ACLF. Baseline CysC may help to identify patients at risk earlier and improve clinical management. (Hepatology 2017;66:1232-1241). © 2017 by the American Association for the Study of Liver Diseases.

  14. Discordance of Patient-Reported and Clinician-Ordered Resuscitation Status in Patients Hospitalized With Acute Decompensated Heart Failure.

    Science.gov (United States)

    Young, Kathleen A; Wordingham, Sara E; Strand, Jacob J; Roger, Vėronique L; Dunlay, Shannon M

    2017-04-01

    Accurate documentation of preferences for cardiopulmonary resuscitation at hospital admission is critical to ensure that patients receive resuscitation or not in accordance with their wishes. We sought to identify and characterize inconsistencies in patient-reported and clinician-ordered resuscitation status in patients hospitalized with acute decompensated heart failure (ADHF). Southeastern Minnesota residents hospitalized with ADHF were prospectively enrolled into a study that included the administration of face-to-face questionnaires from January 2014 to February 2016. Patient-reported resuscitation status was assessed at enrollment using a validated question. Clinician-ordered resuscitation preferences at hospital admission were abstracted from the electronic medical record. Of the 400 patients administered the questionnaire; 213 (53.3%) stated their resuscitation preference as Full Code, 166 (41.5%) do-not-resuscitate (DNR), and 21 (5.3%) were unsure. In comparison, clinician-ordered resuscitation status was Full Code in 263 (65.8%) patients, DNR in 133 (33.3%), and not documented in four (1.0%). Patient-reported and clinician-ordered resuscitation status was discordant in 20% of patients, of whom 5.6% elected Full Code by questionnaire and had a DNR clinician order, and 14.4% elected DNR by questionnaire but had a Full Code clinician order. Differences in age, comorbidities, health literacy, marital status, completion of advance directives, hospital length of stay, and discharge destination in patients with discordant vs. concordant resuscitation preferences were observed. Patient-reported and clinician-ordered resuscitation preferences were discordant in 20% of patients hospitalized with ADHF. The underlying etiology of these inconsistencies may reflect factors such as patient indecisiveness or patient-clinician miscommunication and requires further exploration. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc

  15. Post-Exercise Heart Rate Recovery Independently Predicts Clinical Outcome in Patients with Acute Decompensated Heart Failure.

    Directory of Open Access Journals (Sweden)

    Jong-Chan Youn

    Full Text Available Post-exercise heart rate recovery (HRR is an index of parasympathetic function associated with clinical outcome in patients with chronic heart failure. However, its relationship with the pro-inflammatory response and prognostic value in consecutive patients with acute decompensated heart failure (ADHF has not been investigated.We measured HRR and pro-inflammatory markers in 107 prospectively and consecutively enrolled, recovered ADHF patients (71 male, 59 ± 15 years, mean ejection fraction 28.9 ± 14.2% during the pre-discharge period. The primary endpoint included cardiovascular (CV events defined as CV mortality, cardiac transplantation, or rehospitalization due to HF aggravation.The CV events occurred in 30 (28.0% patients (5 cardiovascular deaths and 7 cardiac transplantations during the follow-up period (median 214 days, 11-812 days. When the patients with ADHF were grouped by HRR according to the Contal and O'Quigley's method, low HRR was shown to be associated with significantly higher levels of serum monokine-induced by gamma interferon (MIG and poor clinical outcome. Multivariate Cox regression analysis revealed that low HRR was an independent predictor of CV events in both enter method and stepwise method. The addition of HRR to a model significantly increased predictability for CV events across the entire follow-up period.Impaired post-exercise HRR is associated with a pro-inflammatory response and independently predicts clinical outcome in patients with ADHF. These findings may explain the relationship between autonomic dysfunction and clinical outcome in terms of the inflammatory response in these patients.

  16. Prognostic Impact of BNP Variations in Patients Admitted for Acute Decompensated Heart Failure with In-Hospital Worsening Renal Function.

    Science.gov (United States)

    Stolfo, D; Stenner, E; Merlo, M; Porto, A G; Moras, C; Barbati, G; Aleksova, A; Buiatti, A; Sinagra, G

    2017-03-01

    The significance of worsening renal function (WRF) in patients admitted for acute decompensated heart failure (ADHF) is still controversial. We hypothesised that changes in brain natriuretic peptide (BNP) might identify patients with optimal diuretic responsiveness resulting in transient WRF, not negatively affecting the prognosis. Our aim was to verify if in-hospital trends of BNP might be helpful in the stratification of patients with WRF after treatment for ADHF. 122 consecutive patients admitted for ADHF were enrolled. Brain natriuretic peptide and eGFR were evaluated at admission and discharge. A 20% relative decrease in eGFR defined WRF, whereas a BNP reduction ≥40% was considered significant. The primary combined endpoint was death/urgent heart transplantation and re-hospitalisation for ADHF. Worsening renal function occurred in 23% of patients without differences in outcome between patients with and without WRF (43% vs. 45%, p=0.597). A significant reduction in BNP levels over the hospitalisation occurred in 59% of the overall population and in 71% of patients with WRF. At a median follow-up of 13.0 (IQR 6-36) months, WRF patients with ≥40% BNP reduction had a lower rate of death/urgent heart transplantation/re-hospitalisation compared to WRF patients without BNP reduction (30% and 75%, respectively; p=0.007). Favourable BNP trend was the strongest variable in predicting the outcome in WRF patients (HR 0.222, 95% CI 0.066-0.753, p=0.016). Worsening renal function does not affect the prognosis of ADHF and, when associated with a significant BNP reduction, identifies patients with adequate decongestion at discharge and favourable outcome. Copyright © 2016 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

  17. Ultrasound Assessment of Kidney Volume in Patients with Acute Decompensated Heart Failure: A Predictor of Diuretic Resistance.

    Science.gov (United States)

    Sugihara, Shinobu; Kinugasa, Yoshiharu; Takata, Tomoaki; Sugihara, Takaaki; Hosho, Keiko; Imai, Chitose; Ito, Hiromi; Yamada, Kensaku; Kato, Masahiko; Yamamoto, Kazuhiro

    2017-09-01

    Diuretics are essential for treating acute decompensated heart failure (ADHF), but the response is inconsistent. This study aimed to clarify whether kidney volume as assessed by ultrasound (US) predicts diuretic resistance in patients with ADHF. We enrolled 29 patients with ADHF and 32 controls. Height-adjusted kidney volume was assessed by US. We divided patients into two groups based on the median value of total daily use of furosemide (intravenous dose plus 0.5 × oral dose of furosemide equivalents) during 3 days from admission. Patients with ADHF had a significantly smaller left kidney volume than did control subjects (27.7 ± 10.0 vs. 32.8 ± 8.8 mL/m, P < 0.05). Patients in the high-dose furosemide group (≥ 51.7 mg/d) had a significantly lower estimated glomerular filtration rate (eGFR) and a significantly smaller kidney volume than did those in the low-dose furosemide group (eGFR: 43.9 ± 20.4 vs. 60.8 ± 21.6 mL/min/1.73 m2, left kidney volume: 23.2 ± 5.2 vs. 32.6 ± 11.0 mL/m, right kidney volume: 26.5 ± 7.5 vs. 32.6 ± 7.9 mL/m, all P < 0.05). Multivariate logistic analysis showed that left kidney volume, but not eGFR, was independently associated with the requirement of high-dose furosemide (odds ratio: 0.856, 95% confidence interval: 0.735-0.997, P < 0.05). Kidney volume as assessed by US is a useful predictor of diuretic resistance in patients with ADHF.

  18. Comparison of risk prediction with the CKD-EPI and MDRD equations in acute decompensated heart failure.

    Science.gov (United States)

    Manzano-Fernández, Sergio; Flores-Blanco, Pedro J; Pérez-Calvo, Juan I; Ruiz-Ruiz, Francisco J; Carrasco-Sánchez, Francisco J; Morales-Rull, José L; Galisteo-Almeda, Luis; Pascual-Figal, Domingo; Valdes, Mariano; Januzzi, James L

    2013-08-01

    Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations estimate glomerular filtration rate (eGFR) more accurately than the Modification of Diet in Renal Disease (MDRD) equation. The aim of this study was to evaluate whether CKD-EPI equations based on serum creatinine and/or cystatin C (CysC) predict risk for adverse outcomes more accurately than the MDRD equation in a hospitalized cohort of patients with acute decompensated heart failure (ADHF). A total of 526 subjects with ADHF were studied. Blood was collected within 48 hours from admission. eGFR was calculated with the use of MDRD and CKD-EPI equations. The occurrences of mortality and heart failure (HF) hospitalization were recorded. Over the study period (median 365 days [interquartile range 238-370]), 305 patients (58%) died or were rehospitalized for HF. Areas under the receiver operator characteristic curves for CKD-EPI CysC and CKD-EPI creatinine-CysC equations were significantly higher than that for the MDRD equation, especially in patients with >60 mL min(-1) 1.73 m(-2). After multivariate adjustment, all eGFR equations were independent predictors of adverse outcomes (P EPI CysC and CKD-EPI creatinine-CysC equations were associated with significant improvement in reclassification analyses (net reclassification improvements 10.8% and 12.5%, respectively). In patients with ADHF, CysC-based CKD-EPI equations were superior to the MDRD equation for predicting mortality and/or HF hospitalization especially in patients with >60 mL min(-1) 1.73 m(-2), and both CKD-EPI equations improved clinical risk stratification. Copyright © 2013 Elsevier Inc. All rights reserved.

  19. A comparison of precipitants and mortality when acute decompensated heart failure occurs in the community and hospital settings.

    Science.gov (United States)

    Taylor, D McD; Fui, M Ng Tang; Chung, A R; Gani, L; Zajac, J D; Burrell, L M

    2012-08-01

    We aimed to compare the precipitants of acute decompensated heart failure (ADHF) among patients admitted with diagnoses inclusive of ADHF (community patients) and patients admitted without ADHF but who developed it during their stay (hospital patients). This was a prospective, analytical, observational study undertaken in the Austin Hospital, a major metropolitan teaching hospital (September 2008-February 2010). Consecutive patients admitted to a general medicine unit, and diagnosed and treated for ADHF were enrolled. The unit medical staff completed a specifically designed data collection document. Three hundred and fifty-nine patients were enrolled (42.9% male, mean age 81.9 years). The community (n=312) and hospital (n=47) patient groups did not differ in age, gender, risk variables (living alone, cognitive impairment, multiple medications, compliance), cardiac failure medication use or cause of known heart failure (ischaemia, hypertension, valve dysfunction, 'other') (p>0.05). The ADHF precipitants comprised infection (39.8% patients), myocardial ischaemia (17.3%), tachyarrhythmia (16.2%), non-compliance with fluid and salt restriction (9.2%), non-compliance with medication (6.7%), renal failure (5.8%), medication reduction (5.0%), intravenous fluid complication (3.9%) and 'other' causes (13.9%). Significantly more hospital patients had their ADHF precipitated by intravenous fluid complications (25.5% versus 0.6%, pheart failure precipitated in hospital is a dangerous condition with a high mortality. While infection and myocardial ischaemia are the common precipitants, complications of intravenous fluid use, an iatrogenic condition, may be considerable and are potentially avoidable. Copyright © 2012 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

  20. Exercise capacity independently predicts bone mineral density and proximal femoral geometry in patients with acute decompensated heart failure.

    Science.gov (United States)

    Youn, J-C; Lee, S J; Lee, H S; Oh, J; Hong, N; Park, S; Lee, S-H; Choi, D; Rhee, Y; Kang, S-M

    2015-08-01

    Heart failure is associated with increased risk of osteoporosis. We evaluated the prevalence and predictors of osteoporosis in hospitalized patients with ADHF using quantitative computed tomography. Osteoporosis and vertebral fracture are prevalent in patients with ADHF and exercise capacity independently predicts bone mass and femoral bone geometry. Heart failure is associated with reduced bone mass and increased risk of osteoporotic fractures. However, the prevalence and predictors of osteoporosis in hospitalized patients with acute decompensated heart failure (ADHF) are not well understood. Sixty-five patients (15 postmenopausal females and 50 males) with ADHF were prospectively and consecutively enrolled. After stabilization of heart failure symptoms, quantitative computed tomography for bone mineral density (BMD) and femoral geometry as well as biochemical, echocardiographic, and cardiopulmonary exercise tests were performed. Fifteen postmenopausal female showed a high prevalence of osteoporosis (40%) and vertebral fracture (53%). Among 50 male patients, 12% had osteoporosis and 32% had osteopenia, while vertebral fracture was found in 12%. Lumbar volumetric BMD (vBMD) was significantly lower in ischemic patients than non-ischemic patients (107.9 ± 47.5 vs. 145.4 ± 40.9 mg/cm(3), p = 0.005) in male. Exercise capacity, indicated by peak oxygen consumption (VO2), was significantly associated with lumbar vBMD (r = 0.576, p fracture are prevalent, and exercise capacity independently predicts bone mass and geometry. Given that heart failure patients with reduced exercise capacity carry a substantial increased risk of fracture, proper osteoporosis evaluation is important in these patients.

  1. Comparison of management and outcomes of ED patients with acute decompensated heart failure between the Canadian and United States' settings.

    Science.gov (United States)

    Lai, Anita; Tenpenny, Elliott; Nestler, David; Hess, Erik; Stiell, Ian G

    2016-03-01

    Introduction The objective of this study was to compare the emergency department (ED) management and rate of admission of acute decompensated heart failure (ADHF) between two hospitals in Canada and the United States and to compare the outcomes of these patients. This was a health records review of adults presenting with ADHF to two EDs in Canada and the United States between January 1 and April 30, 2010. Outcome measures were admission to the hospital, myocardial infarction (MI), and death or relapse rates to the ED. Data were analysed using descriptive, univariate and multivariate analyses. In total, 394 cases were reviewed and 73 were excluded. Comparing 156 Canadian to 165 U.S. patients, respectively, mean age was 76.0 and 75.8 years; male sex was 54.5% and 52.1%. Canadian and U.S. ED treatments were noninvasive ventilation 7.7% v. 12.8% (p=0.13); IV diuretics 77.6% v. 36.0% (p3.0 hours, p<0.001). Proportion of Canadian and U.S. patients who died within 30 days of the ED visit was 5.1% v. 9.7% (p=0.12); relapsed to the ED within 30 days was 20.8% v. 17.5% (p=0.5); and had MI within 30 days was 2.0% v. 1.9% (p=1.0). The U.S. and Canadian centres saw ADHF patients with similar characteristics. Although the U.S. site had almost double the admission rate, the outcomes were similar between the sites, which question the necessity of routine admission for patients with ADHF.

  2. Hypertonic saline plus i.v. furosemide improve renal safety profile and clinical outcomes in acute decompensated heart failure: A meta-analysis of the literature.

    Science.gov (United States)

    De Vecchis, R; Esposito, C; Ariano, C; Cantatrione, S

    2015-05-01

    In advanced congestive heart failure (CHF), intravenous (i.v.) inotropic agents, i.v. diuretics, ultrafiltration, and hemodialysis have been shown to not yield better clinical outcomes. In this scenario, the simultaneous administration of hypertonic saline solution (HSS) and furosemide may offer a more effective therapeutic option with a good safety profile. Therefore, a meta-analysis was performed to compare combined therapy, consisting of i.v. furosemide plus concomitant administration of HSS, with i.v. furosemide alone for acute decompensated heart failure (ADHF). The outcomes we chose were all-cause mortality, risk of re-hospitalization for ADHF, length of hospital stay, weight loss, and variation of serum creatinine. Based on five randomized controlled trials (RCTs) involving 1,032 patients treated with i.v. HSS plus furosemide vs. 1,032 patients treated with i.v. furosemide alone, a decrease in all-cause mortality in patients treated with HSS plus furosemide was proven [RR = 0.57; 95 % confidence interval (CI) = 0.44-0.74, p = 0.0003]. Likewise, combined therapy with HSS plus furosemide was shown to be associated with a reduced risk of ADHF-related re-hospitalization (RR = 0.51; 95 % CI = 0.35-0.75, p = 0.001). Besides, combined therapy with HSS plus furosemide was found to be associated with a reduced length of hospital stay (p = 0.0002), greater weight loss (p furosemide for diuretic-resistant CHF patients led to a better renal safety profile and improved clinical endpoints such as mortality and heart failure-related hospitalizations.

  3. Efficacy and safety of high dose versus low dose furosemide with or without dopamine infusion: the Dopamine in Acute Decompensated Heart Failure II (DAD-HF II) trial.

    Science.gov (United States)

    Triposkiadis, Filippos K; Butler, Javed; Karayannis, Georgios; Starling, Randall C; Filippatos, Gerasimos; Wolski, Kathy; Parissis, John; Parisis, Charalabos; Rovithis, Dimitrios; Koutrakis, Konstantinos; Skoularigis, John; Antoniou, Christos-Konstantinos; Chrysohoou, Christina; Pitsavos, Christos; Stefanadis, Christodoulos; Nastas, John; Tsaknakis, Themistoklis; Mantziari, Lilian; Giannakoulas, Georgios; Karvounis, Haralambos; Kalogeropoulos, Andreas P; Giamouzis, Gregory

    2014-03-01

    The role of low-dose dopamine infusion in patients with acute decompensated heart failure (ADHF) remains controversial. We aim to evaluate the efficacy and safety of high- versus low-dose furosemide with or without low-dose dopamine infusion in this patient population. 161 ADHF patients (78 years; 46% female; ejection fraction 31%) were randomized to 8-hour continuous infusions of: a) high-dose furosemide (HDF, n=50, 20mg/h), b) low-dose furosemide and low-dose dopamine (LDFD, n=56, 5mg/h and 5 μg kg(-1)min(-1) respectively), or c) low-dose furosemide (LDF, n=55, furosemide 5mg/h). The main outcomes were 60-day and one-year all-cause mortality (ACM) and hospitalization for HF (HHF). Dyspnea relief (Borg index), worsening renal function (WRF, rise in serum creatinine (sCr) ≥ 0.3mg/dL), and length of stay (LOS) were also assessed. The urinary output at 2, 4, 6, 8, and 24h was not significantly different in the three groups. Neither the ACM at day 60 (4.0%, 7.1%, and 7.2%; P=0.74) or at one year (38.1%, 33.9% and 32.7%, P=0.84) nor the HHF at day 60 (22.0%, 21.4%, and 14.5%, P=0.55) or one year (60.0%, 50.0%, and 47%, P=0.40) differed between HDF, LDFD, and LDF groups, respectively. No differences in the Borg index or LOS were noted. WRF was higher in the HDF than in LDFD and LDF groups at day 1 (24% vs. 11% vs. 7%, Pfurosemide infusion; the addition of low-dose dopamine infusion was not associated with any beneficial effects. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  4. Raloxifene Plus Antipsychotics Versus Placebo Plus Antipsychotics in Severely Ill Decompensated Postmenopausal Women With Schizophrenia or Schizoaffective Disorder: A Randomized Controlled Trial.

    Science.gov (United States)

    Weiser, Mark; Levi, Linda; Burshtein, Shimon; Hagin, Michal; Matei, Valentin P; Podea, Delia; Micluția, Ioana; Tiugan, Alexandru; Păcală, Bogdan; Grecu, Iosif Gabos; Noy, Adam; Zamora, Daisy; Davis, John M

    2017-07-01

    Several single-center studies have found raloxifene, an estrogen agonist, to be effective in ameliorating symptoms of schizophrenia in stable patients as augmentation of antipsychotics. This multicenter study assessed whether raloxifene plus antipsychotic treatment, in comparison to placebo plus antipsychotics, improves symptoms or cognition in severely ill decompensated schizophrenia patients. In this 16-week, double-blind, randomized, placebo-controlled study, 200 severely ill, decompensated postmenopausal women who met DSM-IV-TR criteria for schizophrenia or schizoaffective disorder were recruited from January 2011 to December 2012 and were randomized to receive either raloxifene 120 mg/d plus antipsychotics or placebo plus antipsychotics. The primary outcome measure was Positive and Negative Syndrome Scale (PANSS) total score at the end of the trial. The placebo plus antipsychotics group experienced statistically significant improvement in PANSS total score (P raloxifene plus antipsychotics group, using mixed models for repeated measures, with results favoring placebo by 4.5 points (95% CI, 2.3-6.7). These results were clearly outside the 95% confidence interval. This negative effect was more pronounced in patients who had more frequent relapses and in those with baseline PANSS scores of 100 or higher. There were no differences between groups in Clinical Global Impression Scale-Severity scores or Composite Brief Assessment of Cognition in Schizophrenia scores at 16 weeks (P > .3). Baseline follicle-stimulating hormone and estradiol levels did not alter the drug-placebo differences. Individuals in the active treatment arm showed worse outcome than those in the placebo arm, most likely as a result of chance variation, but the results unequivocally show no benefit of antipsychotics plus raloxifene versus antipsychotics plus placebo in this large randomized, double-blind, placebo-controlled trial in postmenopausal women. These data do not support the use of

  5. Effect of ultrafiltration versus intravenous furosemide for decompensated heart failure in cardiorenal syndrome: a systematic review with meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Chen, Hsin-Yu; Chou, Kang-Ju; Fang, Hua-Chang; Chen, Chien-Liang; Hsu, Chih-Yang; Huang, Wei-Chieh; Huang, Chien-Wei; Huang, Chun Kai; Lee, Po-Tsang

    2015-01-01

    Ultrafiltration is an adjunctive treatment for decompensated heart failure patients with cardiorenal syndrome. The efficacy and safety of ultrafiltration in the patient cohort are still unknown. We systematically reviewed and evaluated randomized controlled trials, comparing diuretics with ultrafiltration in adult patients with decompensated heart failure and cardiorenal syndrome through January 2014. The primary outcomes were body weight loss and total fluid removal. We identified 8 trials including 608 patients. In a random-effects model, the pooled difference of body weight loss was 1.44 kg between patients receiving ultrafiltration and diuretics (95% CI, 0.29-2.59; p = 0.01). The difference of fluid removal was 1.28 l between groups (95% CI, 0.43-2.12; p = 0.003). The RR for mortality was 0.90 for ultrafiltration compared with diuretics (95% CI, 0.61-1.33; p = 0.60) and the RR for renal function deterioration was 1.29 (95% CI, 0.90-1.85; p = 0.17). There is a trend toward reducing readmission rate in ultrafiltration group. Ultrafiltration is a safe and effective strategy in the treatment of cardiorenal syndrome without increasing the risk of renal deterioration.

  6. MR spectroscopy-based brain metabolite profiling in propionic acidaemia: metabolic changes in the basal ganglia during acute decompensation and effect of liver transplantation

    Directory of Open Access Journals (Sweden)

    McKiernan Patrick J

    2011-05-01

    replenish a compromised Krebs cycle and that this is a marker of compromised aerobic respiration within brain tissue. Thus there is a need for improved brain protective strategies during acute metabolic decompensations. MRS provides a non-invasive tool for which could be employed to evaluate novel treatments aimed at restoring basal ganglia homeostasis. The results from the liver transplantation sub-group supports the hypothesis that liver transplantation provides systemic metabolic stability by providing a hepatic pool of functional propionyl CoA carboxylase, thus preventing further acute decompensations which are associated with the risk of brain infarction.

  7. Associations of anemia and renal dysfunction with outcomes among patients hospitalized for acute decompensated heart failure with preserved or reduced ejection fraction.

    Science.gov (United States)

    Kajimoto, Katsuya; Sato, Naoki; Keida, Takehiko; Sakata, Yasushi; Takano, Teruo

    2014-11-07

    The relationship among anemia, renal dysfunction, left ventricular ejection fraction, and outcomes of patients hospitalized for acute decompensated heart failure is unclear. The aim of this study was to evaluate the association between cardiorenal anemia syndrome and postdischarge outcomes in patients hospitalized for heart failure with a preserved or reduced ejection fraction. Of 4842 patients enrolled in the Acute Decompensated Heart Failure Syndromes Registry between April 1, 2007 and December 31, 2011, 4393 patients were evaluated to investigate the association among anemia, renal dysfunction, preserved or reduced ejection fraction, and the primary end point (mortality and readmission for heart failure since discharge). The patients were divided into four groups on the basis of eGFR and hemoglobin at discharge. The median follow-up period after discharge was 432 (range=253-659) days. The primary end point was reached in 37.6% and 34.8% of the preserved and reduced ejection fraction groups, respectively. After adjustment for multiple comorbidities, there was no significant association of either renal dysfunction or anemia alone with the primary end point in patients with preserved ejection fraction, but the combination of renal dysfunction and anemia was associated with a significantly higher risk than that without either condition (hazard ratio, 1.54; 95% confidence interval, 1.12 to 2.12; Prenal dysfunction alone (hazard ratio, 1.65; 95% confidence interval, 1.21 to 2.25; P=0.002) and also, renal dysfunction plus anemia relative to the risk without either condition (hazard ratio, 2.19; 95% confidence interval, 1.62 to 2.96; Prenal dysfunction combined with anemia is associated with an increased risk of adverse postdischarge outcomes in patients with preserved ejection fraction, whereas renal dysfunction is an independent predictor of the risk of adverse outcomes in patients with reduced ejection fraction, regardless of anemia. Copyright © 2014 by the American

  8. Effects of Tolvaptan With or Without the Pre-Administration of Renin-Angiotensin System Blockers in Hospitalized Patients With Acute Decompensated Heart Failure.

    Science.gov (United States)

    Adachi, Sen; Miura, Shin-Ichiro; Shiga, Yuhei; Arimura, Tadaaki; Morii, Joji; Kuwano, Takashi; Kitajima, Ken; Iwata, Atsushi; Morito, Natsumi; Fujimi, Kanta; Yahiro, Eiji; Nishikawa, Hiroaki; Saku, Keijiro

    2017-05-31

    We examined whether tolvaptan combined with an angiotensin II receptor blocker (ARB) or angiotensin converting enzyme inhibitor (ACE-I) is more effective than tolvaptan alone in the treatment of patients with heart failure (HF). Sixty-five hospitalized patients with acute decompensated HF were included in this study. They were divided into 2 groups; an ARB/ACE-I group (n = 44, who received ARB or ACE-I before the use of tolvaptan) and a non-ARB/ACE-I group (n = 21). There were no significant differences in patient characteristics including medications at baseline between the non-ARB/ACE-I and ARB/ACE-I groups with the exception of the percentages of hypertension and ischemic heart disease. Urinary volume (UV) at baseline in the ARB/ACE-I group was slightly higher than that in the non-ARB/ACE-I group. The increase in UV after the use of tolvaptan in the non-ARB/ACE-I group was significantly higher than that in the ARB/ACE-I group. The cardiothoracic ratio and the reduction in body weight were similar between the groups after tolvaptan use. Finally, in a logistic regression analysis, a response to the use of tolvaptan was independently associated with the non-use of ARB/ACE-I, but not with age, gender, body mass index, loop diuretic, or human arterial natriuretic peptide. In conclusion, tolvaptan alone might induce an increase in UV in decompensated HF patients without ARB/ ACE-I, although the treatment of HF with ARB/ACE-I is the first choice strategy.

  9. Ultrafiltration versus usual care for hospitalized patients with heart failure: the Relief for Acutely Fluid-Overloaded Patients With Decompensated Congestive Heart Failure (RAPID-CHF) trial

    National Research Council Canada - National Science Library

    Bart, Bradley A; Boyle, Andrew; Bank, Alan J; Anand, Inder; Olivari, Maria Teresa; Kraemer, Mark; Mackedanz, Shari; Sobotka, Paul A; Schollmeyer, Mike; Goldsmith, Steven R

    2005-01-01

    ...) in patients admitted with decompensated congestive heart failure (CHF). Ultrafiltration for CHF is usually reserved for patients with renal failure or those unresponsive to pharmacologic management...

  10. Association of haemodynamic changes measured by serial central venous saturation during ultrafiltration for acutely decompensated heart failure with diuretic resistance and change in renal function.

    Science.gov (United States)

    Vazir, Ali; Simpkin, Victoria L; Marino, Philip; Ludman, Andrew; Banya, Winston; Tavazzi, Guido; Bastin, Anthony J; Trenfield, Sarah; Ghori, Arshad; Alexander, Peter D; Griffiths, Mark; Price, Susanna; Sharma, Rakesh; Cowie, Martin R

    2016-10-01

    Patients with acute decompensated heart failure with diuretic resistance (ADHF-DR) have a poor prognosis. The aim of this study was to assess in patients with ADHF-DR, whether haemodynamic changes during ultrafiltration (UF) are associated with changes in renal function (Δcreatinine) and whether Δcreatinine post UF is associated with mortality. Seventeen patients with ADHF-DR underwent 20 treatments with UF. Serial bloods (4-6 hourly) from the onset of UF treatment were measured for renal function, electrolytes and central venous saturation (CVO2). Univariate and multivariate analysis were performed to assess the relationship between changes in markers of haemodynamics [heart rate (HR), systolic blood pressure (SBP), packed cell volume (PCV) and CVO2] and Δcreatinine. Patients were followed up and mortality recorded. Cox-regression survival analysis was performed to determine covariates associated with mortality. Renal function worsened after UF in 17 of the 20 UF treatments (baseline vs. post UF creatinine: 164±58 vs. 185±69μmol/l, Pchanges in SBP, HR and PCV [Pchanges during UF as measured by the surrogate of cardiac output was associated with Δcreatinine. Worsening renal function at end of UF treatment occurred in the majority of patients and was associated with mortality. Copyright © 2016. Published by Elsevier Ireland Ltd.

  11. Clinical findings and prognosis of patients hospitalized for acute decompensated heart failure: Analysis of the influence of Chagas etiology and ventricular function

    Science.gov (United States)

    Moreira, Henry Fukuda; Ayub-Ferreira, Silvia Moreira; Conceição-Souza, Germano Emilio; Salemi, Vera Maria Cury; Chizzola, Paulo Roberto; Oliveira, Mucio Tavares; Lage, Silvia Helena Gelas; Bocchi, Edimar Alcides; Issa, Victor Sarli

    2018-01-01

    Aims Explore the association between clinical findings and prognosis in patients with acute decompensated heart failure (ADHF) and analyze the influence of etiology on clinical presentation and prognosis. Methods and results Prospective cohort of 500 patients admitted with ADHF from Aug/2013-Feb/2016; patients were predominantly male (61.8%), median age was 58 (IQ25-75% 47–66 years); etiology was dilated cardiomyopathy in 141 (28.2%), ischemic heart disease in 137 (27.4%), and Chagas heart disease in 113 (22.6%). Patients who died (154 [30.8%]) or underwent heart transplantation (53[10.6%]) were younger (56 years [IQ25-75% 45–64 vs 60 years, IQ25-75% 49–67], P = 0.032), more frequently admitted for cardiogenic shock (20.3% vs 6.8%, Pheart transplant was higher among patients with Chagas (50.5%). Conclusions A physical exam may identify patients at higher risk in a contemporaneous population. Our findings support specific therapies targeted at Chagas patients in the setting of ADHF. PMID:29432453

  12. Comparative evaluation of copeptin and NT-proBNP in patients with severe acute decompensated heart failure, and prediction of adverse events in a 90-day follow-up period: A prospective clinical observation trial.

    Science.gov (United States)

    Jia, Jun; Chang, Guang-Lei; Qin, Shu; Chen, Jia; He, Wen-Yan; Lu, Kai; Li, Yong; Zhang, Dong-Ying

    2017-04-01

    The present study compared the prognostic value of a marker, the C-terminal section of the arginine vasopressin prohormone (copeptin), with N-terminal B-type natriuretic peptide (NT-proBNP) in patients with severe acute decompensated heart failure. A prospective, observational cohort study was conducted in a tertiary care hospital and enrolled 129 patients with severe acute decompensated heart failure. Clinicians were blinded to investigational markers except NT-proBNP, and the study participants were followed up for 90 days. The end-point was a composite of cardiovascular death or re-hospitalization due to decompensated heart failure. Of the 129 patients enrolled, 47 reached the end-point and 82 were in a stable condition during follow-up. Receiver operating characteristic curve analysis revealed that the areas under curve for the prediction of adverse events within 90 days were similar for copeptin [0.602±0.052; 95% confidence interval (CI), 0.499-0.705], NT-proBNP (0.659±0.048; 95% CI, 0.565-0.753) and their combination (0.670±0.050; 95% CI, 0.573-0.767). Kaplan-Meier survival analysis showed that the predictive value of NT-proBNP regarding the probability of survival was superior compared with that of copeptin (log-rank test for trend, P=0.001 vs. 0.040). Furthermore, multivariate Cox proportional-hazards regression analysis revealed that increased NT-proBNP and copeptin plasma concentrations were significant independent predictors of adverse events. The present study provided evidence that copeptin has similar predictive properties compared with NT-proBNP regarding adverse events within 90-days in patients with severe acute decompensated heart failure, but that copeptin may not provide superior 90-day prediction compared to NT-proBNP.

  13. Evaluation of cardiac sympathetic nerve activity and aldosterone suppression in patients with acute decompensated heart failure on treatment containing intravenous atrial natriuretic peptide

    Energy Technology Data Exchange (ETDEWEB)

    Kasama, Shu [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Cardiovascular Hospital of Central Japan (Kitakanto Cardiovascular Hospital), Department of Cardiovascular Medicine, Gunma (Japan); Toyama, Takuji; Kurabayashi, Masahiko [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Iwasaki, Toshiya; Sumino, Hiroyuki; Kumakura, Hisao; Minami, Kazutomo; Ichikawa, Shuichi [Cardiovascular Hospital of Central Japan (Kitakanto Cardiovascular Hospital), Department of Cardiovascular Medicine, Gunma (Japan); Matsumoto, Naoya [Nihon University School of Medicine, Department of Cardiology, Tokyo (Japan); Nakata, Tomoaki [Sapporo Medical University School of Medicine, Second (Cardiology) Department of Internal Medicine, Sapporo, Hokkaido (Japan)

    2014-09-15

    Aldosterone prevents the uptake of norepinephrine in the myocardium. Atrial natriuretic peptide (ANP), a circulating hormone of cardiac origin, inhibits aldosterone synthase gene expression in cultured cardiocytes. We evaluated the effects of intravenous ANP on cardiac sympathetic nerve activity (CSNA) and aldosterone suppression in patients with acute decompensated heart failure (ADHF). We studied 182 patients with moderate nonischemic ADHF requiring hospitalization and treated with standard therapy containing intravenous ANP and 10 age-matched normal control subjects. ANP was continuously infused for >96 h. In all subjects, delayed total defect score (TDS), heart to mediastinum ratio, and washout rate were determined by {sup 123}I-metaiodobenzylguanidine (MIBG) scintigraphy. Left ventricular (LV) end-diastolic volume, end-systolic volume, and ejection fraction were determined by echocardiography. All patients with acute heart failure (AHF) were examined once within 3 days and then 4 weeks after admission, while the control subjects were examined only once (when their hemodynamics were normal). Moreover, for 62 AHF patients, plasma aldosterone concentrations were measured at admission and 1 h before stopping ANP infusion. {sup 123}I-MIBG scintigraphic and echocardiographic parameters in normal subjects were more favorable than those in patients with AHF (all p < 0.001). After treatment, all these parameters improved significantly in AHF patients (all p < 0.001). We also found significant correlation between percent changes of TDS and aldosterone concentrations (r = 0.539, p < 0.001) in 62 AHF patients. The CSNA and LV performance were all improved in AHF patients. Furthermore, norepinephrine uptake of myocardium may be ameliorated by suppressing aldosterone production after standard treatment containing intravenous ANP. (orig.)

  14. Effects of ventriculoarterial coupling changes on renal function, echocardiographic indices and energy efficiency in patients with acute decompensated systolic heart failure under furosemide and dopamine treatment: a comparison of three therapeutic protocols.

    Science.gov (United States)

    Antoniou, Christos-Konstantinos; Chrysohoou, Christina; Lerakis, Stamatios; Manolakou, Panagiota; Pitsavos, Christos; Tsioufis, Konstantinos; Stefanadis, Christodoulos; Tousoulis, Dimitrios

    2015-11-15

    Ventriculoarterial coupling (VAC) status relates to tissue perfusion and its optimization may improve organ function and energy efficiency (EE) of the cardiovascular system. The effects of non-invasively calculated VAC improvement on echocardiographic parameters, renal function indices and EE improvement in patients with acute decompensated systolic heart failure were studied. Furthermore, effects of different treatment modalities on VAC, renal function and echocardiographic parameters were compared. Systolic heart failure patients with ejection fraction Renal function was evaluated using serum creatinine and creatinine clearance. VAC and EE were assessed noninvasively, by echocardiography. Significant correlations were noted between VAC improvement and improvements in EE and serum creatinine (rho=0.96, pacute decompensated systolic heart failure. Dopamine and furosemide combination seemed to improve VAC and diastolic function but only had a borderline effect on renal function. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. Insufficient reduction in heart rate during hospitalization despite beta-blocker treatment in acute decompensated heart failure: insights from the ASCEND-HF trial.

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    Kitai, Takeshi; Grodin, Justin L; Mentz, Robert J; Hernandez, Adrian F; Butler, Javed; Metra, Marco; McMurray, John J; Armstrong, Paul W; Starling, Randall C; O'Connor, Christopher M; Swedberg, Karl; Tang, W H Wilson

    2017-02-01

    Heart failure (HF) can be associated with a higher resting heart rate (HR), and an elevated HR is associated with adverse long-term events. However, the mechanistic and causal role of HR in HF is unclear. This study aimed to investigate changes in HR during hospitalization, and the association between discharge HR and clinical outcomes as well as an interaction with beta-blocker therapy in patients with acute decompensated HF (ADHF). We studied 2906 patients with an LVEF ≤35%, without AF, who were enrolled in the ASCEND-HF trial. A total of 2492 (85.8%) patients had a HR ≥70 b.p.m. at baseline and 1580 (54.4%) patients were on beta-blocker treatment. Although HR was gradually reduced from baseline to discharge (85.5 ± 15.9 b.p.m. at baseline, 81.7 ± 14.1 b.p.m. at 24 h from treatment initiation, and 79.1 ± 12.2 b.p.m. at discharge), 80.2% of the patients still had a HR ≥70 b.p.m. at discharge. Patients with a HR ≥70 b.p.m. at discharge had significantly lower survival rates than those with a HR beta-blocker therapy at discharge (P = 0.82). Despite current beta-blocker therapy, many patients with hospitalized ADHF with reduced LVEF have relatively high discharge HR, and discharge HR is associated with higher mortality. Further studies are warranted to determine the optimal strategy for HR control to improve outcomes. © 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.

  16. Mortality and readmission rates in patients hospitalized for acute decompensated heart failure: a comparison between cardiology and general-medicine service outcomes in an underserved population.

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    Selim, Ahmed M; Mazurek, Jeremy A; Iqbal, Muhammad; Wang, Dan; Negassa, Abdissa; Zolty, Ronald

    2015-03-01

    With recent legislation imposing penalties on hospitals for above-average 30-day all-cause readmissions for patients with acute decompensated heart failure (ADHF), there is concern these penalties will more heavily impact hospitals serving socioeconomically vulnerable and underserved populations. Patients with ADHF and low socioeconomic status have better postdischarge mortality and readmission outcomes when cardiologists are involved in their in-hospital care. We retrospectively searched the electronic medical record for patients hospitalized for ADHF from 2001 to 2010 in 3 urban hospitals within a large university-based health system. These patients were divided into 2 groups based on whether a cardiologist was involved in their care or not. Measured outcomes were 30- and 60-day postdischarge mortality and readmission rates. Out of the 7516 ADHF patients, 1434 patients were seen by a cardiologist (19%). These patients had lower 60-day mortality (5.4% vs 7.0%; hazard ratio [HR]: 0.70, 95% confidence interval [CI]: 0.52-0.96, P = 0.034) and lower 30- and 60-day readmission rates (16.7% vs 20.6%; HR: 0.76, 95% CI: 0.66-0.89, P = 0.002, and 26.1% vs 30.2%; HR: 0.81, 95% CI: 0.72-0.92, P = 0.003, respectively). There was no significant difference in the in-hospital mortality between the 2 groups. Compared with other races, whites with systolic HF have marginally lower HF-related readmission rates when treated by cardiologists. In this cohort of ADHF patients from the Bronx, New York, involvement of a cardiologist resulted in improved short-term mortality and readmission outcomes compared with treatment by general internal medicine. © 2015 Wiley Periodicals, Inc.

  17. The Effect of Furosemide Dose Administered in the Out-of-hospital Setting on Renal Function Among Patients with Suspected Acute Decompensated Heart Failure.

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    Nieves, L Celeste; Mehrtens, Gia M; Pores, Noah; Pickrell, Christie; Tanis, James; Satty, Timothy; Chuang, Michelle; Young, Tina C; Merlin, Mark A

    2015-02-01

    The most effective dose of prehospital furosemide in acute decompensated heart failure (ADHF) has not yet been identified and concerns of worsening renal function have limited its use. To assess if administering high-dose furosemide is associated with worsening renal function. The authors conducted a 2-center chart review for patients who presented via a single Emergency Medical Service (EMS) from June 5, 2009 through May 17, 2013. Inclusion criteria were shortness of breath, primarily coded as ADHF, and the administration of furosemide prior to emergency department (ED) arrival. A total of 331 charts were identified. The primary endpoint was an increase in creatinine (Cr) of more than 0.3 mg/dL from admission to any time during hospital stay. Exploratory endpoints included survival, length-of-stay (LOS), disposition, urine output in the ED, change in BUN/Cr from admission to discharge, and change in Cr from admission to 72 hours and discharge. When treated as a binary variable, there was no association observed between an increase in Cr of more than 0.3 mg/dL and prehospital furosemide dose. Baseline characteristics found to be associated with dose were included in the logistic regression model. Lowering the dose of prehospital furosemide was associated with higher odds of attaining a 0.3 mg/dL increase in Cr (adjusted OR = 1.49 for a 20 mg decrease; P = .019). There was no association found with any of the exploratory endpoints. Patients who received higher doses of furosemide prehospitally were less likely to have an increase of greater than 0.3 mg/dL in Cr during the hospital course.

  18. [The APULIA HF multicenter study: efficacy of a management protocol shared between hospital and territorial health services for acute decompensated heart failure patients].

    Science.gov (United States)

    Iacoviello, Massimo; Pede, Sergio; Aspromonte, Nadia; Bux, Francesca; Panunzio, Mariligia; Donadeo, Vittorio; De Castro, Alessandra; Antoncecchi, Ettore; D'Amato, Nicola; Squiccimarro, Elisabetta; Silvestri, Bartolomeo; Malerba, Lucia; De Gennaro, Luisa; Modugno, Giuseppe; Serafini, Elena; Curci, Biagio; Grande, Dario; Colivicchi, Furio; De Luca, Giovanni; Ignone, Gianfranco; D'Agostino, Carlo; Caldarola, Pasquale

    2017-02-01

    The aim of this study was to demonstrate the efficacy of a management model to reduce hospitalizations in patients recently admitted for acute decompensated heart failure. The management model was based on a close integration between hospital and territory health services. Clinical evaluation, ECG, echocardiographic findings, total body bioimpedance and brain natriuretic peptide serum levels were used to assess clinical stability of patients at discharge and during follow-up. A dedicated nurse (care manager) was involved in patient empowerment, telephone follow-up, check of adherence to therapy and clinical conditions, and management of scheduled evaluations. All hospitalizations occurring prior to or after enrolment in the municipalities involved in the study were considered, as well as the hospitalizations occurring among enrolled patients. A total of 301 patients were enrolled, 226 of them from the Centers of the Puglia Region, Italy. An overall reduction of 6% in total hospitalizations with DRG 127 was observed; the reduction was most evident in the two centers with the smaller reference population (-16% and -26%, respectively). In the group of patients enrolled, an overall reduction in hospital admissions was observed after comparing the period before and after enrolment. A significant increase in the prescription rate of angiotensin-converting enzyme inhibitor/angiotensin receptor blockers, beta-blockers and aldosterone antagonists was also observed. Finally, an overall reduction in the costs for patient management was demonstrated. Similar results were obtained in the two additional Centers of the Basilicata and Lazio Regions. An integrated management between hospital and territory allows optimization of the management of heart failure patients, with improvement of therapy and reduction in hospitalizations and management costs.

  19. Comparison of salt with low-dose furosemide and carperitide for treating acute decompensated heart failure: a single-center retrospective cohort study.

    Science.gov (United States)

    Okuhara, Yoshitaka; Hirotani, Shinichi; Ando, Tomotaka; Nishimura, Koichi; Orihara, Yoshiyuki; Komamura, Kazuo; Naito, Yoshiro; Mano, Toshiaki; Masuyama, Tohru

    2017-04-01

    Hypertonic saline with furosemide has been proposed for a long time as an effective therapeutic option for the treatment of acute decompensated heart failure (ADHF). We previously reported the efficacy of continuous infusion of 1.7 % hypertonic saline plus low-dose furosemide in treatment for ADHF. Although this therapeutic strategy can be a useful option for effective decongestion in treatment for ADHF, there is no study that assesses the effect and safety of saline supplementation compared with standard therapy in Japan. The aim of this study was to investigate the efficacy, safety, and cost-effectiveness of 1.7 % hypertonic saline plus low-dose furosemide infusion compared with carperitide. We compared clinical outcomes, adverse events, and cost for patients receiving carperitide (carperitide group) with those for patients receiving 1.7 % hypertonic saline plus low-dose furosemide (salt group) during the initial hospitalization for ADHF. The cost analysis was performed on the basis of the previous report about cost-effectiveness of acute heart failure. A total of 175 ADHF patients received either carperitide (n = 111) or 1.7 % hypertonic saline plus low-dose furosemide infusion (n = 64) as initial treatment. There were no differences in length of hospital stay (27 ± 19 vs. 25 ± 16 day, p = 0.170) and infusion period (7.2 ± 6.1 vs. 8.4 ± 7.5 day, p = 0.474) between the two groups. The incidence of rehospitalization did not differ at 1 month (7.6 vs. 6.6 %, p = 1.000) and 1 year (36.8 vs. 37.7 %, p = 0.907) between the two groups. The Kaplan-Meier curves revealed no significant difference for 1 year all-cause mortality between the two groups (log-rank, p = 0.724). The single hospitalization cost was 95,314 yen lower and the yearly hospitalization cost 125,628 yen lower in the salt group compared with the carperitide group. Thus, intravenous 1.7 % hypertonic saline plus low-dose furosemide infusion is as effective as

  20. Comparison of Ambulatory, High-Dose, Intravenous Diuretic Therapy to Standard Hospitalization and Diuretic Therapy for Treatment of Acute Decompensated Heart Failure.

    Science.gov (United States)

    Buckley, Leo F; Seoane-Vazquez, Enrique; Cheng, Judy W M; Aldemerdash, Ahmed; Cooper, Irene M; Matta, Lina; Medina, Danika S; Mehra, Mandeep R; Navarro-Velez, Kristina; Shea, Elaine L; Weintraub, Joanne R; Stevenson, Lynne W; Desai, Akshay S

    2016-11-01

    Innovative treatment strategies for decompensated heart failure (HF) are required to achieve cost savings and improvements in outcomes. We developed a decision analytic model from a hospital perspective to compare 2 strategies for the treatment of decompensated HF, ambulatory diuretic infusion therapy, and hospitalization (standard care), with respect to total HF hospitalizations and costs. The ambulatory diuretic therapy strategy included outpatient treatment with high doses of intravenous loop diuretics in a specialized HF unit whereas standard care included hospitalization for intravenous loop diuretic therapy. Model probabilities were derived from the outcomes of patients who were treated for decompensated HF at Brigham and Women's Hospital (Boston, MA). Costs were based on Centers for Medicare and Medicaid reimbursement and the available reports. Based on a sample of patients treated at our institution, the ambulatory diuretic therapy strategy was estimated to achieve a significant reduction in total HF hospitalizations compared with standard care (relative reduction 58.3%). Under the base case assumptions, the total cost of the ambulatory diuretic therapy strategy was $6,078 per decompensation episode per 90 days compared with $12,175 per 90 days with standard care, for a savings of $6,097. The cost savings associated with the ambulatory diuretic strategy were robust against variation up to 50% in costs of ambulatory diuretic therapy and the likelihood of posttreatment hospitalization. An exploratory analysis suggests that ambulatory diuretic therapy is likely to remain cost saving over the long-term. In conclusion, this decision analytic model demonstrates that ambulatory diuretic therapy is likely to be cost saving compared with hospitalization for the treatment of decompensated HF from a hospital perspective. These results suggest that implementation of outpatient HF units that provide ambulatory diuretic therapy to well-selected subgroup of patients may

  1. Malnutrition as assessed by nutritional risk index is associated with worse outcome in patients admitted with acute decompensated heart failure. An ACAP-HF data analysis

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    Marrick L. Kukin

    2011-06-01

    Full Text Available Malnutrition is common at hospital admission and tends to worsen during hospitalization. This controlled population study aimed to determine if serum albumin or moderate and severe nutritional depletion by Nutritional Risk Index (NRI at hospital admission are associated with increased length of hospital stay (LOS in patients admitted with acute decompensated heart failure (ADHF. Serum albumin levels and lymphocyte counts were retrospectively determined at hospital admission in 1740 consecutive patients admitted with primary and secondary diagnosis of ADHF. The Nutrition Risk Score (NRI developed originally in AIDS and cancer populations was derived from the serum albumin concentration and the ratio of actual to usual weight, as follows: NRI = (1.519 × serum albumin, g/dL + {41.7 × present weight (kg/ideal body weight(kg}. Patients were classified into four groups as no, mild, moderate or severe risk by NRI. Multiple logistic regressions were used to determine the association between nutritional risk category and LOS. 381 Patients (34% were at moderate or severe nutritional risk by NRI score. This cohort had lower BMI (24 ± 5.6 kg/m2, albumin (2.8±0.5 g/dL, mean NRI (73.5±9 and Lower eGFR (50±33 mL/min per 1.73 m2. NRI for this cohort, adjusted for age, was associated with LOS of 10.1 days. Using the Multiple Logistic regression module, NRI was the strongest predictor for LOS (OR 1.7, 95% CI: 1.58-1.9; P=0.005, followed by TIMI Risk Score [TRS] (OR 1.33, 95% CI: 1.03-1.71; P=0.02 and the presence of coronary artery disease (OR 2.29, 95%CI: 1.03-5.1; P=0.04. Moderate and severe NRI score was associated with higher readmission and death rates as compared to the other two groups. Nutritional depletion as assessed by Nutritional Risk Index is associated with worse outcome in patients admitted with ADHF. Therefore; we recommend adding NRI to further risk stratify these patients.

  2. Malnutrition as assessed by nutritional risk index is associated with worse outcome in patients admitted with acute decompensated heart failure: an ACAP-HF data analysis.

    Science.gov (United States)

    Aziz, Emad F; Javed, Fahad; Pratap, Balaji; Musat, Dan; Nader, Amjad; Pulimi, Sandeep; Alivar, Carlos L; Herzog, Eyal; Kukin, Marrick L

    2011-01-01

    Malnutrition is common at hospital admission and tends to worsen during hospitalization. This controlled population study aimed to determine if serum albumin or moderate and severe nutritional depletion by Nutritional Risk Index (NRI) at hospital admission are associated with increased length of hospital stay (LOS) in patients admitted with acute decompensated heart failure (ADHF). Serum albumin levels and lymphocyte counts were retrospectively determined at hospital admission in 1740 consecutive patients admitted with primary and secondary diagnosis of ADHF. The Nutrition Risk Score (NRI) developed originally in AIDS and cancer populations was derived from the serum albumin concentration and the ratio of actual to usual weight, as follows: NRI = (1.519 × serum albumin, g/dL) + {41.7 × present weight (kg)/ideal body weight(kg)}. Patients were classified into four groups as no, mild, moderate or severe risk by NRI. Multiple logistic regressions were used to determine the association between nutritional risk category and LOS.Three hundred and eighty-one patients (34%) were at moderate or severe nutritional risk by NRI score. This cohort had lower BMI (24 ± 5.6 kg/m(2)), albumin (2.8±0.5 g/dL), mean NRI (73.5±9) and lower eGFR (50±33 mL/min per 1.73 m(2)). NRI for this cohort, adjusted for age, was associated with LOS of 10.1 days. Using the Multiple Logistic regression module, NRI was the strongest predictor for LOS (OR 1.7, 95% CI: 1.58-1.9; P=0.005), followed by TIMI Risk Score [TRS] (OR 1.33, 95% CI: 1.03-1.71; P=0.02) and the presence of coronary artery disease (OR 2.29, 95%CI: 1.03-5.1; P=0.04). Moderate and severe NRI score was associated with higher readmission and death rates as compared to the other two groups.Nutritional depletion as assessed by Nutritional Risk Index is associated with worse outcome in patients admitted with ADHF. Therefore; we recommend adding NRI to further risk stratify these patients.

  3. The Usefulness of the Delta Neutrophil Index for Predicting Superimposed Pneumonia in Patients with Acute Decompensated Heart Failure in the Emergency Department.

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    Yong Sung Cha

    Full Text Available Although respiratory infections, such as pneumonia, have long been recognized as precipitators of exacerbation in patients with acute decompensated heart failure (ADHF, identifying signs of concomitant pneumonia in ADHF is a clinical diagnostic challenge. We evaluated the predictive value of the delta neutrophil index (DNI, a new indicator for immature granulocytes, for diagnosing superimposed pneumonia in patients presenting with ADHF in the emergency department (ED.This was a retrospective and observational study of consecutive patients (>18 years old diagnosed with an ADHF in the ED over a 7-month period. Patients were categorized into either the ADHF group or the ADHF with pneumonia group. DNI, serum white blood cell (WBC, C-reactive protein (CRP, and β-natriuretic peptide (BNP were measured upon ED arrival.The ADHF with pneumonia group included 30 patients (20.4%. Median initial DNI, WBC, and CRP were significantly higher in the ADHF with pneumonia group [0% vs. 1.8%, p<0.001, 8,200 cells/mL vs. 10,470 cells/mL, p<0.001, and 0.56 mg/dL vs. 6.10 mg/dL, p<0.001]. Multiple logistic regression analyses showed that only initial DNI significantly predicted the presence of superimposed pneumonia in patients with ADHF. In the receiver operating characteristic curves for initial DNI, WBC, and CRP for differentiating superimposed pneumonia in ADHF patients, the area under curve (AUC of DNI (0.916 [95% confidence interval 0.859-0.955] was good. AUC of DNI was significantly higher than AUC of CRP and WBC [0.828 and 0.715] (DNI vs. CRP, p = 0.047 and DNI vs. WBC, p<0.001.Initial DNI, which was measured upon ED arrival, was significantly higher in the ADHF with pneumonia group than in the ADHF group. The initial DNI's ability of prediction for ADHF with superimposed pneumonia in the ED was good and it was better than those of serum WBC and CRP. Therefore, DNI may serve as a convenient and useful marker for early diagnosis of superimposed pneumonia in

  4. Palliative Care in Decompensated Cirrhosis: A Review.

    Science.gov (United States)

    Langberg, Karl M; Kapo, Jennifer M; Taddei, Tamar H

    2017-11-07

    Decompensated cirrhosis is an illness that causes tremendous suffering. The incidence of cirrhosis is increasing and rates of liver transplant, the only cure, remain stagnant. Palliative care is focused on improving quality of life for patients with serious illness by addressing advanced care planning, alleviating physical symptoms and providing emotional support to the patient and family. Palliative care is used infrequently in patients with decompensated cirrhosis. The allure of transplant as a potential treatment option for cirrhosis, misperceptions about the role of palliative care and difficulty predicting prognosis in liver disease are potential contributors to the underutilization of palliative care in this patient population. Studies have demonstrated some benefit of palliative care in patients with decompensated cirrhosis but the literature is limited to small observational studies. There is evidence that palliative care consultation in other patient populations lowers hospital costs and ICU utilization and improves symptom control and patient satisfaction. Prospective randomized control trials are needed to investigate the effects of palliative care on traditional and patient reported outcomes as well as cost of care in decompensated cirrhosis for transplant eligible and ineligible patient populations. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  5. Pathogenesis of Cardiorenal Syndrome Type 1 in Acute Decompensated Heart Failure : Workgroup Statements from the Eleventh Consensus Conference of the Acute Dialysis Quality Initiative (ADQI)

    NARCIS (Netherlands)

    Haase, Michael; Mueller, Christian; Damman, Kevin; Murray, Patrick T.; Kellum, John A.; Ronco, Claudio; McCullough, Peter A.; McCullough, PA; Kellum, JA; Mehta, RL; Murray, PT; Ronco, C

    2013-01-01

    Pathophysiological mechanisms of cardiorenal syndromes (CRS) types 1-5 are still sparsely characterized. In an attempt to address this issue, a consensus conference on CRS was held in Venice, Italy, in November 2012 under the auspices of the Acute Dialysis Quality Initiative (ADQI). Working group 1

  6. Effects of Hyponatremia Normalization on the Short-Term Mortality and Rehospitalizations in Patients with Recent Acute Decompensated Heart Failure: A Retrospective Study

    Directory of Open Access Journals (Sweden)

    Renato De Vecchis

    2016-10-01

    Full Text Available Background: Several studies have shown that hyponatremia is associated with increased risk of rehospitalization and death in patients with heart failure. In these studies, chronic heart failure (CHF patients with persistent hyponatremia were compared only with CHF patients with a normal sodium level at hospital admission. Aims: In the present retrospective study, conducted in a cohort of patients with recent acute decompensated heart failure (ADHF, all with hyponatremia ascertained at the time of hospital admission, we aimed to evaluate the effect of the normalization of serum sodium on the composite endpoint of short-term rehospitalization and mortality. Methods: A retrospective study centered on medical records of patients hospitalized for ADHF in the period April 2013 to April 2016 was performed. Data regarding serum sodium measurements had to be collected from medical records of cardiology wards of two hospitals, and were then processed for statistical analysis. As an inclusion criterion for enrollment, patients had to be suffering from heart failure that had required at least one hospitalization. Moreover, they had to be suffering from a state of hyponatremia (serum sodium < 135 mEq/L at admission on the occasion of the index hospitalization. Patients with hyponatremia at admission were divided into two groups, one comprising patients with hyponatremia that persisted at the time of discharge (persistent hyponatremia and a second including patients who had achieved normalization of their serum sodium levels (serum Na+ ≥ 135 mEq/L during hospitalization until discharge. For both groups, the risk of mortality and rehospitalization during a 30-day follow-up was assessed. Results: One hundred and sixty CHF patients with various degrees of functional impairment were enrolled in the study. Among them, 56 (35% had persistent hyponatremia over the course of hospitalization. At multivariable Cox proportional-hazards regression analysis, the risk of

  7. Worsening heart failure during hospitalization for acute heart failure: Insights from the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF).

    Science.gov (United States)

    Kelly, Jacob P; Mentz, Robert J; Hasselblad, Vic; Ezekowitz, Justin A; Armstrong, Paul W; Zannad, Faiez; Felker, G Michael; Califf, Robert M; O'Connor, Christopher M; Hernandez, Adrian F

    2015-08-01

    Despite initial in-hospital treatment of acute heart failure (HF), some patients experience worsening HF (WHF). There are limited data about the outcomes and characteristics of patients who experience in-hospital WHF. We assessed the characteristics and outcomes of patients with and without WHF in the ASCEND-HF trial. Worsening HF was defined as at least 1 symptom or sign of new, persistent, or WHF requiring additional intravenous inotropic/vasodilator or mechanical therapy during index hospitalization. We assessed the relationship between WHF and 30-day mortality, 30-day mortality or HF hospitalization, and 180-day mortality. We also assessed whether there was a differential association between early (days 1-3) vs late (day ≥4) WHF and outcomes. Of 7,141 patients with acute HF, 354 (5%) experienced WHF. Patients with WHF were more often male and had a history of atrial fibrillation or diabetes, lower blood pressure, and higher creatinine. After risk adjustment, WHF was associated with increased 30-day mortality (odds ratio 13.37, 95% CI 9.85-18.14), 30-day mortality or HF rehospitalization (odds ratio 6.78, 95% CI 5.25-8.76), and 180-day mortality (hazard ratio 3.90, 95% CI 3.14-4.86) (all P values HF during index hospitalization was associated with worse 30- and 180-day outcomes. Worsening HF may represent an important patient-centered outcome in acute HF and a focus of future treatments. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. A Comparison of Traditional and Novel Definitions (RIFLE, AKIN, and KDIGO) of Acute Kidney Injury for the Prediction of Outcomes in Acute Decompensated Heart Failure.

    Science.gov (United States)

    Roy, Andrew K; Mc Gorrian, Catherine; Treacy, Cecelia; Kavanaugh, Edel; Brennan, Alice; Mahon, Niall G; Murray, Patrick T

    2013-04-01

    To determine if newer criteria for diagnosing and staging acute kidney injury (AKI) during heart failure (HF) admission are more predictive of clinical outcomes at 30 days and 1 year than the traditional worsening renal function (WRF) definition. We analyzed prospectively collected clinical data on 637 HF admissions with 30-day and 1-year follow-up. The incidence, stages, and outcomes of AKI were determined using the following four definitions: KDIGO, RIFLE, AKIN, and WRF (serum creatinine rise ≥0.3 mg/dl). Receiver operating curves were used to compare the predictive ability of each AKI definition for the occurrence of adverse outcomes (death, rehospitalization, dialysis). AKI by any definition occurred in 38.3% (244/637) of cases and was associated with an increased incidence of 30-day (32.3 vs. 6.9%, χ(2) = 70.1; p < 0.001) and 1-year adverse outcomes (67.5 vs. 31.0%, χ(2) = 81.4; p < 0.001). Most importantly, there was a stepwise increase in primary outcome with increasing stages of AKI severity using RIFLE, KDIGO, or AKIN (p < 0.001). In direct comparison, there were only small differences in predictive abilities between RIFLE and KDIGO and WRF concerning clinical outcomes at 30 days (AUC 0.76 and 0.74 vs. 0.72, χ(2) = 5.6; p = 0.02) as well as for KDIGO and WRF at 1 year (AUC 0.67 vs. 0.65, χ(2) = 4.8; p = 0.03). During admission for HF, the benefits of using newer AKI classification systems (RIFLE, AKIN, KDIGO) lie with the ability to identify those patients with more severe degrees of AKI who will go on to experience adverse events at 30 days and 1 year. The differences in terms of predictive abilities were only marginal.

  9. Association between the body mass index and the clinical findings in patients with acute heart failure: evaluation of the obesity paradox in patients with severely decompensated acute heart failure.

    Science.gov (United States)

    Matsushita, Masato; Shirakabe, Akihiro; Hata, Noritake; Shinada, Takuro; Kobayashi, Nobuaki; Tomita, Kazunori; Tsurumi, Masafumi; Okazaki, Hirotake; Yamamoto, Yoshiya; Asai, Kuniya; Shimizu, Wataru

    2017-05-01

    Obesity is known to be associated with the development of heart failure (HF). However, the relationship between the body mass index (BMI) and acute HF (AHF) remains to be elucidated. Eight hundred and eight AHF patients were enrolled in this study. The patients were assigned to four groups according to their BMI values: severely thin (n = 11, BMI valvular disease than normal/underweight patients. The patients in the overweight group were significantly younger than those in the normal/underweight, and those in the overweight group were more likely to have SBP ≥140 mmHg and hypertensive heart disease and less likely to have valvular disease than the patients in the normal/underweight group. The prognosis, including all-cause death, was significantly poorer among patients who were severely thin than those who were normal/underweight, overweight and significantly better among those who were overweight than those who were normal/underweight, severely thin and obese patients. A multivariate Cox regression model identified that severely thin [HR: 3.372, 95% confidence interval (CI) 1.362-8.351] and overweight (HR: 0.615, 95% CI 0.391-0.966) were independent predictors of 910-day mortality as the reference of normal/underweight. Overweight patients tended to have SBP ≥140 mmHg and be relatively young, while severely thin patients tended to have SBP <100 mmHg and be female. These factors were associated with a better prognosis of overweight patients and adverse outcomes in severely thin patients. These factors may contribute to the "obesity paradox" in severely decompensated AHF patients.

  10. Improving Survival in Decompensated Cirrhosis

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    Amar Nath Mukerji

    2012-01-01

    Full Text Available Mortality in cirrhosis is consequent of decompensation, only treatment being timely liver transplantation. Organ allocation is prioritized for the sickest patients based on Model for End Stage Liver Disease (MELD score. In order to improve survival in patients with high MELD score it is imperative to preserve them in suitable condition till transplantation. Here we examine means to prolong life in high MELD score patients till a suitable liver is available. We specially emphasize protection of airways by avoidance of sedatives, avoidance of Bilevel Positive Airway Pressure, elective intubation in grade III or higher encephalopathy, maintaining a low threshold for intubation with lesser grades of encephalopathy when undergoing upper endoscopy or colonoscopy as pre transplant evaluation or transferring patient to a transplant center. Consider post-pyloric tube feeding in encephalopathy to maintain muscle mass and minimize risk of aspiration. In non intubated and well controlled encephalopathy, frequent physical mobility by active and passive exercises are recommended. When renal replacement therapy is needed, night-time Continuous Veno-Venous Hemodialysis may be useful in keeping the daytime free for mobility. Sparing and judicious use of steroids needs to be borne in mind in treatment of ARDS and acute hepatitis from alcohol or autoimmune process.

  11. Atrial fibrillation associated with a thyroid stimulating hormone-secreting adenoma of the pituitary gland leading to a presentation of acute cardiac decompensation: A case report

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    George Jyothis T

    2008-02-01

    Full Text Available Abstract Introduction Hyperthyroidism is a well established cause of atrial fibrillation (AF. Thyroid Stimulating Hormone-secreting pituitary tumours are rare causes of pituitary hyperthyroidism. Whilst pituitary causes of hyperthyroidism are much less common than primary thyroid pathology, establishing a clear aetiology is critical in minimising complications and providing appropriate treatment. Measuring Thyroid Stimulating Hormone (TSH alone to screen for hyperthyroidism may be insufficient to appropriately evaluate the thyroid status in such cases. Case presentation A 63-year-old Caucasian man, previously fit and well, presented with a five-day history of shortness of breath associated with wheeze and dry cough. He denied symptoms of hyperthyroidism and his family, social and past history were unremarkable. Initial investigation was in keeping with a diagnosis of atrial fibrillation (AF with fast ventricular response leading to cardiac decompensation. TSH 6.2 (Normal Range = 0.40 – 4.00 mU/L, Free T3 of 12.5 (4.00 – 6.8 pmol/L and Free T4 51(10–30 pmol/L. Heterophilic antibodies were ruled out. Testosterone was elevated at 43.10 (Normal range: 10.00 – 31.00 nmol/L with an elevated FSH, 18.1 (1.0–7.0 U/L and elevated LH, 12.4 (1.0–8.0 U/L. Growth Hormone, IGF-1 and prolactin were normal. MRI showed a 2.4 cm pituitary macroadenoma. Visual field tests showed a right inferotemporal defect. While awaiting neurosurgical removal of the tumour, the patient was commenced on antithyroid medication (carbimazole and maintained on this until successful trans-sphenoidal excision of the macroadenoma had been performed. AF persisted post-operatively, but was electrically cardioverted subsequently and he remains in sinus rhythm at twelve months follow-up off all treatment. Conclusion This case reiterates the need to evaluate thyroid function in all patients presenting with atrial fibrillation. TSH-secreting pituitary adenomas must be considered

  12. Interaction of Body Mass Index on the Association Between N-Terminal-Pro-b-Type Natriuretic Peptide and Morbidity and Mortality in Patients With Acute Heart Failure: Findings From ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure).

    Science.gov (United States)

    Bhatt, Ankeet S; Cooper, Lauren B; Ambrosy, Andrew P; Clare, Robert M; Coles, Adrian; Joyce, Emer; Krishnamoorthy, Arun; Butler, Javed; Felker, G Michael; Ezekowitz, Justin A; Armstrong, Paul W; Hernandez, Adrian F; O'Connor, Christopher M; Mentz, Robert J

    2018-02-03

    Higher body mass index (BMI) is associated with lower circulating levels of N-terminal-pro-b-type natriuretic peptide (NT-proBNP). The Interaction between BMI and NT-proBNP with respect to clinical outcomes is not well characterized in patients with acute heart failure. A total of 686 patients from the biomarker substudy of the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated HF ) clinical trial with documented NT-proBNP levels at baseline were included in the present analysis. Patients were classified by the World Health Organization obesity classification (nonobese: BMI URL: http://www.clinicaltrials.gov. Unique identifier: NCT00475852. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  13. Acute heart failure volume control multicenter randomized (AVCMA) trial: comparison of tolvaptan and carperitide.

    Science.gov (United States)

    Suzuki, Satoshi; Yoshihisa, Akiomi; Yamaki, Takayoshi; Sugimoto, Koichi; Kunii, Hiroyuki; Nakazato, Kazuhiko; Abe, Yukihiko; Saito, Tomiyoshi; Ohwada, Takayuki; Suzuki, Hitoshi; Saitoh, Shu-ichi; Kubota, Isao; Takeishi, Yasuchika

    2013-12-01

    [corrected] Acute decompensated heart failure (ADHF) is a common and highly morbid cardiovascular disorder. Diuresis is a major therapy for the reduction of congestive symptoms. However, most diuretics cause hyponatremia, which is a worsening factor of ADHF patients prognosis. The purpose of this study was to examine the efficacy and safety of tolvaptan, which is a selective vasopressin V2 receptor antagonist and produces water excretion without changes in sodium excretion, compared with carperitide. One hundred and nine hospitalized ADHF patients were enrolled and randomly assigned to tolvaptan or carperitide treatment groups. Subjective symptoms and plasma BNP level were similarly improved by treatment in both groups. Urine volume was significantly higher in the tolvaptan group (P tolvaptan group (P tolvaptan group after treatment (P tolvaptan group (P = .027). The average drug cost of tolvaptan was lower than that of carperitide (P Tolvaptan might be a novel promising agent for ADHF in terms of efficacy and safety compared to carperitide. © 2013 The Authors. The Journal of Clinical Pharmacology Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology.

  14. Estimating systemic fibrosis by combining galectin-3 and ST2 provides powerful risk stratification value for patients after acute decompensated heart failure.

    Science.gov (United States)

    Wang, Chao-Hung; Yang, Ning-I; Liu, Min-Hui; Hsu, Kuang-Hung; Kuo, Li-Tang

    2016-01-01

    Two fibrosis biomarkers, galectin-3 (Gal-3) and suppression of tumorigenicity 2 (ST2), provide prognostic value additive to natriuretic peptides and traditional risk factors in patients with heart failure (HF). However, it is to be investigated whether their combined measurement before discharge provides incremental risk stratification for patients after acute HF. A total of 344 patients with acute HF were analyzed with Gal-3, and ST2 measured. Patients were prospectively followed for 3.7 ± 1.3 years for deaths, and composite events (death/HF-related re-hospitalizations). The levels of Gal-3 and ST2 were only slightly related (r = 0.20, p risk factors. According to the cutoff at median values, patients were separated into four subgroups based on high and low Gal-3 (HG and LG, respectively) and ST2 levels (HS and LS, respectively). Kaplan-Meier survival curves showed that HGHS powerfully identified patients at risk of mortality (Log rank = 21.27, p risk stratification value.

  15. Effects of adding intravenous nicorandil to standard therapy on cardiac sympathetic nerve activity and myocyte dysfunction in patients with acute decompensated heart failure

    Energy Technology Data Exchange (ETDEWEB)

    Kasama, Shu [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Cardiovascular Hospital of Central Japan (Kitakanto Cardiovascular Hospital), Department of Cardiovascular Medicine, Gunma (Japan); Toyama, Takuji; Funada, Ryuichi; Takama, Noriaki; Koitabashi, Norimichi; Kurabayashi, Masahiko [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Ichikawa, Shuichi [Cardiovascular Hospital of Central Japan (Kitakanto Cardiovascular Hospital), Department of Cardiovascular Medicine, Gunma (Japan); Suzuki, Yasuyuki; Matsumoto, Naoya [Nihon University School of Medicine, Department of Cardiology, Tokyo (Japan); Sato, Yuichi [Health Park Clinic, Department of Imaging, Takasaki, Gunma (Japan)

    2015-04-01

    Nicorandil, an adenosine triphosphate-sensitive potassium channel opener, improves cardiac sympathetic nerve activity (CSNA) in ischemic heart disease or chronic heart failure. However, its effects on CSNA and myocyte dysfunction in acute heart failure (AHF) remain unclear. We investigated the effects of adding intravenous nicorandil to standard therapy on CSNA and myocyte dysfunction in AHF. We selected 70 patients with mild to moderate nonischemic AHF who were treated with standard conventional therapy soon after admission. Thirty-five patients were assigned to additionally receive intravenous nicorandil (4-12 mg/h; group A), whereas the remaining patients continued their current drug regimen (group B). Delayed total defect score (TDS), delayed heart to mediastinum count (H/M) ratio, and washout rate (WR) were determined by {sup 123}I-metaiodobenzylguanidine (MIBG) scintigraphy within 3 days of admission and 4 weeks later. High sensitivity troponin T (hs-TnT) level was also measured at the same time points. After treatment, MIBG scintigraphic parameters significantly improved in both groups. However, the extent of the changes in these parameters in group A significantly exceeded the extent of the changes in group B [TDS -11.3 ± 4.3 in group A vs -4.0 ± 6.0 in group B (p < 0.01); H/M ratio 0.31 ± 0.16 vs 0.14 ± 0.16 (p < 0.01); WR -13.8 ± 7.8 % vs -6.1 ± 8.9 % (p < 0.01)]. The hs-TnT level decreased significantly from 0.052 ± 0.043 to 0.041 ± 0.033 ng/ml (p < 0.05) in group A, but showed no significant change in group B. Moreover, in both groups, no relationships between the extent of changes in MIBG parameters and hs-TnT level were observed. Adding intravenous nicorandil to standard therapy provides additional benefits for CSNA and myocyte dysfunction over conventional therapy alone in AHF patients. Furthermore, the mechanisms of improvement in CSNA and myocyte dysfunction after nicorandil treatment in AHF patients were distinct. (orig.)

  16. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial

    Science.gov (United States)

    2014-09-26

    SEP 2014 2. REPORT TYPE Final 3. DATES COVERED 4. TITLE AND SUBTITLE Ear acupuncture for acute sore throat. A randomized controlled trial...Auncular Acupuncture is a low risk option for acute pain control •Battlefield acupuncture (BFA) IS a specific auncular acupuncture technique •BFA IS...Strengths: Prospect1ve RCT •Weaknesses Small sample stze. no sham acupuncture performed, patients not blinded to treatment •Th1s study represents an

  17. Newer treatments for decompensated heart failure: focus on levosimendan

    Directory of Open Access Journals (Sweden)

    Ferenc Follath

    2009-03-01

    Full Text Available Ferenc FollathUniversity Hospital Zürich, Steering Group Drug Therapy, Zürich, SwitzerlandAbstract: Acute heart failure (AHF is a major cause of hospitalizations. Severe dyspnea, pulmonary congestion and low cardiac output with peripheral vasoconstriction and renal hypoperfusion is a main form of clinical presentation. Most patients with acute worsening have a pre-existing decompensated chronic heart failure (ADCHF, but AHF may also occur as a first manifestation of a previously unknown heart disease. Myocardial ischemia, cardiac arrhythmias, non-compliance with medication and infections are frequent precipitating factors. Management of AHF depends on the underlying heart disease and cause of decompensation. In patients with ADCHF vasodilators and iv diuretics are first-line drugs for rapid reduction of dyspnea and congestion. In patients with signs of low cardiac output and oliguria, inotropic agents are also often administered to prevent further deterioration. Beta-adrenergic agents and phosphodiesterase inhibitors correct the hemodynamic disturbance, but may also induce arrhythmias and worsen myocardial ischemia. Inotropic therapy therefore remains controversial. A novel class of drugs, the calcium sensitizers, represent a new therapeutic option. Levosimendan was shown to improve myocardial contractility without increasing oxygen requirements and to produce peripheral and coronary vasodilation. Its therapeutic effects and tolerance have been tested in several trials. The present review focuses on the clinical pharmacology and therapeutic utility of levosimendan in patients with ADCHF.Keywords: acute heart failure, inotropic agents, calcium sensitizers, levosimendan

  18. The outcome of critical illness in decompensated alcoholic liver cirrhosis

    DEFF Research Database (Denmark)

    Kavli, M; Strøm, T; Carlsson, M

    2012-01-01

    BACKGROUND: The mortality of patients suffering from acute decompensated liver disease treated in the intensive care unit (ICU) varies between 50% and 100%. Previously published data suggest that liver-specific score systems are less accurate compared with the ICU-specific scoring systems acute......: SAPS II 60, SOFA (day 1) 11, APACHE II 31, and Child-Pugh 12. Receiver operating characteristic curves area under curve was 0.79 for APACHE II, 0.83 for SAPS II, and 0.79 for SOFA (day1) compared with 0.59 for Child-Pugh. In patients only in need of mechanical ventilation, the 90-day mortality was 76......%. If respiratory failure was further complicated by shock treated with vasopressor agents, the 90-day mortality increased to 89%. Ninety-day mortality for patients in need of mechanical ventilation, vasoactive medication, and renal replacement therapy because of acute kidney injury was 93%. CONCLUSION: APACHE II...

  19. Rifaximin has no effect on hemodynamics in decompensated cirrhosis

    DEFF Research Database (Denmark)

    Kimer, Nina; Pedersen, Julie Steen; Busk, Troels Malte

    2017-01-01

    Decompensated cirrhosis is characterized by disturbed systemic and splanchnic hemodynamics. Bacterial translocation from the gut is considered the key driver in this process. Intestinal decontamination with rifaximin may improve hemodynamics. This double-blind, randomized, controlled trial...... years (±8.4), average Child score 8.3 (±1.3), and Model for End-Stage Liver Disease score 11.7 (±3.9). Measurements of hepatic venous pressure gradient, cardiac output, and systemic vascular resistance were made at baseline and after 4 weeks. The glomerular filtration rate and plasma renin...

  20. Fluid restriction in the management of decompensated heart failure: no impact on time to clinical stability.

    Science.gov (United States)

    Travers, Bronagh; O'Loughlin, Christina; Murphy, Niamh F; Ryder, Mary; Conlon, Carmel; Ledwidge, Mark; McDonald, Kenneth

    2007-03-01

    To examine the clinical effect of fluid restriction in patients admitted to the hospital with class IV heart failure (HF). This is a single-blind randomized controlled study. Time to clinical stability was compared between the fluid restricted (FR: n = 34) and free fluid (FF: n = 33) groups respectively showing no significant difference (8.3 +/- 6.3 days versus 7.0 +/- 6.0 days, P = .17). There was no significant difference between groups in time to discontinuation of intravenous diuretic therapy (FR: 2.7 +/- 4.5 days, FF: 3.2 +/- 5.6 days, P = .70). Changes from baseline to achievement of clinical stability in serum urea (P = .23), serum creatinine (P = .14), BNP (P = .42), and sodium (P = .14) did not differ between the FF and FR groups. Baseline serum sodium levels did not predict the time to clinical stability (beta = -0.11, 95% CI: -0.60, 0.23). Fluid restriction is not an evidence-based therapy although it is occasionally applied in the management of HF. These results suggest that FR is not of any clinical benefit in patients with acute decompensated HF and this hypothesis should be tested in a larger randomized controlled study.

  1. Changes in autonomic balance in patients with decompensated chronic heart failure.

    Science.gov (United States)

    Rydlewska, Agnieszka; Jankowska, Ewa A; Ponikowska, Beata; Borodulin-Nadzieja, Ludmiła; Banasiak, Waldemar; Ponikowski, Piotr

    2011-02-01

    In chronic heart failure (CHF) episodes of decompensation may be linked to derangements within cardiovascular reflex control. We investigated changes in autonomic tone in patients with decompensated CHF. We examined 17 patients with decompensated CHF (14 men, age 62 ± 2 years, LVEF 32 ± 3%) on admission and after clinical stabilization. Control group consisted of 9 patients (8 men, age 64 ± 7 years, LVEF 30 ± 7%) with stable CHF. Assessment of autonomic tone was based on 5-min ECG and blood pressure recordings using time and frequency domains of heart rate variability (HRV) and a sequence method to derive baroreflex sensitivity (BRS). On admission, decompensated CHF patients had reduced HRV indices (p CHF. After clinical stabilization (4 ± 2 days of treatment) time domain HRV indices and BRS increased (SDNN, 34.4 ± 5.4 vs. 55.8 ± 9.8 ms; RMSSD, 38.4 ± 12.0 vs. 51.1 ± 10.4 ms; BRS, 4.3 ± 0.7 vs. 7.6 ± 1.3 ms/mmHg; all p CHF patients. Breathing with oxygen affected autonomic indices neither in decompensated nor in stable CHF patients. Eight patients developed an episode of additional CHF worsening during hospitalization, in whom the third assessment was performed on discharge. Worsening in clinical status was followed by a decrease in HRV and BRS that became similar to those noted on admission. HRV measures and BRS are severely deranged in the acute phase of CHF decompensation. Clinical stabilization results in an improvement of autonomic indices. However, subsequent clinical worsening adversely affects HRV and BRS.

  2. Randomized controlled trial of nebulized adrenaline in acute bronchiolitis.

    Science.gov (United States)

    Hariprakash, Suriyanarayanapillai; Alexander, John; Carroll, Will; Ramesh, Pavanasam; Randell, Tabitha; Turnbull, Frances; Lenney, Warren

    2003-04-01

    Use of both l-epinephrine and racemic epinephrine (adrenaline) has improved clinical symptoms and composite respiratory scores in acute bronchiolitis. The objective of this randomized double-blind placebo-controlled study was to assess whether there was sufficient improvement in clinical state to reduce hospital admissions. Seventy-five infants aged 1 month to 1 year with a clinical diagnosis of acute bronchiolitis were treated with either 2 ml of 1:1000 nebulized adrenaline or 2 ml of nebulized normal saline administered after baseline assessment and 30 min later. Clinical respiratory parameters were recorded at 15-min intervals for a period of 2 h following the baseline assessment. Admission to hospital was the primary end-point and changes in respiratory parameters were secondary end-points. Fifty percent (19/38) of infants treated with adrenaline were discharged home compared with 38 percent (14/37) of those treated with saline. This 12 percent reduction in rate of admission is not statistically significant (95% CI of difference: -10% to 35%). There was no difference between treated and placebo groups in respiratory rate, oxygen saturation, heart rate or a composite respiratory distress score at 30, 60 or 120 min post-treatment. In this study, nebulized epinephrine did not confer a significant advantage over nebulized saline in the emergency room treatment of acute bronchiolitis.

  3. 7% Hypertonic saline in acute bronchiolitis: a randomized controlled trial.

    Science.gov (United States)

    Jacobs, Jonathan D; Foster, Megan; Wan, Jim; Pershad, Jay

    2014-01-01

    Research suggests that hypertonic saline (HS) may improve mucous flow in infants with acute bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as compared with 0.9% saline mixed with epinephrine. To our knowledge, 7% HS has not been previously investigated. We conducted a prospective, double-blind, randomized controlled trial in 101 infants presenting with moderate to severe acute bronchiolitis. Subjects received either 7% saline or 0.9% saline, both with epinephrine. Our primary outcome was a change in bronchiolitis severity score (BSS), obtained before and after treatment, and at the time of disposition from the emergency department (ED). Secondary outcomes measured were hospitalization rate, proportion of admitted patients discharged at 23 hours, and ED and inpatient length of stay. At baseline, study groups were similar in demographic and clinical characteristics. The decrease in mean BSS was not statistically significant between groups (2.6 vs 2.4 for HS and control groups, respectively). The difference between the groups in proportion of admitted patients (42% in HS versus 49% in normal saline), ED or inpatient length of stay, and proportion of admitted patients discharged at 23 hours was not statistically significant. In moderate to severe acute bronchiolitis, inhalation of 7% HS with epinephrine does not appear to confer any clinically significant decrease in BSS when compared with 0.9% saline with epinephrine.

  4. Nebulized Magnesium Sulfate in Acute Bronchiolitis: A Randomized Controlled Trial.

    Science.gov (United States)

    Modaresi, Mohammad Reza; Faghihinia, Jamal; Kelishadi, Roya; Reisi, Mohsen; Mirlohi, Shahrokh; Pajhang, Farhad; Sadeghian, Majid

    2015-09-01

    To assess the efficacy of nebulized magnesium sulfate as a bronchodilator in infants hospitalized with acute bronchiolitis. This three-center double masked randomized clinical trial comprised 120 children with moderate to severe bronchiolitis. They were randomly assigned into two groups: the first group was treated with nebulized magnesium sulfate (40 mg/kg) and nebulized epinephrine (0.1 ml/kg) and the second group (control) was treated with nebulized epinephrine (0.1 ml/kg). The primary outcome was the length of hospital stay. The use of oxygen, temperature, oxygen saturation (SPO2), pulse rate (PR), respiratory rate (RR) and respiratory distress assessment instrument (RDAI) score were measured in the beginning of the study and during hospitalization. The mean (SD) age of 120 infants was 5.1(± 2.6) mo and 60% were boys. The length of hospital stay was not different between the two groups (P > 0.01). Use of oxygen supplementation, SPO2 and vital signs were similar in the two groups. Improvement in RDAI score was significantly better in infants treated with nebulized magnesium sulfate than in the other group (P 0.01). Thus, in infants with acute bronchiolitis, the effect of nebulized magnesium sulfate is comparable to nebulized epinephrine. However nebulized magnesium sulfate can improve the clinical score so it may have additive effect to reduce symptoms during hospitalization.

  5. A randomized trial of colchicine for acute pericarditis.

    Science.gov (United States)

    Imazio, Massimo; Brucato, Antonio; Cemin, Roberto; Ferrua, Stefania; Maggiolini, Stefano; Beqaraj, Federico; Demarie, Daniela; Forno, Davide; Ferro, Silvia; Maestroni, Silvia; Belli, Riccardo; Trinchero, Rita; Spodick, David H; Adler, Yehuda

    2013-10-17

    Colchicine is effective for the treatment of recurrent pericarditis. However, conclusive data are lacking regarding the use of colchicine during a first attack of acute pericarditis and in the prevention of recurrent symptoms. In a multicenter, double-blind trial, eligible adults with acute pericarditis were randomly assigned to receive either colchicine (at a dose of 0.5 mg twice daily for 3 months for patients weighing >70 kg or 0.5 mg once daily for patients weighing ≤70 kg) or placebo in addition to conventional antiinflammatory therapy with aspirin or ibuprofen. The primary study outcome was incessant or recurrent pericarditis. A total of 240 patients were enrolled, and 120 were randomly assigned to each of the two study groups. The primary outcome occurred in 20 patients (16.7%) in the colchicine group and 45 patients (37.5%) in the placebo group (relative risk reduction in the colchicine group, 0.56; 95% confidence interval, 0.30 to 0.72; number needed to treat, 4; Ppericarditis, colchicine, when added to conventional antiinflammatory therapy, significantly reduced the rate of incessant or recurrent pericarditis. (Funded by former Azienda Sanitaria Locale 3 of Turin [now Azienda Sanitaria Locale 2] and Acarpia; ICAP ClinicalTrials.gov number, NCT00128453.).

  6. Current treatments for acute heart failure: focus on serelaxin

    Directory of Open Access Journals (Sweden)

    Bennett RG

    2014-07-01

    Full Text Available Robert G BennettVA Nebraska-Western Iowa Health Care System and Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USAAbstract: Acute heart failure remains an enormous health concern worldwide, and is a major cause of death and hospitalization. In spite of this, the treatment strategies for acute heart failure have remained largely unchanged for the past 2 decades. Several large randomized, placebo-controlled clinical trials have recently been conducted to attempt to improve the treatment and outcomes of acute decompensated heart failure. Some studies, including the EVEREST (tolvaptan and ASCEND (nesiritide showed efficacy at relieving early symptoms, but failed to improve long-term outcomes. Others, including PROTECT (rolofylline and ASTRONAUT (aliskiren showed little benefit in the relief of early symptoms or long-term outcomes. The recent RELAX-AHF studies using serelaxin, a recombinant form of relaxin, have shown considerable promise. Importantly, serelaxin improved congestion (dyspnea and other early targets of acute decompensated heart failure treatment, but also improved mortality at 180 days. The purpose of this review is to provide an overview of current treatment strategies for acute decompensated heart failure, and a discussion of the recent clinical trials, with an emphasis on the serelaxin studies.Keywords: acute heart failure, dyspnea, relaxin, serelaxin

  7. [ANTIOXIDANT DYSFUNCTIONALITY OF HIGH-DENSITY LIPOPROTEINS (HDL) IN DECOMPENSATED DIABETIC PATIENTS].

    Science.gov (United States)

    Awad, Fernanda; Contreras-Duarte, Susana; Molina, Patricia; Quiñones, Verónica; Serrano, Valentina; Abbott, Eduardo; Maiz, Alberto; Busso, Dolores; Rigotti, Attilio

    2015-09-01

    high density lipoproteins (HDL) have important cardiovascular protective effects mediated by their role in reverse cholesterol transport as well as other functional activities, including significant anti-inflammatory and antioxidant properties. It has been shown that HDL anti-inflammatory and antioxidant functions are defective in metabolically stable diabetic patients; however they have not been evaluated during a hyperglycemic crisis. to determine the antioxidant activity of HDL during a severe diabetic decompensation and to analyze whether this function is restored after resolution of the acute event. the antioxidant activity of HDL was measured in vitro by a fluorescent assay in plasma samples obtained from diabetic patients with acute metabolic decompensation at admission, recovery within the hospital and follow-up in ambulatory care. As a comparison, HDL particles from some healthy subjects were used as controls. the HDL antioxidant function was significantly reduced in patients during an acute diabetic decompensation compared with the control group, and was gradually restored reaching normal values during the ambulatory follow-up. Hyperglycemic crisis also showed low plasma paraoxonase-1 activity, which increased significantly during at follow-up. HDL particles isolated from acute diabetic descompensated patients exhibit a significantly and reversibly low antioxidant capacity, which is probably due to a reduced paraoxonase-1 activity. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  8. Influence of Clinical Trial Site Enrollment on Patient Characteristics, Protocol Completion, and End Points : Insights From the ASCEND-HF Trial (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure)

    NARCIS (Netherlands)

    Greene, Stephen J.; Hernandez, Adrian F.; Sun, Jie-Lena; Metra, Marco; Butler, Javed; Ambrosy, Andrew P.; Ezekowitz, Justin A.; Starling, Randall C.; Teerlink, John R.; Schulte, Phillip J.; Voors, Adriaan A.; Armstrong, Paul W.; O'Connor, Christopher M.; Mentz, Robert J.

    Background Most international acute heart failure trials have failed to show benefit with respect to key end points. The impact of site enrollment and protocol execution on trial performance is unclear. Methods and Results We assessed the impact of varying site enrollment volume among all 7141 acute

  9. Prevalência e preditores de embolia pulmonar em pacientes com insuficiência cardíaca agudamente descompensada Prevalence and predictors of pulmonary embolism in patients with acutely decompensated heart failure

    Directory of Open Access Journals (Sweden)

    Luís C. L. Correia

    2012-02-01

    Full Text Available FUNDAMENTO: Não existe descrição da prevalência de Embolia Pulmonar (EP em pacientes internados por quadro clássico de Insuficiência Cardíaca descompensada (IC. OBJETIVO: Em pacientes internados por IC, (1 descrever a prevalência de EP, e (2 avaliar a acurácia diagnóstica dos Escores de Wells e de Genebra. MÉTODOS: Pacientes internados primariamente por IC realizaram sistematicamente cintilografia pulmonar de ventilação/perfusão, sendo EP definida por laudo de alta probabilidade. Para fins de interpretação, definimos baixa probabilidade clínica de EP como prevalência BACKGROUND: The prevalence of pulmonary embolism (PE has not been reported in patients hospitalized due to classical findings of decompensated heart failure (HF. OBJECTIVE: To describe the prevalence of PE and to assess the diagnostic accuracy of the Wells and Geneva scores in patients hospitalized due to HF. METHODS: Patients hospitalized primarily due to HF underwent systematic ventilation-perfusion lung scan, and PE was defined by a result of high probability. Aiming at interpreting, low clinical probability of PE was defined as prevalence < 5%, according to the literature. When calculating the sample size, 49 patients were required to provide a 95% confidence interval with ±10% accuracy, estimating an a priori prevalence of 15%. RESULTS: Of 51 patients studied, six had a high probability of PE on lung scan, resulting in 12% prevalence (95% CI = 5% - 23%. The Wells and Geneva scores had an area under the ROC curve of 0.53 (95% CI = 0.27 - 0.80; p = 0.80 and 0.43 (95% CI = 0.13 - 0.73; p = 0.56, respectively, indicating lack of accuracy for the diagnosis of PE. Alternatively, variables related to HF showed a tendency towards association with PE, and an exploratory model formed by that type of variable showed diagnostic accuracy for PE (ROC = 0.81; 95% CI = 0.66 - 0.96; p = 0.01. CONCLUSION: (1 Despite the lack of primary suspicion, patients admitted with HF have

  10. Ear Acupuncture for Acute Sore Throat: A Randomized Controlled Trial.

    Science.gov (United States)

    Moss, David A; Crawford, Paul

    2015-01-01

    Sore throat is a common cause of pain in outpatient encounters. Battlefield auricular acupuncture (the placing of needles in specific points in the ear) is a modality used to treat acute pain associated with a variety of ailments. The aim of our study was to determine whether auricular acupuncture reduces pain, medication usage, and missed work hours when added to standard therapy in adult patients with acute sore throat. We conducted an unblinded, pragmatic, randomized controlled trial among adult, nonpregnant patients presenting to an Air Force family medicine clinic with pain from acute sore throat. A total of 54 patients were followed for 48 hours after treatment. Patients receiving auricular acupuncture reported lower pain scores than those who did not at 15 minutes (6.0 [95% confidence interval (CI), 5.4-6.6] vs 2.6 [95% CI, 1.7-3.5]; P vs 2.5 [95% CI, 1.6-3.4]; P = .0005), and 24 hours (4.1 [95% CI, 3.3-4.9] vs 1.3 [95% CI, 1.0-2.8]; P = .0006). They also reported taking fewer cumulative doses of pain medication at 6 hours (1.07 [95% CI, 0.69-1.45] vs 0.39 [95% CI, 0.2-0.58]; P = .003), 24 hours (2.63 [95% CI, 1.95-3.31] vs 1.37 [95% CI, 0.92-1.82]; P = .004), and 48 hours (4.07 [95% CI, 2.9-5.24] vs 2.19 [95% CI, 1.44-2.94]; P = .009). There was no difference in time missed from work between the auricular acupuncture and standard therapy groups. Compared with usual treatment, battlefield auricular acupuncture was associated with reduced sore throat pain for 24 hours and decreased use of pain medication for up to 48 hours. There was no apparent effect on hours missed from work. © Copyright 2015 by the American Board of Family Medicine.

  11. Interleukin-1 Blockade in Recently Decompensated Systolic Heart Failure: Results From REDHART (Recently Decompensated Heart Failure Anakinra Response Trial).

    Science.gov (United States)

    Van Tassell, Benjamin W; Canada, Justin; Carbone, Salvatore; Trankle, Cory; Buckley, Leo; Oddi Erdle, Claudia; Abouzaki, Nayef A; Dixon, Dave; Kadariya, Dinesh; Christopher, Sanah; Schatz, Aaron; Regan, Jessica; Viscusi, Michele; Del Buono, Marco; Melchior, Ryan; Mankad, Pranav; Lu, Juan; Sculthorpe, Robin; Biondi-Zoccai, Giuseppe; Lesnefsky, Edward; Arena, Ross; Abbate, Antonio

    2017-11-01

    An enhanced inflammatory response predicts worse outcomes in heart failure (HF). We hypothesized that administration of IL-1 (interleukin-1) receptor antagonist (anakinra) could inhibit the inflammatory response and improve peak aerobic exercise capacity in patients with recently decompensated systolic HF. We randomly assigned 60 patients with reduced left ventricular ejection fraction (2 mg/L), within 14 days of hospital discharge, to daily subcutaneous injections with anakinra 100 mg for 2 weeks, 12 weeks, or placebo. Patients underwent measurement of peak oxygen consumption (Vo2 [mL/kg per minute]) and ventilatory efficiency (the VE/Vco2 slope). Treatment with anakinra did not affect peak Vo2 or VE/Vco2 slope at 2 weeks. At 12 weeks, patients continued on anakinra showed an improvement in peak Vo2 from 14.5 (10.5-16.6) mL/kg per minute to 16.1 (13.2-18.6) mL/kg per minute (P=0.009 for within-group changes), whereas no significant changes occurred within the anakinra 2-week or placebo groups. The between-groups differences, however, were not statistically significant. The incidence of death or rehospitalization for HF at 24 weeks was 6%, 31%, and 30%, in the anakinra 12-week, anakinra 2-week, and placebo groups, respectively (log-rank test P=0.10). No change in peak Vo2 occurred at 2 weeks in patients with recently decompensated systolic HF treated with anakinra, whereas an improvement was seen in those patients in whom anakinra was continued for 12 weeks. Additional larger studies are needed to validate the effects of prolonged anakinra on peak Vo2 and rehospitalization for HF. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01936909. © 2017 American Heart Association, Inc.

  12. Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

    NARCIS (Netherlands)

    Venekamp, R.P.; Bonten, M.J.; Rovers, M.M.; Verheij, T.J.; Sachs, A.P.

    2012-01-01

    BACKGROUND: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic

  13. Treatment of acute posttraumatic stress disorder with brief cognitive behavioral therapy: a randomized controlled trial

    NARCIS (Netherlands)

    Sijbrandij, Marit; Olff, Miranda; Reitsma, Johannes B.; Carlier, Ingrid V. E.; de Vries, Mirjam H.; Gersons, Berthold P. R.

    2007-01-01

    OBJECTIVE: The purpose of this study was to evaluate the efficacy of brief cognitive behavioral therapy for patients with acute posttraumatic stress disorder (PTSD) resulting from various types of psychological trauma. METHOD: The authors randomly assigned 143 patients with acute PTSD (irrespective

  14. Impact of Orthodontic Decompensation on Bone Insertion

    Directory of Open Access Journals (Sweden)

    Fabio Pinto Guedes

    2014-01-01

    Full Text Available There has always been concern in determining the relationship between orthodontic tooth movement and the consequent biological costs to the periodontium and tooth root. The possibility of evaluating the tooth and bone morphology by CBCT allows more accurate analysis of qualitative and quantitative aspects of these processes. This paper presents a case report of a 20-year-old male patient with Class III malocclusion and hyperdivergent facial pattern, who was surgically treated. A significant amount of labial movement of mandibular incisors was performed during orthodontic treatment before surgery. CBCT was used for evaluation of buccal and lingual bone plates before and after tooth decompensation. The changes in the bone insertion level of maxillary and mandibular incisors in the present case encourage a reflection on the treatment protocol in individuals with dentoskeletal discrepancies.

  15. Biomarkers in acute heart failure.

    Science.gov (United States)

    Mallick, Aditi; Januzzi, James L

    2015-06-01

    The care of patients with acutely decompensated heart failure is being reshaped by the availability and understanding of several novel and emerging heart failure biomarkers. The gold standard biomarkers in heart failure are B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide, which play an important role in the diagnosis, prognosis, and management of acute decompensated heart failure. Novel biomarkers that are increasingly involved in the processes of myocardial injury, neurohormonal activation, and ventricular remodeling are showing promise in improving diagnosis and prognosis among patients with acute decompensated heart failure. These include midregional proatrial natriuretic peptide, soluble ST2, galectin-3, highly-sensitive troponin, and midregional proadrenomedullin. There has also been an emergence of biomarkers for evaluation of acute decompensated heart failure that assist in the differential diagnosis of dyspnea, such as procalcitonin (for identification of acute pneumonia), as well as markers that predict complications of acute decompensated heart failure, such as renal injury markers. In this article, we will review the pathophysiology and usefulness of established and emerging biomarkers for the clinical diagnosis, prognosis, and management of acute decompensated heart failure. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  16. Northern Territory Heart Failure Initiative-Clinical Audit (NTHFI-CA)-a prospective database on the quality of care and outcomes for acute decompensated heart failure admission in the Northern Territory: study design and rationale.

    Science.gov (United States)

    Iyngkaran, Pupalan; Tinsley, Jeff; Smith, David; Haste, Mark; Nadarajan, Kangaharan; Ilton, Marcus; Battersby, Malcolm; Stewart, Simon; Brown, Alex

    2014-01-29

    Congestive heart failure is a significant cause of morbidity and mortality in Australia. Accurate data for the Northern Territory and Indigenous Australians are not presently available. The economic burden of this chronic cardiovascular disease is felt by all funding bodies and it still remains unclear what impact current measures have on preventing the ongoing disease burden and how much of this filters down to more remote areas. Clear differentials also exist in rural areas including a larger Indigenous community, greater disease burden, differing aetiologies for heart failure as well as service and infrastructure discrepancies. It is becoming increasingly clear that urban solutions will not affect regional outcomes. To understand regional issues relevant to heart failure management, an understanding of the key performance indicators in that setting is critical. The Northern Territory Heart Failure Initiative-Clinical Audit (NTHFI-CA) is a prospective registry of acute heart failure admissions over a 12-month period across the two main Northern Territory tertiary hospitals. The study collects information across six domains and five dimensions of healthcare. The study aims to set in place an evidenced and reproducible audit system for heart failure and inform the developing heart failure disease management programme. The findings, is believed, will assist the development of solutions to narrow the outcomes divide between remote and urban Australia and between Indigenous and Non-Indigenous Australians, in case they exist. A combination of descriptive statistics and mixed effects modelling will be used to analyse the data. This study has been approved by respective ethics committees of both the admitting institutions. All participants will be provided a written informed consent which will be completed prior to enrolment in the study. The study results will be disseminated through local and international health conferences and peer reviewed manuscripts.

  17. Northern Territory Heart Failure Initiative–Clinical Audit (NTHFI–CA)–a prospective database on the quality of care and outcomes for acute decompensated heart failure admission in the Northern Territory: study design and rationale

    Science.gov (United States)

    Iyngkaran, Pupalan; Tinsley, Jeff; Smith, David; Haste, Mark; Nadarajan, Kangaharan; Ilton, Marcus; Battersby, Malcolm; Stewart, Simon; Brown, Alex

    2014-01-01

    Introduction Congestive heart failure is a significant cause of morbidity and mortality in Australia. Accurate data for the Northern Territory and Indigenous Australians are not presently available. The economic burden of this chronic cardiovascular disease is felt by all funding bodies and it still remains unclear what impact current measures have on preventing the ongoing disease burden and how much of this filters down to more remote areas. Clear differentials also exist in rural areas including a larger Indigenous community, greater disease burden, differing aetiologies for heart failure as well as service and infrastructure discrepancies. It is becoming increasingly clear that urban solutions will not affect regional outcomes. To understand regional issues relevant to heart failure management, an understanding of the key performance indicators in that setting is critical. Methods and analysis The Northern Territory Heart Failure Initiative—Clinical Audit (NTHFI-CA) is a prospective registry of acute heart failure admissions over a 12-month period across the two main Northern Territory tertiary hospitals. The study collects information across six domains and five dimensions of healthcare. The study aims to set in place an evidenced and reproducible audit system for heart failure and inform the developing heart failure disease management programme. The findings, is believed, will assist the development of solutions to narrow the outcomes divide between remote and urban Australia and between Indigenous and Non-Indigenous Australians, in case they exist. A combination of descriptive statistics and mixed effects modelling will be used to analyse the data. Ethics and dissemination This study has been approved by respective ethics committees of both the admitting institutions. All participants will be provided a written informed consent which will be completed prior to enrolment in the study. The study results will be disseminated through local and international

  18. Corneal decompensation after intraocular ophthalmic surgery--Missouri, 1998.

    Science.gov (United States)

    1998-04-24

    During January 8-14, 1998, six of eight patients undergoing elective intraocular surgery at a Veterans Affairs medical center (VAMC) in St. Louis, Missouri, developed corneal endothelial decompensation (corneal edema and opacification) instruments sterilized by the Abtox Plazlyte system (Abtox, Inc., Chicago, Illinois). This report summarizes the results of the investigation of these cases and indicates that using the Abtox Plazlyte system to sterilize opthalmologic surgical equipment led to corneal decompensation.

  19. [Comprehensive therapy of cerebral and cerebrovascular decompensation (author's transl)].

    Science.gov (United States)

    Hofmann, G

    1980-06-01

    Many psychiatric syndroms in older age are based on cerebral and cerebrovascular decompensation. Diagnosis of metabolic dysfunction or vascular dysregulation--leading to cerebral decompensation--and their therapy is of greater importance than immediate therapy of psychiatric syndroms. We use Strophantin therapy, hemodilation, stabilization of blood pressure, antidiabetics combined with mild sedation by low dose neuroleptics. After achieving metabolic and cerebrovascular equilibrium we start more or less specific psychiatric syndrom therapy like antidepressants.

  20. Acute migraine therapy: recent evidence from randomized comparative trials

    DEFF Research Database (Denmark)

    Mett, A.; Tfelt-Hansen, P.

    2008-01-01

    tolerability over sumatriptan. (3) Combination indomethacin/caffeine/prochlorperazine most likely has similar therapeutic efficacy to triptan therapy, with further research needed to complete understanding of any potential differences between these treatments. (4) Multi-targeted combination therapy...... with a triptan plus a non-steroidal anti-inflammatory (NSAID), such as sumatriptan/naproxen sodium, is more effective in acute migraine treatment than monotherapy with either agent alone. (5) It is unclear whether triptans offer clinically relevant benefits over aspirin or NSAIDs in migraine patients. Thus...

  1. A randomized trial of treatment for acute anterior cruciate ligament tears

    DEFF Research Database (Denmark)

    Frobell, Richard B; Roos, Ewa M; Roos, Harald P

    2010-01-01

    BACKGROUND: The optimal management of a torn anterior cruciate ligament (ACL) of the knee is unknown. METHODS: We conducted a randomized, controlled trial involving 121 young, active adults with acute ACL injury in which we compared two strategies: structured rehabilitation plus early ACL...

  2. Randomized controlled trial of oral vs intravenous therapy for the clinically diagnosed acute uncomplicated diverticulitis.

    LENUS (Irish Health Repository)

    Ridgway, P F

    2009-11-01

    Despite the high prevalence of hospitalization for left iliac fossa tenderness, there is a striking lack of randomized data available to guide therapy. The authors hypothesize that an oral antibiotic and fluids are not inferior to intravenous (IV) antibiotics and \\'bowel rest\\' in clinically diagnosed acute uncomplicated diverticulitis.

  3. Mindfulness-based stress reduction and physiological activity during acute stress : A randomized controlled trial

    NARCIS (Netherlands)

    Nyklicek, I.; Mommersteeg, P.M.C.; van Beugen, S.; Ramakers, C.; van Boxtel, G.J.M.

    2013-01-01

    Objective: The aim was to examine the effects of a Mindfulness-Based Stress Reduction (MBSR) intervention on cardiovascular and cortisol activity during acute stress. Method: Eighty-eight healthy community-dwelling individuals reporting elevated stress levels were randomly assigned to the MBSR

  4. Mindfulness-based stress reduction and physiological activity during acute stress: a randomized controlled trial

    NARCIS (Netherlands)

    Nyklicek, I.; Mommersteeg, P.M.; Beugen, S. van; Ramakers, C.; Boxtel, G.J.M. van

    2013-01-01

    OBJECTIVE: The aim was to examine the effects of a Mindfulness-Based Stress Reduction (MBSR) intervention on cardiovascular and cortisol activity during acute stress. METHOD: Eighty-eight healthy community-dwelling individuals reporting elevated stress levels were randomly assigned to the MBSR

  5. Montelukast as an episodic modifier for acute viral bronchiolitis: a randomized trial.

    Science.gov (United States)

    Zedan, Magdy; Gamil, Nareman; El-Assmy, Mohamed; Fayez, Engy; Nasef, Nehad; Fouda, Ashraf; Settin, Ahmed

    2010-01-01

    This study was designed to evaluate the effect of once-daily montelukast therapy on the clinical progress and the cytokine profile of patients with acute viral bronchiolitis. A randomized, double-blind, placebo-controlled trial included 85 patients (mean age, 3.5 +/- 2.35 months), clinically diagnosed as first-episode acute bronchiolitis in addition to 10 healthy controls of matched age and sex. Patients were randomly assigned to receive either montelukast (4-mg sachets; n = 47) or placebo (n = 38) daily from the time of admission until discharge. The primary outcome measure was the length of hospital stay (LOS), and clinical severity scores (CSs) and changes in plasma levels of interferon gamma and interleukin-4 were secondary outcomes. LOS for the montelukast group was found to be significantly lower than that of the placebo group (p first 24 hours (p episodic modifier in infants with acute viral bronchiolitis.

  6. Comparison of the effect of BCAA granules on between decompensated and compensated cirrhosis.

    Science.gov (United States)

    Habu, Daiki; Nishiguchi, Shuhei; Nakatani, Shinji; Lee, Chulyoo; Enomoto, Masaru; Tamori, Akihiro; Takeda, Tadashi; Ohfuji, Satoko; Fukushima, Wakaba; Tanaka, Takashi; Kawamura, Etsuji; Shiomi, Susumu

    2009-01-01

    We designed a randomized trial to examine whether increase or preservation of serum albumin levels was attained with administration of branched-chain amino acid (BCAA) granules for compensated cirrhosis, compared with decompensated cirrhosis. Sixty-five patients with HCV-related cirrhosis with serum albumin level less than 4.0 g/dl were enrolled in this study. Half of the patients were randomly assigned to receive 14.22 g/day of BCAA granules orally, and half were assigned to a control group. Patients were evaluated at entry and at 1-year intervals for at least 2 years. The parameters were divided into 3 categories. Class 1 was decompensated cirrhosis with serum albumin level less than 3.5 mg/dl. Class 2 was compensated cirrhosis with serum albumin level over 3.6 mg/dl and molar ratio of BCAA to tyrosine (BTR) less than 4. Class 3 was compensated cirrhosis with serum albumin level over 3.6 mg/dl and BTR over 4. In class 1 and class 2, the BCAA group exhibited significantly higher rates of maintaining serum albumin level than the control group for 2 years. In contrast, there was no significant difference between the BCAA group and control group in rate of maintaining serum albumin levels in class 3. Those results suggested that if cirrhotic patients were in the compensated stage at the entry but with lower BTR, as for decompensated cirrhosis, oral BCAA supplementation might be effective in maintaining serum albumin level for 2 years.

  7. A Prospective, Randomized Investigation of Plasma First Resuscitation for Traumatic Hemorrhage and Attenuation of Acute Coagulopathy of Trauma

    Science.gov (United States)

    2016-05-01

    Attenuation of Acute Coagulopathy of Trauma . PRINCIPAL INVESTIGATOR: Ernest E. Moore, MD CONTRACTING ORGANIZATION: University of Colorado Denver...Randomized Investigation of “Plasma First Resuscitation” for Traumatic Hemorrhage and Attenuation of Acute Coagulopathy of Trauma . 5b. GRANT NUMBER...NOTES 14. ABSTRACT The COMBAT (Control of Major Bleeding After Trauma ) study is a randomized clinical trial evaluating the early administration of

  8. Zinc and copper supplementation in acute diarrhea in children: a double-blind randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Mamtani Manju

    2009-05-01

    Full Text Available Abstract Background Diarrhea causes an estimated 2.5 million child deaths in developing countries each year, 35% of which are due to acute diarrhea. Zinc and copper stores in the body are known to be depleted during acute diarrhea. Our objectives were to evaluate the efficacy of zinc and copper supplementation when given with standard treatment to children with acute watery or bloody diarrhea. Methods We conducted a double-blind randomized controlled clinical trial in the Department of Pediatrics at Indira Gandhi Government Medical College Nagpur, India. Eight hundred and eight children aged 6 months to 59 months with acute diarrhea were individually randomized to placebo (Pl, zinc (Zn only, and zinc and copper (Zn+Cu together with standard treatment for acute diarrhea. Results The mean duration of diarrhea from enrolment and the mean stool weight during hospital stay were 63.7 hours and 940 grams, respectively, and there were no significant differences in the adjusted means across treatment groups. Similarly, the adjusted means of the amount of oral rehydration solution or intravenous fluids used, the proportion of participants with diarrhea more than 7 days from onset, and the severity of diarrhea indicated by more than three episodes of some dehydration or any episode of severe dehydration after enrolment, did not differ across the three groups. Conclusion The expected beneficial effects of zinc supplementation for acute diarrhea were not observed. Therapeutic Zn or Zn and Cu supplementation may not have a universal beneficial impact on the duration of acute diarrhea in children. Trial registration The study was registered as an International Standard Randomized Controlled Trial (ISRCTN85071383.

  9. Effect of propranolol on survival in patients with decompensated cirrhosis

    DEFF Research Database (Denmark)

    Bang, Ulrich C; Benfield, Thomas; Hyldstrup, Lars

    2016-01-01

    BACKGROUND & AIMS: We assessed the impact of propranolol on death, risk of hepatorenal syndrome and peritonitis in patients with cirrhosis. METHODS: This study was a retrospective observational study and data were retrieved from Danish databases. We used our own criteria to stratify the patients...... on a propensity score matched cohort. RESULTS: Among 3719 patients, we found 3075 patients with mildly and 644 with severely decompensated cirrhosis. Propranolol was used by 20% of the patients. Among the patients with mildly decompensated cirrhosis, propranolol use vs. non-propranolol was related with a HR of 0.......7 (95% CI 0.6-0.9) and among the patients with severely decompensated cirrhosis, the HR was 0.6 (95% CI 0.4-0.9). Reduced mortality was found for doses of propranolol lower than 160 mg/day only. Among 361 patients with peritonitis, we found reduced mortality in the propranolol group with a HR of 0.5 (95...

  10. Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial.

    Science.gov (United States)

    Fouda, Abdelrahman Y; Newsome, Andrea S; Spellicy, Samantha; Waller, Jennifer L; Zhi, Wenbo; Hess, David C; Ergul, Adviye; Edwards, David J; Fagan, Susan C; Switzer, Jeffrey A

    2017-10-01

    Minocycline is under investigation as a neurovascular protective agent for stroke. This study evaluated the pharmacokinetic, anti-inflammatory, and safety profile of minocycline after intracerebral hemorrhage. This study was a single-site, randomized controlled trial of minocycline conducted from 2013 to 2016. Adults ≥18 years with primary intracerebral hemorrhage who could have study drug administered within 24 hours of onset were included. Patients received 400 mg of intravenous minocycline, followed by 400 mg minocycline oral daily for 4 days. Serum concentrations of minocycline after the last oral dose and biomarkers were sampled to determine the peak concentration, half-life, and anti-inflammatory profile. A total of 16 consecutive eligible patients were enrolled, with 8 randomized to minocycline. Although the literature supports a time to peak concentration (Tmax) of 1 hour for oral minocycline, the Tmax was estimated to be at least 6 hours in this cohort. The elimination half-life (available on 7 patients) was 17.5 hours (SD±3.5). No differences were observed in inflammatory biomarkers, hematoma volume, or perihematomal edema. Concentrations remained at neuroprotective levels (>3 mg/L) throughout the dosing interval in 5 of 7 patients. In intracerebral hemorrhage, a 400 mg dose of minocycline was safe and achieved neuroprotective serum concentrations. However, oral administration led to delayed absorption in these critically ill patients and should not be used when rapid, high concentrations are desired. Given the safety and pharmacokinetic profile of minocycline in intracerebral hemorrhage and promising data in the treatment of ischemic stroke, intravenous minocycline is an excellent candidate for a prehospital treatment trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01805895. © 2017 American Heart Association, Inc.

  11. The Decompensated Monofixation Syndrome (An American Ophthalmological Society Thesis)

    Science.gov (United States)

    Siatkowski, R. Michael

    2011-01-01

    Purpose To describe the clinical features and response to treatment of patients with decompensated monofixation syndrome (MFS) and to propose a hypothesis for a decompensation mechanism in such patients. Methods Fourteen adults with MFS who had been symptomatically stable for a mean duration of 25 years developed diplopia in the absence of neurologic or orbital disease. After retrospective chart review, they underwent detailed orthoptic testing. Results from this cross-sectional analysis were compared with similar data from 16 control subjects with stable MFS. Results Compared to stable MFS patients, decompensated subjects had significantly poorer horizontal fusional amplitudes but greater torsional fusional amplitudes; they were also more likely to have a small vertical strabismus and to have received initial treatment later. Stable subjects, however, also had subnormal horizontal as well as torsional fusional amplitudes. There was no difference between groups with respect to refractive error, amblyopia, type or prior treatment of strabismus, stereoacuity, or angle of deviation. After treatment, all patients regained monofixational alignment, but up to one-third had continued diplopia. Symptoms recurred in two patients whose treatment was initially successful. Conclusions Patients with MFS lose fusional amplitudes over time. In some cases this results in development of sensory torsion with secondary decompensation and diplopia. The rate of decompensation averages 7% per year from ages 20 to 70. Treatment for decompensation offers excellent motor results, but sensory symptoms may persist and recurrent symptoms may develop. Monitoring and maintenance of fusional vergence amplitudes should be part of the routine care for patients with MFS. PMID:22253490

  12. Management of Mechanical Ventilation in Decompensated Heart Failure

    Directory of Open Access Journals (Sweden)

    Brooks T. Kuhn

    2016-12-01

    Full Text Available Mechanical ventilation (MV is a life-saving intervention for respiratory failure, including decompensated congestive heart failure. MV can reduce ventricular preload and afterload, decrease extra-vascular lung water, and decrease the work of breathing in heart failure. The advantages of positive pressure ventilation must be balanced with potential harm from MV: volutrauma, hyperoxia-induced injury, and difficulty assessing readiness for liberation. In this review, we will focus on cardiac, pulmonary, and broader effects of MV on patients with decompensated HF, focusing on practical considerations for management and supporting evidence.

  13. Lactobacillus GG for treatment of acute childhood diarrhoea: an open labelled, randomized controlled trial.

    Science.gov (United States)

    Aggarwal, Sunny; Upadhyay, Amit; Shah, Dheeraj; Teotia, Neeraj; Agarwal, Astha; Jaiswal, Vijay

    2014-03-01

    Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG (LGG) in the treatment of acute watery diarrhoea, but there is paucity of such data from India. The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India. In this open labelled, randomized controlled trial 2000 children with acute watery diarrhoea, aged between 6 months to 5 years visiting outpatient department and emergency room of a teaching hospital in north India were enrolled. The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea. Primary outcomes were duration of diarrhoea and time to change in consistency of stools. Median (inter quartile range) duration of diarrhoea was significantly shorter in children in LGG group [60 (54-72) h vs. 78 (72-90) h; PLactobacillus GG than control group [36 (30-36) h vs. 42 (36-48) h; PLactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group.

  14. A randomized, double-blind, placebo-controlled trial of oral montelukast in acute asthma exacerbation.

    Science.gov (United States)

    Zubairi, Ali Bin Sarwar; Salahuddin, Nawal; Khawaja, Ali; Awan, Safia; Shah, Adil Aijaz; Haque, Ahmed Suleman; Husain, Shahid Javed; Rao, Nisar; Khan, Javaid Ahmad

    2013-03-28

    Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. However, there is very little information as to their role in acute asthma exacerbations. We hypothesized that LTRAs may accelerate lung function recovery when given in an acute exacerbation. A randomized, double blind, placebo-controlled trial was conducted at the Aga Khan University Hospital to assess the efficacy of oral montelukast on patients of 16 years of age and above who were hospitalized with acute asthma exacerbation. The patients were given either montelukast or placebo along with standard therapy throughout the hospital stay for acute asthma. Improvements in lung function and duration of hospital stay were monitored. 100 patients were randomized; their mean age was 52 years (SD +/- 18.50). The majority were females (79%) and non-smokers (89%). The mean hospital stay was 3.70 ± 1.93 days with 80% of patients discharged in 3 days. There was no significant difference in clinical symptoms, PEF over the course of hospital stay (p = 0.20 at day 2 and p = 0.47 at day 3) and discharge (p = 0.15), FEV1 at discharge (p = 0.29) or length of hospital stay (p = 0.90) between the two groups. No serious adverse effects were noted during the course of the study. Our study suggests that there is no benefit of addition of oral montelukast over conventional treatment in the management of acute asthma attack. 375-Med/ERC-04.

  15. Adjunctive Use of Noninvasive Ventilation During Exercise in Patients With Decompensated Heart Failure.

    Science.gov (United States)

    Moraes, Igor Gutierrez; Kimoto, Karen Mota; Fernandes, Marcos Brandmuller; Grams, Samantha Torres; Yamaguti, Wellington Pereira

    2017-02-01

    Noninvasive ventilation (NIV) as an adjunct strategy for increasing exercise tolerance has been widely investigated in patients with pulmonary diseases. To our knowledge, there are no studies that have used NIV during exercise in patients with decompensated heart failure (HF). The aim of this study was to evaluate the effects of NIV on exercise tolerance in hospitalized patients with decompensated HF. Thirteen patients (77 ± 15 years) with a mean left ventricular ejection fraction of 35 ± 15% were included. Patients underwent 2 submaximal exercise tests with constant load for lower limbs using a portable cycle ergometer. Tests were performed on the same day with a 60-minute interval between each one, using a randomized crossover design: sham ventilation (continuous positive airway pressure mode, 4 cm H2O) and intervention situation (NIV in bilevel mode). Primary outcome was the endurance time performed during exercise tests with constant load. Submaximal exercise with NIV in bilevel mode improved endurance time (7.2 ± 2.7 minutes) compared to the tests performed with continuous positive airway pressure (5.1 ± 1.5 minutes; p = 0.008). Increase in endurance time (Δ time) with bilevel test showed a significant correlation with reduction in the slope of dyspnea (Δ Borg) over time (r = -0.73; p = 0.004). There was a significant correlation between endurance time in bilevel tests and maximum inspiratory pressure % predicted (r = 0.68; p = 0.02). In conclusion, NIV was effective in increasing exercise tolerance in hospitalized patients with decompensated HF. (ClinicalTrials.gov registration NCT02122848). Copyright © 2016 Elsevier Inc. All rights reserved.

  16. A pharmacogenetic investigation of intravenous furosemide in decompensated heart failure: a meta-analysis of three clinical trials.

    Science.gov (United States)

    de Denus, S; Rouleau, J L; Mann, D L; Huggins, G S; Cappola, T P; Shah, S H; Keleti, J; Zada, Y F; Provost, S; Bardhadi, A; Phillips, M S; Normand, V; Mongrain, I; Dubé, M-P

    2017-03-01

    We conducted a meta-analysis of pharmacogenomic substudies of three randomized trials conducted in patients with decompensated heart failure (HF) that were led by National Heart Lung and Blood Institute (NHLBI)-funded HF Network to test the hypothesis that candidate genes modulate net fluid loss and weight change in patients with decompensated HF treated with a furosemide-based diuretic regimen. Although none of the genetic variants previously shown to modulate the effects of loop diuretics in healthy individuals were associated with net fluid loss after 72 h of treatment, a set of rare variants in the APOL1 gene, which codes for apolipoprotein L1 (P=0.0005 in the random effects model), was associated with this end point. Moreover, a common variant in the multidrug resistance protein-4 coding gene (ABCC4, rs17268282) was associated with weight loss with furosemide use (P=0.0001). Our results suggest that both common and rare genetic variants modulate the response to a furosemide-based diuretic regimen in patients with decompensated HF.

  17. Decompensated cirrhosis-related admissions in a large urban ...

    African Journals Online (AJOL)

    EB

    Abstract. Background: Cirrhosis-related complications are a major cause of morbidity and mortality in areas where its risk factors are endemic. Objective: We determined the prevalence of decompensated cirrhosis among patients on the gastroenterology service of. Mulago Hospital and described the clinical and laboratory ...

  18. Home medicines reviews following acute coronary syndrome: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bernal Daniel DL

    2012-04-01

    Full Text Available Abstract Background Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service. Methods/Design We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality. Discussion As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible

  19. Interval training early after heart failure decompensation is safe and improves exercise tolerance and quality of life in selected patients.

    Science.gov (United States)

    Doletsky, Artem; Andreev, Denis; Giverts, Ilya; Svet, Alexey; Brand, Anna; Kuklina, Maria; Sedov, Vsevolod; Dikur, Oxana; Syrkin, Abram; Saner, Hugo

    2017-01-01

    Aims To evaluate safety and efficacy of moderate intensity interval exercise training early after heart failure decompensation on exercise tolerance and health-related quality of life (HRQoL). Methods and results This is a prospective randomized controlled study. We screened 234 consecutive patients admitted with decompensated heart failure; 46 patients (42 men/4 women; 61 ± 12 years of age) were randomized to a moderate intensity aerobic interval training ( n = 24) or to a control group ( n = 22). Patients underwent cardiopulmonary exercise testing, echocardiography and Minnesota Living with Heart Failure questionnaire (MLHFQ) at baseline, after three weeks and after three months. After three weeks, peak-VO2 increased by 17% in the training group ( p = 0.003) with further increase by 10% after three months ( p training group (from 64.6 ± 15.6 to 30.8 ± 12.9, p training group, but not in controls. Left ventricular ejection fraction was not significantly different between the two groups at baseline and after three months. No serious adverse events related to exercise testing or training were observed. Conclusions Interval exercise training early after an episode of heart failure decompensation is safe and effective in improving exercise tolerance and health-related quality of life in selected patients after achievement of clinical stability. Positive effects remained sustained after three months. Further studies are needed to define role and indications for interval exercise training early after heart failure decompensation.

  20. Efficacy of dioctahedral smectite in acute watery diarrhea in Indian children: a randomized clinical trial.

    Science.gov (United States)

    Mujawar, Quais Mohammad; Naganoor, Ravi; Ali, Mir Dilshad; Malagi, Naushad; Thobbi, Achyut Narayan

    2012-02-01

    To determine the effects and safety of dioctahedral smectite (DS) on the duration of acute watery diarrhea in children. A Randomized, open labeled, clinical controlled trial in a tertiary care hospital outpatient department (OPD) and emergency department. Participants were one hundred and seventeen children without any chronic illness between 2 and 5 years presenting to OPD, having acute watery diarrhea for diarrhea in children aged 2-5 years. There were no adverse effects on the use of DS. DS was acceptable to the children, and its administration was not accompanied with any side effects. DS reduces the duration of diarrhea in Indian children and prevents a prolonged course, and therefore, may consistently reduce the costs in treatment of acute watery diarrhea.

  1. Mitochondrial Reprogramming Induced by CaMKIIδ Mediates Hypertrophy Decompensation

    Science.gov (United States)

    Westenbrink, B. Daan; Ling, Haiyun; Divakaruni, Ajit; Gray, Charles B. B.; Zambon, Alexander C.; Dalton, Nancy D.; Peterson, Kirk L.; Gu, Yusu; Matkovich, Scot J.; Murphy, Anne; Miyamoto, Shigeki; Dorn, Gerald W.; Brown, Joan Heller

    2015-01-01

    Rationale Sustained activation of Gq signaling during pressure overload causes cardiac hypertrophy that ultimately progresses to dilated cardiomyopathy. The molecular events that drive hypertrophy decompensation are incompletely understood. Ca2+/calmodulin-dependent protein kinase II delta (CaMKIIδ) is activated downstream of Gq and overexpression of Gq and CaMKIIδ recapitulates hypertrophy decompensation. Objective To determine whether CaMKIIδ contributes to hypertrophy decompensation provoked by Gq. Methods and Results Compared to Gαq transgenic (Gq) mice, compound Gq/CaMKIIδ knockout (KO) (Gq/KO) mice developed a similar degree of cardiac hypertrophy but exhibited significantly improved left ventricular function, less cardiac fibrosis and cardiomyocyte apoptosis, and fewer ventricular arrhythmias. Markers of oxidative stress were elevated in mitochondria from Gq vs. WT mice and respiratory rates were lower; these changes in mitochondrial function were restored by CaMKIIδ deletion. Gq-mediated increases in mitochondrial oxidative stress, compromised membrane potential and cell death were recapitulated in NRVMs infected with constitutively active Gq and attenuated by CaMKII inhibition. Deep RNA sequencing revealed altered expression of 41 mitochondrial genes in Gq hearts, with normalization of ~40% of these genes by CaMKIIδ deletion. Uncoupling protein 3 (UCP3) was markedly downregulated in Gq or by Gq expression in NRVMs and reversed by CaMKIIδ deletion or inhibition, as was Peroxisome proliferator-activated receptor alpha (PPAR-α). The protective effects of CaMKIIδ inhibition on ROS generation and cell death were abrogated by knock down of UCP3. Conversely, restoration of UCP3 expression attenuated ROS generation and cell death induced by CaMKIIδ. Our in vivo studies further demonstrated that pressure overload induced decreases in PPAR-α and UCP3, increases in mitochondrial protein oxidation, and hypertrophy decompensation which were attenuated by Ca

  2. Nitazoxanide in Acute Rotavirus Diarrhea: A Randomized Control Trial from a Developing Country.

    Science.gov (United States)

    Mahapatro, Samarendra; Mahilary, Nijwm; Satapathy, Amit Kumar; Das, Rashmi Ranjan

    2017-01-01

    Background. Acute diarrhea is one of the leading causes of childhood mortality, with rotavirus being an important pathogen. Nitazoxanide, an antiparasitic agent, has been shown to inhibit rotavirus. Objective. This double-blind, randomized trial was designed to study the role of nitazoxanide in acute rotavirus diarrhea. Methods. Of 174 children (12 months to 5 years) with acute diarrhea, 50 rotavirus positive cases were randomized. The intervention group received syrup nitazoxanide twice daily (100 mg in 12-47 months, 200 mg in ≥4 yr) for 3 days along with standard treatment of diarrhea. Duration of diarrhea was the primary outcome measure. Results. The median duration (hrs) of diarrhea (54 versus 80; 95% CI: -26 [-13.2 to -38.8]) and hospitalization (68 versus 90; 95% CI: -22 [-12.98 to -31.02]) was significantly shorter in the nitazoxanide group. No significant difference was seen in the median duration (hrs) of fever or vomiting or the proportion of children requiring parenteral rehydration. There was no report of any adverse events. Conclusions. Oral nitazoxanide is effective and safe in the management of acute rotavirus diarrhea in Indian children (CTRI REF/2016/10/012507).

  3. Nitazoxanide in Acute Rotavirus Diarrhea: A Randomized Control Trial from a Developing Country

    Directory of Open Access Journals (Sweden)

    Samarendra Mahapatro

    2017-01-01

    Full Text Available Background. Acute diarrhea is one of the leading causes of childhood mortality, with rotavirus being an important pathogen. Nitazoxanide, an antiparasitic agent, has been shown to inhibit rotavirus. Objective. This double-blind, randomized trial was designed to study the role of nitazoxanide in acute rotavirus diarrhea. Methods. Of 174 children (12 months to 5 years with acute diarrhea, 50 rotavirus positive cases were randomized. The intervention group received syrup nitazoxanide twice daily (100 mg in 12–47 months, 200 mg in ≥4 yr for 3 days along with standard treatment of diarrhea. Duration of diarrhea was the primary outcome measure. Results. The median duration (hrs of diarrhea (54 versus 80; 95% CI: –26 [–13.2 to –38.8] and hospitalization (68 versus 90; 95% CI: –22 [–12.98 to –31.02] was significantly shorter in the nitazoxanide group. No significant difference was seen in the median duration (hrs of fever or vomiting or the proportion of children requiring parenteral rehydration. There was no report of any adverse events. Conclusions. Oral nitazoxanide is effective and safe in the management of acute rotavirus diarrhea in Indian children (CTRI REF/2016/10/012507.

  4. Geographic Differences in Patients in a Global Acute Heart Failure Clinical Trial (from the ASCEND-HF Trial)

    NARCIS (Netherlands)

    Metra, Marco; Mentz, Robert J.; Hernandez, Adrian F.; Heizer, Gretchen M.; Armstrong, Paul W.; Clausell, Nadine; Corbalan, Ramon; Costanzo, Maria Rosa; Dickstein, Kenneth; Dunlap, Mark E.; Ezekowitz, Justin A.; Howlett, Jonathan G.; Komajda, Michel; Krum, Henry; Lombardi, Carlo; Fonarow, Gregg C.; McMurray, John J. V.; Nieminen, Markku S.; Swedberg, Karl; Voors, Adriaan A.; Starling, Randall C.; Teerlink, John R.; O'Connor, Christopher M.

    2016-01-01

    A growing number of countries and geographical regions are involved in major clinical trials. Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure is the largest trial in acutely decompensated heart failure (HF) with patients from 5 geographical regions: North America

  5. Randomized trial of oral versus sequential IV/oral antibiotic for acute pyelonephritis in children.

    Science.gov (United States)

    Bocquet, Nathalie; Sergent Alaoui, Aline; Jais, Jean-Pierre; Gajdos, Vincent; Guigonis, Vincent; Lacour, Bernard; Chéron, Gérard

    2012-02-01

    To confirm whether oral antibiotic treatment is as efficacious as sequential intravenous/oral antibiotic treatment in the prevention of renal scarring in children with acute pyelonephritis and scintigraphy-documented acute lesions. In a prospective multicenter trial, children aged 1 to 36 months with their first case of acute pyelonephritis, a serum procalcitonin concentration ≥0.5 ng/mL, no known uropathy, and a normal ultrasound exam were randomized into 2 treatment groups. They received either oral cefixime for 10 days or intravenous ceftriaxone for 4 days followed by oral cefixime for 6 days. Patients with acute renal lesions detected on early dimercaptosuccinic acid scintigraphy underwent a follow-up scintigraphy 6 to 8 months later. The study included 171 infants and children. There were no significant differences between the 2 groups in any clinical characteristic. Initial scintigraphy results were abnormal for 119 children. Ninety-six children were measured for renal scarring at the follow-up scintigraphy (per protocol analysis population). The incidence of renal scarring was 30.8% in the oral treatment group and 27.3% for children who received the sequential treatment. Although this trial does not statistically demonstrate the noninferiority of oral treatment compared with the sequential treatment, our study confirmed the results of previously published reports and therefore supports the use of an oral antibiotic treatment of primary episodes of acute pyelonephritis in infants and young children.

  6. Patient Activation through Counseling and Exercise--Acute Leukemia (PACE-AL)--a randomized controlled trial.

    Science.gov (United States)

    Jarden, Mary; Møller, Tom; Kjeldsen, Lars; Birgens, Henrik; Christensen, Jesper Frank; Bang Christensen, Karl; Diderichsen, Finn; Hendriksen, Carsten; Adamsen, Lis

    2013-10-02

    Patients with acute leukemia experience a substantial symptom burden and are at risk of developing infections throughout the course of repeated cycles of intensive chemotherapy. Physical activity in recent years has been a strategy for rehabilitation in cancer patients to remedy disease and treatment related symptoms and side effects. To date, there are no clinical practice exercise guidelines for patients with acute leukemia undergoing induction and consolidation chemotherapy. A randomized controlled trial is needed to determine if patients with acute leukemia can benefit by a structured and supervised counseling and exercise program. This paper presents the study protocol: Patient Activation through Counseling and Exercise--Acute Leukemia (PACE-AL) trial, a two center, randomized controlled trial of 70 patients with acute leukemia (35 patients/study arm) following induction chemotherapy in the outpatient setting. Eligible patients will be randomized to usual care or to the 12 week exercise and counseling program. The intervention includes 3 hours + 30 minutes per week of supervised and structured aerobic training (moderate to high intensity 70-80%) on an ergometer cycle, strength exercises using hand weights and relaxation exercise. Individual health counseling sessions include a self directed home walk program with a step counter. The primary endpoint is functional performance/exercise capacity (6 minute walk distance). The secondary endpoints are submaximal VO₂ max test, sit to stand and bicep curl test, physical activity levels, patient reported outcomes (quality of life, anxiety and depression, symptom prevalence, intensity and interference). Evaluation of clinical outcomes will be explored including incidence of infection, hospitalization days, body mass index, time to recurrence and survival. Qualitative exploration of patients' health behavior and experiences. PACE-AL will provide evidence of the effect of exercise and health promotion counseling on

  7. Retroperitoneal haemorrhage in renal angiomyolipoma causing hepatic functional decompensation: a case report

    Directory of Open Access Journals (Sweden)

    Wajed Julekha R

    2007-09-01

    Full Text Available Abstract Renal angiomyolipomata usually present as incidental findings on routine imaging, but rarely they may give rise to significant haemorrhage. If bleeding occurs, first-line treatment is currently angiography with selective embolisation. Prophylactic embolisation may be considered in some cases, depending on lesion size and patient co-morbidities. We present a case of retroperitoneal bleeding from a renal angiomyolipoma in a patient with known cirrhosis of the liver, which caused acute deterioration of liver function and consequent hepatic encephalopathy. Selective embolisation of the lesion was performed with a good subsequent outcome. Such functional hepatic decompensation has not previously been reported in this context and we suggest the use of prophylactic embolisation for incidental renal angiomyolipomata, regardless of size, in all patients with chronic liver disease to prevent this potentially life-threatening complication.

  8. Proton magnetic resonance spectroscopy reflects metabolic decompensation in maple syrup urine disease

    Energy Technology Data Exchange (ETDEWEB)

    Heindel, W. [Dept. of Diagnostic Radiology, Univ. Koeln (Germany); Kugel, H. [Dept. of Diagnostic Radiology, Univ. Koeln (Germany); Wendel, U. [Children`s Hospital, Univ. Duesseldorf (Germany); Roth, B. [Children`s Hospital, Univ. Koeln (Germany); Benz-Bohm, G. [Dept. of Diagnostic Radiology, Univ. Koeln (Germany)

    1995-06-01

    Using localized proton magnetic resonance spectroscopy ({sup 1}H-MRS), accumulation of branchedchain amino acids (BCAA) and their corresponding 2-oxo acids (BCOA) could be non-invasively demonstrated in the brain of a 9-year-old girl suffering from classical maple syrup urine disease. During acute metabolic decompensation, the compounds caused a signal at a chemical shift of 0.9 ppm which was assigned by in vitro experiments. The brain tissue concentration of the sum of BCAA and BCOA could be estimated as 0.9 mmol/l. Localized {sup 1}H-MRS of the brain appears to be suitable for examining patients suffering from maple syrup urine disease in different metabolic states. (orig.)

  9. Organoprotective effects of serelaxin in patients with severe decompensated heart failure

    Directory of Open Access Journals (Sweden)

    Z. D. Kobalava

    2016-01-01

    Full Text Available Serelaxin (recombinant molecule of the human relaxin-2 is an innovative drug for the treatment of acute heart failure. Preclinical and clinical studies demonstrated the ability of serelaxin to relieve the symptoms of heart failure, provide a significant reduction in congestion and have a protective effect on the heart, kidneys, liver. 48-hour serelaxin infusion in patient with ischemic cardiomyopathy and severe decompensated heart failure with cardio-hepatic syndrome led to significant regression of systemic congestion (evaluated by physical signs and by bioimpedance vector analysis, the improvement of structural and functional state of the myocardium (evaluated by standard echocardiography and global systolic longitudinal deformation of the left ventricle with speckle tracking echocardiography, regression of cardio-hepatic syndrome, improvement of renal function. Serelaxin therapy was well tolerated and was safe. Presented case report demonstrates beneficial effects of serelaxin on the heart failure symptoms and the organoprotective effects.

  10. Acupuncture in the Inpatient Acute Care Setting: A Pragmatic, Randomized Control Trial

    Directory of Open Access Journals (Sweden)

    Jeannette Painovich

    2012-01-01

    Full Text Available Purpose. To evaluate the acceptance and effectiveness of acupuncture in a hospital setting. Methods. This 18-month pragmatic randomized controlled trial used a two-tiered consent process for all patients admitted to the acute care unit by study physician groups. The primary study comparison was between those randomized (using biased-coin randomization after initial consent to be offered acupuncture or not. The primary outcome was length of stay (LOS. Other measures include costs, self-reported anxiety, depression, health status, and patient satisfaction. Results. Of the 383 patients consented to the study, 253 were randomized to be offered acupuncture, and 130 were not offered acupuncture. Of those offered acupuncture, 173 (69% accepted and received daily acupuncture. On average, patients offered acupuncture had longer LOSs (4.9 versus 4.1 days than those not offered acupuncture (=.047. Adjustment for diagnosis and severity mix reduced this difference and its significance (=.108. No other significant differences in outcomes were found. Patients who were more anxious (=.000 or depressed (=.017 at admission tended to more often accept acupuncture when offered. Conclusion. Acupuncture is accepted by a majority of hospitalized acute care patients. However, it did not reduce LOS in this already short-stay population.

  11. Mesalazine in the initial management of severely acutely malnourished children with environmental enteric dysfunction: a pilot randomized controlled trial

    National Research Council Canada - National Science Library

    Jones, Kelsey D J; Hünten-Kirsch, Barbara; Laving, Ahmed M R; Munyi, Caroline W; Ngari, Moses; Mikusa, Jenifer; Mulongo, Musa M; Odera, Dennis; Nassir, H Samira; Timbwa, Molline; Owino, Moses; Fegan, Greg; Murch, Simon H; Sullivan, Peter B; Warner, John O; Berkley, James A

    2014-01-01

    .... In this pilot double-blind randomized placebo-controlled trial, 44 children with severe acute malnutrition and evidence of EED were assigned to treatment with mesalazine or placebo for 28 days...

  12. Mesalazine in the initial management of severely acutely malnourished children with environmental enteric dysfunction: a pilot randomized controlled trial

    National Research Council Canada - National Science Library

    Jones, Kelsey D J; Hünten-Kirsch, Barbara; Laving, Ahmed M R; Munyi, Caroline W; Ngari, Moses; Mikusa, Jenifer; Mulongo, Musa M; Odera, Dennis; Nassir, H Samira; Timbwa, Molline; Owino, Moses; Fegan, Greg; Murch, Simon H; Sullivan, Peter B; Warner, John O; Berkley, James A

    2014-01-01

    .... In this pilot double-blind randomized placebo-controlled trial, 44 children with severe acute malnutrition and evidence of EED were assigned to treatment with mesalazine or placebo for 28 days during...

  13. Lactobacillus GG for treatment of acute childhood diarrhoea: An open labelled, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sunny Aggarwal

    2014-01-01

    Full Text Available Background & objectives : 0 Randomized controlled trials in developed countries have reported benefits of Lactobacillus GG (LGG in the treatment of acute watery diarrhoea, but there is paucity of such data from India. The study was aimed to evaluate the efficacy and safety of Lactobacillus GG in the treatment of acute diarrhoea in children from a semi-urban city in north India. Methods: In this open labelled, randomized controlled trial 2000 children with acute watery diarrhoea, aged between 6 months to 5 years visiting 0 outpatient department and emergency room of a teaching hospital in north India were enrolled. The children were randomized into receiving either Lactobacillus GG in dose of 10 billion cfu/day for five days or no probiotic medication in addition to standard WHO management of diarrhoea. 0 Primary outcomes were duration of diarrhoea and time to change in consistency of stools. Results : 0 Median (inter quartile range duration of diarrhoea was significantly shorter in children in LGG group [60 (54-72 h vs. 78 (72-90 h; P<0.001]. Also, there was faster improvement in stool consistency in children receiving Lactobacillus GG than control group [36 (30-36 h vs. 42 (36-48 h; P<0.001]. There was significant reduction in average number of stools per day in LGG group (P<0.001 compared to the control group. These benefits were seen irrespective of rotavirus positivity in stool tests. Interpretation & conclusions : 0 Our results showed that the use of Lactobacillus GG in children with acute diarrhoea resulted in shorter duration and faster improvement in stool consistency as compared to the control group.

  14. Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Levine, David M; Ouchi, Kei; Blanchfield, Bonnie; Diamond, Keren; Licurse, Adam; Pu, Charles T; Schnipper, Jeffrey L

    2018-02-06

    Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. Randomized controlled trial. Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p Home patients were more physically active (median minutes, 209 vs. 78; p home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups. The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety, and patient experience were noted, with more definitive results awaiting a larger trial. Trial Registration NCT02864420.

  15. A randomized, double-blind, placebo-controlled trial of oral montelukast in acute asthma exacerbation

    Science.gov (United States)

    2013-01-01

    Background Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. However, there is very little information as to their role in acute asthma exacerbations. We hypothesized that LTRAs may accelerate lung function recovery when given in an acute exacerbation. Methods A randomized, double blind, placebo-controlled trial was conducted at the Aga Khan University Hospital to assess the efficacy of oral montelukast on patients of 16 years of age and above who were hospitalized with acute asthma exacerbation. The patients were given either montelukast or placebo along with standard therapy throughout the hospital stay for acute asthma. Improvements in lung function and duration of hospital stay were monitored. Results 100 patients were randomized; their mean age was 52 years (SD +/− 18.50). The majority were females (79%) and non-smokers (89%). The mean hospital stay was 3.70 ± 1.93 days with 80% of patients discharged in 3 days. There was no significant difference in clinical symptoms, PEF over the course of hospital stay (p = 0.20 at day 2 and p = 0.47 at day 3) and discharge (p = 0.15), FEV1 at discharge (p = 0.29) or length of hospital stay (p = 0.90) between the two groups. No serious adverse effects were noted during the course of the study. Conclusion Our study suggests that there is no benefit of addition of oral montelukast over conventional treatment in the management of acute asthma attack. Trial registration Trial registration number: 375-Med/ERC-04 PMID:23537391

  16. Efficacy and safety of parecoxib in the treatment of acute renal colic: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Sidney Glina

    2011-12-01

    Full Text Available PURPOSE: Although nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs and opioids are effective treatments for acute renal colic, they are associated with adverse events (AEs. As cyclooxygenase-2 selective NSAIDs may provide a safer alternative, we compared the efficacy and safety of parecoxib versus an nsNSAID in subjects with acute renal colic. MATERIALS AND METHODS: Phase IV., multicenter, double-blind, noninferiority, active-controlled study: 338 subjects with acute renal colic were randomized to parecoxib 40 mg i.v. plus placebo (n = 174 or ketoprofen 100 mg IV plus placebo (n = 164. 338 subjects with acute renal colic were randomized to parecoxib 40 mg IV (n = 174 or ketoprofen 100 mg IV(n = 164 plus placebo. Subjects were evaluated 15, 30, 45, 60, 90 and 120 minutes after treatment start and 24 hours after discharge. Primary endpoint was the mean pain intensity difference (PID at 30 minutes by visual analog scale (VAS (per-protocol population. An ANCOVA model was used with treatment group, country, and baseline score as covariates. Non-inferiority of parecoxib to ketoprofen was declared if the lower bound of the 95% confidence interval (CI for the difference between the two groups excluded the pre-established margin of 10 mm for the primary endpoint. RESULTS: Baseline demographics were similar. The mean (SD mPID30 min was 33.84 (24.61 and 35.16 (26.01 for parecoxib and ketoprofen, respectively. For treatment difference (parecoxib-ketoprofen the lower bound of the 95% CI was 6.53. The mean change from baseline in VAS 30 minutes after study medication was ~43 mm; AEs were comparable between treatments. CONCLUSIONS: Parecoxib is as effective as ketoprofen in the treatment of pain due to acute renal colic, is well tolerated, and has a comparable safety profile.

  17. Hyperoncotic colloids and acute kidney injury: a meta-analysis of randomized trials

    Science.gov (United States)

    2010-01-01

    Introduction It has been hypothesized that hyperoncotic colloids might contribute to acute kidney injury (AKI). However, the validity of this hypothesis remains unclear. Methods A meta-analysis was conducted of randomized controlled trials evaluating AKI after infusion of hyperoncotic albumin and hydroxyethyl starch (HES) solutions. Mortality was a secondary endpoint. Eligible trials were sought by multiple methods, and the pooled odds ratios (OR) for AKI and death and 95% confidence intervals (CI) were computed under a random effects model. Results Eleven randomized trials with a total of 1220 patients were included: 7 evaluating hyperoncotic albumin and 4 hyperoncotic HES. Clinical indications were ascites, surgery, sepsis and spontaneous bacterial peritonitis. Hyperoncotic albumin decreased the odds of AKI by 76% (OR, 0.24; CI, 0.12-0.48; P colloid solutions per se injure the kidney. Renal effects appear instead to be colloid-specific, with albumin displaying renoprotection and HES showing nephrotoxicity. PMID:21029460

  18. A double-blind, randomized trial of IV immunoglobulin treatment in acute optic neuritis

    DEFF Research Database (Denmark)

    Roed, H.G; Langkilde, Annika Reynberg; Sellebjerg, F

    2005-01-01

    -four patients were randomized to IVIG 0.4 g/kg body wt, and 34 patients were randomized to placebo. Infusions were given at days 0, 1, 2, 30, and 60. Contrast sensitivity, visual acuity, and color vision were measured at baseline and after 1 week, 1 month, and 6 months. Pattern reversal visual evoked potential......OBJECTIVE: To investigate if IV immunoglobulin (IVIG) treatment in the acute phase of optic neuritis (ON) could improve visual outcome and reduce MRI disease activity 6 months after onset of ON. METHODS: Sixty-eight patients with ON were randomized within 4 weeks from onset of symptoms. Thirty....... In addition, there was no significant difference in the secondary outcome measures, improvement in the visual function measures and MRI, at any time during follow-up. At baseline, a significantly higher number of patients in the IVIG group had one or more enhancing lesions on MRI and IVIG-treated patients had...

  19. Intravenous chlorpromazine in the acute treatment of episodic tension-type headache: a randomized, placebo controlled, double-blind study

    OpenAIRE

    Marcelo Eduardo Bigal; Carlos Alberto Bordini; José Geraldo Speciali

    2002-01-01

    Acute headache is a very frequent symptom, responsible for a significant percentage of caseload at primary care units and emergency rooms. Chlorpromazine is easily available in such settings. The aim of this study is to conduct a randomized, placebo-controlled, double-blind study to assess the efficacy of chlorpromazine on the acute treatment of episodic tension-type headache. We randomized 30 patients to receive placebo (10 ml of saline intravenous injections) and 30 patients to receive 0.1 ...

  20. A Randomized Trial of Behavioral Physical Therapy Interventions for Acute and Sub-Acute Low Back Pain (NCT00373867)

    Science.gov (United States)

    George, Steven Z.; Zeppieri, Giorgio; Cere, Anthony L.; Cere, Melissa R.; Borut, Michael S.; Hodges, Michael J.; Reed, Dalton M.; Valencia, Carolina; Robinson, Michael E.

    2008-01-01

    Psychological factors consistent with fear-avoidance models are associated with the development of chronic low back pain (LBP). As a result, graded activity (GA) and graded exposure (GX) have been suggested as behavioral treatment options. This clinical trial compared the effectiveness of treatment based classification (TBC) physical therapy alone, to TBC augmented with GA or GX for patients with acute and sub-acute LBP. Our primary hypothesis was that GX would be most effective for those with elevated pain-related fear. In total, 108 patients enrolled in this clinical trial and were randomly assigned to receive TBC, GA, or GX. Outcomes were assessed by a blinded evaluator at 4-weeks and by mail at 6-months. The primary outcomes for this trial were disability and pain intensity, and secondary outcomes were fear-avoidance beliefs, pain catastrophizing, and physical impairment. There were no differences in 4-week and 6-month outcomes for reduction of disability, pain intensity, pain catastrophizing, and physical impairment. GX and TBC were associated with larger reductions in fear-avoidance beliefs at 6-months only. Six month reduction in disability was associated with reduction in pain intensity, while 6-month reduction in pain intensity was associated with reductions in fear-avoidance beliefs and pain catastrophizing. This trial suggests that supplementing TBC with GA or GX was not effective for improving important outcomes related to the development of chronic LBP. PMID:18786762

  1. Multimedia based health information to parents in a pediatric acute ward: a randomized controlled trial.

    Science.gov (United States)

    Botngård, Anja; Skranes, Lars P; Skranes, Jon; Døllner, Henrik

    2013-12-01

    To determine whether multimedia based health information presented to parents of children with breathing difficulties in a pediatric acute ward, is more effective than verbal information, to reduce parental anxiety and increase satisfaction. This randomized controlled trial was conducted in a pediatric acute ward in Norway, from January to March 2011. Parents were randomly assigned to a multimedia intervention (n=53), or verbal health information (n=48). Primary outcome measure was parental anxiety, and secondary outcome measures were parental satisfaction with nursing care and health information. Parental anxiety decreased from arrival to discharge within both groups. At discharge the anxiety levels in the intervention group were no lower than in the control group. There was no difference in satisfaction with nursing care between the groups, but parents in the intervention group reported higher satisfaction with the health information given in the acute ward (p=.005). Multimedia based health information did not reduce anxiety more than verbal information, among parents to children with breathing difficulties. However, after discharge the parents were more satisfied with the multimedia approach. More research is needed to recommend the use of multimedia based information as a routine to parents in pediatric emergency care. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  2. Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

    2013-03-01

    Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Paracetamol versus ibuprofen: a randomized controlled trial of outpatient analgesia efficacy for paediatric acute limb fractures.

    Science.gov (United States)

    Shepherd, Michael; Aickin, Richard

    2009-12-01

    Paediatric limb fracture is a common injury that presents frequently to the ED. The primary objective of the present study was to determine whether ibuprofen provides better analgesia than paracetamol for paediatric patients discharged with acute limb fractures. A prospective, randomized controlled study was conducted in a children's ED. Children aged 5-14 years with an acute limb fracture were randomized to be prescribed paracetamol 15 mg/kg/dose every 4 h or ibuprofen 10 mg/kg/dose every 8 h. Objective (child-reported) pain scores using the 'Faces' pain scale were measured over a 48 h period. Child-reported pain did not differ significantly between the paracetamol and ibuprofen groups (mean pain score paracetamol 2.8 [95% CI 2.4-3.4] vs 2.7 [95% CI 2.1-3.3], P = 0.73). Parent-reported sleep quality did not differ between the two groups (P = 0.78). Child-reported pain score decreased over the 48 h of measurement (P ibuprofen does not provide better analgesia than paracetamol. Pain from an acute fracture can be managed by regular simple oral analgesia and immobilization.

  4. Xyloglucan for the Treatment of Acute Gastroenteritis in Children: Results of a Randomized, Controlled, Clinical Trial

    Directory of Open Access Journals (Sweden)

    Cătălin Pleșea Condratovici

    2016-01-01

    Full Text Available Background. Xyloglucan, a film-forming agent, improves intestinal mucosa resistance to pathologic damage. The efficacy, safety, and time of onset of the antidiarrheal effect of xyloglucan were assessed in children with acute gastroenteritis receiving oral rehydration solution (ORS. Methods. This randomized, controlled, open-label, parallel-group, multicenter, clinical trial included children (3 months–12 years with acute gastroenteritis of infectious origin. Children were randomized to xyloglucan and ORS, or ORS only, for 5 days. Diarrheal symptoms, including stool number/characteristics, and safety were assessed at baseline and after 2 and 5 days and by fulfillment of a parent diary card. Results. Thirty-six patients (58.33% girls were included (n=18/group. Patients receiving xyloglucan and ORS had better symptom evolution than ORS-only recipients, with a faster onset of action. At 6 hours, xyloglucan produced a significantly greater decrease in the number of type 7 stools (0.11 versus 0.44; P=0.027. At days 3 and 5, xyloglucan also produced a significantly greater reduction in types 6 and 7 stools compared with ORS alone. Xyloglucan plus ORS was safe and well tolerated. Conclusions. Xyloglucan is an efficacious and safe option for the treatment of acute gastroenteritis in children, with a rapid onset of action in reducing diarrheal symptoms. This study is registered with ISRCTN number 65893282.

  5. Randomized Clinical Trial of Intraosseous Methylprednisolone Injection for Acute Pulpitis Pain.

    Science.gov (United States)

    Bane, Khaly; Charpentier, Emmanuel; Bronnec, François; Descroix, Vianney; Gaye-N'diaye, Fatou; Kane, Abdoul Wahabe; Toledo, Rafael; Machtou, Pierre; Azérad, Jean

    2016-01-01

    The present study reports the results of a randomized clinical trial comparing local intraosseous methylprednisolone injection and emergency pulpotomy in the management of acute pulpitis on efficacy, safety, and efficiency end points. After providing prior informed written consent, 94 patients consulting for acute irreversible pulpitis pain at university-affiliated teaching hospital dental clinics in Dakar, Senegal were randomly assigned to either the methylprednisolone treatment group (n = 47) or the pulpotomy treatment group (n = 47). Patients were followed up at 1 week and assessed 6 months later to evaluate the therapeutic outcome of their treatment. At day 7 the patients in the methylprednisolone group reported less intense spontaneous and percussion pain in the day 0-day 7 period than the patients in the pulpotomy group. Methylprednisolone treatment took approximately 7 minutes (4.6-9.3) less to accomplish than pulpotomy (or about half the time). No difference in the therapeutic outcome was found between the 2 treatment groups at 6 months (all credible intervals span 0). This study establishes that methylprednisolone injection for acute pulpitis is relieved by a minimally invasive pharmacologic approach more effectively than by the reference pulpotomy and conserves scarce dental resources (ie, endodontic equipment and supplies, dental surgeon's time). Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  6. Predictors of low cardiac output in decompensated severe heart failure

    Directory of Open Access Journals (Sweden)

    Marcelo Eidi Ochiai

    2011-01-01

    Full Text Available OBJECTIVE: To identify predictors of low cardiac output and mortality in decompensated heart failure. INTRODUCTION: Introduction: Patients with decompensated heart failure have a high mortality rate, especially those patients with low cardiac output. However, this clinical presentation is uncommon, and its management is controversial. METHODS: We studied a cohort of 452 patients hospitalized with decompensated heart failure with an ejection fraction of 60 years, and 64.6% were men. Low cardiac output was present in 281 (63% patients on admission. Chagas disease was the cause of heart failure in 92 (20.4% patients who had higher B type natriuretic peptide levels (1,978.38 vs. 1,697.64 pg/mL; P = 0.015. Predictors of low cardiac output were Chagas disease (RR: 3.655, P<0.001, lower ejection fraction (RR: 2.414, P<0.001, hyponatremia (RR: 1.618, P = 0.036, and renal dysfunction (RR: 1.916, P = 0.007. Elderly patients were inversely associated with low cardiac output (RR: 0.436, P = 0.001. Predictors of mortality were Chagas disease (RR: 2.286, P<0.001, ischemic etiology (RR: 1.449, P = 0.035, and low cardiac output (RR: 1.419, P = 0.047. CONCLUSIONS: In severe decompensated heart failure, predictors of low cardiac output are Chagas disease, lower ejection fraction, hyponatremia, and renal dysfunction. Additionally, Chagas disease patients have higher B type natriuretic peptide levels and a worse prognosis independent of lower ejection fraction.

  7. Cerebral collateral therapeutics in acute ischemic stroke: A randomized preclinical trial of four modulation strategies.

    Science.gov (United States)

    Beretta, Simone; Versace, Alessandro; Carone, Davide; Riva, Matteo; Dell'Era, Valentina; Cuccione, Elisa; Cai, Ruiyao; Monza, Laura; Pirovano, Silvia; Padovano, Giada; Stiro, Fabio; Presotto, Luca; Paternò, Giovanni; Rossi, Emanuela; Giussani, Carlo; Sganzerla, Erik P; Ferrarese, Carlo

    2017-10-01

    Cerebral collaterals are dynamically recruited after arterial occlusion and highly affect tissue outcome in acute ischemic stroke. We investigated the efficacy and safety of four pathophysiologically distinct strategies for acute modulation of collateral flow (collateral therapeutics) in the rat stroke model of transient middle cerebral artery (MCA) occlusion. A composed randomization design was used to assign rats (n = 118) to receive phenylephrine (induced hypertension), polygeline (intravascular volume load), acetazolamide (cerebral arteriolar vasodilation), head down tilt (HDT) 15° (cerebral blood flow diversion), or no treatment, starting 30 min after MCA occlusion. Compared to untreated animals, treatment with collateral therapeutics was associated with lower infarct volumes (62% relative mean difference; 51.57 mm3 absolute mean difference; p therapy.

  8. Emergency room management of acute bronchiolitis: a randomized trial of nebulized epinephrine.

    Science.gov (United States)

    Simşek-Kiper, Pelin Ozlem; Kiper, Nural; Hasçelik, Gülşen; Dolgun, Anil; Yalçin, Ebru; Doğru-Ersöz, Deniz; Ozçelik, Uğur

    2011-01-01

    Acute bronchiolitis is a common, potentially life-threatening condition with few therapeutic options. In the present randomized study, we compared the clinical efficacies of nebulized epinephrine and salbutamol in the emergency room management of acute bronchiolitis. Primary outcome measures were improvement in mean respiratory rate, mean oxygen saturation value and severity score. Secondary outcome measures were length of hospital stay, hospitalization and relapse rates. A total of 75 patients were analyzed (36 epinephrine, 39 salbutamol). Both groups experienced a similar pattern of clinical improvement. Hospitalization rates were 8.3% for epinephrine and 5.1% for salbutamol (p > 0.05), whereas relapse rates were 80% for epinephrine and 20% for salbutamol groups (p epinephrine in terms of clinical improvement, but salbutamol can be a drug of choice due to its lower relapse and hospitalization rates compared to epinephrine.

  9. A double-blind, placebo-controlled, randomized trial of montelukast for acute bronchiolitis.

    Science.gov (United States)

    Amirav, Israel; Luder, Anthony S; Kruger, Natalie; Borovitch, Yael; Babai, Ilan; Miron, Dan; Zuker, Miriam; Tal, Gay; Mandelberg, Avigdor

    2008-12-01

    Cysteinyl leukotrienes are implicated in the inflammation of bronchiolitis. Recently, a specific cysteinyl leukotriene receptor antagonist, montelukast (Singulair [MSD, Haarlem, Netherlands]), has been approved for infants in granule sachets. Our goal was to evaluate the effect of montelukast on clinical progress and on cytokines in acute bronchiolitis. This was a randomized, placebo-controlled, double-blind, parallel-group study in 2 medical centers. Fifty-three infants (mean age: 3.8+/-3.5 months) with a first episode of acute bronchiolitis were randomly assigned to receive either 4-mg montelukast sachets or placebo, every day, from hospital admission until discharge. The primary outcome was length of stay, and secondary outcomes included clinical severity score (maximum of 12) and changes in type 1 and 2 cytokine levels (including interleukin4/IFN-gamma ratio as a surrogate for the T-helper 2/T-helper 1 ratio) in nasal lavage. Both groups were comparable at baseline, and cytokine levels correlated positively with disease severity. There were neither differences in length of stay (4.63+/-1.88 [placebo group] vs 4.65+/-1.97 days [montelukast group]) nor in clinical severity score and cytokine levels between the 2 groups. No differences in interleukin 4/IFN-gamma ratio between the 2 groups were seen. There was a slight tendency for infants in the montelukast group to recover more slowly than those in the placebo group (clinical severity score at discharge: 6.1+/-2.4 vs 4.8+/-2.2, respectively). Montelukast did not improve the clinical course in acute bronchiolitis. No significant effect of montelukast on the T-helper 2/T-helper 1 cytokine ratio when given in the early acute phase could be demonstrated.

  10. Prevention of depression in patients with acute coronary syndrome (DECARD) randomized trial

    DEFF Research Database (Denmark)

    Hjorthøj, Carsten Rygaard; Hansen, Baiba Hedegaard; Hanash, Jamal Abed

    2015-01-01

    AIM: Escitalopram may prevent depression following acute coronary syndrome. We sought to estimate the effects of escitalopram on self-reported health and to identify subgroups with higher efficacy. METHODS: This is a secondary analysis of a 12-month double-blind clinical trial randomizing non...... trajectories on any scale compared with placebo (P > 0.28). Efficacy of escitalopram may have been better among those scoring at least the normative score on general health perceptions (hazard ratio (HR) for depression 0.17 (95% confidence interval 0.02-1.42) ) or social functioning (HR = 0.12 (0...

  11. Intrathoracic impedance monitoring for early detection of impending heart failure decompensation.

    Science.gov (United States)

    Abraham, William T

    2007-01-01

    In patients with chronic heart failure, detecting signs and symptoms of worsening congestion early enough to prevent hospitalization is an ongoing challenge. Intrathoracic impedance monitoring is a new, device-based method for detecting fluid accumulation in the lungs. Small clinical trials have shown that it may provide an early warning of impending decompensation and may be useful when used in conjunction with routine clinical assessment in guiding diuresis during hospitalization. Additional large-scale, prospective, randomized clinical trials are currently underway to further evaluate its clinical utility. This review discusses the basic concepts underlying intrathoracic impedance monitoring, the clinical evidence supporting its use, and some common pitfalls to avoid when interpreting intrathoracic impedance data.

  12. A multicentre randomized controlled trial of moderate hypothermia to prevent intracranial hypertension in acute liver failure

    DEFF Research Database (Denmark)

    Bernal, William; Murphy, Nicholas; Brown, Sarah

    2016-01-01

    BACKGROUND & AIMS: Animal models and human case series of acute liver failure (ALF) suggest moderate hypothermia (MH) to have protective effects against cerebral oedema (CO) development and intracranial hypertension (ICH). However, the optimum temperature for patient management is unknown....... In a prospective randomized controlled trial we investigated if maintenance of MH prevented development of ICH in ALF patients at high risk of the complication. METHODS: Patients with ALF, high-grade encephalopathy and intracranial pressure (ICP) monitoring in specialist intensive care units were randomized...... by sealed envelope to targeted temperature management (TTM) groups of 34°C (MH) or 36°C (control) for a period of 72h. Investigators were not blinded to group assignment. The primary outcome was a sustained elevation in ICP >25mmHg, with secondary outcomes the occurrence of predefined serious adverse...

  13. A Randomized Trial of Time-Limited Antiretroviral Therapy in Acute/Early HIV Infection.

    Directory of Open Access Journals (Sweden)

    Joseph B Margolick

    Full Text Available It has been proposed that initiation of antiretroviral treatment (ART very soon after establishment of HIV infection may be beneficial by improving host control of HIV replication and delaying disease progression.People with documented HIV infection of less than 12 months' duration in Baltimore MD and seven Canadian sites were randomized to either a observation and deferred ART, or b immediate treatment with ART for 12 months. All subjects not receiving ART were followed quarterly and permanent ART was initiated according to contemporaneous treatment guidelines. The endpoint of the trial was total ART-free time from study entry until initiation of permanent ART.One hundred thirteen people were randomized, 56 to the observation arm and 57 to the immediate treatment arm. Twenty-three had acute (<2 months infection and 90 early (2-12 months infection. Of those randomized to the immediate treatment arm, 37 completed 12 months of ART according to protocol, 9 declined to stop ART after 12 months, and 11 were nonadherent to the protocol or lost to follow-up. Comparing those in the observation arm to either those who completed 12 months of ART or all 56 who were randomized to immediate ART, there was no significant difference between the arms in treatment-free interval after study entry, which was about 18 months in both arms.This study did not find a benefit from administration of a brief, time-limited (12-month course of ART in acute or early HIV infection.ClinicalTrials.gov NCT00106171.

  14. Can response-adaptive randomization increase participation in acute stroke trials?

    Science.gov (United States)

    Tehranisa, Jason S; Meurer, William J

    2014-07-01

    A response-adaptive randomization (RAR) trial design actively adjusts the ratio of participants assigned to each trial arm, favoring the better performing treatment by using outcome data from participants already in the trial. Compared with a standard clinical trial, an RAR study design has the potential to improve patient participation in acute stroke trials. This cross-sectional randomized survey included adult emergency department patients, age≥18, without symptoms of stroke or other critical illness. A standardized protocol was used, and subjects were randomized to either an RAR or standard hypothetical acute stroke trial. After viewing the video describing the hypothetical trial (http://youtu.be/cKIWduCaPZc), reviewing the consent form, and having questions answered, subjects indicated whether they would consent to the trial. A multivariable logistic regression model was fitted to estimate the impact of RAR while controlling for demographic factors and patient understanding of the design. A total of 418 subjects (210 standard and 208 RAR) were enrolled. All baseline characteristics were balanced between groups. There was significantly higher participation in the RAR trial (67.3%) versus the standard trial (54.5%), absolute increase: 12.8% (95% confidence interval, 3.7-22.2). The RAR group had a higher odds ratio of agreeing to research (odds ratio, 1.89; 95% confidence interval, 1.2-2.9) while adjusting for patient level factors. Trial designs were generally well understood by the participants. The hypothetical RAR trial attracted more research participation than standard randomization. RAR has the potential to increase recruitment and offer benefit to future trial participants. © 2014 American Heart Association, Inc.

  15. Occupational Therapy Predischarge Home Visits in Acute Hospital Care: A Randomized Trial.

    Science.gov (United States)

    Clemson, Lindy; Lannin, Natasha A; Wales, Kylie; Salkeld, Glenn; Rubenstein, Laurence; Gitlin, Laura; Barris, Sarah; Mackenzie, Lynette; Cameron, Ian D

    2016-10-01

    To determine whether an enhanced occupational therapy discharge planning intervention that involved pre- and postdischarge home visits, goal setting, and follow-up (the HOME program) would be superior to a usual care intervention in which an occupational therapy in-hospital consultation for planning and supporting discharge to home is provided to individuals receiving acute care. Randomized controlled trial. Acute and medical wards. Individuals aged 70 and older (N = 400). Primary outcomes: activities daily living (ADLs; Nottingham Extended Activities of Daily Living) and participation in life roles and activities (Late Life Disability Index (LLDI)). Occupational therapist recommendations differed significantly between groups (P occupational therapy recommendations as the in-hospital only consultation, which had a greater emphasis on equipment provision, but HOME did not demonstrate greater benefit in global measures of ADLs or participation in life tasks than in-hospital consultation alone. It is not recommended that home visits be conducted routinely as part of discharge planning for acutely hospitalized medical patients. Further work should develop guidelines for quality in-hospital consultation. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

  16. Treatment of acute bronchitis with EPs 7630: randomized, controlled trial in children and adolescents.

    Science.gov (United States)

    Kamin, Wolfgang; Ilyenko, Lidia I; Malek, Fathi A; Kieser, Meinhard

    2012-04-01

    The aim of this trial was to investigate the efficacy and tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides, in children and adolescents suffering from acute bronchitis, outside the strict indication for antibiotics. A total of 220 patients with acute bronchitis were randomized and given either verum containing EPs 7630 (1-6 years/>6-12 years/>12-18 years: 3 × 10/3 × 20/3 × 30 drops/day) or matching placebo for 7 days. The main outcome measure was the change in the total score of bronchitis-specific symptoms (BSS) from day 0 to day 7. The decrease in the BSS total score was significantly higher for EPs 7630 compared to placebo (change day 0-day 7: 4.4 ± 1.6 vs 2.9 ± 1.4 points; P acute bronchitis in children and adolescents outside the strict indication for antibiotics. © 2012 The Authors. Pediatrics International © 2012 Japan Pediatric Society.

  17. Acupuncture-movement therapy for acute lumbar sprain: a randomized controlled clinical trial.

    Science.gov (United States)

    Lin, Ruizhu; Zhu, Ning; Liu, Jian; Li, Xinjian; Wang, Yue; Zhang, Jie; Xi, Chaolei

    2016-02-01

    Several studies have reported that acupuncture is effective for treatment of acute lumbar sprain, but they neglected to consider that acupuncture cannot remarkably improve lumbar activity. We performed a randomized controlled trial to evaluate the effect of acupuncture-movement therapy versus conventional acupuncture in the treatment of acute lumbar sprain. Sixty patients were randomized into four groups: the acupuncture-movement (AM) group, sham acupuncture-movement (SAM) group, conventional acupuncture (CA) group, and physical therapy (PT) group. Patients in the AM group were treated with acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during acupuncture. Patients in the SAM group were treated with sham acupuncture at Yintang (EX-HN 3) and exercise of the lumbar region during sham acupuncture. Conventional acupuncture was performed in the CA group, and physical therapy was applied in the PT group. Each treatment lasted for 20 min. Patients were assessed before and after treatment using a visual analogue scale (VAS) and the Roland Morris Questionnaire (RMQ). The VAS and RMQ scores in the AM group were significantly lower after than before treatment (P lumbar sprain with a persistent pain-relief and remarkable improvement of lumbar activity. Movement, that is, lumbar exercise during acupuncture, enhances the effect of acupuncture.

  18. Amylase, Lipase, and Acute Pancreatitis in People With Type 2 Diabetes Treated With Liraglutide: Results From the LEADER Randomized Trial.

    Science.gov (United States)

    Steinberg, William M; Buse, John B; Ghorbani, Marie Louise Muus; Ørsted, David D; Nauck, Michael A

    2017-07-01

    To evaluate serum amylase and lipase levels and the rate of acute pancreatitis in patients with type 2 diabetes and high cardiovascular risk randomized to liraglutide or placebo and observed for 3.5-5.0 years. A total of 9,340 patients with type 2 diabetes were randomized to either liraglutide or placebo (median observation time 3.84 years). Fasting serum lipase and amylase were monitored. Acute pancreatitis was adjudicated in a blinded manner. Compared with the placebo group, liraglutide-treated patients had increases in serum lipase and amylase of 28.0% and 7.0%, respectively. Levels were increased at 6 months and then remained stable. During the study, 18 (0.4% [1.1 events/1,000 patient-years of observation] [PYO]) liraglutide-treated and 23 (0.5% [1.7 events/1,000 PYO]) placebo patients had acute pancreatitis confirmed by adjudication. Most acute pancreatitis cases occurred ≥12 months after randomization. Liraglutide-treated patients with prior history of pancreatitis (n = 147) were not more likely to develop acute pancreatitis than similar patients in the placebo group (n = 120). Elevations of amylase and lipase levels did not predict future risk of acute pancreatitis (positive predictive value pancreatitis among liraglutide-treated patients (regardless of previous history of pancreatitis) compared with the placebo group. Liraglutide was associated with increases in serum lipase and amylase, which were not predictive of an event of subsequent acute pancreatitis. © 2017 by the American Diabetes Association.

  19. N-acetylcysteine in Acute Organophosphorus Pesticide Poisoning: A Randomized, Clinical Trial.

    Science.gov (United States)

    El-Ebiary, Ahmad A; Elsharkawy, Rasha E; Soliman, Nema A; Soliman, Mohammed A; Hashem, Ahmed A

    2016-08-01

    Organophosphorus poisoning is a major global health problem with hundreds of thousands of deaths each year. Research interest in N-acetylcysteine has grown among increasing evidence of the role of oxidative stress in organophosphorus poisoning. We aimed to assess the safety and efficacy of N-acetylcysteine as an adjuvant treatment in patients with acute organophosphorus poisoning. This was a randomized, controlled, parallel-group trial on 30 patients suffering from acute organophosphorus poisoning, who were admitted to the Poison Control Center of Tanta University Emergency Hospital, Tanta, Egypt, between April and September 2014. Interventions included oral N-acetylcysteine (600 mg three times daily for 3 days) as an added treatment to the conventional measures versus only the conventional treatment. Outcome measures included mortality, total dose of atropine administered, duration of hospitalization and the need for ICU admission and/or mechanical ventilation. A total of 46 patients were screened and 30 were randomized. No significant difference was found between both groups regarding demographic characteristics and the nature or severity of baseline clinical manifestations. No major adverse effects to N-acetylcysteine therapy were reported. Malondialdehyde significantly decreased and reduced glutathione significantly increased only in the NAC-treated patients. The patients on NAC therapy required less atropine doses than those who received only the conventional treatment; however, the length of hospital stay showed no significant difference between both groups. The study concluded that the use of N-acetylcysteine as an added treatment was apparently safe, and it reduced atropine requirements in patients with acute organophosphorus pesticide poisoning. © 2016 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  20. A cluster randomized trial of decision support strategies for reducing antibiotic use in acute bronchitis.

    Science.gov (United States)

    Gonzales, Ralph; Anderer, Tammy; McCulloch, Charles E; Maselli, Judith H; Bloom, Frederick J; Graf, Thomas R; Stahl, Melissa; Yefko, Michelle; Molecavage, Julie; Metlay, Joshua P

    2013-02-25

    National quality indicators show little change in the overuse of antibiotics for uncomplicated acute bronchitis. We compared the effect of 2 decision support strategies on antibiotic treatment of uncomplicated acute bronchitis. We conducted a 3-arm cluster randomized trial among 33 primary care practices belonging to an integrated health care system in central Pennsylvania. The printed decision support intervention sites (11 practices) received decision support for acute cough illness through a print-based strategy, the computer-assisted decision support intervention sites (11 practices) received decision support through an electronic medical record-based strategy, and the control sites (11 practices) served as a control arm. Both intervention sites also received clinician education and feedback on prescribing practices, as well as patient education brochures at check-in. Antibiotic prescription rates for uncomplicated acute bronchitis in the winter period (October 1, 2009, through March 31, 2010) following introduction of the intervention were compared with the previous 3 winter periods in an intent-to-treat analysis. Compared with the baseline period, the percentage of adolescents and adults prescribed antibiotics during the intervention period decreased at the printed decision support intervention sites (from 80.0% to 68.3%) and at the computer-assisted decision support intervention sites (from 74.0% to 60.7%) but increased slightly at the control sites (from 72.5% to 74.3%). After controlling for patient and clinician characteristics, as well as clustering of observations by clinician and practice site, the differences for the intervention sites were statistically significant from the control sites (P = .003 for control sites vs printed decision support intervention sites and P = .01 for control sites vs computer-assisted decision support intervention sites) but not between themselves (P = .67 for printed decision support intervention sites vs computer

  1. Multicenter Randomized Clinical Trial of Nonoperative Versus Operative Treatment of Acute Acromio-Clavicular Joint Dislocation.

    Science.gov (United States)

    2015-11-01

    To perform a randomized clinical trial of operative versus nonoperative treatment of acute acromio-clavicular (AC) joint dislocations using modern surgical fixation and both patient-based and surgeon-based outcome measures to determine which treatment method was superior. Prospective, randomized. Multicenter. Eight-three patients with acute (dislocations of the AC joint. Patients were randomized to operative repair with hook plate fixation versus nonoperative treatment (operative repair, 40; nonoperative treatment, 43). Disabilities of the Arm, Shoulder and Hand (DASH) score at 1 year after injury. Assessment also included a complete clinical assessment, evaluation of the constant score, and a radiographic evaluation at 6 weeks, and at 3, 6, 12, and 24 months. There were no demographic differences between the 2 groups, and the mechanisms of injury were similar between the 2 groups. The DASH scores (a disability score, lower score is better) were significantly better in the nonoperative group at 6 weeks (operative, 45; nonoperative, 31; P = 0.014) and 3 months (operative, 29; nonoperative, 16; P = 0.005). There were no significant differences between the groups at 6 months (operative, 14; nonoperative, 12; P = 0.442), 1 year (operative, 9; nonoperative, 9; P = 0.997), or 2 years (operative, 5; nonoperative, 6; P = 0.439) after injury. Constant scores were similar (better scores in the nonoperative group at 6 weeks, 3 months, and 6 months; P = 0.0001; and no difference thereafter). Although radiographic results were better in the operative group, the reoperation rate was significantly lower in the nonoperative group (P dislocations of the AC joint. The nonoperative group had better early scores, although both groups improved from a significant level of initial disability to a good or excellent result (mean DASH score, 5-6; mean constant score, 91-95) at 2 years. At present, there is no clear evidence that operative treatment with the currently available hook plate

  2. The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge.

    Science.gov (United States)

    Mahler, Simon A; Riley, Robert F; Hiestand, Brian C; Russell, Gregory B; Hoekstra, James W; Lefebvre, Cedric W; Nicks, Bret A; Cline, David M; Askew, Kim L; Elliott, Stephanie B; Herrington, David M; Burke, Gregory L; Miller, Chadwick D

    2015-03-01

    The HEART Pathway is a decision aid designed to identify emergency department patients with acute chest pain for early discharge. No randomized trials have compared the HEART Pathway with usual care. Adult emergency department patients with symptoms related to acute coronary syndrome without ST-elevation on ECG (n=282) were randomized to the HEART Pathway or usual care. In the HEART Pathway arm, emergency department providers used the HEART score, a validated decision aid, and troponin measures at 0 and 3 hours to identify patients for early discharge. Usual care was based on American College of Cardiology/American Heart Association guidelines. The primary outcome, objective cardiac testing (stress testing or angiography), and secondary outcomes, index length of stay, early discharge, and major adverse cardiac events (death, myocardial infarction, or coronary revascularization), were assessed at 30 days by phone interview and record review. Participants had a mean age of 53 years, 16% had previous myocardial infarction, and 6% (95% confidence interval, 3.6%-9.5%) had major adverse cardiac events within 30 days of randomization. Compared with usual care, use of the HEART Pathway decreased objective cardiac testing at 30 days by 12.1% (68.8% versus 56.7%; P=0.048) and length of stay by 12 hours (9.9 versus 21.9 hours; P=0.013) and increased early discharges by 21.3% (39.7% versus 18.4%; P<0.001). No patients identified for early discharge had major adverse cardiac events within 30 days. The HEART Pathway reduces objective cardiac testing during 30 days, shortens length of stay, and increases early discharges. These important efficiency gains occurred without any patients identified for early discharge suffering MACE at 30 days. URL: http://www.clinicaltrials.gov. Unique Identifier: NCT01665521. © 2015 American Heart Association, Inc.

  3. Azithromycin for Acute Exacerbations of Asthma : The AZALEA Randomized Clinical Trial.

    Science.gov (United States)

    Johnston, Sebastian L; Szigeti, Matyas; Cross, Mary; Brightling, Christopher; Chaudhuri, Rekha; Harrison, Timothy; Mansur, Adel; Robison, Laura; Sattar, Zahid; Jackson, David; Mallia, Patrick; Wong, Ernie; Corrigan, Christopher; Higgins, Bernard; Ind, Philip; Singh, Dave; Thomson, Neil C; Ashby, Deborah; Chauhan, Anoop

    2016-11-01

    Guidelines recommend against antibiotic use to treat asthma attacks. A study with telithromycin reported benefit, but adverse reactions limit its use. To determine whether azithromycin added to standard care for asthma attacks in adults results in clinical benefit. The Azithromycin Against Placebo in Exacerbations of Asthma (AZALEA) randomized, double-blind, placebo-controlled clinical trial, a United Kingdom-based multicenter study in adults requesting emergency care for acute asthma exacerbations, ran from September 2011 to April 2014. Adults with a history of asthma for more than 6 months were recruited within 48 hours of presentation to medical care with an acute deterioration in asthma control requiring a course of oral and/or systemic corticosteroids. Azithromycin 500 mg daily or matched placebo for 3 days. The primary outcome was diary card symptom score 10 days after randomization, with a hypothesized treatment effect size of -0.3. Secondary outcomes were diary card symptom score, quality-of-life questionnaires, and lung function changes, all between exacerbation and day 10, and time to a 50% reduction in symptom score. Of 4582 patients screened at 31 centers, 199 of a planned 380 were randomized within 48 hours of presentation. The major reason for nonrecruitment was receipt of antibiotics (2044 [44.6%] screened patients). Median time from presentation to drug administration was 22 hours (interquartile range, 14-28 hours). Exacerbation characteristics were well balanced across treatment arms and centers. The primary outcome asthma symptom scores were mean (SD), 4.14 (1.38) at exacerbation and 2.09 (1.71) at 10 days for the azithromycin group and 4.18 (1.48) and 2.20 (1.51) for the placebo group, respectively. Using multilevel modeling, there was no significant difference in symptom scores between azithromycin and placebo at day 10 (difference, -0.166; 95% CI, -0.670 to 0.337), nor on any day between exacerbation and day 10. No significant between

  4. Comparision Of The Efficacy Of Nebulized L-Epinephrine, Salbutamoland Normal Saline In Acute Bronchiolitis: A Randomized Clinical Trial

    OpenAIRE

    H. Mussavi; M. Karamiyar; S. Salari Lak; J. Khashabi

    2005-01-01

    Background:Acute bronchiolitis is the most common form of lower respiratory tract infection in infancy.There are numerous contradictory reports regarding the efficacy of nebulized bronchodilators in the management of infants with acute bronchiolitis. This study was designed to compare the efficacy of nebulized epinephrine with salbutamol for treatment of the disease.Methods:In a randomized clinical trial, 72 infants with moderately severe bronchiolitis were enrolled in three equal groups. Thr...

  5. [Intravenous glutamine and early nasojejunal nutrition in severe acute pancreatitis -- a prospective randomized clinical study].

    Science.gov (United States)

    Hajdú, Nóra; Belágyi, Tibor; Issekutz, Akos; Bartek, Péter; Gartner, Béla; Oláh, Attila

    2012-04-01

    Severe acute pancreatitis (SAP) is still one of the great challenges in gastro-intestinal surgery. According to recent studies, intravenously administered glutamine with total parenteral nutrition may be beneficial in the prevention of infectious complications and may reduce mortality rate. However, it has not been investigated yet, whether i.v. glutamine is able to achieve the same effect with early enteral nutrition as well. The objective of our prospective randomized double-blind study was to explore the effects of intravenously administered glutamine with early nasojejunal nutrition in severe acute pancreatitis. Forty-five patients with severe acute pancreatitis (with a Glasgow score at least 3 and/or a CRP level above 150 mg/ml on admission) were randomized into two groups. Group Glutamine (n = 24) was given 0.5 g/kg/die glutamine intravenously, while the control group (n = 21) received normal amino acid solution in the same quantity for 7 days. Nasojejunal nutrition was introduced 48 hours after admission in case of all patients, and their management was the same in every other aspect, too. The primary end-points of the study were the rate of pancreas-specific infectious complications and organ failure, and the secondary end-points were the necessity for radiological and surgical interventions, length of hospital stay and mortality rate. In group Glutamine, infected acute peripancreatic fluid collections (APFC) were detected in 4 patients, 2 patients had post-necrotic pancreatic/peripancreatic fluid collections (PNPFC), 2 patients had infected pseudocysts and 2 patients had walled-off pancreatic necrosis (WOPN). Ten patients were cured by ultrasound assisted puncture or drainage successfully. No surgical intervention was necessary. In the control group, 4 patients had infected APFC, 2 patients had infected PNPFC, infected pseudocysts and infected WOPN were diagnosed in 3 cases. Radiological intervention was effective in 9 cases, but 3 patients needed surgery

  6. A Prospective Randomized Trial Comparing Surgical and Nonsurgical Treatments of Acute Achilles Tendon Ruptures.

    Science.gov (United States)

    Lantto, Iikka; Heikkinen, Juuso; Flinkkila, Tapio; Ohtonen, Pasi; Siira, Pertti; Laine, Vesa; Leppilahti, Juhana

    2016-09-01

    The optimal treatment of acute Achilles tendon ruptures for active patients is under debate. To compare clinical outcomes and calf muscle strength recovery after the nonsurgical treatment and open surgical repair of acute Achilles tendon ruptures with identical accelerated rehabilitation programs. Randomized controlled trial; Level of evidence, 1. From 2009 to 2013, a total of 60 patients with an acute Achilles tendon rupture were randomized to surgery or nonsurgical treatment. Nonsurgical treatment included first a week of cast immobilization, followed by a functional orthosis for 6 weeks, allowing full weightbearing after week 1 and active plantar flexion after week 5. Surgery was simple end-to-end open repair, and postoperative treatment was identical to nonsurgical treatment. Outcome measures included the Leppilahti Achilles tendon performance score, isokinetic calf muscle strength, and RAND 36-Item Health Survey at 18-month follow-up. At 18-month follow-up, the mean Leppilahti score was 79.5 and 75.7 for the surgically and nonsurgically treated groups, respectively (mean difference, 3.8; 95% CI, -1.9 to 9.5; P = .19). Angle-specific peak torque results of affected legs showed that surgery resulted in faster and better recovery of calf muscle strength over the entire range of motion of the ankle joint: at 6 months, the difference varied from 16% to 24% (P = .016), favoring the surgically treated group, whereas at 18 months, surgically treated patients had 10% to 18% greater strength results (P = .037). At 18 months, a 14% difference in the peak torque of the affected leg favored the surgical group versus the nonsurgical group (mean peak torque, 110.3 vs 96.5 N·m, respectively; mean difference, 13.6 N·m; 95% CI, 2.0-25.1 N·m; P = .022). The RAND 36-Item Health Survey indicated better results in the domains of physical functioning (P = .006) and bodily pain (P = .037) for surgically treated patients. Surgical and nonsurgical treatments of acute Achilles tendon

  7. Animal study on transplantation of human umbilical vein endothelial cells for corneal endothelial decompensation

    Directory of Open Access Journals (Sweden)

    Li Cui

    2014-06-01

    Full Text Available AIM: To explore the feasibility of culturing human umbilical vein endothelial cells(HUVECon acellular corneal stroma and performing the posterior lamellar endothelial keratoplasty(PLEKtreating corneal endothelial decompensation.METHODS: Thirty New-Zealand rabbits were divided into three groups randomly, 10 rabbits for experimental group, 10 for stroma group and 10 for control group. Corneal endothelial cells were removed to establish animal model of corneal endothelial failure. PLEK was performed on the rabbits of experimental group and stroma group, and nothing was transplantated onto the rabbits of control group with the deep layer excised only. Postoperative observation was taken for 3mo. The degree of corneal edema and central corneal thickness were recorded for statistical analysis.RESULTS: Corneas in experimental group were relieved in edema obviously compared with that in stroma group and the control group, and showed increased transparency 7d after the operation. The average density of endothelial cells was 2 026.4±129.3cells/mm2, and average central corneal thickness was 505.2±25.4μm in experimental group, while 1 535.6±114.5μm in stroma group and 1 493.5±70.2μm in control group 3mo after operation.CONCLUSION:We achieved preliminary success in our study that culturing HUVEC on acellular corneal stroma and performing PLEK for corneal endothelial decompensation. HUVEC transplanted could survive in vivo, and have normal biological function of keeping cornea transparent. This study provides a new idea and a new way clinically for the treatment of corneal endothelial diseases.

  8. A Retrospective Analysis of Pre-surgical Incisor Decompensation Attained in an Orthognathic Surgery Population

    Science.gov (United States)

    2016-07-01

    by Panula spanned the time period between World War I and World War II during which time surgeons were focused on treating war -related traumatic...decompensated 22-40 percent of the time. Troy et al (2009) also found that the mandibular incisors were decompensated to a greater extent than the maxillary

  9. Multiple infarcted regenerative nodules in liver cirrhosis after decompensation of cirrhosis: a case series

    OpenAIRE

    Müllhaupt Beat; Reineke Tanja; Scholtze Dieter; Gubler Christoph

    2010-01-01

    Abstract Introduction Liver cirrhosis is a common disease with many known complications. Cirrhosis represents a clinical spectrum, ranging from asymptomatic liver disease to hepatic decompensation. Manifestations of hepatic decompensation include variceal bleeding, ascites, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, portopulmonary hypertension and hepatocellular carcinoma. There are reports about infarcted regenerative nodules in cirrhotic livers after gastrointes...

  10. Cognitive processing therapy versus supportive counseling for acute stress disorder following assault: a randomized pilot trial.

    Science.gov (United States)

    Nixon, Reginald D V

    2012-12-01

    The study tested the efficacy and tolerability of cognitive processing therapy (CPT) for survivors of assault with acute stress disorder. Participants (N=30) were randomly allocated to CPT or supportive counseling. Therapy comprised six individual weekly sessions of 90-min duration. Independent diagnostic assessment for PTSD was conducted at posttreatment. Participants completed self-report measures of posttraumatic stress, depression, and negative trauma-related beliefs at pre-, posttreatment, and 6-month follow-up. Results indicated that both interventions were successful in reducing symptoms at posttreatment with no statistical difference between the two; within and between-group effect sizes and the proportion of participants not meeting PTSD criteria was greater in CPT. Treatment gains were maintained for both groups at 6-month follow-up. Copyright © 2012. Published by Elsevier Ltd.

  11. Mobile applications for handheld devices to screen and randomize acute stroke patients in clinical trials.

    Science.gov (United States)

    Qureshi, Ai; Connelly, B; Abbott, Ei; Maland, E; Kim, J; Blake, J

    2012-08-01

    The availability of internet connectivity and mobile application software used by low-power handheld devices makes smart phones of unique value in time-sensitive clinical trials. Trial-specific applications can be downloaded by investigators from various mobile software distribution platforms or web applications delivered over HTTP. The Antihypertensive Treatment in Acute Cerebral Hemorrhage (ATACH) II investigators in collaboration with MentorMate released the ATACH-II Patient Recruitment mobile application available on iPhone, Android, and Blackberry in 2011. The mobile application provides tools for pre-screening, assessment of eligibility, and randomization of patients. Since the release of ATACH-II mobile application, the CLEAR-IVH (Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage) trial investigators have also adopted such a mobile application. The video-conferencing capabilities of the most recent mobile devices open up additional opportunities to involve central coordinating centers in the recruitment process in real time.

  12. A blind, randomized comparison of racecadotril and loperamide for stopping acute diarrhea in adults.

    Science.gov (United States)

    Wang, Hwang-Huei; Shieh, Ming-Jium; Liao, Kuan-Fu

    2005-03-14

    Racecadotril is a specific enkephalinase inhibitor that exhibits intestinal antisecretory activity without affecting intestinal transit. Loperamide is an effective anti-diarrheal agent, but it usually induces constipation. This study is to compare the efficacy, safety, and tolerability of racecadotril versus loperamide in the outpatient treatment of acute diarrhea in adults. A two-center, randomized, parallel-group, single-blind study was carried out to compare the efficacy, tolerability, and safety of racecadotril (100 mg thrice daily) and loperamide (2.0 mg 2 twice daily) in 62 adult patients suffering from acute diarrhea. The main efficacy criterion used was the duration of diarrhea after beginning the treatment (in hours). Other signs and symptoms were also evaluated. The clinical success rates for these anti-diarrheal treatments were 95.7% and 92.0% for racecadotril and loperamide respectively. Patients on racecadotril had a median duration of diarrhea of 19.5 h compared with a median of 13 h for patients on loperamide. Rapid improvement in anal burn and nausea was found for each drug. However, more patients on loperamide suffered from reactive constipation (29.0% vs 12.9%). Itching, another adverse event was notably higher in the racecadotril group (28.6% vs 0%). With regard to other adverse events, the two medications showed similar occurrence rates and similar concomitant medication usage rates. Racecadotril and loperamide are rapid, equally effective treatments for acute diarrhea in adults, but loperamide treatment is associated with a higher incidence of treatment-related constipation.

  13. A randomized controlled trial of intranasal-midazolam versus intravenous-diazepam for acute childhood seizures.

    Science.gov (United States)

    Thakker, Arpita; Shanbag, Preeti

    2013-02-01

    The objective of this study is to compare the safety and efficacy of midazolam given intranasally with diazepam given intravenously in the treatment of acute childhood seizures. A randomized controlled study was conducted in a pediatric emergency department in a tertiary general hospital. Fifty children aged from 1 month to 12 years presenting with acute seizures of at least 10 min duration were enrolled during a 12 month period. Intranasal midazolam (0.2 mg/kg) and intravenous diazepam (0.3 mg/kg) were administered. The main outcome measures were interval between arrival at hospital and starting treatment and interval between arrival at hospital and cessation of seizures. Intranasal midazolam and intravenous diazepam were equally effective. Overall 18 of 27 seizures were controlled with midazolam and 15 of 23 with diazepam. The mean interval between arrival at hospital and starting treatment was significantly shorter in the midazolam group [3.37 min (SD 2.46)] as compared to the diazepam group [14.13 min (SD 3.39)]. The mean interval between cessation of seizures and arrival at hospital was significantly shorter in the midazolam group [6.67 min (SD 3.12)] as compared to the diazepam group [17.18 min (SD 5.09)]. The mean interval between control of seizures and administration of the drug was shorter in the diazepam group [2.67 min (SD 2.31)] as compared to the midazolam group [3.01 min (SD 2.79)]. No significant side effects were observed in either group. Seizures were controlled more quickly with intravenous diazepam than with intranasal midazolam. Midazolam was as safe and effective as diazepam. The overall interval between arrival at hospital and cessation of seizures was shorter with intranasal midazolam than with intravenous diazepam. The intranasal route can be possibly used not only in medical centres, but with appropriate instruction by the parents of children with acute seizures at home.

  14. Nebulized fentanyl vs intravenous morphine for ED patients with acute limb pain: a randomized clinical trial.

    Science.gov (United States)

    Farahmand, Shervin; Shiralizadeh, Said; Talebian, Mohammad-Taghi; Bagheri-Hariri, Shahram; Arbab, Mona; Basirghafouri, Hamed; Saeedi, Morteza; Sedaghat, Mojtaba; Mirzababai, Habibolla

    2014-09-01

    Intravenous morphine has been used as a common method of pain control in emergency care. Nebulized fentanyl is also an effective temporary substitute. This study was designed to compare the effectiveness of nebulized fentanyl with intravenous (IV) morphine on management of acute limb pain. This was a placebo-controlled, double-blind randomized clinical trial. Ninety emergency department patients with moderate to severe pain aged 15 to 50 years were blocked randomized and enrolled in this study. Forty-seven patients in the experimental group received nebulized fentanyl (4 μg/kg) and IV normal saline as placebo, and the remaining 43 patients in the control group received IV morphine (0.1 mg/kg) and nebulized normal saline as placebo. All participants' pain scores were assessed by Numerical Rating Scale before and after intervention at 5-, 10-, 15-, 30-, 45-, and 60-minute intervals. Patients' vital sign and possible adverse effects were recorded respectively. Finally, all participants were assessed for their satisfaction. The mean initial pain score in the experimental group was 8.7 and 8.4 in the control group (P = .1). Pain relief in both groups after 5 and 10 minutes were similar (P = .72). Although the pain relief was significantly greater with fentanyl at 15 minutes, this difference is not clinically significant. Pain management in both groups was successful and was more than 3 scores reduction in Numerical Rating Scale. Patient satisfaction in both groups was similar. No adverse effects were reported in the experimental group. This study suggests that nebulized fentanyl is a rapid, safe, and effective method for temporary control of acute limb pain in emergency department patients. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. Randomized Controlled Trial of Early Versus Delayed Statin Therapy in Patients With Acute Ischemic Stroke: ASSORT Trial (Administration of Statin on Acute Ischemic Stroke Patient).

    Science.gov (United States)

    Yoshimura, Shinichi; Uchida, Kazutaka; Daimon, Takashi; Takashima, Ryuzo; Kimura, Kazuhiro; Morimoto, Takeshi

    2017-11-01

    Several studies suggested that statins during hospitalization were associated with better disability outcomes in patients with acute ischemic stroke, but only 1 small randomized trial is available. We conducted a multicenter, open-label, randomized controlled trial in patients with acute ischemic strokes in 11 hospitals in Japan. Patients with acute ischemic stroke and dyslipidemia randomly received statins within 24 hours after admission in the early group or on the seventh day in the delayed group, in a 1:1 ratio. Statins were administered for 12 weeks. The primary outcome was patient disability assessed by modified Rankin Scale at 90 days. A total of 257 patients were randomized and analyzed (early 131, delayed 126). At 90 days, modified Rankin Scale score distribution did not differ between groups ( P =0.68), and the adjusted common odds ratio of the early statin group was 0.84 (95% confidence interval, 0.53-1.3; P =0.46) compared with the delayed statin group. There were 3 deaths at 90 days (2 in the early group, 1 in the delayed group) because of malignancy. Ischemic stroke recurred in 9 patients (6.9%) in the early group and 5 patients (4.0%) in the delayed group. The safety profile was similar between groups. Our randomized trial involving patients with acute ischemic stroke and dyslipidemia did not show any superiority of early statin therapy within 24 hours of admission compared with delayed statin therapy 7 days after admission to alleviate the degree of disability at 90 days after onset. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02549846. © 2017 American Heart Association, Inc.

  16. A Randomized Control Intervention Investigating the Effects of Acute Exercise on Emotional Regulation.

    Science.gov (United States)

    Edwards, Meghan K; Rhodes, Ryan E; Loprinzi, Paul D

    2017-09-01

    Exercise may help to cope with hectic or demanding events after a stressful situation occurs. Limited research has evaluated whether exercise, prior to a stressor, helps to facilitate subsequent emotional regulation. This pilot study addresses this novel paradigm. We employed a randomized controlled trial evaluating the effects of acute exercise on emotional regulation. Participants were randomly assigned to stretch (control group, N = 10), walk (N = 9), or jog (N = 8) for 15-minutes, after which they were exposed to a film clip intended to elicit a negative emotional response. Participants' emotions were monitored before and during exercise, as well as after the film clip. Emotional responses were evaluated using the Exercise Induced Feeling Inventory and Affective Circumplex Scale. A group x time splitplot interaction effect was significant for anger (p = .046) and anxiousness (p = .038). Follow-up analyses showed that only the stretching group (p = .048) had a significantly increased anger score from baseline to post-film clip, suggesting a protective emotional effect from walking and jogging. Exercise was effective in regulating anger and anxiousness after a stressful event. These findings provide evidence for potential preventive effects of exercise in facilitating emotional regulation.

  17. Topical Calendula and Betamethasone Valerate in the prevention of acute radiation dermatitis: a randomized prospective trial

    Directory of Open Access Journals (Sweden)

    Fotouhi M

    2007-07-01

    Full Text Available Background: Acute radiation dermatitis is a very common side effect of radiation therapy for many cancers, including breast cancer. Despite the high prevalence of acute radiation dermatitis as well as wet desquamation, only a few trials studying the prophylaxis of this complication using topical treatment have been conducted. In spite of these studies, some controversy still exists about regarding treatments for acute radiation dermatitis, as does some concern about their long-term complications. For this reason, we conducted a clinical trial for a new treatment with the same effectiveness as corticosteroids, but fewer complications. Methods: This trial included 60 patients with pathologic diagnoses of breast cancer for whom radiotherapy had been planned. Patients were 30-73 years old. Patients with radical mastectomy received 5000 cGy over five weeks, and those with conservative surgery received 6000 cGy over six weeks divided in 200 cGy fractions. Patients were divided randomly into two groups: one group received a moderately-potent glucocorticoid steroid, 0.1% betamethasone ointment (30, and the other received the new treatment, 0.1% calendula ointment (30. All patients applied their respective drugs twice daily within the tangential field from the first day of radiation treatment until one month after treatment was completed. Starting one week after radiation therapy commenced, patients were monitored weekly for symptoms of dermatitis and the degree of severity as well as possible adverse drug effects, in addition to such monitoring on the days of their appointments. Four weeks after termination of therapy, patients were again examined, at which time they completed a questionnaire about dermatologic complications. Results: The mean time to develop dermatitis was 3.7 weeks for the betamethasone group and 3.87 weeks for the calendula group. Maximal dermatitis intensity during treatment in the betamethasone group was: 0, 6.7%; I, 73.3%; II, 16

  18. Detecting Heart Failure Decompensation by Measuring Transthoracic Bioimpedance in the Outpatient Setting: Rationale and Design of the SENTINEL-HF Study.

    Science.gov (United States)

    Dovancescu, Silviu; Saczynski, Jane S; Darling, Chad E; Riistama, Jarno; Sert Kuniyoshi, Fatima; Meyer, Theo; Goldberg, Robert; McManus, David D

    2015-10-09

    Recurrent hospital admissions are common among patients admitted for acute decompensated heart failure (ADHF), but identification of patients at risk for rehospitalization remains challenging. Contemporary heart failure (HF) management programs have shown modest ability to reduce readmissions, partly because they monitor signs or symptoms of HF worsening that appear late during decompensation. Detecting early stages of HF decompensation might allow for immediate application of effective HF therapies, thereby potentially reducing HF readmissions. One of the earliest indicators of HF decompensation is intrathoracic fluid accumulation, which can be assessed using transthoracic bioimpedance. The SENTINEL-HF study is a prospective observational study designed to test a novel, wearable HF monitoring system as a predictor of HF decompensation among patients discharged after hospitalization for ADHF. SENTINEL-HF tests the hypothesis that a decline in transthoracic bioimpedance, as assessed daily with the Philips fluid accumulation vest (FAV) and transmitted using a mobile phone, is associated with HF worsening and rehospitalization. According to pre-specified power calculations, 180 patients admitted with ADHF are enrolled. Participants transmit daily self-assessments using the FAV-mobile phone dyad for 45 days post-discharge. The primary predictor is the deviation of transthoracic bioimpedance for 3 consecutive days from a patient-specific normal variability range. The ADHF detection algorithm is evaluated in relation with a composite outcome of HF readmission, diuretic up-titration, and self-reported HF worsening (Kansas City Cardiomyopathy Questionnaire) during a 90-day follow-up period. Here, we provide the details and rationale of SENTINEL-HF. Enrollment in the SENTINEL-HF study is complete and the 90-days follow-up is currently under way. Once data collection is complete, the study dataset will be used to evaluate our ADHF detection algorithm and the results

  19. The Effects of Experimentally Manipulated Social Status on Acute Eating Behavior: A Randomized, Crossover Pilot Study

    Science.gov (United States)

    Cardel, MI; Johnson, SL; Beck, J; Dhurandhar, E; Keita, AD; Tomczik, AC; Pavela, G; Huo, T; Janicke, DM; Muller, K; Piff, PK; Peters, JC; Hill, JO; Allison, DB

    2016-01-01

    Both subjective and objectively measured social status has been associated with multiple health outcomes, including weight status, but the mechanism for this relationship remains unclear. Experimental studies may help identify the causal mechanisms underlying low social standing as a pathway for obesity. Our objective was to investigate the effects of experimentally manipulated social status on ad libitum acute dietary intakes and stress-related outcomes as potential mechanisms relating social status and weight. This was a pilot feasibility, randomized, crossover study in Hispanic young adults (n=9; age 19–25; 67% female; BMI ≥18.5 and ≤30 kg/m2). At visit 1, participants consumed a standardized breakfast and were randomized to a high social status position (HIGH) or low social status position (LOW) in a rigged game of Monopoly™. The rules for the game differed substantially in terms of degree of ‘privilege’ depending on randomization to HIGH or LOW. Following Monopoly™, participants were given an ad libitum buffet meal and energy intakes (kcal) were estimated by pre- and post-weighing foods consumed. Stress-related markers were measured at baseline, after the game of Monopoly™, and after lunch. Visit 2 used the same standardized protocol; however, participants were exposed to the opposite social status condition. When compared to HIGH, participants in LOW consumed 130 more calories (p=0.07) and a significantly higher proportion of their daily calorie needs in the ad libitum buffet meal (39% in LOW versus 31% in HIGH; p=0.04). In LOW, participants reported decreased feelings of pride and powerfulness following Monopoly™ (p=0.05) and after their lunch meal (p=0.08). Relative to HIGH, participants in LOW demonstrated higher heart rates following Monopoly™ (p=0.06), but this relationship was not significant once lunch was consumed (p=0.31). Our pilot data suggest a possible causal relationship between experimentally manipulated low social status

  20. A randomized clinical trial of chiropractic treatment and self-management in patients with acute musculoskeletal chest pain

    DEFF Research Database (Denmark)

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner

    2012-01-01

    We have previously reported short-term follow-up from a pragmatic randomized clinical trial comparing 2 treatments for acute musculoskeletal chest pain: (1) chiropractic treatment and (2) self-management. Results indicated a positive effect in favor of the chiropractic treatment after 4 and 12...

  1. Orange pomace improves postprandial glycemic responses: an acute, randomized, placebo-controlled, double-blind, crossover trial in overweight men

    Science.gov (United States)

    Orange pomace (OP), a fiber-rich byproduct of juice production, has the potential for being formulated into a variety of food products. We hypothesized that OP would diminish postprandial glycemic responses to a high carbohydrate/fat breakfast and lunch. We conducted an acute, randomized, placebo-co...

  2. Acute dark chocolate and cocoa ingestion and endothelial function: a randomized controlled crossover trial.

    Science.gov (United States)

    Faridi, Zubaida; Njike, Valentine Yanchou; Dutta, Suparna; Ali, Ather; Katz, David L

    2008-07-01

    Studies suggest cardioprotective benefits of dark chocolate containing cocoa. This study examines the acute effects of solid dark chocolate and liquid cocoa intake on endothelial function and blood pressure in overweight adults. Randomized, placebo-controlled, single-blind crossover trial of 45 healthy adults [mean age: 53 y; mean body mass index (in kg/m(2)): 30]. In phase 1, subjects were randomly assigned to consume a solid dark chocolate bar (containing 22 g cocoa powder) or a cocoa-free placebo bar (containing 0 g cocoa powder). In phase 2, subjects were randomly assigned to consume sugar-free cocoa (containing 22 g cocoa powder), sugared cocoa (containing 22 g cocoa powder), or a placebo (containing 0 g cocoa powder). Solid dark chocolate and liquid cocoa ingestion improved endothelial function (measured as flow-mediated dilatation) compared with placebo (dark chocolate: 4.3 +/- 3.4% compared with -1.8 +/- 3.3%; P cocoa: 5.7 +/- 2.6% and 2.0 +/- 1.8% compared with -1.5 +/- 2.8%; P cocoa compared with placebo (dark chocolate: systolic, -3.2 +/- 5.8 mm Hg compared with 2.7 +/- 6.6 mm Hg; P cocoa: systolic, -2.1 +/- 7.0 mm Hg compared with 3.2 +/- 5.6 mm Hg; P cocoa (5.7 +/- 2.6% compared with 2.0 +/- 1.8%; P cocoa improved endothelial function and lowered blood pressure in overweight adults. Sugar content may attenuate these effects, and sugar-free preparations may augment them.

  3. Chiropractic Treatment vs Self-Management in Patients With Acute Chest Pain: A Randomized Controlled Trial of Patients Without Acute Coronary Syndrome

    DEFF Research Database (Denmark)

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner

    2012-01-01

    OBJECTIVE: The musculoskeletal system is a common but often overlooked cause of chest pain. The purpose of the present study is to evaluate the relative effectiveness of 2 treatment approaches for acute musculoskeletal chest pain: (1) chiropractic treatment that included spinal manipulation and (2......) self-management as an example of minimal intervention. METHODS: In a nonblinded, randomized, controlled trial set at an emergency cardiology department and 4 outpatient chiropractic clinics, 115 consecutive patients with acute chest pain and no clear medical diagnosis at initial presentation were...... included. After a baseline evaluation, patients with musculoskeletal chest pain were randomized to 4 weeks of chiropractic treatment or self-management, with posttreatment questionnaire follow-up 4 and 12 weeks later. Primary outcome measures were numeric change in pain intensity (11-point box numerical...

  4. Glycated Hemoglobin Levels in Patients with Decompensated Cirrhosis

    Directory of Open Access Journals (Sweden)

    Jeffrey Nadelson

    2016-01-01

    Full Text Available Introduction. Aim of this study is to determine if HbA1c levels are a reliable predictor of glycemic control in patients with decompensated cirrhosis. Methods. 200 unique patients referred for liver transplantation at University of Tennessee/Methodist University Transplant Institute with a HbA1c result were included. Three glucose levels prior to the “measured” A1c (MA1c were input into an HbA1c calculator from the American Diabetes Association website to determine the “calculated” A1c (CA1c. The differences between MA1c and CA1c levels were computed. Patients were divided into three groups: group A, difference of 1.5. Results. 97 (49% patients had hemoglobin A1c of less than 5%. Discordance between calculated and measured HbA1c of >0.5% was seen in 47% (n=94. Higher level of discordance of greater than >1.5 was in 12% of patients (n=24. Hemoglobin was an independent predictor for higher discordance (odds ratio 0.77 95%, CI 0.60–0.99, and p value 0.04. HbA1c was an independent predictor of occurrence of HCC (OR 2.69 955, CI 1.38–5.43, and p value 0.008. Conclusion. HbA1c is not a reliable predictor of glycemic control in patients with decompensated cirrhosis, especially in those with severe anemia.

  5. Preventive antibacterial therapy in acute ischemic stroke: a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Hendrik Harms

    Full Text Available BACKGROUND: Pneumonia is a major risk factor of death after acute stroke. In a mouse model, preventive antibacterial therapy with moxifloxacin not only prevents the development of post-stroke infections, it also reduces mortality, and improves neurological outcome significantly. In this study we investigate whether this approach is effective in stroke patients. METHODS: Preventive ANtibacterial THERapy in acute Ischemic Stroke (PANTHERIS is a randomized, double-blind, placebo-controlled trial in 80 patients with severe, non-lacunar, ischemic stroke (NIHSS>11 in the middle cerebral artery (MCA territory. Patients received either intravenous moxifloxacin (400 mg daily or placebo for 5 days starting within 36 hours after stroke onset. Primary endpoint was infection within 11 days. Secondary endpoints included neurological outcome, survival, development of stroke-induced immunodepression, and induction of bacterial resistance. FINDINGS: On intention-to treat analysis (79 patients, the infection rate at day 11 in the moxifloxacin treated group was 15.4% compared to 32.5% in the placebo treated group (p = 0.114. On per protocol analysis (n = 66, moxifloxacin significantly reduced infection rate from 41.9% to 17.1% (p = 0.032. Stroke associated infections were associated with a lower survival rate. In this study, neurological outcome and survival were not significantly influenced by treatment with moxifloxacin. Frequency of fluoroquinolone resistance in both treatment groups did not differ. On logistic regression analysis, treatment arm as well as the interaction between treatment arm and monocytic HLA-DR expression (a marker for immunodepression at day 1 after stroke onset was independently and highly predictive for post-stroke infections. INTERPRETATION: PANTHERIS suggests that preventive administration of moxifloxacin is superior in reducing infections after severe non-lacunar ischemic stroke compared to placebo. In addition, the results emphasize

  6. Mesotherapy versus Systemic Therapy in the Treatment of Acute Low Back Pain: A Randomized Trial.

    Science.gov (United States)

    Costantino, Cosimo; Marangio, Emilio; Coruzzi, Gabriella

    2011-01-01

    Pharmacological therapy of back pain with analgesics and anti-inflammatory drugs is frequently associated with adverse effects, particularly in the elderly. Aim of this study was to compare mesotherapic versus conventional systemic administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids in patients with acute low back pain. Eighty-four patients were randomized to receive anti-inflammatory therapy according to the following protocols: (a) mesotherapy group received the 1st and 4th day 2% lidocaine (1 mL) + ketoprofen 160 mg (1 mL) + methylprednisolone 40 mg (1 mL), then on 7th, 10th, and 13th day, 2% lidocaine (1 mL) + ketoprofen 160 mg (1 mL) + methylprednisolone 20 mg (1 mL) (b) conventional therapy group received ketoprofen 80 mg × 2/die and esomeprazole 20 mg/die orally for 12 days, methylprednisolone 40 mg/die intramuscularly for 4 days, followed by methylprednisolone 20 mg/die for 3 days, and thereafter, methylprednisolone 20 mg/die at alternate days. Pain intensity and functional disability were assessed at baseline (T0), at the end of treatment (T1), and 6 months thereafter (T2) by using visual analogic scale (VAS) and Roland-Morris disability questionnaire (RMDQ). In both groups, VAS and RMDQ values were significantly reduced at the end of drug treatment and after 6 months, in comparison with baseline. No significant differences were found between the two groups. This suggests that mesotherapy may be a valid alternative to conventional therapy in the treatment of acute low back pain with corticosteroids and NSAIDs.

  7. A Randomized Trial of an Intensive Physical Therapy Program for Patients with Acute Respiratory Failure.

    Science.gov (United States)

    Moss, Marc; Nordon-Craft, Amy; Malone, Dan; Van Pelt, David; Frankel, Stephen K; Warner, Mary Laird; Kriekels, Wendy; McNulty, Monica; Fairclough, Diane L; Schenkman, Margaret

    2016-05-15

    Early physical therapy (PT) interventions may benefit patients with acute respiratory failure by preventing or attenuating neuromuscular weakness. However, the optimal dosage of these interventions is currently unknown. To determine whether an intensive PT program significantly improves long-term physical functional performance compared with a standard-of-care PT program. Patients who required mechanical ventilation for at least 4 days were eligible. Enrolled patients were randomized to receive PT for up to 4 weeks delivered in an intensive or standard-of-care manner. Physical functional performance was assessed at 1, 3, and 6 months in survivors who were not currently in an acute or long-term care facility. The primary outcome was the Continuous Scale Physical Functional Performance Test short form (CS-PFP-10) score at 1 month. A total of 120 patients were enrolled from five hospitals. Patients in the intensive PT group received 12.4 ± 6.5 sessions for a total of 408 ± 261 minutes compared with only 6.1 ± 3.8 sessions for 86 ± 63 minutes in the standard-of-care group (P Physical function assessments were available for 86% of patients at 1 month, for 76% at 3 months, and for 60% at 6 months. In both groups, physical function was reduced yet significantly improved over time between 1, 3, and 6 months. When we compared the two interventions, we found no differences in the total CS-PFP-10 scores at all three time points (P = 0.73, 0.29, and 0.43, respectively) or in the total CS-PFP-10 score trajectory (P = 0.71). An intensive PT program did not improve long-term physical functional performance compared with a standard-of-care program. Clinical trial registered with www.clinicaltrials.gov (NCT01058421).

  8. Effects of Early Mobilization after Acute Stroke: A Meta-Analysis of Randomized Control Trials.

    Science.gov (United States)

    Li, Zhuyue; Zhang, Xuemei; Wang, Kang; Wen, Jin

    2018-01-17

    Early mobilization is inconsistently associated with the recovery of stroke. We aim to examine the effect of early mobilization on patients with acute stroke. PubMed, EMBASE, and the Cochrane library were searched up to April 2017. Randomized controlled trials that reported risk estimates or mean with standard deviation were included. Primary outcomes were defined as modified Rankin scale score 0-2 and mortality, and secondary outcomes were Barthel Index, length of stay, and incidence of complications. Summary relative risk, standardized mean difference (SMD), and weighted mean difference (WMD) were calculated as needed. Sensitivity analyses were also conducted to test stability of results. Six studies (8 publications) were included to analyze the effects of early mobilization after stroke. No differences between groups were observed for modified Rankin scale 0-2 (relative risk [RR]: .80; 95% confidence interval [CI]: .58-1.02; I 2 =45%) and the risk of death (RR: 1.21, 95% CI: .76-1.65; I 2 =0%). Compared with conventional practice, early mobilization was superior in Barthel Index (SMD: .66; 95% CI: .00-1.31; I 2 =85.9%), and shorter hospital stay for stroke patients (WMD: -1.97; 95% CI: -2.63 to -1.32; I 2 =15.3%). We found no significant difference between groups on the incidence of complications. Current evidence revealed that no statistical significant difference between early mobilization and non-early mobilization was observed on modified Rankin scale score 0-2 and mortality. Interestingly, early mobilization is associated with an increased Barthel Index and shorter hospital stay for patients. Further research is necessary to verify the effect of early mobilization on patients with acute stroke. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  9. Modular Ankle Robotics Training in Early Sub-Acute Stroke: A Randomized Controlled Pilot Study

    Science.gov (United States)

    Forrester, Larry W.; Roy, Anindo; Krywonis, Amanda; Kehs, Glenn; Krebs, Hermano Igo; Macko, Richard F.

    2014-01-01

    Background Modular lower extremity (LE) robotics may offer a valuable avenue for restoring neuromotor control after hemiparetic stroke. Prior studies show that visually-guided and visually-evoked practice with an ankle robot (anklebot) improves paretic ankle motor control that translates into improved overground walking. Objective Assess the feasibility and efficacy of daily anklebot training during early sub-acute hospitalization post-stroke. Methods Thirty-four inpatients from a stroke unit were randomly assigned to anklebot (N=18) or passive manual stretching (N=16) treatments. All suffered a first stroke with residual hemiparesis (ankle manual muscle test grade 1/5 to 4/5), and at least trace muscle activation in plantar- or dorsiflexion. Anklebot training employed an “assist-as-needed” approach during > 200 volitional targeted paretic ankle movements, with difficulty adjusted to active range of motion and success rate. Stretching included >200 daily mobilizations in these same ranges. All sessions lasted 1 hour and assessments were not blinded. Results Both groups walked faster at discharge, however the robot group improved more in percent change of temporal symmetry (p=0.032) and also of step length symmetry (p=0.038), with longer nonparetic step lengths in the robot (133%) vs. stretching (31%) groups. Paretic ankle control improved in the robot group, with increased peak (p≤ 0.001) and mean (p≤ 0.01) angular speeds, and increased movement smoothness (p≤ 0.01). There were no adverse events. Conclusion Though limited by small sample size and restricted entry criteria, our findings suggest that modular lower extremity robotics during early sub-acute hospitalization is well tolerated and improves ankle motor control and gait patterning. PMID:24515923

  10. Mesotherapy versus Systemic Therapy in the Treatment of Acute Low Back Pain: A Randomized Trial

    Directory of Open Access Journals (Sweden)

    Cosimo Costantino

    2011-01-01

    Full Text Available Pharmacological therapy of back pain with analgesics and anti-inflammatory drugs is frequently associated with adverse effects, particularly in the elderly. Aim of this study was to compare mesotherapic versus conventional systemic administration of nonsteroidal anti-inflammatory drugs (NSAIDs and corticosteroids in patients with acute low back pain. Eighty-four patients were randomized to receive anti-inflammatory therapy according to the following protocols: (a mesotherapy group received the 1st and 4th day 2% lidocaine (1 mL + ketoprofen 160 mg (1 mL + methylprednisolone 40 mg (1 mL, then on 7th, 10th, and 13th day, 2% lidocaine (1 mL + ketoprofen 160 mg (1 mL + methylprednisolone 20 mg (1 mL (b conventional therapy group received ketoprofen 80 mg × 2/die and esomeprazole 20 mg/die orally for 12 days, methylprednisolone 40 mg/die intramuscularly for 4 days, followed by methylprednisolone 20 mg/die for 3 days, and thereafter, methylprednisolone 20 mg/die at alternate days. Pain intensity and functional disability were assessed at baseline (T0, at the end of treatment (T1, and 6 months thereafter (T2 by using visual analogic scale (VAS and Roland-Morris disability questionnaire (RMDQ. In both groups, VAS and RMDQ values were significantly reduced at the end of drug treatment and after 6 months, in comparison with baseline. No significant differences were found between the two groups. This suggests that mesotherapy may be a valid alternative to conventional therapy in the treatment of acute low back pain with corticosteroids and NSAIDs.

  11. Successful Treatment of Acute Radiation Proctitis with Aloe Vera: A Preliminary Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Sahebnasagh, Adeleh; Ghasemi, Arash; Akbari, Jafar; Alipour, Abbas; Lashkardoost, Hossein; Ala, Shahram; Salehifar, Ebrahim

    2017-11-01

    Acute radiation proctitis (ARP) is a common side-effect that affects up to 50% of patients receiving radiotherapy. The aim of this study was to evaluate the role of a topical preparation of Aloe vera in the treatment of ARP induced by radiotherapy of pelvic area. In this double-blind placebo-controlled trial, 20 consecutive patients with ARP after external-beam radiation therapy (46-72 Gy) of pelvic malignancies were randomized to receive either Aloe vera 3% or placebo ointment, 1 g twice daily for 4 weeks. These patients presented with at least two of the following symptoms: rectal bleeding, abdominal/rectal pain, diarrhea, or fecal urgency. These symptoms were rated by the patients in terms of their severity (grade 0-4) for each of the symptoms mentioned earlier at baseline and then weekly for 4 weeks. A symptom index was calculated by the addition of the scores (16 most symptomatic). Radiation Therapy Oncology Group (RTOG) acute toxicity criteria and psychosocial status of the patients were also recorded weekly. The lifestyle impact of the symptoms was assessed by questionnaire grading from 0 (no effect on daily activity) to 4 (afraid to leave home). There was a significant (p Aloe vera) for diarrhea (median score: 0.67 vs. 0.11), fecal urgency (median score: 0.89 vs. 0.11), clinical presentation total (median score: 4.33 vs. 1.22), RTOG total (median score: 2.89 vs. 0.89), and lifestyle (median score: 1.1 vs. 0.33). Hemorrhage and abdominal/rectal pain did not improve significantly. The odds ratios for advantage of Aloe vera over placebo for "clinical presentation total" and "RTOG total" were 3.97 (1.3-11.9) and 5.9 (1.6-21.6), respectively. A substantial number of patients with radiation proctitis seem to benefit from therapy with Aloe vera 3% ointment.

  12. [Methocarbamol in acute low back pain. A randomized double-blind controlled study].

    Science.gov (United States)

    Emrich, Oliver M D; Milachowski, Klaus A; Strohmeier, Martin

    2015-07-01

    Muscle relaxants are widely used to treat low back pain (LBP), one of the most frequent health problems in industrialized countries. For this indication, the European Medicines Agency (EMA) recently had imposed restrictions for some muscle relaxants, anti-inflammatories and analgesics; Tetrazepam even had to be withdrawn from the market. Therefore methocarbamol remains the only approved muscle relaxant. Methocarbamol is well-established for the treatment of LBP associated with myofascial components, although more recent clinical studies have not been published. Therefore this publication summarizes and revaluates post-hoc data of an efficiency study of methocarbamol, that was performed in 2002, but had not been published yet. This was a randomized, placebo controlled multi-centre study. Inclusion criteria were acute low back pain for at least 24 h associated with spasms in the pelvic/lumbar region and restriction of mobility. Patients were randomly assigned to a group treated with orally administered Ortoton® (n = 98) or placebo (n = 104). Drugs were administered for up to 8 days, but treatment of individual patients was discontinued as soon as a pain-free state was achieved. Individual pain perception was quantified by means of a visual analog scale (VAS). The fingertip-to-floor distance was measured as an indicator of lumbar flexion. Mobility restrictions were also assessed by a modified Schober's test. In addition, a questionnaire was used by patients and physicians to rate the efficacy of treatment. In the methocarbamol group 44% of the patients pre-terminated due to complete pain relief (placebo: 18%) and 19% discontinued because the treatment was considered ineffective (placebo 52%, p < 0,0001). Measures of mobility (fingertip-to-floor distance, Schober's test) and improvement of mobility as perceived by physician and patient at the individual end of study all were clearly in favor of the patients treated with methocarbamol. At the final visit, 67% of the

  13. Impact of clinical decision support on radiography for acute ankle injuries: a randomized trial

    Directory of Open Access Journals (Sweden)

    Shahein Tajmir

    2017-04-01

    Full Text Available Introduction: While only 15-20% of patients with foot and ankle injuries presenting to urgent care centers have clinically significant fractures, most undergo radiography. We examined the impact of electronic point-of-care clinical decision support (CDS on adherence to the Ottawa Ankle Rules (OAR, as well as use and yield of foot and ankle radiographs in patients with acute ankle injury. Methods: We obtained institutional review board approval for this randomized controlled study performed April 18, 2012—December 15, 2013. All ordering providers credentialed at an urgent care affiliated with a quaternary care academic hospital were randomized to either receive or not receive CDS, based on the OAR and integrated into the physician order-entry system, with feedback at the time of imaging order. If the patient met OAR low-risk criteria, providers were advised against imaging and could either cancel the order or ignore the alert. We identified patients with foot and ankle complaints via ICD-9 billing codes and electronic health records and radiology reports reviewed for those who were eligible. Chi-square was used to compare adherence to the OAR (primary outcome, radiography utilization rate and radiography yield of foot and ankle imaging (secondary outcomes between the intervention and control groups. Results: Of 14,642 patients seen at urgent care during the study period, 613 (4.2%, representing 632 visits presented with acute ankle injury and were eligible for application of the OAR; 374 (59.2% of these were seen by control-group providers. In the intervention group, CDS adherence was higher for both ankle (239/258=92.6% vs. 231/374=61.8%, p=0.02 and foot radiography (209/258=81.0% vs. 238/374=63.6%; p<0.01. However, ankle radiography use was higher in the intervention group (166/258=64.3% vs. 183/374=48.9%; p<0.01, while foot radiography use (141/258=54.6% vs. 202/374=54.0%; p=0.95 was not. Radiography yield was also higher in the intervention

  14. Efficacy and Safety of Spironolactone in Acute Heart Failure: The ATHENA-HF Randomized Clinical Trial.

    Science.gov (United States)

    Butler, Javed; Anstrom, Kevin J; Felker, G Michael; Givertz, Michael M; Kalogeropoulos, Andreas P; Konstam, Marvin A; Mann, Douglas L; Margulies, Kenneth B; McNulty, Steven E; Mentz, Robert J; Redfield, Margaret M; Tang, W H Wilson; Whellan, David J; Shah, Monica; Desvigne-Nickens, Patrice; Hernandez, Adrian F; Braunwald, Eugene

    2017-09-01

    Persistent congestion is associated with worse outcomes in acute heart failure (AHF). Mineralocorticoid receptor antagonists administered at high doses may relieve congestion, overcome diuretic resistance, and mitigate the effects of adverse neurohormonal activation in AHF. To assess the effect of high-dose spironolactone and usual care on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels compared with usual care alone. This double-blind and placebo (or low-dose)-controlled randomized clinical trial was conducted in 22 US acute care hospitals among patients with AHF who were previously receiving no or low-dose (12.5 mg or 25 mg daily) spironolactone and had NT-proBNP levels of 1000 pg/mL or more or B-type natriuretic peptide levels of 250 pg/mL or more, regardless of ejection fraction. High-dose spironolactone (100 mg) vs placebo or 25 mg spironolactone (usual care) daily for 96 hours. The primary end point was the change in NT-proBNP levels from baseline to 96 hours. Secondary end points included the clinical congestion score, dyspnea assessment, net urine output, and net weight change. Safety end points included hyperkalemia and changes in renal function. A total of 360 patients were randomized, of whom the median age was 65 years, 129 (36%) were women, 200 (55.5%) were white, 151 (42%) were black, 8 (2%) were Hispanic or Latino, 9 (2.5%) were of other race/ethnicity, and the median left ventricular ejection fraction was 34%. Baseline median (interquartile range) NT-proBNP levels were 4601 (2697-9596) pg/mL among the group treated with high-dose spironolactone and 3753 (1968-7633) pg/mL among the group who received usual care. There was no significant difference in the log NT-proBNP reduction between the 2 groups (-0.55 [95% CI, -0.92 to -0.18] with high-dose spironolactone and -0.49 [95% CI, -0.98 to -0.14] with usual care, P = .57). None of the secondary end point or day-30 all-cause mortality or heart failure hospitalization rate differed

  15. Troponin I release after intravenous treatment with high furosemide doses plus hypertonic saline solution in decompensated heart failure trial (Tra-HSS-Fur).

    Science.gov (United States)

    Parrinello, Gaspare; Di Pasquale, Pietro; Torres, Daniele; Cardillo, Mauro; Schimmenti, Caterina; Lupo, Umberto; Iatrino, Rossella; Petrantoni, Rossella; Montaina, Carla; Giambanco, Salvatore; Paterna, Salvatore

    2012-09-01

    High values of cardiac troponin in acute decompensated congestive heart failure (ADHF) identify patients at higher risk and worsened prognosis. A cardiac troponin increase during therapy indicates the need for more appropriate intervention, aimed at compensating cardiac disease and effectively minimizing myocardial wall stress and subsequent cytolysis. This study evaluated the effects of an intravenous high dose of furosemide with (group A) or without small volume hypertonic saline solution (HSS) (group B) on myocardial cytolysis in patients with ADHF. A total of 248 consecutive patients with ADHF (148 men, mean age 74.9 ± 10.9 years) were randomly assigned to group A or B. Plasma levels of cardiac troponin-I, brain natriuretic peptide, glomerular filtration rate by Modification of Diet in Renal Disease formula, bioelectrical impedance analysis measurements, and delta pressure/delta time (dP/dt) rate were observed on admission and discharge for all patients. We observed a significant reduction of cardiac troponin in both groups and a significant improvement in renal function, hydration state, pulmonary capillary wedge pressure (P < .0001), end diastolic volume (P < .01), ejection fraction (P < .01), and dP/dt (P < .004) in group A. We also observed a significant reduction in body weight (64.4 vs 75.8 kg) (P < .001), cardiac troponin I (0.02 vs 0.31 ng/mL) (P < .0001) and brain natriuretic peptide (542 vs 1,284 pg/mL) (P < .0001), and hospitalization time (6.25 vs 10.2 days) (P < .0001) in the HSS group. These data demonstrate that intravenous high doses of furosemide do not increase myocardial injury and, in addition, when associated to HSS, significantly reduce cardiac troponin I release. This behavior is mirrored by the achievement of improved hemodynamic compensation at echocardiography and body hydration normalization. Copyright © 2012 Mosby, Inc. All rights reserved.

  16. Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome after Caesarean Section: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Fusco, Pierfrancesco; Cofini, Vincenza; Petrucci, Emiliano; Scimia, Paolo; Pozone, Tullio; Paladini, Giuseppe; Carta, Gaspare; Necozione, Stefano; Borghi, Battista; Marinangeli, Franco

    2016-01-01

    The international literature is unclear regarding the analgesic efficacy of the transversus abdominis plane block (TAPB) after a Caesarean section (CS). The aim of this study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide better control of acute postoperative pain during the first 72 hours after CS and if it could provide a faster postoperative recovery. A double-blind, randomized, controlled clinical trial on pregnant women who underwent CS. Pain clinic and Anesthesia and Intensive Care Unit in an academic hospital. A double-blind, randomized, controlled study was conducted with 96 patients who underwent CS. The patients in both groups received subarachnoid anesthesia (SAB) with 13 mg of 0.5% isobaric levobupivacaine. The patients were randomized so that some received USG-TAPB with local anesthetic, and the remainder received USG-TAPB with saline. The patients' demographic information and data regarding anesthesia, hemodynamic changes, side effects, acute rest and incident postoperative pain, painkiller consumption, recovery time of bowel function, and the time of hospital discharge were recorded. Our data reinforce the assumption that if TAP block is performed correctly and is part of a multimodal analgesic scheme, effective pain control is possible both for somatic and visceral acute pain. Furthermore, the need for painkillers is reduced, and their related side effects are moderate, yielding a positive benefit/cost ratio. USG-TAPB provides good analgesia for acute postoperative somatic pain, but opiates were still needed for the management of visceral acute postoperative pain. These results could confirm the assumption that the correct performance of an USG-TAPB as part of a multimodal analgesic treatment could represent a viable alternative to common analgesic procedures performed for acute postoperative pain control after a CS.Key words: Bowel function, Caesarian section, incident pain, local anesthetics

  17. Hemodynamic effects of digoxin in acute myocardial infarction in man: a randomized controlled trial.

    Science.gov (United States)

    Marchionni, N; Pini, R; Vannucci, A; Conti, A; De Alfieri, W; Calamandrei, M; Di Bari, M; Ferrucci, L; Moschi, G; Lombardi, A

    1985-01-01

    Hemodynamic effects of digoxin in acute myocardial infarction (AMI) have been acknowledged to depend on the basal cardiocirculatory state. In the present study, the effects of digoxin in patients with AMI were evaluated in four hemodynamic subsets, based on the relationship between mean pulmonary capillary wedge pressure (PCWP, in mm Hg) and left ventricular stroke work index (LVSWI, in g-m/m2): subset 1: normal (less than or equal to 15 mm Hg) PCWP and normal (greater than or equal to 35 g-m/m2) LVSWI; subset 2: elevated (greater than 15 mm Hg) PCWP and normal LVSWI; subset 3: reduced (less than 35 g-m/m2) LVSWI and normal PCWP; and subset 4: elevated PCWP and LVSWI moderately reduced to a range between 16 and 34 g-m/m2. Forty patients were admitted to the study and were randomly assigned to one of two groups in each subset: control group (19 patients) and treated group (21 patients). Five patients were randomized into each of the subsets 2, 3, and 4 in both the control and treated groups, while in subset 1 there were four control and six digoxin-treated patients. Control patients were administered a placebo saline solution and digoxin-treated patients received 0.50 mg of the drug intravenously in 20 minutes. The effects of the placebo and of the drug were evaluated at 30, 60, and 90 minutes from the end of the infusion. Hemodynamic data did not vary in the control group, and digoxin did not exert any relevant effect in subsets 1 and 2. After drug infusion, cardiac index (Cl, in L/min/m2) significantly increased in subset 3 patients.(ABSTRACT TRUNCATED AT 250 WORDS)

  18. The impact of immunoglobulin in acute HIV infection on the HIV reservoir: a randomized controlled trial.

    Science.gov (United States)

    Tiraboschi, J; Ray, S; Patel, K; Teague, A; Pace, M; Phalora, P; Robinson, N; Hopkins, E; Meyerowitz, J; Wang, Y; Cason, J; Kaye, S; Sanderson, J; Klenerman, P; Fidler, S; Frater, J; Fox, J

    2017-11-01

    Antiretroviral therapy (ART) during acute HIV infection (AHI) restricts the HIV reservoir, but additional interventions are necessary to induce a cure. Intravenous immunoglobulin (IVIG) is not HIV-specific but is safe and temporarily reduces the HIV reservoir in chronic HIV infection. We present a randomized controlled trial to investigate whether IVIG plus ART in AHI reduces the HIV reservoir and immune activation compared with ART alone. Ten men with AHI (Fiebig II-IV) initiated ART (tenofovir, entricitabine, ritonavir boosted darunavir and raltegravir) at HIV-1 diagnosis and were randomized to ART alone or ART plus 5 days of IVIG, once virally suppressed (week 19). Blood samples were evaluated for viral reservoir, immune activation, immune exhaustion and microbial translocation. Flexible sigmoidoscopy was performed at weeks 19, 24 and 48, and gut proviral DNA and cell numbers determined. IVIG was well tolerated and no viral blips (> 50 HIV-1 RNA copies/mL) occurred during IVIG therapy. From baseline to week 48, total HIV DNA in peripheral blood mononuclear cells (PBMCs) (cases: -3.7 log 10 copies/10 6 CD4 cells; controls: -3.87 log 10 copies/10 6 CD4 cells) declined with no differences observed between the groups (P = 0.49). Declines were observed in both groups from week 19 to week 48 in total HIV DNA in PBMCs (P = 0.38), serum low copy RNA (P = 0.57) and gut total HIV DNA (P = 0.55), but again there were no significant differences between arms. Biomarkers of immune activation, immune exhaustion and microbial translocation and the CD4:CD8 ratio were similar between arms for all comparisons. Although safe, IVIG in AHI did not impact total HIV DNA, immune function or microbial translocation in peripheral blood or gut tissue. © 2017 British HIV Association.

  19. Acute Alcohol Consumption Directly Increases HIV Transmission Risk: A Randomized Controlled Experiment.

    Science.gov (United States)

    Shuper, Paul A; Joharchi, Narges; Monti, Peter M; Loutfy, Mona; Rehm, Jürgen

    2017-12-15

    Alcohol consumption has frequently been purported as a driver of condomless sex and HIV transmission, but to date, experimental evidence for the causal risk-taking impact of alcohol among HIV-positive populations is lacking. The present experiment sought to determine whether acute alcohol consumption has a direct causal impact on condomless sex intentions among HIV-positive men-who-have-sex-with-men (MSM), and to assess whether alcohol's impact differs between MSM who are HIV-positive versus HIV-negative. In a randomized controlled alcohol administration experiment, HIV-positive and HIV-negative MSM were brought into a specialized barroom laboratory and randomly assigned to beverage consumption condition: alcohol (target blood alcohol concentration = 0.080%), placebo alcohol (target blood alcohol concentration = 0.000%), or water (control). Participants then underwent a video-based sexual arousal manipulation (sexually aroused/nonaroused) and indicated their intentions to engage in condom-protected and condomless sexual acts in a standardized paradigm. The primary outcome entailed intentions to engage in condomless receptive and condomless insertive anal sex. A total of 282 MSM (141 HIV-positive; 141 HIV-negative) completed experimental procedures. MSM who received alcohol reported significantly stronger intentions to engage in condomless sex than those who received placebo alcohol or water (F(1,274) = 9.43, P = 0.002). The impact of alcohol did not differ between HIV-positive and HIV-negative MSM (F(1,274) = 1.86, P = 0.174). The present investigation entailed the first risk-focused alcohol administration experiment to involve an HIV-positive sample, and results demonstrated that consuming alcohol had an independent, causal impact on intentions to engage in sexual behaviors that can result in HIV transmission. Findings strongly suggest that alcohol-focused initiatives should be incorporated into HIV prevention efforts.

  20. Randomized controlled trial of TY-51924, a novel hydrophilic NHE inhibitor, in acute myocardial infarction.

    Science.gov (United States)

    Kimura, Kazuo; Nakao, Koichi; Shibata, Yoshisato; Sone, Takahito; Takayama, Tadateru; Fukuzawa, Shigeru; Nakama, Yasuharu; Hirayama, Haruo; Matsumoto, Naoya; Kosuge, Masami; Hiro, Takafumi; Sakuma, Hajime; Ishihara, Masaharu; Asakura, Masanori; Hamada, Chikuma; Kaneko, Akira; Yokoi, Toshiaki; Hirayama, Atsushi

    2016-04-01

    In patients with ST-elevation acute myocardial infarction (STEMI), reperfusion therapy limits infarct size, but can directly evoke myocardial reperfusion injury. Activation of the Na(+)/H(+) exchanger (NHE) plays an important role in reperfusion injury. TY-51924, a novel NHE inhibitor, significantly reduced infarct size in animal studies and was well tolerated in early-phase clinical trials. This study aim was to evaluate the efficacy and safety of TY-51924 in patients with STEMI. In this multicenter, randomized, double-blind, placebo-controlled Phase II trial, 105 patients with first anterior STEMI undergoing primary percutaneous coronary intervention (pPCI) were randomly assigned to receive an intravenous infusion of either TY-51924 or placebo. Primary endpoints were myocardial salvage index (MSI) as determined by single photon emission computed tomography (SPECT) 3-5 days after pPCI and safety up to 7 days. Baseline characteristics were similar in the two groups. MSI 3-5 days after pPCI (0.200 vs. 0.290, p=0.56), 3 months after pPCI (0.470 vs. 0.500, p=0.76), and the incidences of side effects did not differ between the two groups as a whole. However, on post hoc analysis of 52 patients with a large area at risk (AAR) (≥38%) and no antegrade coronary flow, MSI by SPECT at 3 months after pPCI was significantly higher in TY-51924 group (0.450 vs. 0.320, p=0.03). TY-51924 did not adversely influence hemodynamics. TY-51924 did not improve MSI or increase side effects as a whole. However, TY-51924 is potentially cardioprotective in the presence of a large AAR and no antegrade coronary flow. Copyright © 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  1. Treating Acute Insomnia: A Randomized Controlled Trial of a “Single-Shot” of Cognitive Behavioral Therapy for Insomnia

    OpenAIRE

    Ellis, Jason; Cushing, Toby; Germain, Anne

    2015-01-01

    Study Objectives\\ud Despite considerable evidence supporting cognitive behavioral therapy for insomnia (CBT-I) for chronic insomnia, it remains untested within the context of acute insomnia. This study examined the efficacy of a single session of CBT-I, with an accompanying self-help pamphlet, for individuals with acute insomnia.\\ud \\ud Design\\ud A pragmatic parallel group randomized controlled trial.\\ud \\ud Participants\\ud Forty adults (mean age 32.9 + 13.72 y) with Diagnostic and Statistica...

  2. Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial

    DEFF Research Database (Denmark)

    Connor, Kathryn M; Aurora, Sheena K; Loeys, Tom

    2011-01-01

    To evaluate the long-term tolerability of telcagepant for acute treatment of intermittent migraine attacks. Background.- Telcagepant is a calcitonin gene-related peptide (CGRP) receptor antagonist being investigated for the acute treatment of migraine....

  3. Vagus nerve stimulation for treatment-resistant depression: a randomized, controlled acute phase trial.

    Science.gov (United States)

    Rush, A John; Marangell, Lauren B; Sackeim, Harold A; George, Mark S; Brannan, Stephen K; Davis, Sonia M; Howland, Robert; Kling, Mitchel A; Rittberg, Barry R; Burke, William J; Rapaport, Mark H; Zajecka, John; Nierenberg, Andrew A; Husain, Mustafa M; Ginsberg, David; Cooke, Robert G

    2005-09-01

    Vagus nerve stimulation (VNS) alters both concentrations of neurotransmitters or their metabolites and functional activity of central nervous system regions dysregulated in mood disorders. An open trial has suggested efficacy. This 10-week, acute, randomized, controlled, masked trial compared adjunctive VNS with sham treatment in 235 outpatients with nonpsychotic major depressive disorder (n = 210) or nonpsychotic, depressed phase, bipolar disorder (n = 25). In the current episode, participants had not responded adequately to between two and six research-qualified medication trials. A two-week, single-blind recovery period (no stimulation) and then 10 weeks of masked active or sham VNS followed implantation. Medications were kept stable. Primary efficacy outcome among 222 evaluable participants was based on response rates (>/=50% reduction from baseline on the 24-item Hamilton Rating Scale for Depression [HRSD(24)]). At 10-weeks, HRSD(24) response rates were 15.2% for the active (n = 112) and 10.0% for the sham (n = 110) groups (p = .251, last observation carried forward [LOCF]). Response rates with a secondary outcome, the Inventory of Depressive Symptomatology - Self-Report (IDS-SR(30)), were 17.0% (active) and 7.3% (sham) (p = .032, LOCF). VNS was well tolerated; 1% (3/235) left the study because of adverse events. This study did not yield definitive evidence of short-term efficacy for adjunctive VNS in treatment-resistant depression.

  4. Use of racecadotril as outpatient treatment for acute gastroenteritis: a prospective, randomized, parallel study.

    Science.gov (United States)

    Santos, Mar; Marañón, Rafael; Miguez, Concepión; Vázquez, Paula; Sánchez, Cesar

    2009-07-01

    To compare the efficacy of therapy with racecadotril plus oral rehydration versus oral rehydration alone in children with gastroenteritis in an outpatient setting care. Prospective, randomized, open and parallel study performed in a Pediatric Emergency Service of a tertiary care hospital. The study included 189 patients, ages 3 to 36 months, with acute gastroenteritis: 94 were administered an oral rehydration solution (OR), 94 received oral rehydration solution plus racecadotril (OR + R). The principal variable studied was the number of bowel movements in 48 hours after initiating treatment. The groups were comparable clinically and epidemiologically at enrollment. No significant differences were found in the number of bowel movements between the 2 groups 48 hours after initiating treatment (4.1 +/- 2.7 bowel movements in the OR group vs 3.8 +/- 2.4 bowel movements in the OR + R group). No differences were found in the average duration of gastroenteritis (4.7 +/- 2.2 days in the OR group, 4.0 +/- 2.1 days in the OR + R group; P = .15). The incidence of adverse events was similar in both groups (19 patients [20.2%] in the OR group, 18 patients [19.1%] in the OR + R group). In our study group, the use of racecadotril did not improve the symptoms of diarrhea compared with standard rehydration therapy.

  5. Randomized comparative study of ceftibuten versus cefaclor in the treatment of acute lower respiratory tract infections.

    Science.gov (United States)

    Kammer, R B; Ress, R

    1991-01-01

    In a randomized, single-blind trial, ceftibuten in doses of 200 mg and 300 mg administered b.i.d., was compared with cefaclor 500 mg t.i.d. in acute lower respiratory tract infections. A total 545 patients were enrolled, of which 263 were evaluable for efficacy. All patients were adults with a diagnosis of either bacterial pneumonia or bronchitis. The infective organism was eliminated in 83% of the patients in the ceftibuten 200-mg b.i.d. treatment group and in 85% of patients in the 300-mg b.i.d. treatment group. The organisms were eliminated in 79% of cefaclor-treated patients. Satisfactory clinical responses were obtained in 91% of patients in the ceftibuten 200-mg b.i.d. treatment group and in 92% of patients in the ceftibuten 300-mg b.i.d. group. Satisfactory clinical responses were obtained in 91% of cefaclor-treated patients. Predominant pathogens isolated were Streptococcus pneumoniae, Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, and strains of Enterobacteriaceae. Adverse experiences reported were similar for the ceftibuten and cefaclor treatment groups. Gastrointestinal side effects occurred in 6% of patients treated with ceftibuten 200 mg BID, 9% in those treated with 300 mg BID, and 7% of cefaclor-treated patients. Ceftibuten 200 and 300 mg twice daily was as effective as cefaclor bacteriologically and clinically in the treatment of lower respiratory tract infections.

  6. Intravitreal Triamcinolone for Acute Branch Retinal Vein Occlusion: a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Alireza Ramezani

    2011-01-01

    Full Text Available Purpose: To evaluate the therapeutic effect of intravitreal triamcinolone (IVT injection for recent branch retinal vein occlusion (BRVO. Methods: In a randomized controlled clinical trial, 30 phakic eyes with recent (less than 10 weeks′ duration BRVO were assigned to two groups. The treatment group (16 eyes received 4 mg IVT and the control group (14 eyes received subconjunctival sham injections. Changes in visual acuity (VA were the main outcome measure. Results: VA and central macular thickness (CMT changes were not significantly different between the study groups at any time point. Within group analysis showed significant VA improvement from baseline in the IVT group up to three months (P 0.05. Significant reduction in CMT was noticed only in the treatment group (‑172 ± 202 μm, P = 0.029 and at 4 months. Ocular hypertension occurred in 4 (25% and 2 (14.3% eyes in the IVT and control groups, respectively. Conclusion: A single IVT injection had a non-significant beneficial effect on VA and CMT in acute BRVO as compared to the natural history of the condition. The 3-month deferred treatment protocol advocated by the Branch Vein Occlusion Study Group may be a safer option than IVT injection considering its potential side effects.

  7. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial.

    Science.gov (United States)

    Gajdos, Vincent; Katsahian, Sandrine; Beydon, Nicole; Abadie, Véronique; de Pontual, Loïc; Larrar, Sophie; Epaud, Ralph; Chevallier, Bertrand; Bailleux, Sylvain; Mollet-Boudjemline, Alix; Bouyer, Jean; Chevret, Sylvie; Labrune, Philippe

    2010-09-28

    Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy combining the increased exhalation technique (IET) and assisted cough (AC). Our objective was to evaluate the efficacy of chest physiotherapy (IET + AC) in previously healthy infants hospitalized for a first episode of acute bronchiolitis. We conducted a multicenter, randomized, outcome assessor-blind and parent-blind trial in seven French pediatric departments. We recruited 496 infants hospitalized for first-episode acute bronchiolitis between October 2004 and January 2008. Patients were randomly allocated to receive from physiotherapists three times a day, either IET + AC (intervention group, n=246) or nasal suction (NS, control group, n=250). Only physiotherapists were aware of the allocation group of the infant. The primary outcome was time to recovery, defined as 8 hours without oxygen supplementation associated with minimal or no chest recession, and ingesting more than two-thirds of daily food requirements. Secondary outcomes were intensive care unit admissions, artificial ventilation, antibiotic treatment, description of side effects during procedures, and parental perception of comfort. Statistical analysis was performed on an intent-to-treat basis. Median time to recovery was 2.31 days, (95% confidence interval [CI] 1.97-2.73) for the control group and 2.02 days (95% CI 1.96-2.34) for the intervention group, indicating no significant effect of physiotherapy (hazard ratio [HR]=1.09, 95% CI 0.91-1.31, p=0.33). No treatment by age interaction was found (p=0.97). Frequency of vomiting and transient respiratory destabilization was higher in the IET + AC group during the procedure (relative risk [RR]=10.2, 95% CI 1.3-78.8, p=0.005 and RR=5.4, 95% CI 1.6-18.4, p=0.002, respectively). No difference between groups in bradycardia with or without

  8. Oral steroids for acute radiculopathy due to a herniated lumbar disk: a randomized clinical trial.

    Science.gov (United States)

    Goldberg, Harley; Firtch, William; Tyburski, Mark; Pressman, Alice; Ackerson, Lynn; Hamilton, Luisa; Smith, Wayne; Carver, Ryan; Maratukulam, Annu; Won, Lawrence A; Carragee, Eugene; Avins, Andrew L

    2015-05-19

    Oral steroids are commonly used to treat acute sciatica due to a herniated disk but have not been evaluated in an appropriately powered clinical trial. To determine if oral prednisone is more effective than placebo in improving function and pain among patients with acute sciatica. Randomized, double-blind, placebo-controlled clinical trial conducted from 2008 to 2013 in a large integrated health care delivery system in Northern California. Adults (n=269) with radicular pain for 3 months or less, an Oswestry Disability Index (ODI) score of 30 or higher (range, 0-100; higher scores indicate greater dysfunction), and a herniated disk confirmed by magnetic resonance imaging were eligible. Participants were randomly assigned in a 2:1 ratio to receive a tapering 15-day course of oral prednisone (5 days each of 60 mg, 40 mg, and 20 mg; total cumulative dose = 600 mg; n = 181) or matching placebo (n = 88). The primary outcome was ODI change at 3 weeks; secondary outcomes were ODI change at 1 year, change in lower extremity pain (measured on a 0-10 scale; higher scores indicate more pain), spine surgery, and Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores (0-100 scale; higher scores better). Observed baseline and 3-week mean ODI scores were 51.2 and 32.2 for the prednisone group and 51.1 and 37.5 for the placebo group, respectively. The prednisone-treated group showed an adjusted mean 6.4-point (95% CI, 1.9-10.9; P = .006) greater improvement in ODI scores at 3 weeks than the placebo group and a mean 7.4-point (95% CI, 2.2-12.5; P = .005) greater improvement at 52 weeks. Compared with the placebo group, the prednisone group showed an adjusted mean 0.3-point (95% CI, -0.4 to 1.0; P = .34) greater reduction in pain at 3 weeks and a mean 0.6-point (95% CI, -0.2 to 1.3; P = .15) greater reduction at 52 weeks. The prednisone group showed an adjusted mean 3.3-point (95% CI, 1.3-5.2; P

  9. Effectiveness of chest physiotherapy in infants hospitalized with acute bronchiolitis: a multicenter, randomized, controlled trial.

    Directory of Open Access Journals (Sweden)

    Vincent Gajdos

    2010-09-01

    Full Text Available Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy combining the increased exhalation technique (IET and assisted cough (AC. Our objective was to evaluate the efficacy of chest physiotherapy (IET + AC in previously healthy infants hospitalized for a first episode of acute bronchiolitis.We conducted a multicenter, randomized, outcome assessor-blind and parent-blind trial in seven French pediatric departments. We recruited 496 infants hospitalized for first-episode acute bronchiolitis between October 2004 and January 2008. Patients were randomly allocated to receive from physiotherapists three times a day, either IET + AC (intervention group, n=246 or nasal suction (NS, control group, n=250. Only physiotherapists were aware of the allocation group of the infant. The primary outcome was time to recovery, defined as 8 hours without oxygen supplementation associated with minimal or no chest recession, and ingesting more than two-thirds of daily food requirements. Secondary outcomes were intensive care unit admissions, artificial ventilation, antibiotic treatment, description of side effects during procedures, and parental perception of comfort. Statistical analysis was performed on an intent-to-treat basis. Median time to recovery was 2.31 days, (95% confidence interval [CI] 1.97-2.73 for the control group and 2.02 days (95% CI 1.96-2.34 for the intervention group, indicating no significant effect of physiotherapy (hazard ratio [HR]=1.09, 95% CI 0.91-1.31, p=0.33. No treatment by age interaction was found (p=0.97. Frequency of vomiting and transient respiratory destabilization was higher in the IET + AC group during the procedure (relative risk [RR]=10.2, 95% CI 1.3-78.8, p=0.005 and RR=5.4, 95% CI 1.6-18.4, p=0.002, respectively. No difference between groups in bradycardia with or

  10. Effectiveness of Chest Physiotherapy in Infants Hospitalized with Acute Bronchiolitis: A Multicenter, Randomized, Controlled Trial

    Science.gov (United States)

    Gajdos, Vincent; Katsahian, Sandrine; Beydon, Nicole; Abadie, Véronique; de Pontual, Loïc; Larrar, Sophie; Epaud, Ralph; Chevallier, Bertrand; Bailleux, Sylvain; Mollet-Boudjemline, Alix; Bouyer, Jean; Chevret, Sylvie; Labrune, Philippe

    2010-01-01

    Background Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy combining the increased exhalation technique (IET) and assisted cough (AC). Our objective was to evaluate the efficacy of chest physiotherapy (IET + AC) in previously healthy infants hospitalized for a first episode of acute bronchiolitis. Methods and Findings We conducted a multicenter, randomized, outcome assessor-blind and parent-blind trial in seven French pediatric departments. We recruited 496 infants hospitalized for first-episode acute bronchiolitis between October 2004 and January 2008. Patients were randomly allocated to receive from physiotherapists three times a day, either IET + AC (intervention group, n = 246) or nasal suction (NS, control group, n = 250). Only physiotherapists were aware of the allocation group of the infant. The primary outcome was time to recovery, defined as 8 hours without oxygen supplementation associated with minimal or no chest recession, and ingesting more than two-thirds of daily food requirements. Secondary outcomes were intensive care unit admissions, artificial ventilation, antibiotic treatment, description of side effects during procedures, and parental perception of comfort. Statistical analysis was performed on an intent-to-treat basis. Median time to recovery was 2.31 days, (95% confidence interval [CI] 1.97–2.73) for the control group and 2.02 days (95% CI 1.96–2.34) for the intervention group, indicating no significant effect of physiotherapy (hazard ratio [HR]  = 1.09, 95% CI 0.91–1.31, p = 0.33). No treatment by age interaction was found (p = 0.97). Frequency of vomiting and transient respiratory destabilization was higher in the IET + AC group during the procedure (relative risk [RR]  = 10.2, 95% CI 1.3–78.8, p = 0.005 and RR  = 5.4, 95% CI 1.6–18

  11. Long-term tolerability of telcagepant for acute treatment of migraine in a randomized trial

    DEFF Research Database (Denmark)

    Connor, Kathryn M; Aurora, Sheena K; Loeys, Tom

    2011-01-01

    To evaluate the long-term tolerability of telcagepant for acute treatment of intermittent migraine attacks. Background.- Telcagepant is a calcitonin gene-related peptide (CGRP) receptor antagonist being investigated for the acute treatment of migraine.......To evaluate the long-term tolerability of telcagepant for acute treatment of intermittent migraine attacks. Background.- Telcagepant is a calcitonin gene-related peptide (CGRP) receptor antagonist being investigated for the acute treatment of migraine....

  12. A Randomized Trial of Balloon Kyphoplasty and Nonsurgical Management for Treating Acute Vertebral Compression Fractures

    Science.gov (United States)

    Van Meirhaeghe, Jan; Bastian, Leonard; Boonen, Steven; Ranstam, Jonas; Tillman, John B.; Wardlaw, Douglas

    2013-01-01

    Study Design. Multicenter randomized controlled trial. Objective. To compare the efficacy and safety of balloon kyphoplasty (BKP) with nonsurgical management (NSM) during 24 months in patients with painful vertebral compression fractures (VCFs). Summary of Background Data. Recently, several large randomized controlled trials have been conducted and reported how vertebral augmentation compares with NSM for patients with acute VCFs. Few of these trials report on the surgical aspects and radiographical vertebral deformity results. Methods. Adults with 1 to 3 VCFs were randomized within 3 months of pain to undergo bilateral BKP (n = 149) or NSM (n = 151). Surgical parameters, subjective quality of life assessments and objective functional (timed up and go) and radiographical assessments were collected. Results. Compared with NSM, the BKP group had greater improvements in SF-36 physical component summary (PCS) scores at 1 month (5.35 points; 95% CI, 3.41−7.30; P kyphoplasty group also had greater functionality by assessing timed up and go (overall treatment effect −2.49 s; 95% CI, −0.82 to −4.15; P = 0.0036). At 24 months, the change in index fracture kyphotic angulation was statistically significantly improved in the kyphoplasty group (average 3.13° of correction for kyphoplasty compared with 0.82° in the control, P = 0.003). Number of baseline prevalent fractures (P = 0.0003) and treatment assignment (P = 0.004) are the most predictive variables for PCS improvement; however, in patients who underwent BKP, there may also be a link with kyphotic angulation. In BKP, the highest quart for kyphotic angulation correction had higher PCS improvement (13.4 points) than the quart having lowest correction of angulation (7.40 points, P = 0.0146 for difference). The most common adverse events temporally related to surgery (i.e., within 30 d) were back pain (20 BKP, 11 NSM) new VCF (11 BKP, 7 NSM), nausea/vomiting (12 BKP, 4 NSM), and urinary tract infection (10 BKP, 3

  13. Acute effects of reducing sitting time in adolescents: a randomized cross-over study

    Directory of Open Access Journals (Sweden)

    Anisse Penning

    2017-08-01

    Full Text Available Abstract Background Levels of sitting among adolescents are high, especially during the school day. The acute cognitive and health consequences associated with prolonged sitting are poorly understood in adolescents. This randomized crossover design study examined the acute effects of a simulated school day with reduced sitting or usual sitting on adolescents’ cognitive function and cardiometabolic biomarkers. Methods Eighteen healthy school aged adolescents were recruited from the community to the study (11 males; 7 females; mean age [SD] = 13.5 ± 0.9 years. Two protocols were developed to simulate an adolescent school day, the amount of time spent sitting was manipulated reflecting: a ‘typical’ day (65% of the time spent sitting with two sitting bouts sitting >20 min and a ‘reduced sitting’ day (adolescents sat for 50% less time with no bouts of sitting >20 mins. The order that participants were exposed to each condition was randomized (via random number generator. Participants were not fully blinded as they could observe the difference between conditions. Energy intake and moderate to vigorous physical activity (MVPA were standardized for both conditions and monitored for 48 h post-condition for compensatory effects. Cognitive (working memory and cardiometabolic outcomes (lipids, glucose, insulin, IL-6, apo-A1, apo-B, blood pressure, were assessed pre and post for both conditions, BMI and body fat were assessed on the morning of the intervention. Data were analyzed using linear mixed models. Standardised effect sizes were calculated. Results Compared with the typical school day, the reduced sitting day demonstrated significant positive effects for apoB/apoA-1 ratio (adjusted difference ± SD -0.02 ± 0.03; P = 0.03; effect size [Cohen’s d] = −0.67. Findings for total cholesterol −0.19 ± 0.27; P = 0.28; d = −0.71; HDL cholesterol −0.23 ± 0.50; P = 0.12 d = −0.66; and total cholesterol

  14. The Effect of Massage on Acute Postoperative Pain in Critically and Acutely Ill Adults Post-thoracic Surgery: Systematic Review and Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Boitor, Madalina; Gélinas, Céline; Richard-Lalonde, Melissa; Thombs, Brett D

    Critical care practice guidelines identify a lack of clear evidence on the effectiveness of massage for pain control. To assess the effect of massage on acute pain in critically and acutely ill adults post-thoracic surgery. Medline, Embase, CINAHL, PsychInfo, Web of Science, Scopus and Cochrane Library databases were searched. Eligible studies were randomized controlled trials (RCTs) evaluating the effect of massage compared to attention control/sham massage or standard care alone on acute pain intensity post-thoracic surgery. Twelve RCTs were included. Of these, nine evaluated massage in addition to standard analgesia, including 2 that compared massage to attention control/sham massage in the intensive care unit (ICU), 6 that compared massage to standard analgesia alone early post-ICU discharge, and 1 that compared massage to both attention control and standard care in the ICU. Patients receiving massage with analgesia reported less pain (0-10 scale) compared to attention control/sham massage (3 RCTs; N = 462; mean difference -0.80, 95% confidence interval [CI] -1.25 to -0.35; p Massage, in addition to pharmacological analgesia, reduces acute post-cardiac surgery pain intensity. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Patient Activation through Counseling and Exercise – Acute Leukemia (PACE-AL) – a randomized controlled trial

    DEFF Research Database (Denmark)

    Jarden, Mary; Møller, Tom; Kjeldsen, Lars

    2013-01-01

    , sit to stand and bicep curl test, physical activity levels, patient reported outcomes (quality of life, anxiety and depression, symptom prevalence, intensity and interference). Evaluation of clinical outcomes will be explored including incidence of infection, hospitalization days, body mass index......Patients with acute leukemia experience a substantial symptom burden and are at risk of developing infections throughout the course of repeated cycles of intensive chemotherapy. Physical activity in recent years has been a strategy for rehabilitation in cancer patients to remedy disease...... and treatment related symptoms and side effects. To date, there are no clinical practice exercise guidelines for patients with acute leukemia undergoing induction and consolidation chemotherapy. A randomized controlled trial is needed to determine if patients with acute leukemia can benefit by a structured...

  16. Early Aldosterone Blockade in Acute Myocardial Infarction: The ALBATROSS Randomized Clinical Trial.

    Science.gov (United States)

    Beygui, Farzin; Cayla, Guillaume; Roule, Vincent; Roubille, François; Delarche, Nicolas; Silvain, Johanne; Van Belle, Eric; Belle, Loic; Galinier, Michel; Motreff, Pascal; Cornillet, Luc; Collet, Jean-Philippe; Furber, Alain; Goldstein, Patrick; Ecollan, Patrick; Legallois, Damien; Lebon, Alain; Rousseau, Hélène; Machecourt, Jacques; Zannad, Faiez; Vicaut, Eric; Montalescot, Gilles

    2016-04-26

    Mineralocorticoid receptor antagonists (MRA) improve outcome in the setting of post-myocardial infarction (MI) heart failure (HF). The study sought to assess the benefit of an early MRA regimen in acute MI irrespective of the presence of HF or left ventricular (LV) dysfunction. We randomized 1,603 patients to receive an MRA regimen with a single intravenous bolus of potassium canrenoate (200 mg) followed by oral spironolactone (25 mg once daily) for 6 months in addition to standard therapy or standard therapy alone. The primary outcome of the study was the composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, indication for implantable defibrillator, or new or worsening HF at 6-month follow-up. Key secondary/safety outcomes included death and other individual components of the primary outcome and rates of hyperkalemia at 6 months. The primary outcome occurred in 95 (11.8%) and 98 (12.2%) patients in the treatment and control groups, respectively (hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.73 to 1.28). Death occurred in 11 (1.4%) and 17 (2.1%) patients in the treatment and control groups, respectively (HR: 0.65; 95% CI: 0.30 to 1.38). In a non-pre-specified exploratory analysis, the odds of death were reduced in the treatment group (3 [0.5%] vs. 15 [2.4%]; HR: 0.20; 95% CI: 0.06 to 0.70) in the subgroup of ST-segment elevation MI (n = 1,229), but not in non-ST-segment elevation MI (p for interaction = 0.01). Hyperkalemia >5.5 mmol/l(-1) occurred in 3% and 0.2% of patients in the treatment and standard therapy groups, respectively (p < 0.0001). The study failed to show the benefit of early MRA use in addition to standard therapy in patients admitted for MI. (Aldosterone Lethal effects Blockade in Acute myocardial infarction Treated with or without Reperfusion to improve Outcome and Survival at Six months follow-up; NCT01059136). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All

  17. Mental Fitness for patients with acute coronary syndrome: A randomized clinical trial.

    Science.gov (United States)

    Chiavarino, Claudia; Cavallero, Erika; Rabellino, Daniela; Palumbo, Luigi; Bianchino, Claudia; Gaita, Fiorenzo; Bergerone, Serena; Bara, Bruno G

    2016-09-01

    The aim of this study was to verify the efficacy of a manualized, cognitively oriented psychological intervention, called Mental Fitness, in improving the mental and physical health of patients with acute coronary syndrome (ACS). Mental Fitness is a small-group four-session treatment aimed at increasing awareness of one's own bodily perceptions, emotions, and thoughts and is overall tailored on participants' perception of control over their health. Prospective randomized controlled single-blind trial. Patients with ACS were recruited within a week from their acute cardiac event. Patients in the intervention group underwent one of two variants of Mental Fitness, depending on their perceived (internal or external) control over their health. Patients in the control group underwent standard treatment. All the patients were submitted to a clinical and psychological follow-up for 8 months. The patients who underwent the Mental Fitness intervention (N = 31) showed, compared to the control patients (N = 34), increased quality of life in its physical, psychological, social and environmental domains, more functional emotional and problem-centred coping strategies, and higher emotional awareness. They also showed improved high-density lipoprotein cholesterol, triglycerides, heart rate, and left ventricular ejection fraction compared to the controls. In addition, they were more successful in maintaining physical exercise. This study demonstrates the efficacy of Mental Fitness in modifying specific psychological and physical variables conditioning cardiological patients' prognosis. It also confirms the importance of differentiating psychological interventions based on the psychological characteristics of the patients. Statement of contribution What is already known on this subject? Traditional symptom-based interventions in heart disease are aimed at diagnosing and reducing psychological symptomatology (e.g., depression), but recent work has shown the usefulness of

  18. Combination of Thrombolysis and Statins in Acute Stroke Is Safe: Results of the STARS Randomized Trial (Stroke Treatment With Acute Reperfusion and Simvastatin).

    Science.gov (United States)

    Montaner, Joan; Bustamante, Alejandro; García-Matas, Silvia; Martínez-Zabaleta, Maite; Jiménez, Carmen; de la Torre, Javier; Rubio, Francisco R; Segura, Tomás; Masjuán, Jaime; Cánovas, David; Freijo, Mar; Delgado-Mederos, Raquel; Tejada, Javier; Lago, Aida; Bravo, Yolanda; Corbeto, Natália; Giralt, Dolors; Vives-Pastor, Bárbara; de Arce, Anna; Moniche, Francisco; Delgado, Pilar; Ribó, Marc

    2016-11-01

    The STARS trial (Stroke Treatment With Acute Reperfusion and Simvastatin) was conducted to demonstrate the efficacy and safety of simvastatin treatment in acute stroke. STARS07 was a multicentre, phase IV, prospective, randomized, double-blind, placebo-controlled trial. Patients with Acute ischemic stroke recruited within 12 hours from symptom onset were randomized to oral simvastatin 40 mg or placebo, once daily for 90 days. Primary outcome was proportion of independent patients (modified Rankin Scale score of ≤2) at 90 days. Safety end points were hemorrhagic transformation, hemorrhagic events, death, infections, and serious adverse events. From April 2009 to March 2014, 104 patients were included. Fifty-five patients received intravenous tissue-type plasminogen activator. No differences were found between treatment arms regarding the primary outcome (adjusted odds ratio, 0.99 [0.35-2.78]; P=0.98). Concerning safety, no significant differences were found in the rate of hemorrhagic transformation of any type, nor symptomatic hemorrhagic transformation. There were no differences in other predefined safety outcomes. In post hoc analyses, for patients receiving tissue-type plasminogen activator, a favorable effect for simvastatin treatment was noted with higher proportion of patients experiencing major neurological recovery (adjusted odds ratio, 4.14 [1.18-14.4]; P=0.02). Simvastatin plus tissue-type plasminogen activator combination seems safe in acute stroke, with low rates of bleeding complications. Because of the low recruitment, the STARS trial was underpowered to detect differences in simvastatin efficacy. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01073007. © 2016 American Heart Association, Inc.

  19. Efficacy of intravenous ondansetron to prevent vomiting episodes in acute gastroenteritis: a randomized, double blind, and controlled trial

    Directory of Open Access Journals (Sweden)

    Sanguansak Rerksuppaphol

    2010-09-01

    Full Text Available Acute gastroenteritis is one of the most common infectious diseases of childhood. Its symptoms are vomiting, diarrhea, and dehydration. In the emergency ward, intravenous rather than oral rehydration is usually preferred because of the high likelihood of emesis. Treatments to reduce emesis are of value in improving the rehydration procedure. Our study is a double-blind randomized trial and proposes the use of ondansetron as an anti-emetic drug to treat children with acute gastroenteritis. Seventy-four in-patients, aged 3 months to 15 years, were enrolled and randomly assigned to an ondansetron or placebo group. Inclusion criteria were the diagnosis of acute gastroenteritis and the absence of other diseases or allergies to drugs. A single bolus (0.15 mg/kg of ondansetron was injected intravenously; normal 0.9% saline solution was used as a placebo. This treatment induced vomiting cessation in the ondansetron group significantly in comparison to the placebo group. The length of the hospital stay and the oral rehydration fluid volume were similar in the two groups and no adverse effects were noticed. Thus, safety, low cost, and overall bene­fit of ondansetron treatment suggests that this drug can be administered successfully to children with acute gastroenteritis.

  20. Early Versus Delayed Cholecystectomy for Acute Cholecystitis, Are the 72 hours Still the Rule?: A Randomized Trial.

    Science.gov (United States)

    Roulin, Didier; Saadi, Alend; Di Mare, Luca; Demartines, Nicolas; Halkic, Nermin

    2016-11-01

    The aim of this study was to compare clinical outcomes of early versus delayed laparoscopic cholecystectomy (LC) in acute cholecystitis with more than 72 hours of symptoms. LC is the treatment of acute cholecystitis, with consensus recommendation that patients should be operated within 72 hours of evolution. Data however remain weak with no prospective study focusing on patients beyond 72 hours of symptoms. Patients with acute cholecystitis and more than 72 hours of symptoms were randomly assigned to early LC (ELC) or delayed LC (DLC). ELC was performed following hospital admission. DLC was planned at least 6 weeks after initial antibiotic treatment. Primary outcome was overall morbidity following initial diagnosis. Secondary outcomes were total length of stay, duration of antibiotic therapy, hospital costs, and surgical outcome. Eighty-six patients were randomized (42 in ELC and 44 in DLC group). Overall morbidity was lower in ELC [6 (14%) vs 17 (39%) patients, P = 0.015]. Median total length of stay (4 vs 7 days, P acute cholecystitis even beyond 72 hours of symptoms is safe and associated with less overall morbidity, shorter total hospital stay, and duration of antibiotic therapy, as well as reduced cost compared with delayed cholecystectomy (NCT01548339).

  1. Chiropractic treatment vs self-management in patients with acute chest pain: a randomized controlled trial of patients without acute coronary syndrome.

    Science.gov (United States)

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner; Høilund-Carlsen, Poul F; Haghfelt, Torben; Hartvigsen, Jan

    2012-01-01

    The musculoskeletal system is a common but often overlooked cause of chest pain. The purpose of the present study is to evaluate the relative effectiveness of 2 treatment approaches for acute musculoskeletal chest pain: (1) chiropractic treatment that included spinal manipulation and (2) self-management as an example of minimal intervention. In a nonblinded, randomized, controlled trial set at an emergency cardiology department and 4 outpatient chiropractic clinics, 115 consecutive patients with acute chest pain and no clear medical diagnosis at initial presentation were included. After a baseline evaluation, patients with musculoskeletal chest pain were randomized to 4 weeks of chiropractic treatment or self-management, with posttreatment questionnaire follow-up 4 and 12 weeks later. Primary outcome measures were numeric change in pain intensity (11-point box numerical rating scale) and self-perceived change in pain (7-point ordinal scale). Both groups experienced decreases in pain, self-perceived positive changes, and increases in Medical Outcomes Study Short Form 36-Item Health Survey scores. Observed between-group significant differences were in favor of chiropractic treatment at 4 weeks regarding the primary outcome of self-perceived change in chest pain and at 12 weeks with respect to the primary outcome of numeric change in pain intensity. To the best of our knowledge, this is the first randomized trial assessing chiropractic treatment vs minimal intervention in patients without acute coronary syndrome but with musculoskeletal chest pain. Results suggest that chiropractic treatment might be useful; but further research in relation to patient selection, standardization of interventions, and identification of potentially active ingredients is needed. Copyright © 2012 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  2. Effect of tolvaptan on acute heart failure with hyponatremia – A randomized, double blind, controlled clinical trial

    Science.gov (United States)

    Shanmugam, Elangovan; Doss, C.R. Madhu Prabhu; George, Melvin; Jena, Amrita; Rajaram, Muthukumar; Ramaraj, Balaji; Anjaneyan, Karthik; Kanagesh, B.

    2016-01-01

    Objectives To assess the efficacy of tolvaptan in acute heart failure with hyponatremia using a randomized double-blinded placebo-controlled study design. Background Tolvaptan is a selective vasopressin receptor 2 antagonist. There are no published clinical trials on the utility of tolvaptan in acute heart failure with hyponatremia in the Indian population. Methods After screening and informed consent, 51 HF patients with hyponatremia were randomized using computer-generated randomization sequence to receive placebo or 15 mg of tolvaptan for 5 days along with conventional medical therapy. The patient's perception of dyspnea using Likert score and the plasma sodium was measured at baseline and for the next 4 days. Results There was a mean improvement in sodium concentration by 5 mEq/L (p = 0.001) in patients receiving tolvaptan, whereas no significant improvement was seen in the placebo group (p = 0.33). Significant improvement in Likert score was observed in both the groups (p = 0.001), even though there was no difference between both the groups. Dry mouth and thirst were the most commonly occurring adverse effects observed in both the groups. There were no significant hemodynamic changes with tolvaptan therapy. Conclusion Tolvaptan at a dose of 15 mg is effective in reversing hyponatremia in acute heart failure and may be a suitable option in these patients. PMID:27056648

  3. Effect of tolvaptan on acute heart failure with hyponatremia--a randomized, double blind, controlled clinical trial.

    Science.gov (United States)

    Shanmugam, Elangovan; Doss, C R Madhu Prabhu; George, Melvin; Jena, Amrita; Rajaram, Muthukumar; Ramaraj, Balaji; Anjaneyan, Karthik; Kanagesh, B

    2016-04-01

    To assess the efficacy of tolvaptan in acute heart failure with hyponatremia using a randomized double-blinded placebo-controlled study design. Tolvaptan is a selective vasopressin receptor 2 antagonist. There are no published clinical trials on the utility of tolvaptan in acute heart failure with hyponatremia in the Indian population. After screening and informed consent, 51 HF patients with hyponatremia were randomized using computer-generated randomization sequence to receive placebo or 15mg of tolvaptan for 5 days along with conventional medical therapy. The patient's perception of dyspnea using Likert score and the plasma sodium was measured at baseline and for the next 4 days. There was a mean improvement in sodium concentration by 5mEq/L (p=0.001) in patients receiving tolvaptan, whereas no significant improvement was seen in the placebo group (p=0.33). Significant improvement in Likert score was observed in both the groups (p=0.001), even though there was no difference between both the groups. Dry mouth and thirst were the most commonly occurring adverse effects observed in both the groups. There were no significant hemodynamic changes with tolvaptan therapy. Tolvaptan at a dose of 15mg is effective in reversing hyponatremia in acute heart failure and may be a suitable option in these patients. Copyright © 2015 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  4. Carbohydrate Antigen-125-Guided Therapy in Acute Heart Failure: CHANCE-HF: A Randomized Study.

    Science.gov (United States)

    Núñez, Julio; Llàcer, Pau; Bertomeu-González, Vicente; Bosch, Maria José; Merlos, Pilar; García-Blas, Sergio; Montagud, Vicente; Bodí, Vicent; Bertomeu-Martínez, Vicente; Pedrosa, Valle; Mendizábal, Andrea; Cordero, Alberto; Gallego, Jorge; Palau, Patricia; Miñana, Gema; Santas, Enrique; Morell, Salvador; Llàcer, Angel; Chorro, Francisco J; Sanchis, Juan; Fácila, Lorenzo

    2016-11-01

    This study sought to evaluate the prognostic effect of carbohydrate antigen-125 (CA125)-guided therapy (CA125 strategy) versus standard of care (SOC) after a hospitalization for acute heart failure (AHF). CA125 has emerged as a surrogate of fluid overload and inflammatory status in AHF. After an episode of AHF admission, elevated values of this marker at baseline as well as its longitudinal profile relate to adverse outcomes, making it a potential tool for treatment guiding. In a prospective multicenter randomized trial, 380 patients discharged for AHF and high CA125 were randomly assigned to the CA125 strategy (n = 187) or SOC (n = 193). The aim in the CA125 strategy was to reduce CA125 to ≤35 U/ml by up or down diuretic dose, enforcing the use of statins, and tightening patient monitoring. The primary endpoint was 1-year composite of death or AHF readmission. Treatment strategies were compared as a time to first event and longitudinally. Patients allocated to the CA125 strategy were more frequently visited, and treated with ambulatory intravenous loop diuretics and statins. Likewise, doses of oral loop diuretics and aldosterone receptor blockers were more frequently modified. The CA125 strategy resulted in a significant reduction of the primary endpoint, whether evaluated as time to first event (66 events vs. 84 events; p = 0.017) or as recurrent events (85 events vs. 165 events; incidence rate ratio: 0.49; 95% confidence interval: 0.28 to 0.82; p = 0.008). The effect was driven by significantly reducing rehospitalizations but not mortality. The CA125 strategy was superior to the SOC in terms of reducing the risk of the composite of 1-year death or AHF readmission. This effect was mainly driven by significantly reducing the rate of rehospitalizations. (Carbohydrate Antigen-125-guided Therapy in Heart Failure [CHANCE-HF]; NCT02008110). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  5. Drug-eluting stents for acute coronary syndrome: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Lishan Wang

    Full Text Available Drug-eluting stents (DES are increasingly used for treatment of acute coronary syndrome (ACS. However, clinical efficacy and safety of various types of DES is not well established in these subjects. We therefore evaluated clinical utility of second-generation and first-generation DES in patients with ACS by conducting a meta-analysis.A search of Medline, Embase, the Cochrane databases, and Web of Science was made. Randomized controlled trials (RCTs which compared second-generation DES (everolimus-eluting stents [EES] or zotarolimus-eluting stents [ZES] versus first-generation DES (sirolimus-eluting stents [SES] or paclitaxe-eluting stents [PES] in patients with ACS and provided data on clinical efficacy or safety endpoints were included. Pooled estimates were calculated using random-effects model.A total of 2,757 participants with ACS in 6 RCTs were included. Compared with first-generation one, second-generation DES trended to be associated with the decreased incidence of definite or probable stent thrombosis in ACS patients (risk ratio [RR]  = 0.60, 95% confidence intervals [CI] 0.33 to 1.07, p = 0.09. However, the rate of target lesion revascularization (TLR significantly increased in second-generation DES (RR = 2.08, 95%CI 1.25 to 3.47, p = 0.005. There were no significant differences in the incidence of major adverse cardiac events (MACEs, all-cause death, cardiac death, and recurrent myocardial infarction between the two arms (all p>0.10. The second-generation EES showed a tendency towards lower risk of MACEs (p = 0.06 and a beneficial effect on reducing stent thrombosis episodes (p = 0.009, while the second-generation ZES presented an increased occurrence of MACEs (p = 0.02 and TLR (p = 0.003.Second-generation DES, especially EES, appeared to present a lower risk of stent thrombosis, whereas second-generation ZES might increase the need for repeat revascularization in ACS patients. During coronary

  6. Randomized Trial of Cognitive-Behavioral Therapy Versus Light Therapy for Seasonal Affective Disorder: Acute Outcomes.

    Science.gov (United States)

    Rohan, Kelly J; Mahon, Jennifer N; Evans, Maggie; Ho, Sheau-Yan; Meyerhoff, Jonah; Postolache, Teodor T; Vacek, Pamela M

    2015-09-01

    Whereas considerable evidence supports light therapy for winter seasonal affective disorder (SAD), data on cognitive-behavioral therapy for SAD (CBT-SAD) are promising but preliminary. This study estimated the difference between CBT-SAD and light therapy outcomes in a large, more definitive test. The participants were 177 adults with a current episode of major depression that was recurrent with a seasonal pattern. The randomized clinical trial compared 6 weeks of CBT-SAD (N=88) and light therapy (N=89). Light therapy consisted of 10,000-lux cool-white florescent light, initiated at 30 minutes each morning and adjusted according to a treatment algorithm based on response and side effects. CBT-SAD comprised 12 sessions of the authors' SAD-tailored protocol in a group format and was administered by Ph.D. psychologists in two 90-minute sessions per week. Outcomes were continuous scores on the Structured Interview Guide for the Hamilton Rating Scale for Depression-SAD Version (SIGH-SAD, administered weekly) and Beck Depression Inventory-Second Edition (BDI-II, administered before treatment, at week 3, and after treatment) and posttreatment remission status based on cut points. Depression severity measured with the SIGH-SAD and BDI-II improved significantly and comparably with CBT-SAD and light therapy. Having a baseline comorbid diagnosis was associated with higher depression scores across all time points in both treatments. CBT-SAD and light therapy did not differ in remission rates based on the SIGH-SAD (47.6% and 47.2%, respectively) or the BDI-II (56.0% and 63.6%). CBT-SAD and light therapy are comparably effective for SAD during an acute episode, and both may be considered as treatment options.

  7. [Heparin in coronary angioplasty. Randomized study in cases with low risk of acute occlusion].

    Science.gov (United States)

    Tanajura, L F; Sousa, A G; Pinto, I M; Chaves, A J; Centemero, M P; Feres, F; Mattos, L A; Cano, M N; Maldonado, G A; Sousa, J E

    1993-02-01

    To assess the efficacy of heparin in preventing the abrupt closure after coronary angioplasty in low risk patients for this phenomenon. In the last 4 years, 525 patients successfully dilated were randomized to receive intravenous heparin (n = 264) or not (n = 261) after the angioplasty. The excluding criteria were contraindications for heparin and risk for abrupt closure (refractory unstable angina, primary coronary angioplasty in acute myocardial infarction, evidence of intracoronary thrombus, intimal tear after the procedure and cases of chronic total occlusions). Both heparin and non heparin groups were similar in respect to female sex (15% x 17%; p = NS), age over 70 years old (7% x 9%; p = NS), previous myocardial infarction (26% x 24%; p = NS), multi-vessel procedures (4% x 7%; p = NS, stable angina (40% x 46%; p = NS), unstable angina (52% x 48%; p = NS) and angioplasty after thrombolytic therapy (8% x 6%; p = NS). The overall incidence of abrupt closure was 2/525 (0.4%), with one case (0.4%) in each group. The in-hospital mortality was 1/525 (0.2%), which occurred in a non-heparin patient, due to a anterior myocardial infarction. Major complications occurred similarly in heparin and non-heparin groups (0.4%). Bleeding complications were observed more frequently in the heparin group (7% x 2%; p = 0.002). All of them were in the catheterization site and none required blood transfusion. Severe systemic bleeding were not observed. In patients regarded as low risk for abrupt closure, the incidence of this complication was really low (0.4%) and heparin probably do not prevent it.

  8. School-based prevention of acute rheumatic fever: a group randomized trial in New Zealand.

    Science.gov (United States)

    Lennon, Diana; Stewart, Joanna; Farrell, Elizabeth; Palmer, Anne; Mason, Henare

    2009-09-01

    Acute rheumatic fever (ARF) and its sequela, rheumatic heart disease is the commonest cause of childhood cardiac morbidity globally. The current approach to the prevention of a primary attack of rheumatic fever in children using oral medication for streptococcal pharyngitis is poorly supported. The efficacy of injectable penicillin, in high rheumatic fever incidence military environments is indisputable. To evaluate school-based control of rheumatic fever in an endemic area. Fifty-three schools ( approximately 22,000 students) from a rheumatic fever high incidence setting ( approximately 60/100,000) in Auckland, New Zealand were randomized. The control group received routine general practice care. The intervention was a school-based sore throat clinic program with free nurse-observed oral penicillin treatment of group A streptococcal pharyngitis. The outcome measure was ARF in any child attending a study school. Analysis A defined ARF cases using criteria derived from Jones Criteria 1965 (definite) and 1956 (probable) with more precise definitions. Analysis B was based on 1992 Jones criteria but also included echocardiography to determine definite cases. In Analysis A, 24 (55/100,000) cases occurred in clinic schools and 29 (67/100,000) in nonclinic schools, a 21% reduction when adjusted for demography and study design (P = 0.47). Analysis B revealed a 28% reduction 26 (59/100,000) and 33 (77/100,000) cases, respectively (P = 0.27). This study involving 86,874 person-years showed a nonsignificant reduction in the school-based sore throat clinic programs.

  9. Effects of Normobaric Hyperoxia in Severe Acute Stroke: a Randomized Controlled Clinical Trial Study.

    Science.gov (United States)

    Mazdeh, Mehrdokht; Taher, Abbas; Torabian, Saadat; Seifirad, Soroush

    2015-11-01

    Oxygen therapy might increase damaged tissue oxygenation, turn on the aerobic pathway, and save neurons from death and could improve clinical outcome of the patients with stroke and head trauma. Hyperbaric oxygen therapy is accompanied by some unfavorable effects. Results of normobaric oxygen therapy on clinical outcomes of patients with stroke were controversial up till now.  This study was therefore designed to evaluate effects of normobaric hyperoxia on clinical outcomes of patients with severe acute stroke. A total of 52 consecutive patients with stroke who meet the inclusion criteria of the study were entered into this randomized controlled clinical trial. The patients in the case group underwent oxygen therapy with Venturi mask for first 12 hours of admission. The patients were examined for neurologic defects at the time of discharge and after six months using both Barthel and modified Rankin Scale (mRS) neurologic disability scoring systems. There was no significant sex difference between the two groups (P=0.5). There was no statistically significant difference between ischemic-hemorrhagic stroke constitutions of two groups (P=0.2). There were no significant difference in Barthel index scores of both groups at the time of discharge as well as the follow-up examination (P=0.7) According to the mRS scoring system, there was no difference between the patients of both groups at the time of admission (P= 0.8), however after treatment there was a significant difference between mRS scores of the treated group compared to the controls (P=0.04). According to the results of this study, normobaric oxygen therapy in the first 12 hours of accident could improve long time outcome of the patients with either ischemic or hemorrhagic stroke.

  10. Early Halt of a Randomized Controlled Study with 3% Hypertonic Saline in Acute Bronchiolitis.

    Science.gov (United States)

    Carsin, Ania; Sauvaget, Emilie; Bresson, Violaine; Retornaz, Karine; Cabrera, Maria; Jouve, Elisabeth; Truillet, Romain; Bosdure, Emmanuelle; Dubus, Jean-Christophe

    2017-01-01

    Albeit not recommended because of contradictory results, nebulized 3% hypertonic saline is widely used for treating acute viral bronchiolitis. Whether clinical differences may be attributed to the type of nebulizer used has never been studied. By modifying the amount of salt deposited into the airways, the nebulizer characteristics might influence clinical response. A prospective, randomized, controlled trial included infants hospitalized in a French university hospital for a first episode of bronchiolitis. Each child received 6 nebulizations of 3% hypertonic saline during 48 h delivered with 1 of the 3 following nebulizers: 2 jet nebulizers delivering large or small particles, with a low aerosol output, and 1 mesh nebulizer delivering small particles, with a high aerosol output. The primary endpoint was the difference in the Wang score at 48 h. Only 61 children of 168 were recruited before stopping this study because of severe adverse events (n = 4) or parental requests for discontinuation due to discomfort to their child during nebulization (n = 2). One minor adverse event was noted in 91.8% (n = 56/61) of children. A high aerosol output induced 75% of the severe adverse events; it was significantly associated with the nebulization-induced cough between 24 and 48 h (p = 0.036). Decreases in Wang scores were not significantly different between the groups at 48 h, 9 recoveries out of 10 being obtained with small particles. No beneficial effects and possibly severe adverse events are observed with 3% hypertonic saline in the treatment of bronchiolitis. © 2017 S. Karger AG, Basel.

  11. Randomized pilot trial comparing tolvaptan with furosemide on renal and neurohumoral effects in acute heart failure.

    Science.gov (United States)

    Jujo, Kentaro; Saito, Katsumi; Ishida, Issei; Furuki, Yuho; Kim, Ahsung; Suzuki, Yuki; Sekiguchi, Haruki; Yamaguchi, Junichi; Ogawa, Hiroshi; Hagiwara, Nobuhisa

    2016-09-01

    Loop diuretics are first-line medications for congestive heart failure (CHF); however, they are associated with serious adverse effects, including decreased renal function, and sympathetic nervous and renin-angiotensin system activation. We tested whether tolvaptan, a vasopressin V2-receptor antagonist, could reduce unfavourable furosemide-induced effects during CHF treatment. Sixty patients emergently hospitalized owing to CHF-induced dyspnea were randomly assigned to receive either 40 mg intravenous furosemide daily or 7.5 mg oral tolvaptan for 5 days after admission. Both groups also received intravenous carperitide and canrenoate potassium. As results, baseline patient characteristics were similar between the furosemide (n = 30) and the tolvaptan (n = 30) groups, with no significant difference in 5 day urine volume or fluid balance. Brain natriuretic peptide and body weight improvements were similar between groups. However, serum creatinine (Cr) level did not increase, and the incidence of worsening renal function was significantly lower in the tolvaptan group. Consequently, the Cr increase to gain 1000 mL urine was 2.5-fold lower in the tolvaptan group. Furthermore, the blood urea nitrogen (BUN)/Cr ratio significantly decreased in the tolvaptan group, suggesting that renal perfusion was preserved, and urea reuptake and passive water reabsorption were suppressed following tolvaptan treatment. Although catecholamine improvements after treatment were not significantly different, plasma renin activity was enhanced in the furosemide group. As compared with furosemide, tolvaptan in patients with acute heart failure is associated with comparable decongestion, better preservation of renal function and less activation of renin-angiotensin system. (UMIN 000014134).

  12. Anal self-massage in the treatment of acute anal fissure: a randomized prospective study.

    Science.gov (United States)

    Gaj, Fabio; Biviano, Ivano; Candeloro, Laura; Andreuccetti, Jacopo

    2017-01-01

    An anal fissure (AF) is a tear in the epithelial lining of the anal canal. This is a very common condition, but the choice of treatment is unclear. The use of anal dilators is effective, economic, and safe. The aim of the study was to compare the efficacy of two conservative treatments, the use of anal dilators or a finger for anal dilatation, in reducing anal pressure and resolving anal fissures. Fifty patients with a clinical diagnosis of AF were randomly assigned to one of the treatments, self-massage of the anal sphincter (group A, 25 patients) or passive dilatation using dilators (group B, 25 patients). All patients were evaluated at baseline, at the end of treatment, and after 12 weeks and 6 months. Pain was measured using a visual analog scale. After the treatment, 60% of patients treated with dilators and 80% of patients treated with anal self-massage using a finger showed disappearance of their anal fissures. A comparison between signs and symptoms reported by the patients in the two groups showed a statistically significant reduction in anal pain (group A, P=0.0001; group B, P=0.0001) and bleeding after defecation (group A, P=0.001, group B, P=0.001). At 6 months after treatment, a significantly greater reduction in anal pain was observed in Group A compared to Group B (P=0.02). The use of anal self-massage with a finger appears to induce a better resolution of acute anal fissure than do anal dilators, and in a shorter time.

  13. Severe steatohepatitis with hepatic decompensation resulting from malnutrition after pancreaticoduodenectomy

    Directory of Open Access Journals (Sweden)

    Eun Hui Sim

    2012-12-01

    Full Text Available The most common finding related to nonalcoholic steatohepatitis is obesity, but a status of severe malnutrition can also induce the steatohepatitis. The authors report a rare case of steatohepatitis leading to hepatic decompensation caused by malnutrition after pancreaticoduodenectomy. A 68-year-old female patient who had been previously diagnosed with pancreatic cancer and had undergone pancreaticoduodenectomy 5 months previously presented with abdominal distension. Routine CT performed 3 months after the surgery revealed severe fatty liver without evidence of tumor recurrence. After undergoing pancreaticoduodenectomy her food intake had reduced, and as a result she had lost 7 kg of body weight over 2 months. At this admission, CT revealed moderate amounts of ascites without tumor recurrence. Furthermore, her albumin and lipid profile levels were markedly decreased, and she had a flapping tremor and slurred speech suggestive of hepatic encephalopathy. Her liver biopsy findings were consistent with steatohepatitis and disclosed macrovesicular steatosis without definite fibrosis. After careful nutritional control, her symptoms disappeared and her laboratory findings improved.

  14. Acute effects of intracranial hypertension and ARDS on pulmonary and neuronal damage: a randomized experimental study in pigs.

    Science.gov (United States)

    Heuer, Jan Florian; Pelosi, Paolo; Hermann, Peter; Perske, Christina; Crozier, Thomas A; Brück, Wolfgang; Quintel, Michael

    2011-07-01

    To determine reciprocal and synergistic effects of acute intracranial hypertension and ARDS on neuronal and pulmonary damage and to define possible mechanisms. Twenty-eight mechanically ventilated pigs were randomized to four groups of seven each: control; acute intracranial hypertension (AICH); acute respiratory distress syndrome (ARDS); acute respiratory distress syndrome in combination with acute intracranial hypertension (ARDS + AICH). AICH was induced with an intracranial balloon catheter and the inflation volume was adjusted to keep intracranial pressure (ICP) at 30-40 cmH2O. ARDS was induced by oleic acid infusion. Respiratory function, hemodynamics, extravascular lung water index (ELWI), lung and brain computed tomography (CT) scans, as well as inflammatory mediators, S100B, and neuronal serum enolase (NSE) were measured over a 4-h period. Lung and brain tissue were collected and examined at the end of the experiment. In both healthy and injured lungs, AICH caused increases in NSE and TNF-alpha plasma concentrations, extravascular lung water, and lung density in CT, the extent of poorly aerated (dystelectatic) and atelectatic lung regions, and an increase in the brain tissue water content. ARDS and AICH in combination induced damage in the hippocampus and decreased density in brain CT. AICH induces lung injury and also exacerbates pre-existing damage. Increased extravascular lung water is an early marker. ARDS has a detrimental effect on the brain and acts synergistically with intracranial hypertension to cause histological hippocampal damage.

  15. Acupuncture-movement therapy for acute lumbar sprain: a randomized controlled clinical trial

    National Research Council Canada - National Science Library

    Lin Ruizhu Zhu Ning Liu Jian Li Xinjian Wang Yue Zhang Jie Xi Chaolei

    2016-01-01

    OBJECTIVE: Several studies have reported that acupuncture is effective for treatment of acute lumbar sprain, but they neglected to consider that acupuncture cannot remarkably improve lumbar activity...

  16. A Randomized Controlled Trial on Very Early Speech and Language Therapy in Acute Stroke Patients with Aphasia

    Directory of Open Access Journals (Sweden)

    A.C. Laska

    2011-07-01

    Full Text Available Background: Aphasia affects one third of acute stroke patients. There is a considerable spontaneous recovery in aphasia, but impaired communication ability remains a great problem. Communication difficulties are an impediment to rehabilitation. Early treatment of the language deficits leading to increased communication ability would improve rehabilitation. The aim of this study is to elucidate the efficacy of very early speech and language therapy (SLT in acute stroke patients with aphasia. Methods: A prospective, open, randomized, controlled trial was carried out with blinded endpoint evaluation of SLT, starting within 2 days of stroke onset and lasting for 21 days. 123 consecutive patients with acute, first-ever ischemic stroke and aphasia were randomized. The SLT treatment was Language Enrichment Therapy, and the aphasia tests used were the Norsk grunntest for afasi (NGA and the Amsterdam-Nijmegen everyday language test (ANELT, both performed by speech pathologists, blinded for randomization. Results: The primary outcome, as measured by ANELT at day 21, was 1.3 in the actively treated patient group and 1.2 among controls. NGA led to similar results in both groups. Patients with a higher level of education (>12 years improved more on ANELT by day 21 than those with Conclusions: Very early intensive SLT with the Language Enrichment Therapy program over 21 days had no effect on the degree of aphasia in unselected acute aphasic stroke patients. In aphasic patients with more fluency, SLT resulted in a significant improvement as compared to controls. A higher educational level of >12 years was beneficial.

  17. Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial.

    Science.gov (United States)

    Steg, P Gabriel; Harrington, Robert A; Emanuelsson, Håkan; Katus, Hugo A; Mahaffey, Kenneth W; Meier, Bernhard; Storey, Robert F; Wojdyla, Daniel M; Lewis, Basil S; Maurer, Gerald; Wallentin, Lars; James, Stefan K

    2013-09-03

    We aimed to describe the effects of ticagrelor versus clopidogrel on stent thrombosis in the Platelet Inhibition and Patient Outcomes (PLATO) trial. Of 18 624 patients hospitalized for acute coronary syndromes, 11 289 (61%) had at least 1 intracoronary stent. Ticagrelor reduced stent thrombosis compared with clopidogrel across all definitions: definite, 1.37% (n=71) versus 1.93% (n=105; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.50-0.90; P=0.0091); definite or probable, 2.21% (n=118) versus 2.87% (n=157; HR, 0.75; 95% CI, 0.59-0.95; P=0.017); and definite, probable, and possible, 2.94% (n=154) versus 3.77 (n=201; HR, 0.77; 95% CI, 0.62-0.95). The reduction in definite stent thrombosis was consistent regardless of acute coronary syndrome type, presence of diabetes mellitus, stent type (drug-eluting or bare metal stent), CYP2C19 genetic status, loading dose of aspirin, dose of clopidogrel before randomization, and use of glycoprotein IIb/IIIa inhibitors at randomization. The reduction in stent thrombosis with ticagrelor was numerically greater for late (>30 days; HR, 0.48; 95% CI, 0.24-0.96) and subacute (4 hours-30 days; HR, 0.60; 95% CI, 0.39-0.93) compared with acute (<24 hours; HR, 0.94; 95% CI, 0.43-2.05) stent thrombosis or for patients compliant to therapy (ie, taking blinded study treatment ≥80% of the time) compared with less compliant patients. Randomization to ticagrelor was a strong independent inverse predictor of definite stent thrombosis (HR, 0.65; 95% CI, 0.48-0.88). Ticagrelor compared with clopidogrel reduces the incidence of stent thrombosis in patients with acute coronary syndromes, with consistent benefit across a broad range of patient, stent, and treatment characteristics.

  18. Dietary nitrate supplementation in COPD: An acute, double-blind, randomized, placebo-controlled, crossover trial.

    LENUS (Irish Health Repository)

    Kerley, Conor P

    2014-12-19

    The acute consumption of dietary nitrate has been shown to improve exercise capacity in athletes, healthy adults and subjects with peripheral vascular disease. Many COPD patients have reduced exercise capacity. We hypothesized that acute nitrate consumption might increase incremental shuttle walk test (ISWT) distance in COPD subjects.

  19. Probiotics, calcium and acute diarrhea : a randomized trial in Indonesian children

    NARCIS (Netherlands)

    Agustina, R.

    2012-01-01

    Background
    Acute diarrhea and acute respiratory tract infections (ARTIs) continue to lead the infectious cause of morbidity and mortality among children <5 years of age in developing countries, including Indonesia. Efforts to prevent diarrheal disease by probiotics and milk calcium

  20. Effect of paracetamol (acetaminophen) and ibuprofen on body temperature in acute ischemic stroke PISA, a phase II double-blind, randomized, placebo-controlled trial [ISRCTN98608690].

    NARCIS (Netherlands)

    D.W.J. Dippel (Diederik); E.J. van Breda (Eric); H.B. van der Worp (Bart); H.M.A. van Gemert (Maarten); R.J. Meijer (Ron); L.J. Kappelle (Jaap); P.J. Koudstaal (Peter Jan)

    2003-01-01

    textabstractBACKGROUND: Body temperature is a strong predictor of outcome in acute stroke. In a previous randomized trial we observed that treatment with high-dose acetaminophen (paracetamol) led to a reduction of body temperature in patients with acute ischemic stroke, even when

  1. Rationale, design and methodology of a double-blind, randomized, placebo-controlled study of escitalopram in prevention of Depression in Acute Coronary Syndrome (DECARD)

    DEFF Research Database (Denmark)

    Hansen, Baiba Hedegaard; Hanash, Jamal Abed; Rasmussen, Alice

    2009-01-01

    with acute coronary syndrome. METHODS: Two hundred forty non-depressed patients with acute coronary syndrome are randomized to treatment with either escitalopram or placebo for 1 year. Psychiatric and cardiac assessment of patients is performed to evaluate the possibility of preventing depression. Diagnosis...

  2. The efficacy of nebulized racemic epinephrine in children with acute asthma: a randomized, double-blind trial.

    Science.gov (United States)

    Plint, A C; Osmond, M H; Klassen, T P

    2000-10-01

    Recent work in bronchiolitis has demonstrated a significant clinical improvement in children treated with epinephrine over nebulized salbutamol. The objective of this study was to determine whether nebulized epinephrine, as compared with nebulized salbutamol, causes a greater clinical improvement in children with acute asthma. Children, aged 1 to 17 years, with acute asthma presenting to the emergency department (ED) were eligible. In this double-blind study, patients were randomly allocated to receive either salbutamol or racemic epinephrine by nebulization at 0, 20, and 40 minutes. All patients received oral steroids. The primary outcome measure was a change in pulmonary index score (PIS). One hundred twenty patients were randomized. The groups were comparable in terms of age, gender, asthma severity, previous treatments, and use of inhaled steroids. There was no significant difference between treatments in the change in PIS, length of stay, admission to hospital, or relapse rate. The epinephrine-treated group had significantly more minor side effects (such as excess or brownish nasal discharge). There is no significant clinical benefit of nebulized epinephrine over salbutamol in children 1-17 years old with mild to moderate acute asthma. Salbutamol remains the treatment of choice in children with known asthma.

  3. Rat models of acute inflammation: a randomized controlled study on the effects of homeopathic remedies

    Directory of Open Access Journals (Sweden)

    Menniti-Ippolito Francesca

    2007-01-01

    Full Text Available Abstract Background One of the cardinal principles of homeopathy is the "law of similarities", according to which patients can be treated by administering substances which, when tested in healthy subjects, cause symptoms that are similar to those presented by the patients themselves. Over the last few years, there has been an increase in the number of pre-clinical (in vitro and animal studies aimed at evaluating the pharmacological activity or efficacy of some homeopathic remedies under potentially reproducible conditions. However, in addition to some contradictory results, these studies have also highlighted a series of methodological difficulties. The present study was designed to explore the possibility to test in a controlled way the effects of homeopathic remedies on two known experimental models of acute inflammation in the rat. To this aim, the study considered six different remedies indicated by homeopathic practice for this type of symptom in two experimental edema models (carrageenan- and autologous blood-induced edema, using two treatment administration routes (sub-plantar injection and oral administration. Methods In a first phase, the different remedies were tested in the four experimental conditions, following a single-blind (measurement procedure. In a second phase, some of the remedies (in the same and in different dilutions were tested by oral administration in the carrageenan-induced edema, under double-blind (treatment administration and measurement and fully randomized conditions. Seven-hundred-twenty male Sprague Dawley rats weighing 170–180 g were used. Six homeopathic remedies (Arnica montana D4, Apis mellifica D4, D30, Atropa belladonna D4, Hamamelis virginiana D4, Lachesis D6, D30, Phosphorus D6, D30, saline and indomethacin were tested. Edema was measured using a water-based plethysmometer, before and at different times after edema induction. Data were analyzed by ANOVA and Student t test. Results In the first phase

  4. [Acute lumbar sprain treated with massage combined with acupuncture at different distal acupoints: a randomized controlled trial].

    Science.gov (United States)

    Cao, Ye; Wang, Yueqiu

    2015-05-01

    To observe treatment efficacy of acupuncture at different distal acupoints for acute lumbar sprain after massage. One hundred and fifty patients with acute lumbar sprain were randomly divided into a Yaotongdian (Extra) group, a Houxi (SI 3) group, a Weizhong (BL 40) group, a Chengshan (BL 57) group and a Shuigou (GV 26) group, total 5 groups, 30 cases in each one. After the same massage treatment and based on groups divided, different distal acupoints above-mentioned were selected to be acupunctured. Visual analogue scale (VAS) scores, lumbar activity and treatment efficacy of patients in 5 groups were evaluated. With acupuncture at distal acupoints after massage,VAS scores of patients in 5 groups were decreased compared with those after massage treatment (all Plumbar activity was all obviously improved (all Plumbar activity and cured and markedly effective rates were not statistically significant(all P>0.05). Based on massage treatment, acupuncture at distal acupoints could further improve the treatment efficacy for acute lumbar sprain, but there is no obvious effective difference among every distal acupoint. As long as choosing acupoints with lower pain threshold and stimulating enough, good efficacy could be acquired for acute lumbar sprain.

  5. A Randomized Trial of an Intensive Physical Therapy Program for Patients with Acute Respiratory Failure

    OpenAIRE

    Moss, Marc; Nordon-Craft, Amy; Malone, Dan; Van Pelt, David; Frankel, Stephen K.; Warner, Mary Laird; Kriekels, Wendy; McNulty, Monica; Fairclough, Diane L.; Schenkman, Margaret

    2016-01-01

    Rationale: Early physical therapy (PT) interventions may benefit patients with acute respiratory failure by preventing or attenuating neuromuscular weakness. However, the optimal dosage of these interventions is currently unknown.

  6. Randomized clinical trial of extended versus single-dose perioperative antibiotic prophylaxis for acute calculous cholecystitis

    NARCIS (Netherlands)

    Loozen, C. S.; Kortram, K.; Kornmann, V. N. N.; van Ramshorst, B.; Vlaminckx, B.; Knibbe, C. A. J.; Kelder, J. C.; Donkervoort, S. C.; Nieuwenhuijzen, G. A. P.; Ponten, J. E. H.; van Geloven, A. A. W.; van Duijvendijk, P.; Bos, W. J. W.; Besselink, M. G. H.; Gouma, D. J.; van Santvoort, H. C.; Boerma, D.

    2017-01-01

    Many patients who have surgery for acute cholecystitis receive postoperative antibiotic prophylaxis, with the intent to reduce infectious complications. There is, however, no evidence that extending antibiotics beyond a single perioperative dose is advantageous. This study aimed to determine the

  7. A Multicenter, Randomized Controlled Trial of Cerebrospinal Fluid Drainage in Acute Spinal Cord Injury

    Science.gov (United States)

    2017-10-01

    AWARD NUMBER: W81XWH-14-2-0191 TITLE: A Multicenter, Randomnized Controlled Trial of Cerebrospinal Fluid Drainage in Acute Spinal Cord Injury ...CSFD and elevation of mean arterial pressure (MAP) in patients with acute spinal cord injury . This study is currently screening and enrolling patients...in Tucson and the University of Alabama in Birmingham. Steps have been initiated to add a high-volume spinal cord injury site from the East Coast to

  8. Internal gallbladder drainage prevents development of acute cholecystitis in a pig model: a randomized study

    DEFF Research Database (Denmark)

    Kjaer, Daniel W; Mortensen, Frank V; Møller, Jens K

    2010-01-01

    removed and histologically scored for the presence of cholecystitis. Bile and blood samples were collected for bacterial culturing and biochemical analyses. RESULTS: The histological examination demonstrated statistical significant differences in acute cholecystitis development between groups, the degree...... of inflammation being highest in undrained pigs. There were no differences in bacterial cultures between the two groups. CONCLUSION: Internal drainage of the gallbladder protected against the development of acute cholecystitis in the present pig model. These findings support the theory that gallstone impaction...

  9. Ibuprofen plus paracetamol versus ibuprofen in acute low back pain: a randomized open label multicenter clinical study

    Directory of Open Access Journals (Sweden)

    Predrag Ostojic

    2017-01-01

    Full Text Available Objective: to estimate whether combination of ibuprofen and paracetamol is more effective than ibuprofen in monotherapy, in the treatment of acute low back pain. Methods: 80 adult patients with acute low back pain were randomized into two subgroups. In the first subgroup, 40 patients were treated with ibuprofen 400mg three times a day (TID, whilst patients in the second subgroup (n=40 were treated with a fixed-dose combination tablet of ibuprofen 200mg plus paracetamol 325mg TID, for three consecutive days. Patients were followed for another 7 days. Efficacy and tolerability of both treatment options was assessed. Results: A statistically significant decrease in pain intensity, assessed using a visual analogue scale (p

  10. Acute neurocognitive response to methylphenidate among survivors of childhood cancer: a randomized, double-blind, cross-over trial.

    Science.gov (United States)

    Conklin, Heather M; Khan, Raja B; Reddick, Wilburn E; Helton, Susan; Brown, Ronald; Howard, Scott C; Bonner, Melanie; Christensen, Robbin; Wu, Shengjie; Xiong, Xiaoping; Mulhern, Raymond K

    2007-10-01

    To investigate the acute efficacy and adverse side effects of methylphenidate (MPH) among survivors of childhood cancer [acute lymphoblastic leukemia (ALL) or brain tumor (BT)] with learning impairments. Participants (N = 122) completed a two-day, in-clinic, double-blind, cross-over trial during which they received MPH (0.60 mg/kg of body weight) and placebo that were randomized in administration order across participants. Performance was evaluated using measures of attention, memory, and academic achievement. A significant MPH versus placebo effect was revealed on a measure of attention, cognitive flexibility, and processing speed (Stroop Word-Color Association Test). Male gender, older age at treatment, and higher intelligence were predictive of better medication response. No significant differences were found for number or severity of adverse side effects as a function of active medication. MPH shows some neurocognitive benefit and is well tolerated by the majority of children surviving ALL and BT.

  11. Single-Blind Randomized Controlled Trial of Poly-Herbal Formula Sahatsatara for Acute Low Back Pain: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Thiyapha Verayachankul

    2016-01-01

    Full Text Available Objective: To evaluate the efficacy and safety of poly-herbal formula Sahatsatara (SHT in pain reduction in acute low back pain (LBP patients. Methods: Twenty-nine patients aged 18-65 years with a history of moderate to severe acute LBP ≤3-day (score ≥4 on a 0-10 numeric rating scale [NRS] were enrolled and randomized to receive an ibuprofen (400 mg after meals three times daily or SHT (1,350 mg before meals three times daily for 7 days. The non-inferiority trial margin was set at ±10 percentage points. The outcomes were measured on pain intensity on the 0-10 NRS, disability on the Thai version of the Oswestry disability index [ODI], total analgesic consumption, patient satisfaction, and safety. Results: Fourteen patients and 15 patients were randomly allocated to ibuprofen and SHT groups, respectively. The mean difference in pain intensity and disability between the two groups at day 7 adjusted according to baseline was within ±1 for pain (-0.3; 95% CI, -1.48 to 0.96 and ±10% (-4.9%; 95% CI, -14.86% to 5.02% for the NRS and ODI scores, respectively. One patient in the SHT group and 5 in the ibuprofen group had gastrointestinal irritation, but the difference was not statistically significant. Conclusion: SHT was not inferior to ibuprofen in pain relieving and disability in patients with acute LBP. The result suggests a role for SHT as an alternative analgesic in acute LBP. (Thai Clinical Trials Registry number 20141027001

  12. Recovery of hand function with robot-assisted therapy in acute stroke patients: a randomized-controlled trial.

    Science.gov (United States)

    Sale, Patrizio; Mazzoleni, Stefano; Lombardi, Valentina; Galafate, Daniele; Massimiani, Maria P; Posteraro, Federico; Damiani, Carlo; Franceschini, Marco

    2014-09-01

    In the last few years, not many studies on the use of robot-assisted therapy to recover hand function in acute stroke patients have been carried out. This randomized-controlled observer trial is aimed at evaluating the effects of intensive robot-assisted hand therapy compared with intensive occupational therapy in the early recovery phases after stroke with a 3-month follow-up. Twenty acute stroke patients at their first-ever stroke were enrolled and randomized into two groups. The experimental treatment was performed using the Amadeo Robotic System. Control treatment, instead, was carried out using occupational therapy executed by a trained physiotherapist. All participants received 20 sessions of treatment for 4 consecutive weeks (5 days/week). The following clinical scales, Fugl-Meyer Scale (FM), Medical Research Council Scale for Muscle Strength (hand flexor and extensor muscles) (MRC), Motricity Index (MI) and modified Ashworth Scale for wrist and hand muscles (MAS), were performed at baseline (T0), after 20 sessions (end of treatment) (T1) and at the 3-month follow-up (T2). The Barthel Index was assessed only at T0 and T1. Evidence of a significant improvement was shown by the Friedman test for the FM [experimental group (EG): P=0.0039, control group (CG): Phand recovery functions in individuals with acute stroke. The robotic rehabilitation treatment may contribute toward the recovery of hand motor function in acute stroke patients. The positive results obtained through the safe and reliable robotic rehabilitation treatment reinforce the recommendation to extend it to a larger clinical practice.

  13. Study protocol: the effect of whole body vibration on acute unilateral unstable lateral ankle sprain- a biphasic randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Baumbach Sebastian Felix

    2013-01-01

    Full Text Available Abstract Background Ankle sprains often result in ankle instability, which is most likely caused by damage to passive structures and neuromuscular impairment. Whole body vibration (WBV is a neuromuscular training method improving those impaired neurologic parameters. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains. Methods/Design 60 patients, aged 18–40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Samples will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-dependent weight bearing, limited functional immobilization by orthosis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, for 30 minutes for a period of 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform exercises similar to those of the control group, on a side-alternating sinusoidal vibration platform. Two time-dependent primary outcome parameters will be assessed: short-term outcome after six weeks will be postural control quantified by the sway index; mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include: return to pre-injury level of activities, residual pain, recurrence, objective instability, energy/coordination, Foot and Ankle Disability Index and EQ 5D. Discussion This is the first trial investigating the effects of WBV in patients with acute soft tissue injury. Inversion ankle sprains often result in ankle instability, which is most likely due to damage of neurological structures. Due to its unique, frequency dependent, influence on various

  14. Economic evaluation of antibiotic therapy versus appendicectomy for the treatment of uncomplicated acute appendicitis from the APPAC randomized clinical trial.

    Science.gov (United States)

    Sippola, S; Grönroos, J; Tuominen, R; Paajanen, H; Rautio, T; Nordström, P; Aarnio, M; Rantanen, T; Hurme, S; Salminen, P

    2017-09-01

    An increasing amount of evidence supports antibiotic therapy for treating uncomplicated acute appendicitis. The objective of this study was to compare the costs of antibiotics alone versus appendicectomy in treating uncomplicated acute appendicitis within the randomized controlled APPAC (APPendicitis ACuta) trial. The APPAC multicentre, non-inferiority RCT was conducted on patients with CT-confirmed uncomplicated acute appendicitis. Patients were assigned randomly to appendicectomy or antibiotic treatment. All costs were recorded, whether generated by the initial visit and subsequent treatment or possible recurrent appendicitis during the 1-year follow-up. The cost estimates were based on cost levels for the year 2012. Some 273 patients were assigned to the appendicectomy group and 257 to antibiotic treatment. Most patients randomized to antibiotic treatment did not require appendicectomy during the 1-year follow-up. In the operative group, overall societal costs (€5989·2, 95 per cent c.i. 5787·3 to 6191·1) were 1·6 times higher (€2244·8, 1940·5 to 2549·1) than those in the antibiotic group (€3744·4, 3514·6 to 3974·2). In both groups, productivity losses represented a slightly higher proportion of overall societal costs than all treatment costs together, with diagnostics and medicines having a minor role. Those in the operative group were prescribed significantly more sick leave than those in the antibiotic group (mean(s.d.) 17·0(8·3) (95 per cent c.i. 16·0 to 18·0) versus 9·2(6·9) (8·3 to 10·0) days respectively; P appendicitis incurred lower costs than those who had surgery. © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

  15. Direct Xa inhibitors in addition to antiplatelet therapy in acute coronary syndrome: meta-analysis of randomized trials.

    Science.gov (United States)

    Villablanca, Pedro A; Holmes, David; Mohananey, Divyanshu; Briceno, David F; Núñez Gil, Ivan J; Kargoli, Faraj; Gupta, Tanush; Kizer, Jorge R; Bortnick, Anna E; Wiley, Jose; Menegus, Mark A; Pyo, Robert; García, Mario; Ramakrishna, Harish; Mookadam, Farouk

    2017-08-01

    We carried out a meta-analysis summarizing the efficacy and safety of direct factor Xa inhibitor (DXI) in patients receiving guideline-based antiplatelet therapy (GBAT) after an acute coronary syndrome. Randomized-controlled trials have shown that the addition of a DXI to GBAT after acute coronary syndrome can reduce ischemic events, the trade-off being an increase in major bleeding complications. PubMed, Central, Embase, The Cochrane Register, Google Scholar databases, and the scientific session abstracts were searched for eligible randomized trials from 1 January 1990 through 31 December 2016. Nine randomized-controlled trials were included in this meta-analysis enrolling a total of 45651 patients. There was a significant reduction in major adverse cardiovascular events with DXIs/GBAT compared with GBAT alone [odds ratio (OR): 0.88; 95% confidence interval (CI): 0.82-0.94, number needed to treat=52]. There were also significant reductions in two individual components of major adverse cardiovascular events: myocardial infarction (OR: 0.89; 95% CI: 0.81-0.98) and stent thrombosis (OR: 0.73; 95% CI: 0.59-0.90), favoring the DXI/GBAT group. There was an increased risk of major bleeding (OR: 2.51; 95% CI: 1.82-3.46) and intracranial hemorrhage (OR: 3.47; 95% CI: 1.76-6.86) compared with GBAT. In acute coronary syndromes, the addition of a DXI to GBAT results in a significant reduction of major adverse cardiovascular events, myocardial infarction, and stent thrombosis, offset by an increased risk of bleeding.

  16. Treating Acute Insomnia: A Randomized Controlled Trial of a “Single-Shot” of Cognitive Behavioral Therapy for Insomnia

    Science.gov (United States)

    Ellis, Jason G.; Cushing, Toby; Germain, Anne

    2015-01-01

    Study Objectives: Despite considerable evidence supporting cognitive behavioral therapy for insomnia (CBT-I) for chronic insomnia, it remains untested within the context of acute insomnia. This study examined the efficacy of a single session of CBT-I, with an accompanying self-help pamphlet, for individuals with acute insomnia. Design: A pragmatic parallel group randomized controlled trial. Setting: Community. Participants: Forty adults (mean age 32.9 ± 13.72 y) with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) defined insomnia disorder, except a self-reported duration of less than 3 mo (i.e., acute insomnia), who reported no previous exposure to CBT-I and were not currently taking medication for sleep. Interventions: A single 60- to 70-min session of CBT-I (n = 20), with an accompanying self-help pamphlet, or wait list control group (n = 20). All subjects were offered a full individual course of CBT-I on completion of the study, regardless of group allocation. Measurements and Results: Subjects completed sleep diaries and the Insomnia Severity Index (ISI) pretreatment and 1 mo following treatment. There were no between-group differences on baseline ISI scores or subjective sleep continuity. The intervention group reported significantly lower ISI scores than controls (t(38) 2.24, P insomnia caseness (i.e., ≥ 10), 60% of those in the CBT-I group had remitted by 1 mo compared to 15% of those in the control group. Conclusions: This single session of cognitive behavioral therapy for insomnia (CBT-I) is sufficiently efficacious for a significant proportion of those with acute insomnia. The results are discussed in terms of integrating this brief form of CBT-I into the “stepped care” model of insomnia. Trial Registration: Testing the efficacy of an early intervention for acute insomnia (SRCTN05891695) http://www.controlled-trials.com/ISRCTN05891695. Citation: Ellis JG, Cushing T, Germain A. Treating acute insomnia: a randomized

  17. Effects of compression at myofascial trigger points in patients with acute low back pain: A randomized controlled trial.

    Science.gov (United States)

    Takamoto, K; Bito, I; Urakawa, S; Sakai, S; Kigawa, M; Ono, T; Nishijo, H

    2015-09-01

    Although there is some evidence that massage therapy, especially compression at myofascial trigger points (MTrPs), is effective for sub-acute and chronic low back pain, the effectiveness of massage therapy with compression at MTrPs for acute low back pain has not been studied. To evaluate the effectiveness of compression at MTrPs for acute low back pain, 63 patients with acute low back pain were randomly assigned to one of three groups: the MTrP group who received compression at MTrPs (N = 23), the non-MTrP group who received compression at non-trigger points (N = 21), and the effleurage massage group who received superficial massage (N = 19). The patients received the assigned treatment 3 times/week for 2 weeks. The subjective pain intensity in static and dynamic conditions and disability caused by low back pain were measured by the visual analogue scale (VAS) and Roland-Morris questionnaire (RMQ), respectively; along with the range of motion (ROM) at the lumbar region and pressure pain threshold (PPT) at trigger points before treatment (baseline), 1 week after the start of treatment, and 1 month after the end of treatment (follow-up). Static and dynamic VAS score, PPT and ROM were significantly improved in the MTrP group compared with those in the non-MTrP and effleurage groups. These results indicate that compression at MTrPs is effective to treat acute low back pain compared with compression at non-MTrPs and superficial massage. For this article, a commentary is available at the Wiley Online Library. © 2015 European Pain Federation - EFIC®

  18. Treating Acute Insomnia: A Randomized Controlled Trial of a "Single-Shot" of Cognitive Behavioral Therapy for Insomnia.

    Science.gov (United States)

    Ellis, Jason G; Cushing, Toby; Germain, Anne

    2015-06-01

    Despite considerable evidence supporting cognitive behavioral therapy for insomnia (CBT-I) for chronic insomnia, it remains untested within the context of acute insomnia. This study examined the efficacy of a single session of CBT-I, with an accompanying self-help pamphlet, for individuals with acute insomnia. A pragmatic parallel group randomized controlled trial. Community. Forty adults (mean age 32.9 ± 13.72 y) with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) defined insomnia disorder, except a self-reported duration of less than 3 mo (i.e., acute insomnia), who reported no previous exposure to CBT-I and were not currently taking medication for sleep. A single 60- to 70-min session of CBT-I (n = 20), with an accompanying self-help pamphlet, or wait list control group (n = 20). All subjects were offered a full individual course of CBT-I on completion of the study, regardless of group allocation. Subjects completed sleep diaries and the Insomnia Severity Index (ISI) pretreatment and 1 mo following treatment. There were no between-group differences on baseline ISI scores or subjective sleep continuity. The intervention group reported significantly lower ISI scores than controls (t(38) 2.24, P insomnia caseness (i.e., ≥ 10), 60% of those in the CBT-I group had remitted by 1 mo compared to 15% of those in the control group. This single session of cognitive behavioral therapy for insomnia (CBT-I) is sufficiently efficacious for a significant proportion of those with acute insomnia. The results are discussed in terms of integrating this brief form of CBT-I into the "stepped care" model of insomnia. Testing the efficacy of an early intervention for acute insomnia (SRCTN05891695) http://www.controlled-trials.com/ISRCTN05891695. © 2015 Associated Professional Sleep Societies, LLC.

  19. Home telemonitoring for patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial.

    Science.gov (United States)

    Vianello, Andrea; Fusello, Massimo; Gubian, Lorenzo; Rinaldo, Claudia; Dario, Claudio; Concas, Alessandra; Saccavini, Claudio; Battistella, Laura; Pellizzon, Giulia; Zanardi, Giuseppe; Mancin, Silvia

    2016-11-22

    Although a number of studies have suggested that the use of Telemonitoring (TM) in patients with Chronic Obstructive Pulmonary Disease (COPD) can be useful and efficacious, its real utility in detecting Acute Exacerbation (AE) signaling the need for prompt treatment is not entirely clear. The current study aimed to investigate the benefits of a TM system in managing AE in advanced-stage COPD patients to improve their Health-Related Quality of Life (HRQL) and to reduce utilization of healthcare services. A 12-month Randomised Controlled Trial (RCT) was conducted in the Veneto region (Italy). Adult patients diagnosed with Class III-IV COPD in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification were recruited and provided a TM system to alert the clinical staff via a trained operator whenever variations in respiratory parameters fell beyond the individual's normal range. The study's primary endpoint was HRQL, measured by the Italian version of the two Short Form 36-item Health Survey (SF36v2). Its secondary endpoints were: scores on the Hospital Anxiety and Depression Scale (HADS); the number and duration of hospitalizations; the number of readmissions; the number of appointments with a pulmonary specialist; the number of visits to the emergency department; and the number of deaths. Three hundred thirty-four patients were enrolled and randomized into two groups for a 1 year period. At its conclusion, changes in the SF36 Physical and Mental Component Summary scores did not significantly differ between the TM and control groups [(-2.07 (8.98) vs -1.91 (7.75); p = 0.889 and -1.08 (11.30) vs -1.92 (10.92); p = 0.5754, respectively]. Variations in HADS were not significantly different between the two groups [0.85 (3.68) vs 0.62 (3.6); p = 0.65 and 0.50 (4.3) vs 0.72 (4.5); p = 0.71]. The hospitalization rate for AECOPD and/or for any cause was not significantly different in the two groups [IRR = 0.89 (95% CI

  20. A double-blind, randomized trial of IV immunoglobulin treatment in acute optic neuritis

    DEFF Research Database (Denmark)

    Roed, H.G; Langkilde, Annika Reynberg; Sellebjerg, F

    2005-01-01

    -four patients were randomized to IVIG 0.4 g/kg body wt, and 34 patients were randomized to placebo. Infusions were given at days 0, 1, 2, 30, and 60. Contrast sensitivity, visual acuity, and color vision were measured at baseline and after 1 week, 1 month, and 6 months. Pattern reversal visual evoked potential...

  1. Comparison between Intravenous Sodium Valproate and Subcutaneous Sumatriptan for Treatment of Acute Migraine Attacks; Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Abolghasem Rahimdel

    2014-03-01

    Full Text Available Background: Sodium valproate (SV has been approved for migraine prophylaxis and its intravenous form is used to treat acute migraine attacks. We compared the efficacy and safety of intravenous SV and subcutaneous Sumatriptan in managing acute migraine attacks. Methods: This double-blind randomized clinical trial divided 90 patients into two groups: one group received 400 mg of intravenous SV and the second group received 6 mg of subcutaneous Sumatriptan. Headache severity before treatment and half an hour, one hour, and two hours after treatment was measured based on the VNRS in the groups. Associated symptoms, i.e., photophobia, phonophobia, nausea, and vomiting, were assayed on admission and 2 hours after treatment. Side effects of the drugs were checked 2 hours after injection. Obtained data from the groups were compared. Results: In both groups, pain decrement at the mentioned time points was significant (P0.05, indicating the similar effect of both drugs on pain improvement. In the SV group, photophobia, phonophobia, nausea, and vomiting were improved significantly, while in the Sumatriptan group, only photophobia and vomiting were decreased significantly, indicating the advantage of SV in improving the associated symptoms. Nausea, vomiting, facial paresthesia, and hypotension were more significantly frequent in the Sumatriptan group than in the SV group (P<0.05. Conclusion: Intravenous SV (400 mg was as effective as subcutaneous Sumatriptan in the treatment of acute migraine attacks, but with more improvement in associated symptoms and with fewer side effects. Trial Registration Number: IRCT201108025943N4

  2. Efficacy and Safety of Saccharomyces boulardii in Acute Rotavirus Diarrhea: Double Blind Randomized Controlled Trial from a Developing Country.

    Science.gov (United States)

    Das, Susrut; Gupta, Pradeep Kumar; Das, Rashmi Ranjan

    2016-12-01

    To study the efficacy and safety of Saccharomyces boulardii (SB) in acute childhood rotavirus diarrhea. Children (3 months to 5 years) with WHO-defined acute watery diarrhea and stool rotavirus positive (n  =  60) were randomized into intervention (n  =  30) and control (n  =  30) groups. The intervention group received SB (500 mg/day) for 5 days. The median duration (hours) of diarrhea was significantly shorter in the intervention group (60 vs. 89; 95% CI: -41.2 to - 16.8). A significantly shorter duration of hospitalization (74 vs. 91; 95% CI: -33.46 to - 0.54) was also seen in the intervention group, but no significant difference was seen for fever and vomiting. There was also no difference between the two groups in the proportion of children requiring parenteral rehydration and persistence of diarrhea lasting beyond day 7. There was no report of any adverse events. The present trial showed that SB is effective and safe in acute rotavirus diarrhea. © The Author [2016]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  3. Acute changes of hip joint range of motion using selected clinical stretching procedures: A randomized crossover study.

    Science.gov (United States)

    Hammer, Adam M; Hammer, Roger L; Lomond, Karen V; O'Connor, Paul

    2017-09-01

    Hip adductor flexibility and strength is an important component of athletic performance and many activities of daily living. Little research has been done on the acute effects of a single session of stretching on hip abduction range of motion (ROM). The aim of this study was to compare 3 clinical stretching procedures against passive static stretching and control on ROM and peak isometric maximal voluntary contraction (MVC). Using a randomized crossover study design, a total of 40 participants (20 male and 20 female) who had reduced hip adductor muscle length attended a familiarization session and 5 testing sessions on non-consecutive days. Following the warm-up and pre-intervention measures of ROM and MVC, participants were randomly assigned 1 of 3 clinical stretching procedures (modified lunge, multidirectional, and joint mobilization) or a static stretch or control condition. Post-intervention measures of ROM and MVC were taken immediately following completion of the assigned condition. An ANOVA using a repeated measure design with the change score was conducted. All interventions resulted in small but statistically significant (p stretching was greater than control (p = 0.031). These data suggest that a single session of stretching has only a minimal effect on acute changes of hip abduction ROM. Although hip abduction is a frontal plane motion, to effectively increase the extensibility of the structures that limit abduction, integrating multi-planar stretches may be indicated. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. The Effect of Black Tea (Camellia sinensis (L) Kuntze) on Pediatrics With Acute Nonbacterial Diarrhea: A Randomized Controlled Trial.

    Science.gov (United States)

    Doustfatemeh, Sareh; Imanieh, Mohammad Hadi; Mohagheghzade, Abdolali; Zarshenas, Mohammad M; Torkamani, Zahra; Yousefi, Gholamhossein; Farahangiz, Saman; Salehi, Alireza

    2017-01-01

    We aimed to evaluate the antidiarrheal effect of black tea in pediatric patients with acute nonbacterial diarrhea. This single-blind randomized clinical trial study was performed on 2 to 12-year-old patients, with acceptable criteria for acute nonbacterial diarrhea in Shiraz, Iran. In total, 120 patients took part in this study. Blocked randomization method was used to allocate them into 2 groups of intervention (black tea tablet + standard treatment) and control group (standard treatment; 60 patients in each). Frequency of defecation, volume, and consistency of stool were registered on arrival and 24 hours later. We used χ2 test, t test, and Mann-Whitney U test. After a 24-hour follow-up, the proportion of patients with formed stool was higher in the intervention group when compared with the control group (P < .001). There was a significant difference between the mean number of defecations per 24 hours in both groups, after treatment (P < .001). We found a possible antidiarrheal effect of black tea. © The Author(s) 2016.

  5. Effect of Nebulized Hypertonic Saline Treatment in Emergency Departments on the Hospitalization Rate for Acute Bronchiolitis: A Randomized Clinical Trial.

    Science.gov (United States)

    Angoulvant, François; Bellêttre, Xavier; Milcent, Karen; Teglas, Jean-Paul; Claudet, Isabelle; Le Guen, Christèle Gras; de Pontual, Loïc; Minodier, Philippe; Dubos, François; Brouard, Jacques; Soussan-Banini, Valérie; Degas-Bussiere, Vanessa; Gatin, Amélie; Schweitzer, Cyril; Epaud, Ralph; Ryckewaert, Amélie; Cros, Pierrick; Marot, Yves; Flahaut, Philippe; Saunier, Pascal; Babe, Philippe; Patteau, Géraldine; Delebarre, Mathilde; Titomanlio, Luigi; Vrignaud, Bénédicte; Trieu, Thanh-Van; Tahir, Abdelilah; Regnard, Delphine; Micheau, Pascale; Charara, Oussama; Henry, Simon; Ploin, Dominique; Panjo, Henri; Vabret, Astrid; Bouyer, Jean; Gajdos, Vincent

    2017-08-07

    Acute bronchiolitis is the leading cause of hospitalization among infants. Previous studies, underpowered to examine hospital admission, have found a limited benefit of nebulized hypertonic saline (HS) treatment in the pediatric emergency department (ED). To examine whether HS nebulization treatment would decrease the hospital admission rate among infants with a first episode of acute bronchiolitis. The Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) study was a multicenter, double-blind randomized clinical trial on 2 parallel groups conducted during 2 bronchiolitis seasons (October through March) from October 15, 2012, through April 15, 2014, at 24 French pediatric EDs. Among the 2445 infants (6 weeks to 12 months of age) assessed for inclusion, 777 with a first episode of acute bronchiolitis with respiratory distress and no chronic medical condition were included. Two 20-minute nebulization treatments of 4 mL of HS, 3%, or 4 mL of normal saline (NS), 0.9%, given 20 minutes apart. Hospital admission rate in the 24 hours after enrollment. Of the 777 infants included in the study (median age, 3 months; interquartile range, 2-5 months; 468 [60.2%] male), 385 (49.5%) were randomized to the HS group and 387 (49.8%) to the NS group (5 patients did not receive treatment). By 24 hours, 185 of 385 infants (48.1%) in the HS group were admitted compared with 202 of 387 infants (52.2%) in the NS group. The risk difference for hospitalizations was not significant according to the mixed-effects regression model (adjusted risk difference, -3.2%; 95% CI, -8.7% to 2.2%; P = .25). The mean (SD) Respiratory Distress Assessment Instrument score improvement was greater in the HS group (-3.1 [3.2]) than in the NS group (-2.4 [3.3]) (adjusted difference, -0.7; 95% CI, -1.2 to -0.2; P = .006) and similarly for the Respiratory Assessment Change Score. Mild adverse events, such as worsening of cough, occurred more frequently among children in the HS group

  6. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction

    NARCIS (Netherlands)

    M.L. Simoons (Maarten); E.J. Topol (Eric); R.M. Califf (Robert); F.J.J. van de Werf (Frans); P.W. Armstrong (Paul); P.E. Aylward (Philip Edmund); G.I. Barbash; E.R. Bates (Eric); A. Betriu; J.H. Chesebro (James); J.J. Col (Jacques); D.P. de Bono (David); J.M. Gore (Joel); A.D. Guerci (Alan); J.R. Hampton (John)

    1993-01-01

    textabstractBACKGROUND: The relative efficacy of streptokinase and tissue plasminogen activator and the roles of intravenous as compared with subcutaneous heparin as adjunctive therapy in acute myocardial infarction are unresolved questions. The current trial was designed to compare new, aggressive

  7. A blind, randomized comparison of racecadotril and loperamide for stopping acute diarrhea in adults

    OpenAIRE

    Wang, Hwang-Huei; Shieh, Ming-Jium; Liao, Kuan-Fu

    2005-01-01

    AIM: Racecadotril is a specific enkephalinase inhibitor that exhibits intestinal antisecretory activity without affecting intestinal transit. Loperamide is an effective anti-diarrheal agent, but it usually induces constipation. This study is to compare the efficacy, safety, and tolerability of racecadotril versus loperamide in the outpatient treatment of acute diarrhea in adults.

  8. Homeopathic medicine for acute cough in upper respiratory tract infections and acute bronchitis: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Zanasi, Alessandro; Mazzolini, Massimiliano; Tursi, Francesco; Morselli-Labate, Antonio Maria; Paccapelo, Alexandro; Lecchi, Marzia

    2014-02-01

    Cough is a frequent symptom associated to upper respiratory tract infections (URTIs) and, although being self-limiting, it might deeply affect the quality of life. Homeopathic products are often employed by patients to treat cough, but the evidence on their efficacy is scarce. Thus, we tested the efficacy of a homeopathic syrup in treating cough arising from URTIs with a randomized, double blind, placebo controlled clinical trial. Patients were treated with either the homeopathic syrup or a placebo for a week, and recorded cough severity in a diary by means of a verbal category-descriptive score for two weeks. Sputum viscosity was assessed with a viscosimeter before and after 4 days of treatment; patients were also asked to provide a subjective evaluation of viscosity. Eighty patients were randomized to receive placebo (n = 40) or the homeopathic syrup (n = 40). All patients completed the study. In each group cough scores decreased over time, however, after 4 and 7 days of treatment, cough severity was significantly lower in the homeopathic group than in the placebo one (p acute cough induced by URTIs. Copyright © 2013 Elsevier Ltd. All rights reserved.

  9. Low-dose dopamine or low-dose nesiritide in acute heart failure with renal dysfunction: the ROSE acute heart failure randomized trial.

    Science.gov (United States)

    Chen, Horng H; Anstrom, Kevin J; Givertz, Michael M; Stevenson, Lynne W; Semigran, Marc J; Goldsmith, Steven R; Bart, Bradley A; Bull, David A; Stehlik, Josef; LeWinter, Martin M; Konstam, Marvin A; Huggins, Gordon S; Rouleau, Jean L; O'Meara, Eileen; Tang, W H Wilson; Starling, Randall C; Butler, Javed; Deswal, Anita; Felker, G Michael; O'Connor, Christopher M; Bonita, Raphael E; Margulies, Kenneth B; Cappola, Thomas P; Ofili, Elizabeth O; Mann, Douglas L; Dávila-Román, Víctor G; McNulty, Steven E; Borlaug, Barry A; Velazquez, Eric J; Lee, Kerry L; Shah, Monica R; Hernandez, Adrian F; Braunwald, Eugene; Redfield, Margaret M

    2013-12-18

    Small studies suggest that low-dose dopamine or low-dose nesiritide may enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction; however, neither strategy has been rigorously tested. To test the 2 independent hypotheses that, compared with placebo, addition of low-dose dopamine (2 μg/kg/min) or low-dose nesiritide (0.005 μg/kg/min without bolus) to diuretic therapy will enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction. Multicenter, double-blind, placebo-controlled clinical trial (Renal Optimization Strategies Evaluation [ROSE]) of 360 hospitalized patients with acute heart failure and renal dysfunction (estimated glomerular filtration rate of 15-60 mL/min/1.73 m2), randomized within 24 hours of admission. Enrollment occurred from September 2010 to March 2013 across 26 sites in North America. Participants were randomized in an open, 1:1 allocation ratio to the dopamine or nesiritide strategy. Within each strategy, participants were randomized in a double-blind, 2:1 ratio to active treatment or placebo. The dopamine (n = 122) and nesiritide (n = 119) groups were independently compared with the pooled placebo group (n = 119). Coprimary end points included 72-hour cumulative urine volume (decongestion end point) and the change in serum cystatin C from enrollment to 72 hours (renal function end point). Compared with placebo, low-dose dopamine had no significant effect on 72-hour cumulative urine volume (dopamine, 8524 mL; 95% CI, 7917-9131 vs placebo, 8296 mL; 95% CI, 7762-8830 ; difference, 229 mL; 95% CI, -714 to 1171 mL; P = .59) or on the change in cystatin C level (dopamine, 0.12 mg/L; 95% CI, 0.06-0.18 vs placebo, 0.11 mg/L; 95% CI, 0.06-0.16; difference, 0.01; 95% CI, -0.08 to 0.10; P = .72). Similarly, low-dose nesiritide had no significant effect on 72-hour cumulative urine volume (nesiritide, 8574 mL; 95% CI, 8014-9134 vs placebo

  10. Comparison of Amniotic Membrane Transplantation and Umbilical Cord Serum in Acute Ocular Chemical Burns: A Randomized Controlled Trial.

    Science.gov (United States)

    Sharma, Namrata; Singh, Divya; Maharana, Prafulla K; Kriplani, Alka; Velpandian, Thirumurthy; Pandey, Ravindra Mohan; Vajpayee, Rasik B

    2016-08-01

    To compare the efficacy of topical umbilical cord serum drops (UCS) and amniotic membrane transplantation (AMT) in acute ocular chemical burns. Randomized controlled trial. setting: Tertiary care hospital. Forty-five eyes with acute chemical burns of grade III, IV, and V (Dua's classification) presenting within the first week of injury were randomized into 3 groups (15 each). Patients with perforation/impending corneal perforation were excluded from the study. Groups 1, 2, and 3 received UCS with medical therapy (MT), AMT with MT, and MT alone, respectively. Time to complete epithelialization. The mean time to complete epithelialization was 56.7 ± 14.9, 22.0 ± 10.2, and 22.9 ± 10.1 days in MT, AMT, and UCS groups, respectively, with a significant difference between MT and AMT (P = .001) and between MT and UCS (P = .001), but not between UCS and AMT (P = .9). Improvement in pain score was better with UCS than AMT (P value: .012, .002, and .012 on days 7, 14, and 21, respectively). Corneal clarity was better in the UCS group at 21 (P = .008) and 30 days (P = .002), but not at 3 months (P = .9). By month 3, visual outcome, symblepharon, tear film status, and lid abnormalities were comparable between the 3 groups. UCS and AMT, as an adjuvant to standard medical therapy in acute chemical injury, are equally efficacious. UCS has the advantage of faster improvement in corneal clarity, better pain control, and avoidance of surgery in an inflamed eye. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial.

    Science.gov (United States)

    Bronfort, Gert; Evans, Roni; Anderson, Alfred V; Svendsen, Kenneth H; Bracha, Yiscah; Grimm, Richard H

    2012-01-03

    Mechanical neck pain is a common condition that affects an estimated 70% of persons at some point in their lives. Little research exists to guide the choice of therapy for acute and subacute neck pain. To determine the relative efficacy of spinal manipulation therapy (SMT), medication, and home exercise with advice (HEA) for acute and subacute neck pain in both the short and long term. Randomized, controlled trial. (ClinicalTrials.gov registration number: NCT00029770) 1 university research center and 1 pain management clinic in Minnesota. 272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks. 12 weeks of SMT, medication, or HEA. The primary outcome was participant-rated pain, measured at 2, 4, 8, 12, 26, and 52 weeks after randomization. Secondary measures were self-reported disability, global improvement, medication use, satisfaction, general health status (Short Form-36 Health Survey physical and mental health scales), and adverse events. Blinded evaluation of neck motion was performed at 4 and 12 weeks. For pain, SMT had a statistically significant advantage over medication after 8, 12, 26, and 52 weeks (P ≤ 0.010), and HEA was superior to medication at 26 weeks (P = 0.02). No important differences in pain were found between SMT and HEA at any time point. Results for most of the secondary outcomes were similar to those of the primary outcome. Participants and providers could not be blinded. No specific criteria for defining clinically important group differences were prespecified or available from the literature. For participants with acute and subacute neck pain, SMT was more effective than medication in both the short and long term. However, a few instructional sessions of HEA resulted in similar outcomes at most time points. National Center for Complementary and Alternative Medicine, National Institutes of Health.

  12. The effect of Kinesio taping application for acute non-specific low back pain: a randomized controlled clinical trial.

    Science.gov (United States)

    Kelle, Bayram; Güzel, Rengin; Sakallı, Hakan

    2016-10-01

    To investigate the effect of Kinesio taping application in acute non-specific low back pain. A randomized controlled clinical trial. Physical Medicine and Rehabilitation Clinic. A total of 109 patients with acute low back pain were randomized into either Kinesio taping (n = 54) or control (n = 55) groups. The intervention group was treated with information and reassurance plus Kinesio taping, while the control group received merely information and reassurance. All participants were allowed to use as-needed doses of paracetamol. Kinesio tape was applied to the most painful area of the low back for a total of 12 days. Worst pain and disability were assessed at baseline, after the 12-day intervention, and at four weeks follow-up. During the first 12 days, participants filled in a pain diary consisting of a numeric rating scale and recorded the number of paracetamol tablets consumed daily. Disability was assessed with the Oswestry Disability Index. After 12 days of intervention, pain intensity and the Oswestry Disability Index improved significantly in both groups; the improvements were significantly superior in the Kinesio taping group (p = 0.003, p = 0.011). The Kinesio taping group reached pain control earlier (sixth day vs. 12th day) and consumed less paracetamol. At the fourth week, although pain intensity was significantly more reduced in the Kinesio taping group (p = 0.015), there were no differences with regard to disability. Kinesio taping provided significant improvements in pain and disability; thus, it can be used as a complementary method in acute non-specific low back pain. © The Author(s) 2015.

  13. A randomized trial of nebulized 3% hypertonic saline with salbutamol in the treatment of acute bronchiolitis in hospitalized infants.

    Science.gov (United States)

    Flores, Pedro; Mendes, Ana Luisa; Neto, Ana S

    2016-04-01

    Acute bronchiolitis is a common disorder of infants that often results in hospitalization. Apart from supportive care, no therapy has been shown to influence the course of the disease, except for a possible effect of nebulized hypertonic saline (HS). To determine whether this does have beneficial effects on length of stay in hospital or on severity scores, we undertook a double-blind, randomized, controlled trial in a pediatric department of a Portuguese hospital. Previously healthy infants, younger than 12 months, hospitalized with mild-to-moderate acute viral bronchiolitis were randomized to receive either nebulized 3% (hypertonic, HS) or 0.9% (normal, NS) saline during their entire hospital stay. Primary endpoints were: length of hospital stay and severity scores on each day of hospitalization. Need for supplemental oxygen, further add-on medications and adverse effects were also analyzed. Sixty-eight patients completed the study (HS: 33; NS: 35). The median length of hospital stay did not differ between groups: HS: 5.6 ± 2.3 days; NS: 5.4 ± 2.1 days (P = 0.747). We found no difference between groups in severity scores from day 1 to day 4. There were no differences in need for supplemental oxygen or add-on medications. Patients in HS group had significantly more cough (46% vs. 20%, P = 0.025) and rhinorrhoe (58% vs. 31%, P = 0.30). This study does not support the use of nebulized HS over NS in therapy of hospitalized children with mild-to-moderate acute viral bronchiolitis. © 2015 Wiley Periodicals, Inc.

  14. Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen, dan D-dimer Sebagai Prediktor Decompensated Disseminated Intravascular Coagulation Sisseminated pada Sepsis

    Directory of Open Access Journals (Sweden)

    Fenny

    2011-03-01

    Full Text Available Sepsis is a systemic response to infection especially in pneumonia case. Sepsis can cause complications such as disseminated intravascular coagulation (DIC which can be divided into compensated and decompensated DIC. The purpose of this study was to assess whether the value of prothrombin time (PT, activated partial thromboplastin time (aPTT, fibrinogen, and D-dimer levels can be used as predictors of decompensated DIC in sepsis patients. This study was conducted at the Laboratory of Clinical Pathology Rumah Sakit Hasan Sadikin Bandung since September 2008 to June 2010. Subjects were patients with sepsis caused by pneumonia. PT and aPTT values, fibrinogen, and D-dimer levels was recorded from all sepsis patients then patients were observed until diagnosed decompensated or non-decompensated DIC, then the value of PT, aPTT, fibrinogen and D-dimer levels in the group of decompensated DIC and non-decompensated DIC were analysed. This study used cohort design. Subjects were 39 sepsis patients (58% with outcome decompensated DIC and 28 sepsis patients (42% with outcome non-decompensated DIC. From the hemostasis parameter test out, it was found that PT, aPTT, and fibrinogen were the predictor of decompensated DIC in patients with sepsis with relative risk 240.500, 7.157, and 6.421; respectively. Conclusions, prothrombin time, aPTT, fibrinogen are the test to know coagulation activation. Hemostasis parameter to predict decompensated DIC in sepsis patients are the shorten PT, aPTT, and the increased fibrinogen

  15. The effect of acute alcohol intoxication on gut wall integrity in healthy male volunteers; a randomized controlled trial.

    Science.gov (United States)

    de Jong, W J; Cleveringa, A M; Greijdanus, B; Meyer, P; Heineman, E; Hulscher, J B

    2015-02-01

    The aim of the study is to determine the effect of acute alcohol consumption on enterocytes. Chronic alcohol consumption has been known to induce a decrease in gut wall integrity in actively drinking alcoholics and patients with alcohol-induced liver disease. Data on the extent of the damage induced by acute alcohol consumption in healthy human beings is scarce. Studies show that heavy incidental alcohol consumption is a growing problem in modern society. Data on this matter may provide insights into the consequences of this behavior for healthy individuals. In a randomized clinical trial in crossover design, 15 healthy volunteers consumed water one day and alcohol the other. One blood sample was collected pre-consumption, five every hour post-consumption, and one after 24 h. Intestinal fatty acid binding protein (I-FABP) was used as a marker for enterocyte damage. Liver fatty acid binding protein (L-FABP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT) were used as markers for hepatocyte damage. Lipopolysaccharide binding protein (LBP) and soluble CD14 (sCD14) were used as a measure of translocation. Interleukin-6 (IL-6) was used to assess the acute inflammatory response to endotoxemia. Alcohol consumption caused a significant increase in serum I- and L-FABP levels, compared to water consumption. Levels increased directly post-consumption and decreased to normal levels within 4 h. LBP, sCD14, and IL-6 levels were not significantly higher in the alcohol group. Moderate acute alcohol consumption immediately damages the enterocyte but does not seem to cause endotoxemia. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Economic evaluation of zinc and copper use in treating acute diarrhea in children: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dhande Leena A

    2003-08-01

    Full Text Available Abstract Background The therapeutic effects of zinc and copper in reducing diarrheal morbidity have important cost implications. This health services research study evaluated the cost of treating a child with acute diarrhea in the hospital, the impact of micronutrient supplementation on the mean predicted costs and its cost-effectiveness as compared to using only standard oral rehydration solution (ORS, from the patient's and government's (providers perspective. Methods Children aged 6 months to 59 months with acute diarrhea were randomly assigned to receive either the intervention or control. The intervention was a daily dose of 40 mg of zinc sulfate and 5 mg of copper sulfate powder dissolved in a liter of standard ORS (n = 102. The control was 50 mg of standard ORS powder dissolved in a liter of standard ORS (n = 98. The cost measures were the total mean cost of treating acute diarrhea, which included the direct medical, the direct non-medical and the indirect costs. The effectiveness measures were the probability of diarrhea lasting ≤ 4 days, the disability adjusted life years (DALYs and mortality. Results The mean total cost of treating a child with acute diarrhea was US $14 of which the government incurred an expenditure of 66%. The factors that increased the total were the number of stools before admission (p = 0.01, fever (p = 0.01, increasing grade of dehydration (p = 0.00, use of antibiotics (p = 0.00, use of intra-venous fluids (p = 0.00, hours taken to rehydrate a child (p = 0.00, the amount of oral rehydration fluid used (p = 0.00, presence of any complications (p = 0.00 and the hospital stay (p = 0.00. The supplemented group had a 8% lower cost of treating acute diarrhea, their cost per unit health (diarrhea lasting ≤ 4 days was 24% less and the incremental cost-effectiveness ratio indicated cost savings (in Rupees with the intervention [-452; 95%CI (-11306, 3410]. However these differences failed to reach conventional levels

  17. Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Schepers, Nicolien J; Bakker, Olaf J; Besselink, Marc G H; Bollen, Thomas L; Dijkgraaf, Marcel G W; van Eijck, Casper H J; Fockens, Paul; van Geenen, Erwin J M; van Grinsven, Janneke; Hallensleben, Nora D L; Hansen, Bettina E; van Santvoort, Hjalmar C; Timmer, Robin; Anten, Marie-Paule G F; Bolwerk, Clemens J M; van Delft, Foke; van Dullemen, Hendrik M; Erkelens, G Willemien; van Hooft, Jeanin E; Laheij, Robert; van der Hulst, René W M; Jansen, Jeroen M; Kubben, Frank J G M; Kuiken, Sjoerd D; Perk, Lars E; de Ridder, Rogier J J; Rijk, Marno C M; Römkens, Tessa E H; Schoon, Erik J; Schwartz, Matthijs P; Spanier, B W Marcel; Tan, Adriaan C I T L; Thijs, Willem J; Venneman, Niels G; Vleggaar, Frank P; van de Vrie, Wim; Witteman, Ben J; Gooszen, Hein G; Bruno, Marco J

    2016-01-05

    Acute pancreatitis is mostly caused by gallstones or sludge. Early decompression of the biliary tree by endoscopic retrograde cholangiography (ERC) with sphincterotomy may improve outcome in these patients. Whereas current guidelines recommend early ERC in patients with concomitant cholangitis, early ERC is not recommended in patients with mild biliary pancreatitis. Evidence on the role of routine early ERC with endoscopic sphincterotomy in patients without cholangitis but with biliary pancreatitis at high risk for complications is lacking. We hypothesize that early ERC with sphincterotomy improves outcome in these patients. The APEC trial is a randomized controlled, parallel group, superiority multicenter trial. Within 24 hours after presentation to the emergency department, patients with biliary pancreatitis without cholangitis and at high risk for complications, based on an Acute Physiology and Chronic Health Evaluation (APACHE-II) score of 8 or greater, Modified Glasgow score of 3 or greater, or serum C-reactive protein above 150 mg/L, will be randomized. In 27 hospitals of the Dutch Pancreatitis Study Group, 232 patients will be allocated to early ERC with sphincterotomy or to conservative treatment. The primary endpoint is a composite of major complications (that is, organ failure, pancreatic necrosis, pneumonia, bacteremia, cholangitis, pancreatic endocrine, or exocrine insufficiency) or death within 180 days after randomization. Secondary endpoints include ERC-related complications, infected necrotizing pancreatitis, length of hospital stay and an economical evaluation. The APEC trial investigates whether an early ERC with sphincterotomy reduces the composite endpoint of major complications or death compared with conservative treatment in patients with biliary pancreatitis at high risk of complications. Current Controlled Trials ISRCTN97372133 (date registration: 17-12-2012).

  18. Efficacy and Safety of Intravenous Urapidil for Older Hypertensive Patients with Acute Heart Failure: A Multicenter Randomized Controlled Trial.

    Science.gov (United States)

    Yang, Wei; Zhou, Yu Jie; Fu, Yan; Qin, Jian; Qin, Shu; Chen, Xiao Min; Guo, Jin Cheng; Wang, De Zhao; Zhan, Hong; Li, Jing; He, Jing Yu; Hua, Qi

    2017-01-01

    Urapidil is putatively effective for patients with hypertension and acute heart failure, although randomized controlled trials thereon are lacking. We investigated the efficacy and safety of intravenous urapidil relative to that of nitroglycerin in older patients with hypertension and heart failure in a randomized controlled trial. Patients (>60 y) with hypertension and heart failure were randomly assigned to receive intravenous urapidil (n=89) or nitroglycerin (n=91) for 7 days. Hemodynamic parameters, cardiac function, and safety outcomes were compared. Patients in the urapidil group had significantly lower mean systolic blood pressure (110.1±6.5 mm Hg) than those given nitroglycerin (126.4±8.1 mm Hg, p=0.022), without changes in heart rate. Urapidil was associated with improved cardiac function as reflected by lower N terminal-pro B type natriuretic peptide after 7 days (3311.4±546.1 ng/mL vs. 4879.1±325.7 ng/mL, p=0.027) and improved left ventricular ejection fraction (62.2±3.4% vs. 51.0±2.4%, p=0.032). Patients given urapidil had fewer associated adverse events, specifically headache (p=0.025) and tachycardia (p=0.004). The one-month rehospitalization and all-cause mortality rates were similar. Intravenous administration of urapidil, compared with nitroglycerin, was associated with better control of blood pressure and preserved cardiac function, as well as fewer adverse events, for elderly patients with hypertension and acute heart failure.

  19. Early oral refeeding based on hunger in moderate and severe acute pancreatitis: a prospective controlled, randomized clinical trial.

    Science.gov (United States)

    Zhao, Xian L; Zhu, Shi F; Xue, Gui J; Li, Juan; Liu, Yi L; Wan, Mei H; Huang, Wei; Xia, Qing; Tang, Wen F

    2015-01-01

    Early enteral nutrition is beneficial for acute pancreatitis (AP), but the optimal timing and criteria remain unclear. The aim of this study was to explore the feasibility and safety of early oral refeeding (EORF) based on hunger in patients with moderate or severe AP. In a prospective, single-center, controlled, randomized clinical trial (ChiCTR-TRC-12002994), eligible patients with moderate or severe AP were randomized to either EORF or conventional oral refeeding (CORF). Patients in the EORF group restarted an oral diet when they felt hungry, regardless of laboratory parameters. Those in the CORF group restarted an oral diet only when clinical and laboratory symptoms had resolved. Clinical outcomes were compared between the two groups. In all, 146 eligible patients with moderate or severe AP were included and randomized to the EORF (n = 70) or CORF (n = 76) group. There were eight dropouts after randomization (three in EORF group; five in CORF group). The groups had similar baseline characteristics. The total length of hospitalization (13.7 ± 5.4 d versus 15.7 ± 6.2 d; P = 0.0398) and duration of fasting (8.3 ± 3.9 d versus 10.5 ± 5.1 d; P = 0.0047) were shorter in the EORF group than in the CORF group. There was no difference in the number of adverse events or complications between the two groups. The mean blood glucose level after oral refeeding was higher in the EORF group than in the CORF group (P = 0.0030). This controlled, randomized clinical trial confirmed the effectiveness and feasibility of EORF based on hunger in patients with moderate or severe AP. EORF could shorten the length of hospitalization in patients with moderate or severe AP. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  20. Effect of smoking cessation intervention on results of acute fracture surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Nåsell, Hans; Adami, Johanna; Samnegård, Eva

    2010-01-01

    Tobacco smoking is a major health and economic concern and is also known to have a significant negative effect on surgical outcomes. The benefits of a smoking cessation intervention prior to elective orthopaedic surgery have been evaluated previously. Our aim was to assess whether a smoking cessa...... cessation program, initiated during the acute hospitalization period and carried out for six weeks, could reduce the number of complications following emergency surgical treatment of fractures....

  1. Unani Treatment Decreased Fibrosis and Improved Liver Functions in Decompensated Cirrhosis of Liver: A Case Series

    Directory of Open Access Journals (Sweden)

    Akhtar Siddiqui

    2016-03-01

    Full Text Available At present, liver transplantation remains the only curative option for the patients with cirrhosis and end-stage liver diseases. The survival rate and recurrent diseases remain the major issues in the patient post-transplantation. Unani medicine is one of the oldest traditional systems of medicine which has been treating chronic liver diseases and cirrhosis (Talayyaful-Kabid for centuries. The current study aimed to assess the impact of Unani treatment on decompensated cirrhosis and collect data to warrant further clinical trials. Authors conducted a case series on five patients with decompensated cirrhosis and portal hypertension. The disease was confirmed through FibroScan and ultrasound and treated with Unani treatment orally for seven months. Results were evaluated based on FibroScan, liver function test (LFT, EuroQol-5D (EQ5D, Child-Pugh and TTO-TIME (trade-off question. Significant improvements in LFT, fibrosis and quality of life were achieved in the studied patients. The literature related to the herbal constituents of chief medicines used to treat in this case was reviewed. The herbs proved their potential anti-oxidative, anti-inflammatory, hepato-protective, immuno-modulator and antiviral activities, suggesting plausible mechanisms of action in the cases. The preliminary findings indicated the potential therapeutic role of Unani treatment in decompensated cirrhosis. Clinical trials should be conducted to explore further therapeutic potential of Unani treatment in decompensated cirrhosis.

  2. [Value of sonography in the diagnosis of decompensated autonomous thyroid adenoma].

    Science.gov (United States)

    Maier, W; von Dewitz, H; Langer, M; Langer, R; Schumacher, K A

    1981-06-01

    In 30 patients with decompensated autonomous adenoma of the thyroid gland, the possibility was investigated whether sonography of the thyroid gland could replace the thyroid stimulation scintigram or a diagnostically insufficient, saturated scintigram. It was found that the thyroid sonogram--which has a lower specificity--has a markedly higher sensitivity than the saturated scintigram of the thyroid gland.

  3. Multiple infarcted regenerative nodules in liver cirrhosis after decompensation of cirrhosis: a case series

    Directory of Open Access Journals (Sweden)

    Müllhaupt Beat

    2010-11-01

    Full Text Available Abstract Introduction Liver cirrhosis is a common disease with many known complications. Cirrhosis represents a clinical spectrum, ranging from asymptomatic liver disease to hepatic decompensation. Manifestations of hepatic decompensation include variceal bleeding, ascites, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, portopulmonary hypertension and hepatocellular carcinoma. There are reports about infarcted regenerative nodules in cirrhotic livers after gastrointestinal hemorrhage. Case presentation We report three Caucasian patients (one female and two male patients; ages: 52, 54 and 60 years with decompensated liver cirrhosis, who showed newly infarcted regenerative nodules at necropsy. Two of them suffered from gastric variceal bleeding. Histopathology showed extensive infarction in all three cases. Hemorrhage and inflammatory changes were also observed around the infarcted regenerative nodules. Conclusion These patients showed focal liver lesions, to be considered in the differential diagnosis of cirrhotic livers. Infarcted regenerative nodules may be underdiagnosed in patients with decompensation of cirrhosis. In order to differentiate these lesions from malignant tumors, serial imaging seems to be helpful. However, the main differential diagnosis should be an abscess. It is important to know the wide spectrum of image appearances of these lesions. Hypotension can lead to a reduction of portal and arterial liver flow. Since variceal bleeding or septic shock can induce hypotension - as observed in our patients - we conclude that this leads to infarction of such nodules.

  4. The first use of N-carbamylglutamate in a patient with decompensated maple syrup urine disease

    NARCIS (Netherlands)

    Ucar, Sema Kalkan; Coker, Mahmut; Habif, Sara; Saz, Eylem Ulas; Karapinar, Bulent; Ucar, Hakan; Kitis, Omer; Duran, Marinus

    2009-01-01

    Maple syrup urine disease (MSUD) is a defect in the catabolism of the branched-chain amino acids; leucine, isoleucine, and valine. Affected patients may also develop hyperammonaemia of unknown etiology. This report describes a four-year-old girl with MSUD, who presented with decompensated

  5. A randomized controlled trial of nurses vs. doctors in the resolution of acute disease of low complexity in primary care.

    Science.gov (United States)

    Iglesias, Begoña; Ramos, Francisca; Serrano, Beatriz; Fàbregas, Mireia; Sánchez, Carmen; García, María José; Cebrian, Hèlia Marta; Aragonés, Rosa; Casajuana, Josep; Esgueva, Neus

    2013-11-01

    To compare the effectiveness of care delivered by nurses to the usual care delivered by general practitioners, in adult patients requesting same day appointments in primary care practices in Catalonia (Spain). Same day appointments conducted by nurses are characterized by high patient satisfaction and a high resolution index. The profile of nursing and the organization of primary care services in our country differ from other countries. Multicentre, randomized, unblinded clinical trial with two parallel groups. Patients were randomized to an intervention group (seen by nurses trained to respond to low complexity problems) or a control group (seen by the general practitioner) using an automatic probabilistic function. 38 primary care practices in Catalonia, 142 general practitioners and 155 nurses participated. Population study: ≥ 18-year-old patients who requested a same day consultation. Recruitment period: January-May, 2009. Of the 1,461 randomized patients, 92.5% completed the study. resolution of symptoms and patient satisfaction 2 weeks after the visit. Seven hundred and fifty-three patients were assigned to the intervention group and 708 to the control group. Nurses successfully solved 86.3% of the cases. We did not observe any differences in resolution of symptoms or patient satisfaction between the groups. Nurses trained specifically to resolve acute health problems of low complexity give comparable quality of care to that provided by general practitioners in terms of resolution of the problem 15 days after the visit and in patient satisfaction with the visit. © 2013 Blackwell Publishing Ltd.

  6. Treatment of acute sciatica with transforaminal epidural corticosteroids and local anesthetic: design of a randomized controlled trial.

    Science.gov (United States)

    Ter Meulen, Bastiaan C; Maas, Esther T; Vyas, Amrita; van der Vegt, Marinus; de Priester, Koo; de Boer, Michiel R; van Tulder, Maurits W; Weinstein, Henry C; Ostelo, Raymond W J G

    2017-05-25

    Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However there is much debate about their safety and effectiveness. It is important to identify patients that benefit most from TESI and only few trials have yet evaluated the effects in patients with acute sciatica. We describe a prospective, randomized controlled trial (RCT), with the aim to evaluate the hypothesis that TESI plus Levobupivacaine (TESI-plus) added to oral pain medication is more effective compared to pain medication alone or compared to transforaminal injection with a local anesthetic of short duration among patients with acute sciatica. We will recruit a total of 264 patients with sciatica (TESI-plus (intervention group one), 3) oral pain medication and transforaminal epidural injection (TEI) with Levobupivaine and saline solution (intervention group two). Primary outcomes are functional status (Roland-Morris Disability Questionnaire), pain intensity for both leg and back, (100 mm visual analogous scale (VAS)), and global perceived recovery (GPR, reported on a 7-point Likert scale, dichotomized into 'recovered' and 'not recovered'). The secondary outcomes are health-related quality of life (EQ5D-5 L) and patient satisfaction (7-point Likert scale). We will also collect information on healthcare utilization and costs, to perform an economic evaluation. All outcomes are measured at three and six weeks, three and six months after randomization. We defined a minimal clinically relevant difference between groups as a difference between both intervention groups and the control group of 20 points for pain (100-point VAS), four points for functional status (24-point RDQ) and a 20% difference on dichotomized GPR (recovered versus not recovered). A clinically relevant outcome in favor of TESI-plus implies that future patients with acute sciatica should be recommended TESI-plus within the first few weeks rather than being treated with pain medication

  7. A meta-analysis of randomized controlled trials on statins for the prevention of contrast-induced acute kidney injury in patients with and without acute coronary syndromes.

    Science.gov (United States)

    Marenzi, Giancarlo; Cosentino, Nicola; Werba, José P; Tedesco, Calogero C; Veglia, Fabrizio; Bartorelli, Antonio L

    2015-03-15

    We assessed whether short-term, pre-procedural, intensive statin treatment may reduce contrast-induced acute kidney injury (CI-AKI) incidence in patients with and without acute coronary syndromes (ACS) undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI). Statins may exert renal-protective effects through their pleiotropic properties. However, there have been conflicting reports on the CI-AKI preventive effect of pre-procedural statin administration. Randomized controlled trials published between January 1st, 2003 and February 28th, 2014 comparing the preventive effects against CI-AKI of pre-procedural statins vs. control (lower statin dose, no statin, or placebo) in patients undergoing CA/PCI were included. Data were combined from 9 clinical trials enrolling 5212 patients (age 65 ± 5 years, 63% males). Pooled analysis showed that intensive, short-term statin pre-treatment significantly reduced the risk of CI-AKI as compared to control (relative risk [RR] 0.50; 95% confidence interval [CI] 0.39 to 0.64; P<0.001). Pre-specified subgroup analysis showed that intensive statin pre-treatment significantly reduced CI-AKI risk in patients with ACS (RR 0.37; 95% CI 0.25 to 0.55; P<0.0001), with only a non-significant positive trend in patients without ACS (RR 0.65; 95% CI 0.41 to 1.03; P=0.07). No evidence of publication bias was detected. Short-term, pre-procedural, intensive statin treatment significantly reduced CI-AKI incidence in ACS patients, and may contribute to the overall clinical benefit associated with the early use of these drugs in this clinical setting. Its role in non-ACS patients warrants further investigation. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  8. Meta-analysis of high doses of ambroxol treatment for acute lung injury/acute respiratory distress syndrome based on randomized controlled trials.

    Science.gov (United States)

    Wu, Xiangdong; Li, Suwei; Zhang, Jiuzhi; Zhang, Yongli; Han, Lili; Deng, Qiuming; Wan, Xianyao

    2014-11-01

    This study seeks to evaluate the potential benefits of high doses of ambroxol treatment for acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) by conducting a meta-analysis based on randomized controlled trials (RCTs). We searched the Pubmed, Embase, China National Knowledge Infrastructure, and Wanfang databases through December 2013. Only RCTs evaluating high doses of ambroxol (≥15 mg/kg or 1000 mg/day) treatment for patients with ALI/ARDS were selected. We included 10 RCTs involving 508 patients. Adjuvant treatment with high doses of ambroxol increased PaO(2)/FiO(2) (weight mean differences [WMD] = 69.18, 95% confidence intervals [CI]: 41.71-96.65), PO(2) (WMD = 11.74, 95% CI: 8.50-14.99), and SaO(2) (WMD = 2.15, 95% CI: 1.60-2.71) compared with usual treatment. Treatment with high doses of ambroxol appeared to reduce serum tumor necrosis factor-α level (WMD -7.92 µg/L; 95% CI, -10.94 to -4.9) and interleukin-6 level (WMD = -20.65 µg/L, 95% CI: -24.74 to -16.55) and to increase serum superoxide dismutase level (WMD = 19.07 NU/mL, 95% CI: 6.16-31.97). The findings suggest that treatment with high doses of ambroxol appears to improve PaO(2)/FiO(2), PO(2), and SaO(2), and the benefits might be related to ambroxol's anti-oxidant and anti-inflammatory properties. © 2014, The American College of Clinical Pharmacology.

  9. TLR4/CD14 Variants-Related Serologic and Immunologic Dys-Regulations Predict Severe Sepsis in Febrile De-Compensated Cirrhotic Patients.

    Directory of Open Access Journals (Sweden)

    Wen-Chien Fan

    Full Text Available Genetic variants and dysfunctional monocyte had been reported to be associated with infection susceptibility in advanced cirrhotic patients. This study aims to explore genetic predictive markers and relevant immune dysfunction that contributed to severe sepsis in febrile acute de-compensated cirrhotic patents. Polymorphism analysis of candidate genes was undergone in 108 febrile acute de-compensated cirrhotic patients and 121 healthy volunteers. Various plasma inflammatory/regulatory cytokines, proportion of classical (CD 16-, phagocytic and non-classical (CD16+, inflammatory monocytes, lipopolysaccharide (LPS-stimulated toll-like receptor 4 (TLR4 and intracellular/extracellular cytokines on cultured non-classical monocytes, mCD14/HLA-DR expression and phagocytosis of classical monocytes were measured. For TLR4+896A/G variant allele carriers with severe sepsis, high plasma endotoxin/IL-10 inhibits HLA-DR expression and impaired phagocytosis were noted in their classical monocyte. In the same group, increased non-classical monocyte subset, enhanced LPS-stimulated TLR4 expression and TNFα/nitrite production, and systemic inflammation [high plasma soluble CD14 (sCD14 and total nitric oxide (NOx levels] were noted. For CD14-159C/T variant allele carriers with severe sepsis, persist endotoxemia inhibited mCD14/HLA-DR expression and impaired phagocytosis of their classical monocyte. In the same group, increased non-classical monocyte subset up-regulated TLR4-NFκB-iNOS and p38MAPK pathway, stimulated TNFα/nitrite production and elicited systemic inflammation. In febrile acute de-compensated cirrhotic patients, TLR4+896A/G and CD14-159C/T polymorphisms-related non-classical and classical monocytes dysfunction resulted in increased severe sepsis risk. Malnutrition, high plasma endotoxin and sCD14 levels, single TLR4+896A/G or CD14-159C/T variant allele carriers and double variant allele carriers are significant predictive factors for the development

  10. Effect of Losmapimod on Cardiovascular Outcomes in Patients Hospitalized With Acute Myocardial Infarction: A Randomized Clinical Trial.

    Science.gov (United States)

    O'Donoghue, Michelle L; Glaser, Ruchira; Cavender, Matthew A; Aylward, Philip E; Bonaca, Marc P; Budaj, Andrzej; Davies, Richard Y; Dellborg, Mikael; Fox, Keith A A; Gutierrez, Jorge Antonio T; Hamm, Christian; Kiss, Robert G; Kovar, František; Kuder, Julia F; Im, Kyung Ah; Lepore, John J; Lopez-Sendon, Jose L; Ophuis, Ton Oude; Parkhomenko, Alexandr; Shannon, Jennifer B; Spinar, Jindrich; Tanguay, Jean-Francois; Ruda, Mikhail; Steg, P Gabriel; Theroux, Pierre; Wiviott, Stephen D; Laws, Ian; Sabatine, Marc S; Morrow, David A

    2016-04-19

    p38 Mitogen-activated protein kinase (MAPK)-stimulated inflammation is implicated in atherogenesis, plaque destabilization, and maladaptive processes in myocardial infarction (MI). Pilot data in a phase 2 trial in non-ST elevation MI indicated that the p38 MAPK inhibitor losmapimod attenuates inflammation and may improve outcomes. To evaluate the efficacy and safety of losmapimod on cardiovascular outcomes in patients hospitalized with an acute myocardial infarction. LATITUDE-TIMI 60, a randomized, placebo-controlled, double-blind, parallel-group trial conducted at 322 sites in 34 countries from June 3, 2014, until December 8, 2015. Part A consisted of a leading cohort (n = 3503) to provide an initial assessment of safety and exploratory efficacy before considering progression to part B (approximately 22,000 patients). Patients were considered potentially eligible for enrollment if they had been hospitalized with an acute MI and had at least 1 additional predictor of cardiovascular risk. Patients were randomized to either twice-daily losmapimod (7.5 mg; n = 1738) or matching placebo (n = 1765) on a background of guideline-recommended therapy. Patients were treated for 12 weeks and followed up for an additional 12 weeks. The primary end point was the composite of cardiovascular death, MI, or severe recurrent ischemia requiring urgent coronary revascularization with the principal analysis specified at week 12. In part A, among the 3503 patients randomized (median age, 66 years; 1036 [29.6%] were women), 99.1% had complete ascertainment for the primary outcome. The primary end point occurred by 12 weeks in 123 patients treated with placebo (7.0%) and 139 patients treated with losmapimod (8.1%; hazard ratio, 1.16; 95% CI, 0.91-1.47; P = .24). The on-treatment rates of serious adverse events were 16.0% with losmapimod and 14.2% with placebo. Among patients with acute MI, use of losmapimod compared with placebo did not reduce the risk of major ischemic

  11. High serum ferritin is associated with worse outcome of patients with decompensated cirrhosis

    Science.gov (United States)

    Oikonomou, Theodora; Goulis, Ioannis; Soulaidopoulos, Stergios; Karasmani, Areti; Doumtsis, Petros; Tsioni, Konstantina; Mandala, Eudokia; Akriviadis, Evangelos; Cholongitas, Evangelos

    2017-01-01

    Background Studies in patients with decompensated cirrhosis showed a correlation between serum ferritin levels and patients’ prognosis. Besides, red blood cell distribution width (RDW) and mean platelet volume (MPV) have been associated with the severity of hepatic function. The aim of this study was to evaluate the prognostic impact of serum ferritin and RDW/MPV in the outcome [survival, death, or liver transplantation (LT)] of patients with stable decompensated cirrhosis. Methods Consecutive adult patients with stable decompensated cirrhosis admitted to our department between September 2010 and February 2016 were included. Serum ferritin, RDW and MPV were recorded in every patient. They were followed up and their outcome (alive, death, or LT) was evaluated. Results 192 consecutive patients with stable decompensated cirrhosis (142 men, age 54.2±12 years); at the end of follow up [12 (range: 1-64) months] 62 patients remained alive and 130 died or underwent LT. In multivariate analysis, serum ferritin (HR 1.001, 95%CI 1.00-1.002, P=0.005) and GFR (HR 0.96, 95%CI 0.92-0.99, P=0.035) were the only independent factors significantly associated with the outcome. Ferritin had low discriminative ability (AUC: 0.61) to the outcome yielding a sensitivity and specificity of 85.3% and 44.2%, respectively, at the best cut-off point (>55 ng/mL), while patients with ferritin >55 ng/mL (n=145) had a worse outcome compared to those with ferritin ≤55 ng/mL (n=47) (log rank P=0.001). RDW and MPV were not associated with the outcome. Conclusion High serum ferritin, but not RDW/MPV, is associated with worse outcome in patients with established decompensated cirrhosis. However, further studies are needed to elucidate better this issue. PMID:28243043

  12. The Aged Residential Care Healthcare Utilization Study (ARCHUS): a multidisciplinary, cluster randomized controlled trial designed to reduce acute avoidable hospitalizations from long-term care facilities.

    Science.gov (United States)

    Connolly, Martin J; Boyd, Michal; Broad, Joanna B; Kerse, Ngaire; Lumley, Thomas; Whitehead, Noeline; Foster, Susan

    2015-01-01

    To assess effect of a complex, multidisciplinary intervention aimed at reducing avoidable acute hospitalization of residents of residential aged care (RAC) facilities. Cluster randomized controlled trial. RAC facilities with higher than expected hospitalizations in Auckland, New Zealand, were recruited and randomized to intervention or control. A total of 1998 residents of 18 intervention facilities and 18 control facilities. A facility-based complex intervention of 9 months' duration. The intervention comprised gerontology nurse specialist (GNS)-led staff education, facility bench-marking, GNS resident review, and multidisciplinary (geriatrician, primary-care physician, pharmacist, GNS, and facility nurse) discussion of residents selected using standard criteria. Primary end point was avoidable hospitalizations. Secondary end points were all acute admissions, mortality, and acute bed-days. Follow-up was for a total of 14 months. The intervention did not affect main study end points: number of acute avoidable hospital admissions (RR 1.07; 95% CI 0.85-1.36; P = .59) or mortality (RR 1.11; 95% CI 0.76-1.61; P = .62). This multidisciplinary intervention, packaging selected case review, and staff education had no overall impact on acute hospital admissions or mortality. This may have considerable implications for resourcing in the acute and RAC sectors in the face of population aging. Australian and New Zealand Clinical Trials Registry (ACTRN12611000187943). Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  13. Does epicatechin contribute to the acute vascular function effects of dark chocolate? A randomized, crossover study

    NARCIS (Netherlands)

    Dower, James I.; Geleijnse, Marianne; Kroon, Paul A.; Philo, Mark; Mensink, Marco; Kromhout, Daan; Hollman, Peter C.H.

    2016-01-01

    Scope: Cocoa, rich in flavan-3-ols, improves vascular function, but the contribution of specific flavan-3-ols is unknown. We compared the effects of pure epicatechin, a major cocoa flavan-3-ol, and chocolate. Methods and results: In a randomized crossover study, twenty healthy men (40-80 years)

  14. Further evidence for a non-random chromosomal abnormality in acute promyelocytic leukemia

    Energy Technology Data Exchange (ETDEWEB)

    Rowley, J.D.; Golomb, H.M.; Vardiman, J.; Fukahara, S.; Dougherty, C.; Potter, D.

    1977-01-01

    We have previously reported on two patients with acute promyelocytic leukemia (APL) who had what appeared to be a deletion of chromosome No. 17. We now describe a third patient with APL. All three patients had a structural rearrangement involving No. 15 and No. 17. Our current interpretation of the chromosomal abnormality is that it is a reciprocal translocation, t (15; 17) (q22; q21). Evidence that this is a consistent rearrangement associated with APL comes not only from our three patients, but also from two other published cases of APL, studied with banding, who also had an identical abnormality.

  15. Effect of intravenous sodium valproate vs dexamethasone on acute migraine headache: a double blind randomized clinical trial.

    Science.gov (United States)

    Mazaheri, Shahir; Poorolajal, Jalal; Hosseinzadeh, Akram; Fazlian, Mohammad Mahdi

    2015-01-01

    Despite the impact of sodium valproate and dexamethasone on migraine headache, the efficacy of the two drugs has not been properly investigated and compared. This trial compared the effect of the two drugs on acute migraine headache. This double blind randomized clinical trial was conducted on patients aged 18 to 65 years with acute migraine headache who referred to the emergency departments of Beasat and Farshchian Hospitals in Hamadan, Iran, from April 2012 to June 2014. Patients were randomly assigned to receive a single-dose of either 400 mg sodium valproate or 16 mg dexamethasone plus 50 ml saline normal solution within 15 min intravenously. The severity of headache in the two groups was evaluated at baseline, 0.5 and 2 hours later using the Visual Analog Scale (VAS) on a scale of 0 to 10. Of 104 patients enrolled, 72 patients remained for analysis. The effect of both sodium valproate and dexamethasone on acute migraine headache was statistically significant at 0.5 and 2 hours post-treatment compared to pre-treatment (P=0.001). The severity of headache based on VAS reduced form 8.20 (7.72, 8.68) before treatment to 5.31 (4.74, 5.89) and 3.66 (2.99, 4.33) at 0.5 and 2 hours after treatment, respectively, in patients receiving sodium valproate and from 8.46 (8.05, 8.86) before treatment to 5.46 (4.81, 6.11) and 3.59 (2.84, 4.35) at 0.5 and 2 hours after treatment, respectively, in patients receiving dexamethasone. Both drugs were highly effective in improvement of acute headache in patients without aura. However, sodium valproate significantly improved the acute headache in patients with aura but dexamethasone did not. The severity of headache based on VAS reduced form 8.50 (7.40, 9.60) before treatment to 4.67 (2.40, 6.93) and 3.50 (1.78, 5.22) at 0.5 and 2 hours after treatment, respectively, in patients with aura receiving sodium valproate and from 8.80 (7.76, 9.84) before treatment to 7.20 (4.98, 9.42) and 6.20 (2.43, 9.97) at 0.5 and 2 hours after treatment

  16. The use of Animal-Assisted Therapy in adolescents with acute mental disorders: A randomized controlled study.

    Science.gov (United States)

    Stefanini, M C; Martino, A; Allori, P; Galeotti, F; Tani, F

    2015-02-01

    The aim of this study was to compare the effects of Animal-Assisted Therapy (AAT) with a standard treatment protocol in children and adolescents admitted to the psychiatry hospital for acute mental disorders. We used a methodology involving high quality standards for AAT research. A pre-post experimental design with a randomized controlled trial (RCT) in 34 hospitalized patients (17 treatment, 17 control) was carried out. The study focused on improvement in clinical status including, global functioning measured by the Children Global Assessment Scale (C GAS), format of care and ordinary school attendance measured by a rating scale. Our results indicate a statistically significant improvement in global functioning, reduction in format of care and increased ordinary school attendance in the treatment group, but not in the control group. Our results verify that AAT can have significant positive effects on therapeutic progress and the recovery process. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. A randomized, double-blind trial on the use of 1% hydrocortisone cream for the prevention of acute radiation dermatitis.

    Science.gov (United States)

    Meghrajani, Chandra F; Co, Henri S; Arcillas, Jon G; Maaño, Clarita C; Cupino, Nonette A

    2016-01-01

    To determine whether the application of 1% hydrocortisone cream during radiation therapy can prevent the occurrence of moist desquamation. Fifty adult female breast carcinoma patients were randomized after modified radical mastectomy and chemotherapy to receive prophylactic placebo cream (n = 27) or 1% hydrocortisone cream (n = 23) during radiation therapy. The patients, caregiver and assessor were all blinded to the treatment received. Occurrence of moist desquamation, severity of acute radiation dermatitis (ARD) and hyperpigmentation were evaluated weekly until the end of radiotherapy. Five patients in each group developed moist desquamation; however, its extent and severity were milder in the steroid group. Mean ARD scores were also lower in the steroid group (0.713 vs. 0.874, p = 0.024). A lower incidence of Grades 1 and 2 radiation dermatitis was also noted in the steroid group at weeks 2 and 4, respectively, indicating prophylactic use of steroids delayed the onset of radiodermatitis.

  18. Ginsenoside-Rd improves outcome of acute ischaemic stroke - a randomized, double-blind, placebo-controlled, multicenter trial.

    Science.gov (United States)

    Liu, X; Wang, L; Wen, A; Yang, J; Yan, Y; Song, Y; Liu, X; Ren, H; Wu, Y; Li, Z; Chen, W; Xu, Y; Li, L; Xia, J; Zhao, G

    2012-06-01

     Ginsenoside-Rd is a receptor-operated calcium channel antagonist and has shown promise as a neuroprotectant in our phase II study. As an extended work, we sought to confirm its efficacy and safety of Ginsenoside-Rd in patients with acute ischaemic stroke. We conducted a randomized, double-blind, placebo-controlled trial involving 390 patients with acute ischaemic stroke in a 3:1 ratio to receive a 14-day intravenous infusion of Ginsenoside-Rd or placebo within 72 h after the onset of stroke. Our primary end-point was the distribution of disability scores on the modified Rankin scale (mRs) at 90 days.   The efficacy analysis was based on 386 patients (Ginsenoside-Rd group: 290; placebo group: 96). Ginsenoside-Rd significantly improved the overall distribution of scores on the mRs, as compared with the placebo (P = 0.02; odds ratios [OR], 1.74; 95% confidence interval [CI], 1.08-2.78). There were significant differences between the two groups when we categorized the scores into 0-1 vs. 2-5 (P = 0.01; OR, 2.32; 95% CI, 1.23-4.38; 66.8% vs. 53.1%). It also improved the National Institutes of Health Stroke Scale (NIHSS) at 15 days [P Rd improved the primary outcome of acute ischaemic stroke and had an acceptable adverse-event profile. © 2012 The Author(s). European Journal of Neurology © 2012 EFNS.

  19. Comparison of two combinations of opioid and non-opioid analgesics for acute periradicular abscess: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Manuela Favarin Santini

    Full Text Available Abstract Acute periradicular abscess is a condition characterized by the formation and propagation of pus in the periapical tissues and generally associated with debilitating pain. Objective: The aim of this study was to compare the overall analgesic effectiveness of two combinations of opioid and non-opioid analgesics for acute periradicular abscess. Material and Methods: This study included 26 patients who sought emergency care in a Brazilian dental school. The patients were randomly divided into two groups: Co/Ac - oral prescription of codeine (30 mg plus acetaminophen (500 mg, every 4 h, for 3 days or Tr/Ac - oral prescription of tramadol hydrochloride (37.5 mg plus acetaminophen (500 mg on the same schedule. Two factors were evaluated: (1 pain scores recorded by the patients in a pain diary 6, 12, 24, 48, and 72 h after treatment, using the Visual Analogue Scale; and (2 the occurrence of adverse effects. Results: In both groups, there was a reduction in pain scores over time. For the Co/Ac group, there was a significant reduction in the scores 12, 24, 48, and 72 hours after treatment (P0.05, i.e., both treatments were effective in controlling pain caused by APA; however, the combination of Tr/Ac caused more adverse reactions as two patients had to stop using the medication. Conclusion: This study suggests that, considering both analgesic efficacy and safety, the combination of codeine and acetaminophen is more effective to control moderate to severe pain from acute periradicular abscesses.

  20. Early education and counselling of patients with acute coronary syndrome. A pilot study for a randomized controlled trial.

    Science.gov (United States)

    Weibel, Lukas; Massarotto, Paola; Hediger, Hannele; Mahrer-Imhof, Romy

    2016-06-01

    At time of discharge, patients with acute coronary syndrome often have a knowledge deficit regarding their disease, further treatment and necessary behavioural changes. It is well known that self-efficacy as a prerequisite for behavioural changes can be influenced by patient education. This study investigated whether an individualized education programme starting early in the cardiac care unit enhanced self-efficacy and rehabilitation programme attendance, and was feasible and satisfying for patients. In a pilot randomized controlled trial, 40 patients with acute coronary syndrome were enrolled. The intervention group received in addition to standard care an early individual needs-oriented educational session in the cardiac care unit and subsequently one on the ward addressing risk factors, medication and self-management as well as referral to a rehabilitation programme by a nurse. Self-efficacy was assessed twice, at attendance in a rehabilitation programme six weeks after discharge. The participants' satisfaction with the intervention was assessed qualitatively. When controlling for anxiety and depression, the intervention group showed significant better self-efficacy scores on the ability to control the symptoms (p=0.034). When controlling additionally for age, no significant differences could be detected. The attendance of a rehabilitation programme was higher in the intervention group. The participants in the intervention group reported high satisfaction with the early education. Early education seems to benefit patients with acute coronary syndrome. In light of increased confidence to control one's symptoms and the higher attendance in rehabilitation programmes, as well as a high satisfaction with the intervention, a full powered study will be pursued. © The European Society of Cardiology 2014.

  1. Efficacy of Hand Behind Back Mobilization With Movement for Acute Shoulder Pain and Movement Impairment: A Randomized Controlled Trial.

    Science.gov (United States)

    Satpute, Kiran H; Bhandari, Prashant; Hall, Toby

    2015-06-01

    The aim of this study was to investigate the effects of hand-behind-back (HBB) Mulligan mobilization with movement (MWM) techniques on acute shoulder pain, impairment, and disability. This double-blind, randomized, controlled trial recruited 44 patients with acute shoulder pain and movement impairment presenting to an Indian general hospital. Participants were allocated to receive either MWM and exercise/hot pack (n = 22) or exercise/hot pack alone (n = 22). The average duration of symptoms was 4.1 and 4.7 weeks in the exercise and MWM groups, respectively. The primary outcome was HBB range of motion (ROM). Secondary variables were shoulder internal rotation ROM, pain intensity score, and shoulder disability identified by the shoulder pain and disability index. All variables were evaluated by a blinded assessor before and immediately after 9 treatment sessions over 3 weeks. Paired t tests revealed that both groups demonstrated statistically significant improvements (P < .001) with large effect sizes for all variables. However, for all variables, the MWM-with-exercise group showed significantly greater improvements (P < .05) than the exercise group. Hand-behind-back ROM showed a mean difference of 9.31° (95% confidence interval, 7.38-11.27), favoring greater improvement in the MWM-with-exercise group. In this study, the outcomes of patients with acute shoulder pain and disability receiving shoulder HBB MWM with exercise improved greater than those receiving exercise/hot packs alone. Copyright © 2015 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

  2. A novel approach in the treatment of acute whiplash syndrome: Ultrasound-guided needle percutaneous electrolysis. A randomized controlled trial.

    Science.gov (United States)

    García Naranjo, J; Barroso Rosa, S; Loro Ferrer, J F; Limiñana Cañal, J M; Suarez Hernández, E

    2017-12-01

    Whiplash associated disorders are currently a common musculoskeletal problem. Besides the high incidence in western countries, the costs derived from prolonged treatment and medicolegal compensation, make this entity a challenging problem for clinicians and insurance companies. To date, no conservative treatment has shown clear superiority in the management of acute cases. Percutaneous needle electrolysis (PNE) is an effective approach for the treatment of Quebec type II acute whiplash syndrome (AWS). PNE consists in the application of brief galvanic currents into a damaged structure, producing a local controlled inflammatory response, with subsequent tissular healing enhancement. One hundred AWS patients were randomized into: (a) standard physiotherapy intervention for AWS; (b) a standardized PNE protocol for AWS. Both groups were assessed for treatment outcome at the 5th week mark. Both groups showed a statistically significant improvement according to the Northwick Park Neck Questionnaire, visual analogic scale and pressure pain threshold. The improvement was similar in both groups, except for the pain pressure threshold, with a 56.6% reduction vs. 44.4% reduction in favour of the PNE group (P=0.035). In addition, the physio group consumed a mean treatment time of 20hours, while the PNE intervention averaged less than 1 hour in total. PNE can be considered as an effective treatment option for AWS. Importantly, the technique is highly cost-effective, with limited equipment required and a notable treatment time reduction, compared to more comprehensive physiotherapy protocols. Randomized controlled trial. 1b. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  3. Effects of intracutaneous injections of sterile water in patients with acute low back pain: a randomized, controlled, clinical trial

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    J.Z. Cui

    2016-03-01

    Full Text Available Intracutaneous sterile water injection (ISWI is used for relief of low back pain during labor, acute attacks of urolithiasis, chronic neck and shoulder pain following whiplash injuries, and chronic myofascial pain syndrome. We conducted a randomized, double-blinded, placebo-controlled trial to evaluate the effect of ISWI for relief of acute low back pain (aLBP. A total of 68 patients (41 females and 27 males between 18 and 55 years old experiencing aLBP with moderate to severe pain (scores ≥5 on an 11-point visual analogue scale [VAS] were recruited and randomly assigned to receive either ISWIs (n=34 or intracutaneous isotonic saline injections (placebo treatment; n=34. The primary outcome was improvement in pain intensity using the VAS at 10, 45, and 90 min and 1 day after treatment. The secondary outcome was functional improvement, which was assessed using the Patient-Specific Functional Scale (PSFS 1 day after treatment. The mean VAS score was significantly lower in the ISWI group than in the control group at 10, 45, and 90 min, and 1 day after injection (P<0.05, t-test. The mean increment in PSFS score of the ISWI group was 2.9±2.2 1 day after treatment, while that in the control group was 0.9±2.2. Our study showed that ISWI was effective for relieving pain and improving function in aLBP patients at short-term follow-up. ISWI might be an alternative treatment for aLBP patients, especially in areas where medications are not available, as well as in specific patients (e.g., those who are pregnant or have asthma, who are unable to receive medications or other forms of analgesia because of side effects.

  4. High frequency oscillatory ventilation versus conventional mechanical ventilation in pediatric acute respiratory distress syndrome: A randomized controlled study.

    Science.gov (United States)

    El-Nawawy, Ahmed; Moustafa, Azza; Heshmat, Hassan; Abouahmed, Ahmed

    2017-01-01

    El-Nawawy A, Moustafa A, Heshmat H, Abouahmed A. High frequency oscillatory ventilation versus conventional mechanical ventilation in pediatric acute respiratory distress syndrome: A randomized controlled study. Turk J Pediatr 2017; 59: 130-143. The aim of this prospective randomized study is to compare the outcomes of the early use of either high frequency oscillation (HFO) or conventional mechanical ventilation (CMV) in patients with pediatric acute respiratory distress syndrome (PARDS). We allocated two hundred PARDS patients over 5 years in 1:1 ratio to either mode. The HFO group showed a significantly higher median partial arterial oxygen pressure to fraction of inspired oxygen (PaO2/FiO2) values after 24 hours of enrollment (p=0.011), higher oxygenation index (OI) decrease percent (p=0.004) and lower cross-over rates (p ventilation days (p=0.77, p=0.28, p=0.65 respectively). The second day values (after 24 hours) of both OI and PaO 2 /FiO 2 were found to be more significant discriminators for mortality when compared to the baseline values (cutoff values > 8.5, ≤139 respectively). PARDS patients with baseline OI > 16 had a better chance of survival if initially ventilated with the HFO (p=0.004). Although the HFO mode appeared to be a safe mode with a significant better oxygenation improvement (after the first 24 hours) and fewer cross-over rates, it failed to show differences as regards mortality or LOS when compared to the CMV adopting protective lung strategy. In PARDS, HFO had a superior advantage in improving oxygenation, yet with no significant mortality improvement, as multi-organ dysfunction syndrome (MODS) was the most common cause of death in our study and not refractory hypoxemia which is the main problem in PARDS; highlighting that mortality in PARDS is multi-factorial and may not depend only on how fast oxygenation improves.

  5. Comparision Of The Efficacy Of Nebulized L-Epinephrine, Salbutamoland Normal Saline In Acute Bronchiolitis: A Randomized Clinical Trial

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    H. Mussavi

    2005-08-01

    Full Text Available Background:Acute bronchiolitis is the most common form of lower respiratory tract infection in infancy.There are numerous contradictory reports regarding the efficacy of nebulized bronchodilators in the management of infants with acute bronchiolitis. This study was designed to compare the efficacy of nebulized epinephrine with salbutamol for treatment of the disease.Methods:In a randomized clinical trial, 72 infants with moderately severe bronchiolitis were enrolled in three equal groups. Three doses of epinephrine, salbutamol, and normal saline as a placebo nebulized with oxygen were given at 20 minute intervals. Oxygen saturation, respiratory rate and distress were recorded before intervention and I0 minutes after each dose of the drugs. Results: At the end of the study, pre- and post-treatment mean oxygen saturation values, clinical scores and respiratory rates showed significant differences between the epinephrine and salbutamol groups in comparison with the placebo group. The results were more significant in the epinephrine group than other groups. After the treatment course 66%, 50%, and 25% of patients in epinephrine, salbutamol, and placebo groups respectively showed significant improvement at a degree that they could be sent home. No serious side effects were observed.Conclusion: Both nebulized epinephrine and salbutamol improved oxygenation and decreased respiratory distress better than normal saline. L-epinephrim was more effective in relieving respiratory distress and improving oxygen saturation as well as the need for hospitalization than nebulized salbutamol.

  6. Acute effects of foam rolling on passive tissue stiffness and fascial sliding: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Krause, Frieder; Wilke, Jan; Niederer, Daniel; Vogt, Lutz; Banzer, Winfried

    2017-03-09

    Self-myofascial release (SMR) aims to mimic the effects of manual therapy and tackle dysfunctions of the skeletal muscle and connective tissue. It has been shown to induce improvements in flexibility, but the underlying mechanisms are still poorly understood. In addition to neuronal mechanisms, improved flexibility may be driven by acute morphological adaptations, such as a reduction in passive tissue stiffness or improved movement between fascial layers. The aim of the intended study is to evaluate the acute effects of SMR on the passive tissue stiffness of the anterior thigh muscles and the sliding properties of the associated fasciae. In a crossover study design, 16 participants will receive all of the following interventions in a permutated random order: (1) one session of 2 × 60 s of SMR at the anterior thigh, (2) one session of 2 × 60 s of passive static stretching of the anterior thigh and (3) no intervention. Passive tissue stiffness, connective tissue sliding, angle of first stretch sensation, as well as maximal active and passive knee flexion angle, will be evaluated before and directly after each intervention. The results of the intended study will allow a better understanding of, and provide further evidence on, the local effects of SMR techniques and the underlying mechanisms for flexibility improvements. ClinicalTrials.gov, identifier: NCT02919527 . Registered on 27 September 2016.

  7. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial.

    Science.gov (United States)

    Davenport, Todd E; Kulig, Kornelia; Fisher, Beth E

    2010-10-19

    Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM) is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. http://www.clinicaltrials.gov identifier NCT00888498.

  8. Safety of dexamphetamine in acute ischemic stroke: a randomized, double-blind, controlled dose-escalation trial.

    Science.gov (United States)

    Martinsson, Louise; Wahlgren, Nils Gunnar

    2003-02-01

    Amphetamine is reported to enhance recovery after experimental stroke, but results from the first few trials in humans are inconclusive. Limited information is available on treatment safety. This study intended to investigate the safety and tolerability of dexamphetamine in patients with acute cerebral ischemia. Forty-five patients with cerebral ischemia were enrolled within 72 hours after onset of symptoms. Patients were randomized to 1 of 3 dose levels (2.5, 5, or 10 mg orally twice daily) or placebo for 5 consecutive days. Adverse events, blood pressure, heart rate, body temperature, consciousness level, and functional outcome measures were followed up daily during treatment. Follow-ups were made at day 7 and 1 and 3 months after stroke. Mean systolic and diastolic blood pressures and heart rate increased 14 mm Hg, 8 mm Hg, and 9 bpm, respectively, with dexamphetamine treatment compared with placebo (P< or =0.01). There was no difference between dexamphetamine and placebo regarding adverse events, body temperature, or consciousness level. During treatment, there was a benefit of dexamphetamine in neurological and functional outcome (P<0.05), but differences were not maintained at follow-up. Overall, dexamphetamine was safe and well tolerated by patients with acute cerebral ischemia, but blood pressure and heart rate increased during treatment in comparison to placebo. These observations may be important in the future planning of amphetamine trials because changes in these variables have been observed to interfere with clinical outcome. The suggestions of improvement in outcome must be confirmed in further studies.

  9. Hypertonic (3%) saline vs 0.93% saline nebulization for acute viral bronchiolitis: a randomized controlled trial.

    Science.gov (United States)

    Sharma, Bhagwan S; Gupta, Mukesh K; Rafik, Shaikh P

    2013-08-01

    To compare the length of hospital stay (primary) and improvement in clinical severity scores (secondary) among children with bronchiolitis nebulized with 3 % hypertonic saline or 0.9% saline. Randomized double blind controlled trial. Tertiary care teaching hospital. Hospitalized children (1-24 months) with acute bronchiolitis of moderate severity. Nebulization of 4 ml of 3% hypertonic saline or 4 mL of 0.9% saline, along with 2.5 mg salbutamol, at 4-hourly intervals till the patient was ready for discharge. Baseline characteristics were similar in two groups. Median clinical severity score at admission was 6 (IQR-1) in both the groups. Clinical severity scores monitored afterwards 12-hourly till discharge (132 h) did not show statistically significant differences in 3% and 0.9% saline groups. Mean length of hospital stay (time to reach predefined clinical severity scoresaline group and 63.51 ± 21.27 h in 0.9% saline group (P=0.878). No adverse events were reported by the parents, caregivers or treating medical attendants in both groups. Nebulized 3 % saline is not superior to 0.9% saline in infants with clinically diagnosed acute bronchiolitis.

  10. Statistical analysis plan for the Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART). A randomized controlled trial.

    Science.gov (United States)

    Damiani, Lucas Petri; Berwanger, Otavio; Paisani, Denise; Laranjeira, Ligia Nasi; Suzumura, Erica Aranha; Amato, Marcelo Britto Passos; Carvalho, Carlos Roberto Ribeiro; Cavalcanti, Alexandre Biasi

    2017-01-01

    The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy). To describe the data management process and statistical analysis plan. The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes. According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results. ClinicalTrials.gov number, NCT01374022.

  11. Ankle manual therapy for individuals with post-acute ankle sprains: description of a randomized, placebo-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Fisher Beth E

    2010-10-01

    Full Text Available Abstract Background Ankle sprains are common within the general population and can result in prolonged disablement. Limited talocrural dorsiflexion range of motion (DF ROM is a common consequence of ankle sprain. Limited talocrural DF ROM may contribute to persistent symptoms, disability, and an elevated risk for re-injury. As a result, many health care practitioners use hands-on passive procedures with the intention of improving talocrural joint DF ROM in individuals following ankle sprains. Dosage of passive hands-on procedures involves a continuum of treatment speeds. Recent evidence suggests both slow- and fast-speed treatments may be effective to address disablement following ankle sprains. However, these interventions have yet to be longitudinally compared against a placebo study condition. Methods/Design We developed a randomized, placebo-controlled clinical trial designed to test the hypotheses that hands-on treatment procedures administered to individuals following ankle sprains during the post-acute injury period can improve short-, intermediate-, and long-term disablement, as well as reduce the risk for re-injury. Discussion This study is designed to measure the clinical effects of hands-on passive stretching treatment procedures directed to the talocrural joint that vary in treatment speed during the post-acute injury period, compared to hands-on placebo control intervention. Trial Registration http://www.clinicaltrials.gov identifier NCT00888498.

  12. Constraint-Induced Aphasia Therapy in the Acute Stage: What Is the Key Factor for Efficacy? A Randomized Controlled Study.

    Science.gov (United States)

    Woldag, Hartwig; Voigt, Nancy; Bley, Maria; Hummelsheim, Horst

    2017-01-01

    Constraint-induced aphasia therapy (CIAT) has proven effective in patients with subacute and chronic forms of aphasia. It has remained unclear, however, whether intensity of therapy or constraint is the relevant factor. Data about intensive speech and language therapy (SLT) are conflicting. To identify the effective component of CIAT and assess the feasibility of SLT in the acute stage after stroke. A total of 60 patients with aphasia (68.2 ± 11.7 years) were enrolled 18.9 days after first-ever stroke. They were randomly distributed into 3 groups: (1) CIAT group receiving therapy for 3 hours per day (10 workdays, total 30 hours); (2) conventional communication treatment group, with same intensity without constraints; and (3) control group receiving individual therapy twice a day as well as group therapy (total 14 hours). Patients were assessed pretreatment and posttreatment using the Aachener Aphasia Test (primary end point: token test) and the Communicative Activity Log (CAL). Pretreatment, there were no between-group differences. Posttreatment, all groups showed significant improvements without between-group differences. It was found that 14 hours of aphasia therapy administered within 2 weeks as individual therapy, focusing on individual deficits, combined with group sessions has proven to be most efficient. This approach yielded the same outcome as 30 hours of group therapy, either in the form of CIAT or group therapy without constraints. SLT in an intensive treatment schedule is feasible and was well tolerated in the acute stage after stroke. © The Author(s) 2016.

  13. Decompensated Heart Failure is Associated with Reduced Corin Levels and Decreased Cleavage of Pro-Atrial Natriuretic Peptide

    Science.gov (United States)

    Ibebuogu, Uzoma N.; Gladysheva, Inna P.; Houng, Aiilyan K.; Reed, Guy L.

    2013-01-01

    Background By promoting salt and water excretion, the corin and the atrial natriuretic peptide (ANP) system should help to maintain fluid balance in heart failure. Yet, the development of fluid retention despite high levels of ANP-related peptides, suggests that this compensatory system is limited. Methods and Results Levels of circulating corin (the pro-ANP converting enzyme) and pro-ANP were measured in hospitalized patients with heart failure, using novel immunoassays. Patients (n = 14) had severe heart failure (NYHA class III–IV) with a median ejection fraction of 18 % and median BNP levels of 1940 pg/ml. In heart failure, median plasma corin levels were 7.6-fold lower than measured in plasma from 16 normal controls (180 vs. 1368 pg/ml, pANP peptides (N-ANP and pro-ANP) levels were markedly elevated (42.0 vs. 7.5 ng/ml, pANP, measured by novel immunoassays, were significantly higher in heart failure patients (p ANP was impaired. Median plasma levels of cGMP were elevated in heart failure patients (150.0 vs. 7.6 pmol/ml, pANP (rs = 0.59, p ANP, implying that the cellular response to ANP remained intact. Conclusions Taken together these data suggest that there may be patients for whom low corin levels and impaired pro-ANP cleavage contribute to acute decompensation. PMID:21216831

  14. Cupping therapy for acute and chronic pain management: a systematic review of randomized clinical trials

    OpenAIRE

    Cao, Huijuan; Li, Xun; Yan, Xue; Wang, Nissi S.; Bensoussan, Alan; Liu, Jianping

    2014-01-01

    Objective: Cupping as a traditional therapy is used to treat a myriad of health conditions, including pain. This systematic review assessed the effectiveness and safety of cupping for different types of pain. Methods: Thirteen databases and four trial registries were searched for randomized clinical trials. Meta-analysis of data was conducted if there was non-significant clinical and statistical heterogeneity (measured by I2 test) among trials. Results: Sixteen trials with 921 participa...

  15. Pancreatic resection versus peritoneal lavation for acute fulminant pancreatitis. A randomized prospective study.

    Science.gov (United States)

    Kivilaakso, E; Lempinen, M; Mäkeläinen, A; Nikki, P; Schröder, T

    1984-04-01

    Thirty-five patients with acute fulminant (hemorrhagic) pancreatitis, verified at laparotomy, were allocated to either pancreatic resection (18 patients) or peritoneal lavation (17 patients) therapy groups. Pancreatic resection was carried out by removing the distal pancreas well cephalad to the portal vein. For peritoneal lavation, two inlet silicone catheters were inserted at laparotomy around the pancreas and an outlet catheter was inserted in the lower abdomen, and the peritoneal cavity was thereafter lavated (1000 ml/hr) with a standard peritoneal dialysis fluid for 7 to 12 days (or until death if met earlier). In other respects, the postoperative care was similar, including intravenous fluids with total parenteral nutrition until oral intake of food was resumed, prophylactic antibiotics (tobramycin and clindamycin) and stress ulcer prophylaxis (cimetidine and antacids). In the resection group, four of the 18 patients (22.2%) died, while in the lavation group eight of the 17 patients (47.1%) died. The most common cause of death was septic complications with multiple organ failure, but one patient in each group died accidentally of airway complications. There was no difference in the incidence of septic complications (sepsis and/or intra-abdominal abscesses), but the incidence and severity of pulmonary and renal complications were greater in the lavation group. However, these complications accumulated to patients who ultimately died. Also, the need for reoperation was greater in the lavation group (20 reoperations/10 patients versus 12 reoperation/eight patients). Yet, the length of overall hospital stay was equal in the two groups. Six of the 14 survivors in the resection group developed diabetes, whereas none of the nine survivors in the lavation group got this complication. The results suggest that pancreatic resection is superior to peritoneal lavation in the management of acute fulminant (hemorrhagic) pancreatitis, decreasing mortality and affording

  16. Efficacy and Safety of Cerebrolysin for Acute Ischemic Stroke: A Meta-Analysis of Randomized Controlled Trials

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    Danfeng Zhang

    2017-01-01

    Full Text Available Cerebrolysin was reported to be effective in the neurological improvement of patients with acute ischemic stroke (AIS in experimental models, while data from clinical trials were inconsistent. We performed a meta-analysis to explore the efficacy and safety of cerebrolysin for AIS. PubMed, EMBASE, and Cochrane Library were searched for randomized controlled trials, which intervened within 72 hours after the stroke onset. We investigated the efficacy and safety outcomes, respectively. Risk ratios and mean differences were pooled with fixed-effects model or random-effects model. Seven studies were identified, involving 1779 patients with AIS. The summary results failed to demonstrate significant superiority of cerebrolysin in the assessment of efficacy outcomes of mRS and BI. Similarly, administration of cerebrolysin had neutral effects on safety outcomes compared with placebo, including mortality and SAE. However, the number of included studies was small, especially in the analysis of efficacy outcomes, which might cause publication bias and inaccurate between-studies variance in the meta-analysis. Conclusively, although it seemed to be safe, routine use of cerebrolysin to improve the long-term rehabilitation after stroke could not be supported by available evidence.

  17. Randomized, Double-Blind Clinical Trial to Assess the Acute Diuretic Effect of Equisetum arvense (Field Horsetail in Healthy Volunteers

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    Danilo Maciel Carneiro

    2014-01-01

    Full Text Available In this double-blind, randomized clinical trial, 36 healthy male volunteers were randomly distributed into three groups (n=12 that underwent a three-step treatment. For four consecutive days, we alternately administered a standardized dried extract of Equisetum arvense (EADE, 900 mg/day, placebo (corn starch, 900 mg/day, or hydrochlorothiazide (25 mg/day, separated by a 10-day washout period. Each volunteer served as his own control, and the groups’ results were compared. We repeated the same evaluation after each stage of treatment to evaluate the safety of the drug. The diuretic effect of EADE was assessed by monitoring the volunteers’ water balance over a 24 h period. The E. arvense extract produced a diuretic effect that was stronger than that of the negative control and was equivalent to that of hydrochlorothiazide without causing significant changes in the elimination of electrolytes. There was no significant increase in the urinary elimination of catabolites. Rare minor adverse events were reported. The clinical examinations and laboratory tests showed no changes before or after the experiment, suggesting that the drug is safe for acute use. Further research is needed to better clarify the mechanism of diuretic action and the other possible pharmacological actions of this phytomedicine.

  18. A randomized, controlled trial of acetaminophen, ibuprofen, and codeine for acute pain relief in children with musculoskeletal trauma.

    Science.gov (United States)

    Clark, Eric; Plint, Amy C; Correll, Rhonda; Gaboury, Isabelle; Passi, Brett

    2007-03-01

    Our goal was to determine which of 3 analgesics, acetaminophen, ibuprofen, or codeine, given as a single dose, provides the most efficacious analgesia for children presenting to the emergency department with pain from acute musculoskeletal injuries. Children 6 to 17 years old with pain from a musculoskeletal injury (to extremities, neck, and back) that occurred in the preceding 48 hours before presentation in the emergency department were randomly assigned to receive orally 15 mg/kg acetaminophen, 10 mg/kg ibuprofen, or 1 mg/kg codeine. Children, parents, and the research assistants were blinded to group assignment. The primary outcome was change in pain from baseline to 60 minutes after treatment with study medication as measured by using a visual analog scale. A total of 336 patients were randomly assigned, and 300 were included in the analysis of the primary outcome (100 in the acetaminophen group, 100 in the ibuprofen group, and 100 in the codeine group). Study groups were similar in age, gender, final diagnosis, previous analgesic given, and baseline pain score. Patients in the ibuprofen group had a significantly greater improvement in pain score (mean decrease: 24 mm) than those in the codeine (mean decrease: 11 mm) and acetaminophen (mean decrease: 12 mm) groups at 60 minutes. In addition, at 60 minutes more patients in the ibuprofen group achieved adequate analgesia (as defined by a visual analog scale ibuprofen provides the best analgesia among the 3 study medications.

  19. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department.

    Science.gov (United States)

    Grewal, Simran; Ali, Samina; McConnell, Don W; Vandermeer, Ben; Klassen, Terry P

    2009-11-01

    To determine whether nebulized 3% hypertonic saline with epinephrine is more effective than nebulized 0.9% saline with epinephrine in the treatment of bronchiolitis in the emergency department. Randomized, double-blind, controlled trial. Single-center urban pediatric emergency department. Infants younger than 12 months with mild to moderate bronchiolitis. Patients were randomized to receive nebulized racemic epinephrine in either hypertonic or normal saline. The primary outcome measure was the change in respiratory distress, as measured by the Respiratory Assessment Change Score (RACS) from baseline to 120 minutes. The change in oxygen saturation was also determined. Secondary outcome measures included the rates of hospital admission and return to the emergency department. Forty-six patients were enrolled and evaluated. The 2 study groups had similar baseline characteristics. The RACS from baseline to 120 minutes demonstrated no improvement in respiratory distress in the hypertonic saline group compared with the normal saline control group. The change in oxygen saturation in the hypertonic saline group was not significant when compared with the control group. Rates of admission and return to the emergency department were not different between the 2 groups. In the treatment of acute bronchiolitis, hypertonic saline and epinephrine did not improve clinical outcome any more than normal saline and epinephrine in the emergency setting. This differs from previously published results of outpatient and inpatient populations and merits further evaluation. isrctn.org Identifier: ISRCTN66632312.

  20. A randomized controlled trial comparing treatment regimens for acute pain for topical oleoresin capsaicin (pepper spray) exposure in adult volunteers.

    Science.gov (United States)

    Barry, James D; Hennessy, Robert; McManus, John G

    2008-01-01

    Several topical therapies have been proposed to treat acute pain from exposure to oleoresin capsaicin (OC). The purpose of this study was to determine the most beneficial topical treatment for relieving contact dermatitis pain caused by OC exposure. We performed a single-blind, randomized human experiment evaluating the effectiveness of five different regimens for the treatment of topical facial OC exposure. Forty-nine volunteer, adult law enforcement trainees were exposed to OC during a routine training exercise and were randomized to one of five treatment groups (aluminum hydroxide-magnesium hydroxide [Maalox], 2% lidocaine gel, baby shampoo, milk, or water). After initial self-decontamination with water, subjects rated their pain using a 10-cm visual analog scale (VAS) and then every 10 minutes, for a total of 60 minutes. Subjects were blinded to previous VAS recordings. A two-factor analysis of variance (ANOVA) (treatment, time) with repeated measures on one factor (time) was performed using a 1.3-cm difference as clinically significant. Forty-four men and five women, with an average age of 24 years, participated in the study. There was a significant difference in pain with respect to time (p 0.05). There was no significant difference in pain between treatment groups (p > 0.05). In this study, there was no significant difference in pain relief provided by five different treatment regimens. Time after exposure appeared to be the best predictor for decrease in pain.

  1. Randomized controlled study of 3 different types of hemoclips for hemostasis of bleeding canine acute gastric ulcers.

    Science.gov (United States)

    Jensen, Dennis M; Machicado, Gustavo A; Hirabayashi, Ken

    2006-11-01

    Mechanical closure of bleeding vessels is clinically appealing, and several types of hemoclips are now marketed for endoscopic hemostasis of nonvariceal lesions. No comparative data have been reported on ease of clip placement, hemostasis efficacy, or clip retention rates on bleeding ulcers. To compare 3 different types of hemoclips for hemostasis of bleeding ulcers. Randomized controlled study. Seven adult dogs with prehepatic portal hypertension were heparinized, and acute gastric ulcers were made with jumbo biopsy forceps. Animals had oral proton pump inhibitors daily and weekly endoscopies to quantitate clip retention and ulcer healing. Bleeding ulcers were randomized in pairs (2 for each treatment/dog) to endoscopic hemoclip treatment or control. Initial times and success of deployment, hemostasis efficacy, clip retention rates, and ulcer healing during endoscopic follow-ups. There was no difference in initial hemostasis rates of hemoclips, and no major complications occurred. Ulcer healing times were faster (Resolution Clip [RC] or TriClip [TC]) or similar (QuickClip2 [QC]) to controls. Clip retention at 1 week was significantly less with TC and, at 3 to 7 weeks, was significantly higher with RC. (1) For the 3 hemoclip devices, initial hemostasis rates were 100%, but all devices required similar learning time to place clips successfully. (2) Short-term retention rates of TC were significantly less than QC or RC. (3) Long-term clip retention was significantly higher with RC. (4) All 3 hemoclips were safe, and none interfered with ulcer healing.

  2. Standardized Rehabilitation and Hospital Length of Stay Among Patients With Acute Respiratory Failure: A Randomized Clinical Trial.

    Science.gov (United States)

    Morris, Peter E; Berry, Michael J; Files, D Clark; Thompson, J Clifton; Hauser, Jordan; Flores, Lori; Dhar, Sanjay; Chmelo, Elizabeth; Lovato, James; Case, L Douglas; Bakhru, Rita N; Sarwal, Aarti; Parry, Selina M; Campbell, Pamela; Mote, Arthur; Winkelman, Chris; Hite, Robert D; Nicklas, Barbara; Chatterjee, Arjun; Young, Michael P

    2016-06-28

    Physical rehabilitation in the intensive care unit (ICU) may improve the outcomes of patients with acute respiratory failure. To compare standardized rehabilitation therapy (SRT) to usual ICU care in acute respiratory failure. Single-center, randomized clinical trial at Wake Forest Baptist Medical Center, North Carolina. Adult patients (mean age, 58 years; women, 55%) admitted to the ICU with acute respiratory failure requiring mechanical ventilation were randomized to SRT (n=150) or usual care (n=150) from October 2009 through May 2014 with 6-month follow-up. Patients in the SRT group received daily therapy until hospital discharge, consisting of passive range of motion, physical therapy, and progressive resistance exercise. The usual care group received weekday physical therapy when ordered by the clinical team. For the SRT group, the median (interquartile range [IQR]) days of delivery of therapy were 8.0 (5.0-14.0) for passive range of motion, 5.0 (3.0-8.0) for physical therapy, and 3.0 (1.0-5.0) for progressive resistance exercise. The median days of delivery of physical therapy for the usual care group was 1.0 (IQR, 0.0-8.0). Both groups underwent assessor-blinded testing at ICU and hospital discharge and at 2, 4, and 6 months. The primary outcome was hospital length of stay (LOS). Secondary outcomes were ventilator days, ICU days, Short Physical Performance Battery (SPPB) score, 36-item Short-Form Health Surveys (SF-36) for physical and mental health and physical function scale score, Functional Performance Inventory (FPI) score, Mini-Mental State Examination (MMSE) score, and handgrip and handheld dynamometer strength. Among 300 randomized patients, the median hospital LOS was 10 days (IQR, 6 to 17) for the SRT group and 10 days (IQR, 7 to 16) for the usual care group (median difference, 0 [95% CI, -1.5 to 3], P = .41). There was no difference in duration of ventilation or ICU care. There was no effect at 6 months for handgrip (difference, 2.0 kg [95% CI

  3. Simulation-Based Training for Residents in the Management of Acute Agitation: A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Vestal, Heather S; Sowden, Gillian; Nejad, Shamim; Stoklosa, Joseph; Valcourt, Stephanie C; Keary, Christopher; Caminis, Argyro; Huffman, Jeff

    2017-02-01

    Simulations are used extensively in medicine to train clinicians to manage high-risk situations. However, to our knowledge, no studies have determined whether this is an effective means of teaching residents to manage acutely agitated patients. This study aimed to determine whether simulation-based training in the management of acute agitation improves resident knowledge and performance, as compared to didactic-based instruction. Following a standard lecture on the management of agitated patients, first-year psychiatry residents were randomized (in clusters of three to four residents) to either the intervention (n = 15) or control arm (n = 11). Residents in the intervention arm then received simulation-based training on the management of acute agitation using a scenario with an agitated standardized patient. Those in the control arm received simulation-based training on a clinical topic unrelated to the management of agitation using a scenario with a non-agitated standardized patient who had suffered a fall. Baseline confidence and knowledge were assessed using pre-intervention self-assessment questionnaires and open-ended clinical case vignettes. Efficacy of the intervention as a teaching tool was assessed with post-intervention open-ended clinical case vignettes and videotaped simulation-based assessment, using a different scenario of an agitated standardized patient. Residents who received the agitation simulation-based training showed significantly greater improvement in knowledge (intervention = 3.0 vs. control = 0.3, p = 0.007, Cohen's d = 1.2) and performance (intervention = 39.6 vs control = 32.5, p = 0.001, Cohen's d = 1.6). Change in self-perceived confidence did not differ significantly between groups. In this study, simulation-based training appeared to be more effective at teaching knowledge and skills necessary for the management of acutely agitated patients, as compared to didactic-based instruction alone

  4. Efficacy and safety of puerarin injection in curing acute ischemic stroke: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zheng, Qing-Hua; Li, Xiao-Li; Mei, Zhi-Gang; Xiong, Li; Mei, Qing-Xian; Wang, Jin-Feng; Tan, Ling-Jing; Yang, Song-Bai; Feng, Zhi-Tao

    2017-01-01

    Previous studies indicated that the puerarin injection has been widely employed in China for the treatment of acute ischemic stroke. We aim to evaluate the efficacy and safety of the puerarin injection for the treatment of acute ischemic stroke. A systematic literature search was performed in PUBMED, EMBASE, SPRINGER LINK, Scopus, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Journals Database, Wanfang database and the China Biological Medicine database before November 2016, randomized controlled clinical trials (RCTs) of puerarin injection treating acute ischemic stroke were included. In addition, we searched reference lists of relevant retrieved articles. Two authors extracted data independently. The effective rate, the neurologic deficit score, the blood rheology indexes, and fibrinogen were assessed and analyzed by the Review Manager 5.3 software. The continuous variables were expressed as MD with 95% CI and dichotomous data used RR or ORs. Adverse reactions related to the puerarin injection were also examined. Thirty-five RCTs with a total of 3224 participants were identified in the meta-analysis. The combined results of 32 trials indicated that the puerarin injection was better than control drugs at the clinical effective rate (RR 1.22, 95% CI 1.17 to 1.28, P < 0.001) and 16 studies showed the neurological deficit was significantly improved (MD -3.69, 95% CI -4.67 to -2.71, P < 0.001); the hemorheology index and fibrinogen were much lower with the puerarin injection when compared with western conventional medicines (WCM) or other control drugs (the whole blood viscosity: MD -0.89, 95% CI -1.37 to -0.41, P < 0.001; the HCT: MD -0.04, 95% CI -0.06 to -0.02, P < 0.001; the fibrinogen: MD -0.64, 95% CI -0.96 to -0.31, P < 0.001). Eleven trials reported that the adverse reactions related to the puerarin injection included facial flushing, dizziness, vomiting, nausea, and other mild gastrointestinal discomfort and

  5. Sleep and circadian rhythms in hospitalized patients with decompensated cirrhosis: effect of light therapy.

    Science.gov (United States)

    De Rui, M; Middleton, B; Sticca, A; Gatta, A; Amodio, P; Skene, D J; Montagnese, S

    2015-02-01

    Patients with liver cirrhosis often exhibit sleep-wake abnormalities, which are, at least to some extent, circadian in origin. A relatively novel non-pharmacological approach to circadian disruption is appropriately timed bright light therapy. The aims of this pilot study were to investigate sleep-wake characteristics of a well-characterized population of inpatients with cirrhosis, and to evaluate the efficacy of bright light therapy in the hospital setting. Twelve consecutive inpatients with cirrhosis underwent complete sleep-wake assessment, to include qualitative and semi-quantitative (actigraphic) indices of night-time sleep quality, daytime sleepiness, diurnal preference, habitual sleep timing, quality of life, mood and circadian rhythmicity [i.e. urine collections for measurement of the melatonin metabolite 6-sulphatoxymelatonin (aMT6s)]. Patients showed extremely impaired night sleep quality (Pittsburg Sleep Quality Index global score: 16.3 ± 2.1) and daytime sleepiness was common (Epworth Sleepiness Scale: 8.3 ± 3.2). Five patients were randomly assigned to a single room in which lighting was controlled in relation to timing, spectral composition and intensity (lights on at 06:30 and off at 22:30, blue-enriched, more intense light in the morning, red-enriched, less intense light in the afternoon/evening); the others stayed in identical rooms with standard lighting. Sleep diaries revealed poor sleep quality, prolonged sleep latency (67 ± 138 min) and a reduced sleep efficiency (69 ± 21%). These features were confirmed by actigraphy (sleep efficiency: 71 ± 13%; fragmentation index: 55 ± 15%). Quality of life was globally impaired, and mood moderately depressed (Beck Depression Inventory: 19.4 ± 7.9). Seven patients underwent serial urine collections: no circadian aMT6s rhythm was detected in any of them, neither at baseline, nor during the course of hospitalization in either room (n = 4). In conclusion, sleep and circadian rhythms in hospitalized

  6. Intranasal Lidocaine in Acute Treatment of Migraine: A Randomized Controlled Trial.

    Science.gov (United States)

    Avcu, Nazire; Doğan, Nurettin Özgür; Pekdemir, Murat; Yaka, Elif; Yılmaz, Serkan; Alyeşil, Cansu; Akalın, Latif Erdem

    2017-06-01

    The study aims to evaluate the efficacy and safety of intranasal lidocaine administration for migraine treatment. This single-center, double-blind, randomized, controlled trial was conducted in a tertiary care emergency department. Included patients met the migraine criteria of the International Headache Society. Patients were randomized to intranasal lidocaine or saline solution; all participants received 10 mg of intravenous metoclopramide. Patient pain intensity was assessed with an 11-point numeric rating scale score. The primary outcome measure was the change in pain scores at 15 minutes; secondary outcomes were changes in pain intensity after pain onset and need for rescue medication. Patients (n=162) were randomized into 2 groups with similar baseline migraine characteristics and numeric rating scale scores. The median reduction in numeric rating scale score at 15 minutes was 3 (interquartile range [IQR] 2 to 5) for the lidocaine group and 2 (IQR 1 to 4) for the saline solution group (median difference=1.0; 95% confidence interval 0.1 to 2.1). The reduction in pain score at 30 minutes was 4 (IQR 3 to 7) for the lidocaine group and 5 (IQR 2 to 7) for the saline solution group (median difference=1.0; 95% confidence interval 0.1 to 2.1). Need for rescue medication did not differ between the groups, and local irritation was the most common adverse event in the lidocaine group. Although intranasal lidocaine was found no more efficacious than normal saline solution in our study, future studies should focus on patients who present earlier after headache onset. Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  7. Early fiberoptic bronchoscopy during non-invasive ventilation in patients with decompensated chronic obstructive pulmonary disease due to community-acquired-pneumonia.

    Science.gov (United States)

    Scala, Raffaele; Naldi, Mario; Maccari, Uberto

    2010-01-01

    Inefficient clearance of copious respiratory secretion is a cause of non-invasive positive pressure ventilation (NPPV) failure, especially in chronic respiratory patients with community-acquired-pneumonia (CAP) and impaired consciousness. We postulated that in such a clinical scenario, when intubation and conventional mechanical ventilation (CMV) are strongly recommended, the suction of secretions with fiberoptic bronchoscopy (FBO) may increase the chance of NPPV success. The objective of this pilot study was, firstly, to verify the safety and effectiveness of early FBO during NPPV and, secondly, to compare the hospital outcomes of this strategy versus a CMV-based strategy in patients with decompensated chronic obstructive pulmonary disease (COPD) due to CAP who are not appropriate candidates for NPPV because of inefficient mucous clearance and hypercapnic encephalopathy (HE). This is a 12-month prospective matched case-control study performed in one respiratory semi-intensive care unit (RSICU) with expertise in NPPV and in one intensive care unit (ICU). Fifteen acutely decompensated COPD patients with copious secretion retention and HE due to CAP undergoing NPPV in RSICU, and 15 controls (matched for arterial blood gases, acute physiology and chronic health evaluation score III, Kelly-Matthay scale, pneumonia extension and severity) receiving CMV in the ICU were studied. Two hours of NPPV significantly improved arterial blood gases, Kelly and cough efficiency scores without FBO-related complications. NPPV avoided intubation in 12/15 patients (80%). Improvement in arterial blood gases was similar in the two groups, except for a greater PaO2/fraction of inspired oxygen ratio with CMV. The rates of overall and septic complications, and of tracheostomy were lower in the NPPV group (20%, 20%, and 0%) versus the CMV group (80%, 60%, and 40%; P < 0.05). Hospital mortality, duration of hospitalisation and duration of ventilation were similar in the two groups. In patients

  8. Acute management of propionic acidemia.

    Science.gov (United States)

    Chapman, Kimberly A; Gropman, Andrea; MacLeod, Erin; Stagni, Kathy; Summar, Marshall L; Ueda, Keiko; Ah Mew, Nicholas; Franks, Jill; Island, Eddie; Matern, Dietrich; Pena, Loren; Smith, Brittany; Sutton, V Reid; Urv, Tiina; Venditti, Charles; Chakrapani, Anupam

    2012-01-01

    Propionic acidemia or aciduria is an intoxication-type disorder of organic metabolism. Patients deteriorate in times of increased metabolic demand and subsequent catabolism. Metabolic decompensation can manifest with lethargy, vomiting, coma and death if not appropriately treated. On January 28-30, 2011 in Washington, D.C., Children's National Medical Center hosted a group of clinicians, scientists and parental group representatives to design recommendations for acute management of individuals with propionic acidemia. Although many of the recommendations are geared toward the previously undiagnosed neonate, the recommendations for a severely metabolically decompensated individual are applicable to any known patient as well. Initial management is critical for prevention of morbidity and mortality. The following manuscript provides recommendations for initial treatment and evaluation, a discussion of issues concerning transport to a metabolic center (if patient presents to a non-metabolic center), acceleration of management and preparation for discharge. Copyright © 2011. Published by Elsevier Inc. All rights reserved.

  9. Randomized comparison of tape versus semi-rigid and versus lace-up ankle support in the treatment of acute lateral ankle ligament injury

    NARCIS (Netherlands)

    van den Bekerom, M. P. J.; van Kimmenade, Robert; Sierevelt, I. N.; Eggink, Karin; Kerkhoffs, G. M. M. J.; van Dijk, C. N.; Raven, E. E. J.

    2016-01-01

    Functional treatment is the optimal non-surgical treatment for acute lateral ankle ligament injury (ALALI) in favour of immobilization treatment. There is no single most effective functional treatment (tape, semi-rigid brace or lace-up brace) based on currently available randomized trials. This

  10. Cost-Effectiveness of Primary Care Management With or Without Early Physical Therapy for Acute Low Back Pain: Economic Evaluation of a Randomized Clinical Trial.

    Science.gov (United States)

    Fritz, Julie M; Kim, Minchul; Magel, John S; Asche, Carl V

    2017-03-01

    Economic evaluation of a randomized clinical trial. Compare costs and cost-effectiveness of usual primary care management for patients with acute low back pain (LBP) with or without the addition of early physical therapy. Low back pain is among the most common and costly conditions encountered in primary care. Early physical therapy after a new primary care consultation for acute LBP results in small clinical improvement but cost-effectiveness of a strategy of early physical therapy is unknown. Economic evaluation was conducted alongside a randomized clinical trial of patients with acute, nonspecific LBP consulting a primary care provider. All patients received usual primary care management and education, and were randomly assigned to receive four sessions of physical therapy or usual care of delaying referral consideration to permit spontaneous recovery. Data were collected in a randomized trial involving 220 participants age 18 to 60 with LBP Early physical therapy resulted in higher total 1-year costs (mean difference in adjusted total costs = $580, 95% CI: $175, $984, P = 0.005) and better quality of life (mean difference in QALYs = 0.02, 95% CI: 0.005, 0.35, P = 0.008) after 1-year. The incremental cost-effectiveness ratio was $32,058 (95% CI: $10,629, $151,161) per QALY. Our results support early physical therapy as cost-effective relative to usual primary care after 1 year for patients with acute, nonspecific LBP. 2.

  11. ACUTE TOXICITY PROFILE AND COMPLIANCE TO ACCELERATED RADIOTHERAPY PLUS CARBOGEN AND NICOTINAMIDE FOR CLINICAL STAGE T2-4 LARYNGEAL CANCER : RESULTS OF A PHASE III RANDOMIZED TRIAL

    NARCIS (Netherlands)

    Janssens, Geert O.; Terhaard, Chris H.; Doornaert, Patricia A.; Bijl, Hendrik P.; van den Ende, Piet; Chin, Alim; Pop, Lucas A.; Kaanders, Johannes H.

    2012-01-01

    Purpose: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. Methods and Materials: From April 2001 to February 2008, 345 patients with

  12. Acute toxicity profile and compliance to accelerated radiotherapy plus carbogen and nicotinamide for clinical stage T2-4 laryngeal cancer: results of a phase III randomized trial.

    NARCIS (Netherlands)

    Janssens, G.O.R.J.; Terhaard, C.H.J.; Doornaert, P.A.; Bijl, H.P.; Ende, P. van den; Chin, A.; Pop, L.A.M.; Kaanders, J.H.A.M.

    2012-01-01

    PURPOSE: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. METHODS AND MATERIALS: From April 2001 to February 2008, 345 patients with

  13. MRI findings in acute hyperammonemic encephalopathy resulting from decompensated chronic liver disease.

    Science.gov (United States)

    Sureka, Jyoti; Jakkani, Ravi Kanth; Panwar, Sanuj

    2012-06-01

    Hyperammonemic encephalopathy is a type of metabolic encephalopathy with diversified etiology. Hyperammonemia is the end result of several metabolic disorders such as congenital deficiencies of urea cycle enzymes, hepatic encephalopathy, Reye's syndrome and other toxic encephalopathies. Non-specific clinical presentation poses a great challenge in early diagnosis of this entity. Irrespective of the underlying etiology, hyperammonemia causes a distinctive pattern of brain parenchymal injury. The cingulate gyrus and insular cortex are more vulnerable to this type of toxic insult. Characteristic magnetic resonance imaging findings in combination with laboratory parameters can help to differentiate this entity from other metabolic encephalopathy and thus aiding in early diagnosis and treatment.

  14. A prospective, randomized, trial of phenobarbital versus benzodiazepines for acute alcohol withdrawal.

    Science.gov (United States)

    Hendey, Gregory W; Dery, Robert A; Barnes, Randy L; Snowden, Brandy; Mentler, Philippe

    2011-05-01

    The aim of this study was to compare phenobarbital (PB) versus lorazepam (LZ) in the treatment of alcohol withdrawal in the emergency department (ED) and at 48 hours. Prospectively, randomized, consenting patients were assessed using a modified Clinical Institute Withdrawal Assessment (CIWA) score and given intravenous PB (mean, 509 mg) or LZ (mean, 4.2 mg). At discharge, LZ patients received chlordiazepoxide (Librium), and PB patients received placebo. Of 44 patients, 25 received PB, and 19 LZ. Both PB and LZ reduced CIWA scores from baseline to discharge (15.0-5.4 and 16.8-4.2, P alcohol withdrawal in the ED and at 48 hours. Copyright © 2011 Elsevier Inc. All rights reserved.

  15. Prognostic Factors for Survival at 6-Month Follow-up of Hospitalized Patients with Decompensated Congestive Heart Failure

    OpenAIRE

    Cheraghi, Mostafa; Sadeghi, Masoumeh; Sarrafzadegan, Nizal; Pourmoghadas, Ali; Ramezani, Mohammad Arash

    2010-01-01

    BACKGROUND The prevalence of Congestive Heart Failure (CHF) is increasing in recent years. Factors associated with mortality in CHF patients are important to be determined in order to select therapeutic modality by physicians. The purpose of the current study was to declare predictors of 6-months survival in patients hospitalized for decompensated CHF in Isfahan. METHODS A cohort of 301 hospitalized patients with decompensated CHF were recruited in this study. The diagnosis of CHF was based o...

  16. A randomized clinical trial of ibuprofen versus acetaminophen with codeine for acute pediatric arm fracture pain.

    Science.gov (United States)

    Drendel, Amy L; Gorelick, Marc H; Weisman, Steven J; Lyon, Roger; Brousseau, David C; Kim, Michael K

    2009-10-01

    We compare the treatment of pain in children with arm fractures by ibuprofen 10 mg/kg versus acetaminophen with codeine 1 mg/kg/dose (codeine component). This was a randomized, double-blind, clinical trial of children during the first 3 days after discharge from the emergency department (ED). The primary outcome was failure of the oral study medication, defined as use of the rescue medication. Pain medication use, pain scores, functional outcomes, adverse effects, and satisfaction were also assessed. Three hundred thirty-six children were randomized to treatment, 169 to ibuprofen and 167 to acetaminophen with codeine; 244 patients were analyzed. Both groups used a median of 4 doses (interquartile range 2, 6.5). The proportion of treatment failures for ibuprofen (20.3%) was lower than for acetaminophen with codeine (31.0%), though not statistically significant (difference=10.7%; 95% confidence interval -0.2 to 21.6). The proportion of children who had any function (play, sleep, eating, school) affected by pain when pain was analyzed by day after injury was significantly lower for the ibuprofen group. Significantly more children receiving acetaminophen with codeine reported adverse effects and did not want to use it for future fractures. Ibuprofen was at least as effective as acetaminophen with codeine for outpatient analgesia for children with arm fractures. There was no significant difference in analgesic failure or pain scores, but children receiving ibuprofen had better functional outcomes. Children receiving ibuprofen had significantly fewer adverse effects, and both children and parents were more satisfied with ibuprofen. Ibuprofen is preferable to acetaminophen with codeine for outpatient treatment of children with uncomplicated arm fractures.

  17. A randomized trial of aripiprazole vs blonanserin for the treatment of acute schizophrenia and related disorders

    Directory of Open Access Journals (Sweden)

    Kishi T

    2016-11-01

    Full Text Available Taro Kishi,1 Yuki Matsuda,1 Shinji Matsunaga,1 Tomohiko Mukai,1,2 Masatsugu Moriwaki,1,2 Hideaki Tabuse,3 Kiyoshi Fujita,2 Nakao Iwata1 1Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 2Department of Psychiatry, Okehazama Hospital, Toyoake, Aichi, 3Department of Psychiatry, Holy Cross Hospital, Toki, Gifu, Japan Objective: There has been no direct comparison of aripiprazole and blonanserin for schizophrenia treatment. We conducted a 24-week, rater-masked, randomized trial of aripiprazole (6-30 mg/d vs blonanserin (4-24 mg/d in schizophrenia patients who were not taking any antipsychotic medication for more than 2 weeks before enrollment (UMIN000011194.Methods: The primary outcome measure for efficacy was improvement of Positive and Negative Syndrome Scale (PANSS total score at week 24. Secondary outcomes were PANSS subscale scores, 21-item Hamilton Rating Scale for Depression (HAMD-21 score, response rate, discontinuation rate, and individual adverse events.Results: Forty-four patients were recruited. The discontinuation rate was 86.4% in the aripiprazole group and 68.2% in the blonanserin treatment group. There was no significant difference in mean time to discontinuation between the groups. Although both treatment groups showed significant reductions in the PANSS total score, PANSS subscale scores, and HAMD-21 scores at week 24, the magnitudes of the changes did not differ between the groups. There were no significant differences in the incidences of adverse events including somnolence, extrapyramidal symptoms, prolactin-related adverse events, and weight change between the groups.Conclusion: Our results suggest similar efficacy and safety profiles of aripiprazole and blonanserin in the patients with schizophrenia. Double-blind controlled studies are needed to further explore the efficacy and safety of aripiprazole and blonanserin in schizophrenia. Keywords: aripiprazole, blonanserin, schizophrenia

  18. Immediate and short-term pain relief by acute sciatic nerve press: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zhang Wenlong

    2007-05-01

    Full Text Available Abstract Background Despite much research, an immediately available, instantly effective and harmless pain relief technique has not been discovered. This study describes a new manipulation: a "2-minute sciatic nerve press", for rapid short-term relief of pain brought on by various dental and renal diseases. Methods This randomized, single-blind, placebo-controlled trial ran in three hospitals in Anhui Province, China, with an enrollment of 66 out of 111 solicited patients aged 16 to 74 years. Patients were recruited sequentially, by specific participating physicians at their clinic visits to three independent hospitals. The diseases in enrolled dental patients included dental caries, periodontal diseases and dental trauma. Renal diseases in recruits included kidney infections, stones and some other conditions. Patients were randomly assigned to receive the "2-minute sciatic nerve press" or the "placebo press". For the "2-minute sciatic nerve press", pressure was applied simultaneously to the sciatic nerves at the back of the thighs, using the fists while patients lay prone. For the "placebo press", pressure was applied simultaneously to a parallel spot on the front of the thighs, using the fists while patients lay supine. Each fist applied a pressure of 11 to 20 kg for 2 minutes, after which, patients arose to rate pain. Results The "2-minute sciatic nerve press" produced greater pain relief than the "placebo press". Within the first 10 minutes after sciatic pressure, immediate pain relief ratings averaged 66.4% (p Conclusion Two minutes of pressure on both sciatic nerves can produce immediate significant conduction analgesia, providing a convenient, safe and powerful way to overcome clinical pain brought on by dental diseases and renal diseases for short term purposes. Trial registration ACTR 12606000439549

  19. Colloid osmotic pressure in decompensated cirrhosis. A 'mirror image' of portal venous hypertension

    DEFF Research Database (Denmark)

    Henriksen, J H

    1985-01-01

    Colloid osmotic pressure in plasma (IIP) and ascitic fluid (IIA) and hydrostatic pressures in the hepatoportal system were measured simultaneously in 20 patients with decompensated cirrhosis. IIP was significantly decreased (mean, 21 mm Hg, versus normal, 30 mm Hg; P less than 0.01), and IIA....../IIP (r = -0.77, P less than 0.001). WHV--IVCP was in most patients in the same order as and closely correlated to effective colloid osmotic pressure (IIP--IIA) (r = 0.88, P less than 0.001). No relationship was found between WHV--IVCP and IIP. The results indicate that a fall in colloid osmotic pressure...... in the interstitial space and ascitic fluid is related to and most likely secondary to the elevated portal pressure in decompensated cirrhosis. Effective colloid osmotic pressure may therefore be regarded as a 'mirror image' of transmural portal pressure. The role of colloid osmotic pressure in the genesis...

  20. Corneal decompensation following filtering surgery with the Ex-PRESS® mini glaucoma shunt device

    Directory of Open Access Journals (Sweden)

    Tojo N

    2015-03-01

    Full Text Available Naoki Tojo, Atsushi Hayashi, Akio Miyakoshi Department of Ophthalmology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan Purpose: To report a case of corneal decompensation due to the Ex-PRESS® mini glaucoma shunt device (Ex-PRESS.Patient and methods: A 75-year-old man had pseudoexfoliation glaucoma in his right eye. He underwent filtration surgery with Ex-PRESS. His intraocular pressure was 7 mmHg after 9 months.Results: We observed partial decompensation of the corneal endothelium adjacent to the filtering bleb. Specular microscopy revealed a marked decrease in the endothelial cell density at the center of the cornea.Conclusion: Anterior segment optical coherence tomography is very useful for evaluating corneal edema and the position of Ex-PRESS. It is important to follow up with an examination of the corneal endothelial cells. Keywords: Ex-PRESS, bullous keratopathy, trabeculectomy, complication, cornea 

  1. Effect of Oral Dexamethasone Without Immediate Antibiotics vs Placebo on Acute Sore Throat in Adults: A Randomized Clinical Trial.

    Science.gov (United States)

    Hayward, Gail Nicola; Hay, Alastair D; Moore, Michael V; Jawad, Sena; Williams, Nicola; Voysey, Merryn; Cook, Johanna; Allen, Julie; Thompson, Matthew; Little, Paul; Perera, Rafael; Wolstenholme, Jane; Harman, Kim; Heneghan, Carl

    2017-04-18

    Acute sore throat poses a significant burden on primary care and is a source of inappropriate antibiotic prescribing. Corticosteroids could be an alternative symptomatic treatment. To assess the clinical effectiveness of oral corticosteroids for acute sore throat in the absence of antibiotics. Double-blind, placebo-controlled randomized trial (April 2013-February 2015; 28-day follow-up completed April 2015) conducted in 42 family practices in South and West England, enrolled 576 adults recruited on the day of presentation to primary care with acute sore throat not requiring immediate antibiotic therapy. Single oral dose of 10 mg of dexamethasone (n = 293) or identical placebo (n = 283). Primary: proportion of participants experiencing complete resolution of symptoms at 24 hours. Secondary: complete resolution at 48 hours, duration of moderately bad symptoms (based on a Likert scale, 0, normal; 6, as bad as it could be), visual analog symptom scales (0-100 mm; 0, no symptom to 100, worst imaginable), health care attendance, days missed from work or education, consumption of delayed antibiotics or other medications, adverse events. Among 565 eligible participants who were randomized (median age, 34 years [interquartile range, 26.0-45.5 year]; 75.2% women; 100% completed the intervention), 288 received dexamethasone; 277, placebo. At 24 hours, 65 participants (22.6%) in the dexamethasone group and 49 (17.7%) in the placebo group achieved complete resolution of symptoms, for a risk difference of 4.7% (95% CI, -1.8% to 11.2%) and a relative risk of 1.28 (95% CI; 0.92 to 1.78; P = .14). At 24 hours, participants receiving dexamethasone were not more likely than those receiving placebo to have complete symptom resolution. At 48 hours, 102 participants (35.4%) in the dexamethasone group vs 75 (27.1%) in the placebo group achieved complete resolution of symptoms, for a risk difference of 8.7% (95% CI, 1.2% to 16.2%) and a relative risk of 1.31 (95% CI, 1.02 to 1

  2. The effectiveness of ibuprofen and lorazepam combination therapy in treating the symptoms of acute Migraine: A randomized clinical trial

    Science.gov (United States)

    Rad, Reza Ebrahimi; Ghaffari, Fatemeh; Fotokian, Zahra; Ramezani, Azadeh

    2017-01-01

    Background Migraine is a common, episodic and debilitating disease. The migraineur not only suffers from pain, but also lives with a diminished to poor quality of life. Several medicinal therapies are used to abate the debilitating symptoms of this disease. Objective The present study was conducted to determine the effectiveness of Ibuprofen and Lorazepam combination therapy in treating the symptoms of acute migraine. Methods The present randomized clinical trial study used the pretest-posttest design with three comparison treatments, to examine 90 patients with an average of two to six attacks per month and an initial diagnosis of migraine based on the International Headache Society (HIS) criteria. The study was conducted on patients during the first half of 2014 with a diagnosis of acute migraine attack who were referred to Babol Ayatollah Rouhani Hospital in Iran. The patients were randomly divided into three groups of 30. The first group was administered 200 mg Ibuprofen capsules, the second group 400 mg Ibuprofen capsules and the third group a combination of 200 mg Ibuprofen capsules and 1 mg Lorazepam tablets. The medications were taken in the presence of the researcher. A checklist was used to assess the severity of headache and other migraine symptoms such as nausea, vomiting, photophobia and phonophobia in the patients, before and two hours after the intervention. Data were analyzed in SPSS-18 using the Mann-Whitney test, the McNemar test, Wilcoxon’s test, the NOVA and the Chi-squared test at the significance level of p<0.05, and power analysis with 30 patients in each group to perform this study was 0.8(1-β). Results The mean age of participants was reported as 52±8 years and the condition was more frequent in women (56%). All three treatment regimens reduced the severity of headache significantly in the patients (p<0.001); nevertheless, the combination therapy used, produced the lowest mean severity of headache (p<0.001). The highest reduction in

  3. Use of Wavelet Transform to Detect Compensated and Decompensated Stages in the Congestive Heart Failure Patient

    Directory of Open Access Journals (Sweden)

    Pratibha Sharma

    2017-09-01

    Full Text Available This research work is aimed at improving health care, reducing cost, and the occurrence of emergency hospitalization in patients with Congestive Heart Failure (CHF by analyzing heart and lung sounds to distinguish between the compensated and decompensated states. Compensated state defines stable state of the patient but with lack of retention of fluids in lungs, whereas decompensated state leads to unstable state of the patient with lots of fluid retention in the lungs, where the patient needs medication. Acoustic signals from the heart and the lung were analyzed using wavelet transforms to measure changes in the CHF patient’s status from the decompensated to compensated and vice versa. Measurements were taken on CHF patients diagnosed to be in compensated and decompensated states by using a digital stethoscope and electrocardiogram (ECG in order to monitor their progress in the management of their disease. Analysis of acoustic signals of the heart due to the opening and closing of heart valves as well as the acoustic signals of the lungs due to respiration and the ECG signals are presented. Fourier, short-time Fourier, and wavelet transforms are evaluated to determine the best method to detect shifts in the status of a CHF patient. The power spectra obtained through the Fourier transform produced results that differentiate the signals from healthy people and CHF patients, while the short-time Fourier transform (STFT technique did not provide the desired results. The most promising results were obtained by using wavelet analysis. Wavelet transforms provide better resolution, in time, for higher frequencies, and a better resolution, in frequency, for lower frequencies.

  4. Impact of physician specialty on quality care for patients hospitalized with decompensated cirrhosis.

    Directory of Open Access Journals (Sweden)

    Nicholas Lim

    Full Text Available Decompensated cirrhosis is a common precipitant for hospitalization, and there is limited information concerning factors that influence the delivery of quality care in cirrhotic inpatients. We sought to determine the relation between physician specialty and inpatient quality care for decompensated cirrhosis.We reviewed 247 hospital admissions for decompensated cirrhosis, managed by hospitalists or intensivists, between 2009 and 2013. The primary outcome was quality care delivery, defined as adherence to all evidence-based specialty society practice guidelines pertaining to each specific complication of cirrhosis. Secondary outcomes included new complications, length-of-stay, and in-hospital death.Overall, 147 admissions (59.5% received quality care. Quality care was given more commonly by intensivists, compared with hospitalists (71.7% vs. 53.1%, P = .006, and specifically for gastrointestinal bleeding (72% vs. 45.8%, P = .03 and hepatic encephalopathy (100% vs. 63%, P = .005. Involvement of gastroenterology consultation was also more common in admissions in which quality care was administered (68.7% vs. 54.0%, P = .023. Timely diagnostic paracentesis was associated with reduced new complications in admissions for refractory ascites (9.5% vs. 46.6%, P = .02, and reduced length-of-stay in admissions for spontaneous bacterial peritonitis (5 days vs. 13 days, P = .02.Adherence to quality indicators for decompensated cirrhosis is suboptimal among hospitalized patients. Although quality care adherence appears to be higher among cirrhotic patients managed by intensivists than by hospitalists, opportunities for improvement exist in both groups. Rational and cost-effective strategies should be sought to achieve this end.

  5. Orthodontic decompensation in skeletal Class III malocclusion: redefining the amount of movement assessed by Cone-Beam Computed Tomography

    Directory of Open Access Journals (Sweden)

    José Antonio Zuega Cappellozza

    2015-10-01

    Full Text Available Introduction:Cone-Beam Computed Tomography (CBCT is essential for tridimensional planning of orthognathic surgery, as it allows visualization and evaluation of bone structures and mineralized tissues. Tomographic slices allow evaluation of tooth inclination and individualization of movement performed during preoperative decompensation. The aim of this paper was to assess maxillary and mandibular incisors inclination pre and post orthodontic decompensation in skeletal Class III malocclusion.Methods:The study was conducted on six individuals with skeletal Class III malocclusion, surgically treated, who had Cone-Beam Computed Tomographic scans obtained before and after orthodontic decompensation. On multiplanar reconstruction view, tomographic slices (axial, coronal and sagittal were obtained on the long axis of each incisor. The sagittal slice was used for measurement taking, whereas the references used to assess tooth inclination were the long axis of maxillary teeth in relation to the palatal plane and the long axis of mandibular teeth in relation to the mandibular plane.Results:There was significant variation in the inclination of incisors before and after orthodontic decompensation. This change was of greater magnitude in the mandibular arch, evidencing that natural compensation is more effective in this arch, thereby requiring more intensive decompensation.Conclusion:When routinely performed, the protocols of decompensation treatment in surgical individuals often result in intensive movements, which should be reevaluated, since the extent of movement predisposes to reduction in bone attachment levels and root length.

  6. RECAST (Remote Ischemic Conditioning After Stroke Trial): A Pilot Randomized Placebo Controlled Phase II Trial in Acute Ischemic Stroke.

    Science.gov (United States)

    England, Timothy J; Hedstrom, Amanda; O'Sullivan, Saoirse; Donnelly, Richard; Barrett, David A; Sarmad, Sarir; Sprigg, Nikola; Bath, Philip M

    2017-05-01

    Repeated episodes of limb ischemia and reperfusion (remote ischemic conditioning [RIC]) may improve outcome after acute stroke. We performed a pilot blinded placebo-controlled trial in patients with acute ischemic stroke, randomized 1:1 to receive 4 cycles of RIC within 24 hours of ictus. The primary outcome was tolerability and feasibility. Secondary outcomes included safety, clinical efficacy (day 90), putative biomarkers (pre- and post-intervention, day 4), and exploratory hemodynamic measures. Twenty-six patients (13 RIC and 13 sham) were recruited 15.8 hours (SD 6.2) post-onset, age 76.2 years (SD 10.5), blood pressure 159/83 mm Hg (SD 25/11), and National Institutes of Health Stroke Scale (NIHSS) score 5 (interquartile range, 3.75-9.25). RIC was well tolerated with 49 out of 52 cycles completed in full. Three patients experienced vascular events in the sham group: 2 ischemic strokes and 2 myocardial infarcts versus none in the RIC group ( P =0.076, log-rank test). Compared with sham, there was a significant decrease in day 90 NIHSS score in the RIC group, median NIHSS score 1 (interquartile range, 0.5-5) versus 3 (interquartile range, 2-9.5; P =0.04); RIC augmented plasma HSP27 (heat shock protein 27; P stroke is well tolerated and appears safe and feasible. RIC may improve neurological outcome, and protective mechanisms may be mediated through HSP27. A larger trial is warranted. URL: http://www.isrctn.com. Unique identifier: ISRCTN86672015. © 2017 American Heart Association, Inc.

  7. Regulation of Lipolysis and Adipose Tissue Signaling during Acute Endotoxin-Induced Inflammation: A Human Randomized Crossover Trial.

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    Rittig, Nikolaj; Bach, Ermina; Thomsen, Henrik Holm; Pedersen, Steen Bønlykke; Nielsen, Thomas Sava; Jørgensen, Jens O; Jessen, Niels; Møller, Niels

    2016-01-01

    Lipolysis is accelerated during the acute phase of inflammation, a process being regulated by pro-inflammatory cytokines (e.g. TNF-α), stress-hormones, and insulin. The intracellular mechanisms remain elusive and we therefore measured pro- and anti-lipolytic signaling pathways in adipocytes after in vivo endotoxin exposure. Eight healthy, lean, male subjects were investigated using a randomized cross over trial with two interventions: i) bolus injection of saline (Placebo) and ii) bolus injection of lipopolysaccharide endotoxin (LPS). A 3H-palmitate tracer was used to measure palmitate rate of appearance (Rapalmitate) and indirect calorimetry was performed to measure energy expenditures and lipid oxidation rates. A subcutaneous abdominal fat biopsy was obtained during both interventions and subjected to western blotting and qPCR quantifications. LPS caused a mean increase in serum free fatty acids (FFA) concentrations of 90% (CI-95%: 37-142, p = 0.005), a median increase in Rapalmitate of 117% (CI-95%: 77-166, ptrend towards elevated pHSL at ser552 (p = 0.09) and cAMP-dependent protein kinase A (PKA) phosphorylation of perilipin 1 (PLIN1) (p = 0.09). Phosphatase and tensin homolog (PTEN) also tended to increase (p = 0.08) while phosphorylation of Akt at Thr308 tended to decrease (p = 0.09) during LPS compared with Placebo. There was no difference between protein or mRNA expression of ATGL, G0S2, and CGI-58. LPS stimulated lipolysis in adipose tissue and is associated with increased pHSL and signs of increased PLIN1 phosphorylation combined with a trend toward decreased insulin signaling. The combination of these mechanisms appear to be the driving forces behind the increased lipolysis observed in the early stages of acute inflammation and sepsis. ClinicalTrials.gov NCT01705782.

  8. Acute and second-meal effects of almond form in impaired glucose tolerant adults: a randomized crossover trial

    Directory of Open Access Journals (Sweden)

    Considine Robert V

    2011-01-01

    Full Text Available Abstract Background Nut consumption may reduce the risk of developing type 2 diabetes. The aim of the current study was to measure the acute and second-meal effects of morning almond consumption and determine the contribution of different nut fractions. Methods Fourteen impaired glucose tolerant (IGT adults participated in a randomized, 5-arm, crossover design study where whole almonds (WA, almond butter (AB, defatted almond flour (AF, almond oil (AO or no almonds (vehicle - V were incorporated into a 75 g available carbohydrate-matched breakfast meal. Postprandial concentrations of blood glucose, insulin, non-esterified free fatty acids (NEFA, glucagon-like peptide-1 (GLP-1 and appetitive sensations were assessed after treatment breakfasts and a standard lunch. Results WA significantly attenuated second-meal and daylong blood glucose incremental area under the curve (AUCI and provided the greatest daylong feeling of fullness. AB and AO decreased blood glucose AUCI in the morning period and daylong blood glucose AUCI was attenuated with AO. WA and AO elicited a greater second-meal insulin response, particularly in the early postprandial phase, and concurrently suppressed the second-meal NEFA response. GLP-1 concentrations did not vary significantly between treatments. Conclusions Inclusion of almonds in the breakfast meal decreased blood glucose concentrations and increased satiety both acutely and after a second-meal in adults with IGT. The lipid component of almonds is likely responsible for the immediate post-ingestive response, although it cannot explain the differential second-meal response to AB versus WA and AO.

  9. Amino acid supplementation is anabolic during the acute phase of endotoxin-induced inflammation: A human randomized crossover trial.

    Science.gov (United States)

    Rittig, N; Bach, E; Thomsen, H H; Johannsen, M; Jørgensen, J O; Richelsen, B; Jessen, N; Møller, N

    2016-04-01

    Inflammation is catabolic and causes muscle loss. It is unknown if amino acid supplementation reverses these effects during the acute phase of inflammation. The aim was to test whether amino acid supplementation counteracts endotoxin-induced catabolism. Eight young, healthy, lean males were investigated three times in randomized order: (i) normal conditions (Placebo), (ii) endotoxemia (LPS), and (iii) endotoxemia with amino acid supplementation (LPS + A). Protein kinetics were determined using phenylalanine, tyrosine, and urea tracers. Each study day consisted of a four-hour non-insulin stimulated period and a two-hour hyperinsulinemic euglycemic clamp period. Muscle biopsies were collected once each period. Endotoxin administration created a significant inflammatory response (cytokines, hormones, and vital parameters) without significant differences between LPS and LPS + A. Whole body protein breakdown was elevated during LPS compared with Placebo and LPS + A (p translation factor 4E-binding protein 1 (4EBP1) phosphorylation (p = 0.007) without activating AMPK or affecting insulin signaling through Akt. During insulin stimulation net muscle phenylalanine release and protein degradation were further reduced. Amino acid supplementation in the acute phase of inflammation reduces whole body and muscle protein loss, and this effect is associated with activation of mTOR and downstream signaling to protein synthesis through mTORC1, suggesting a therapeutic role for intravenous amino acids in inflammatory states. The Central Denmark Region Ethics Commitee (1-10-71-410-12) www.clinicaltrials.gov (identification number NCT01705782). Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  10. A randomized clinical trial of high volume peritoneal dialysis versus extended daily hemodialysis for acute kidney injury patients.

    Science.gov (United States)

    Ponce, D; Berbel, M N; Abrão, J M G; Goes, C R; Balbi, A L

    2013-06-01

    Acute kidney injury (AKI) requiring dialysis in critically ill patients is associated with an in-hospital mortality rate of 50-80 %. Extended daily hemodialysis (EHD) and high volume peritoneal dialysis (HVPD) have emerged as alternative modalities. A double-center, randomized, controlled trial was conducted comparing EHD versus HVPD for the treatment for AKI in the intensive care unit (ICU). Four hundred and seven patients were randomized and 143 patients were analyzed. Principal outcome measure was hospital mortality, and secondary end points were recovery of renal function and metabolic and fluid control. There was no difference between the two groups in relation to median ICU stay [11 (5.7-20) vs. 9 (5.7-19)], recovery of kidney function (26.9 vs. 29.6 %, p = 0.11), need for chronic dialysis (9.7 vs. 6.5 %, p = 0.23), and hospital mortality (63.4 vs. 63.9 %, p = 0.94). The groups were different in metabolic and fluid control. Blood urea nitrogen (BUN), creatinine, and bicarbonate levels were stabilized faster in EHD group than in HVPD group. Delivered Kt/V and ultrafiltration were higher in EHD group. Despite randomization, there were significant differences between the groups in some covariates, including age, pre-dialysis BUN, and creatinine levels, biased in favor of the EHD. Using logistic regression to adjust for the imbalances in group assignment, the odds of death associated with HVPD was 1.4 (95 % CI 0.7-2.4, p = 0.19). A detailed investigation of the randomization process failed to explain the marked differences in patient assignment. Despite faster metabolic control and higher dialysis dose and ultrafiltration with EHD, this study provides no evidence of a survival benefit of EHD compared with HVPD. The limitations of this study were that the results were not presented according to the intention to treat and it did not control other supportive management strategies as nutrition support and timing of dialysis initiation that might influence outcomes in

  11. Submucosal Diclofenac for Acute Postoperative Pain in Third Molar Surgery: A Randomized, Controlled Clinical Trial.

    Science.gov (United States)

    Gorecki, P; Rainsford, K D; Taneja, P; Bulsara, Y; Pearson, D; Saund, D; Ahmed, B; Dietrich, T

    2017-12-01

    Diclofenac sodium is a widely used nonsteroidal anti-inflammatory drug (NSAID) for relief of inflammatory pain. A recent formulation combines this drug with hydroxypropyl-β-cyclodextrin (HPβCD) to improve its solubility and to enable subcutaneous administration. Previous studies confirmed the efficacy of this combination. This study's aim was to evaluate the efficacy, safety, and local tolerability of diclofenac HPβCD administered as a local submucosal injection prior to lower third molar surgery. We conducted a prospective, randomized, double-blind, placebo-controlled, parallel-group phase II single-center study. Seventy-five patients requiring mandibular third molar surgery were randomized into 1 of 5 groups: 5 mg/1 mL diclofenac HPβCD, 12.5 mg/1 mL diclofenac HPβCD, 25 mg/1 mL diclofenac HPβCD, 50 mg/1 mL diclofenac HPβCD, or 1 mL placebo. The respective study drug was injected into the mucosal tissue surrounding the surgical site prior to surgery following achievement of local anesthesia. The primary outcome measure was the area under the curve (AUC) of cumulative pain scores from end of surgery to 6 h postsurgery. This demonstrated a global treatment effect between the active groups and placebo, hence confirming the study drug's efficacy ( P = 0.0126). Secondary outcome measures included the time until onset of pain and the time until patients required rescue medication, both showing statistical significance of the study drug compared to placebo ( P < 0.0161 and P < 0.0001, respectively). The time until rescue medication ranged between 7.8 h (for 25 mg/1 mL diclofenac HPβCD) and 16 h (for 50 mg/1 mL diclofenac HPβCD). Interestingly, the 5-mg/1-mL solution appeared superior to the 12.5-mg/1-mL and 25-mg/1-mL solutions (time until rescue medication = 12.44 h). A total of 14% of patients experienced minor adverse drug reactions (ADRs), of which 2 cases demonstrated flap necrosis. These resolved without further intervention. The study results overall

  12. Nicoboxil/nonivamide cream effectively and safely reduces acute nonspecific low back pain – a randomized, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Blahova Z

    2016-12-01

    Full Text Available Zuzana Blahova,1 Janina Claudia Holm,1 Thomas Weiser,2 Erika Richter,2 Matthias Trampisch,2 Elena Akarachkova3 1Boehringer Ingelheim RCV GmbH & Co KG, Vienna, Austria; 2Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim am Rhein, Germany; 3I.M. Sechenov First Moscow State Medical University, Moscow, Russian Federation Background/objective: Low back pain affects many patients and has a high socioeconomic impact. Topical capsaicinoids have been used for decades to treat musculoskeletal pain. This study investigated the effects of the fixed dose combination (FDC of nonivamide (a capsaicinoid and nicoboxil (a nicotinic acid ester cream in the treatment of acute nonspecific low back pain.Materials and methods: This phase III randomized, double-blind, placebo-controlled, multinational, multi-center trial investigated efficacy, safety, and tolerability of topical nicoboxil 1.08%/nonivamide 0.17% (Finalgon® cream in treatment of acute nonspecific low back pain with the endpoints: pain intensity (PI difference between pre-dose baseline and 8 hours after first application and the end of treatment, mobility score, and efficacy score.Results: Patients (n=138, 21–65 years of age, were treated for up to 4 days with FDC or placebo cream. Mean baseline PI was 6.8 on a 0–10 point numerical rating scale. After 8 hours, pain was more reduced with the FDC than with placebo (adjusted means: 2.824 vs. 0.975 points; p<0.0001. On the last treatment day, mean pain reduction by the FDC was stronger than with placebo (adjusted means: 5.132 vs. 2.174 points; p<0.0001. Mobility on Day 1 was in favor of the FDC when compared to placebo (odds ratio [95% confidence interval {CI}]: 7.200 [3.609, 14.363], p<0.0001. At the end of treatment, patients treated with the FDC rated efficacy significantly higher than placebo (odds ratio [95% CI]: 11.370 [5.342, 24.199], p<0.0001. Both treatments were tolerated well. No serious adverse events were reported.Conclusion: Nicoboxil

  13. Comparison of oral montelukast with oral zileuton in acute asthma: A randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Rahul Magazine

    2016-01-01

    Full Text Available Background: Leukotriene modifiers have an established role in the management of chronic asthma but their role in acute asthma is still under evaluation. Objective: To study and compare the effects of oral montelukast with oral zileuton in acute asthma. Materials and Methods: This study included 120 asthmatics and was conducted from September 2012 to March 2014. Patients were randomized into three different groups to receive montelukast or zileuton or placebo in addition to standard treatment for asthma exacerbation. Peak expiratory flow rate (PEFR values, details of rescue medication and vital signs were recorded at 6 h, 12 h, 24 h, and 48 h of drug or placebo administration and at discharge. Additional recording was done in the morning (8-10 am following admission. The primary endpoint was the mean PEFR of each group at these time points; the secondary end point being the need for rescue medications. Results: The mean PEFR recordings of the three study groups - placebo, montelukast, and zileuton - respectively, at various time points were as follows: at 6 h (223.25 ± 90.40, 199.00 ± 82.52, 233.75 ± 84.05; P = 0.240; at 12 h (271.00 ± 109.38, 251.50 ± 101.44, 309.50 ± 129.63; P = 0.048; at 24 h (288.25 ± 114.26, 269.00 ± 107.51, 324.50 ± 127.88; P = 0.080; and at 48 h (295.00 ± 114.80, 293.50 ± 113.24, 344.75 ± 119.91; P = 0.015; discharge (305.00 ± 118.56, 305.25 ± 119.51, 361.25 ± 119.70; P = 0.010. The mean PEFR for the three study groups at 8-10 am on the morning following admission was 268.75 ± 111.43, 252.50 ± 99.99, 306.75 ± 114.44; P = 0.047. Total rescue doses needed were 10, 1, and 0, respectively (P = 0.049. Conclusion: Zileuton is better than montelukast as an additional drug in acute asthma and results in significant improvement in lung function, and reduction in the need for rescue medications.

  14. Prasugrel Versus Ticagrelor in Patients With Acute Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention: Multicenter Randomized PRAGUE-18 Study.

    Science.gov (United States)

    Motovska, Zuzana; Hlinomaz, Ota; Miklik, Roman; Hromadka, Milan; Varvarovsky, Ivo; Dusek, Jaroslav; Knot, Jiri; Jarkovsky, Jiri; Kala, Petr; Rokyta, Richard; Tousek, Frantisek; Kramarikova, Petra; Majtan, Bohumil; Simek, Stanislav; Branny, Marian; Mrozek, Jan; Cervinka, Pavel; Ostransky, Jiri; Widimsky, Petr

    2016-11-22

    No randomized head-to-head comparison of the efficacy and safety of ticagrelor and prasugrel has been published in the 7 years since the higher efficacy of these newer P2Y12 inhibitors were first demonstrated relative to clopidogrel. This academic study was designed to compare the efficacy and safety of prasugrel and ticagrelor in acute myocardial infarction treated with primary or immediate percutaneous coronary intervention. A total of 1230 patients were randomly assigned across 14 sites to either prasugrel or ticagrelor, which was initiated before percutaneous coronary intervention. Nearly 4% were in cardiogenic shock, and 5.2% were on mechanical ventilation. The primary end point was defined as death, reinfarction, urgent target vessel revascularization, stroke, or serious bleeding requiring transfusion or prolonging hospitalization at 7 days (to reflect primarily the in-hospital phase). This analysis presents data from the first 30 days (key secondary end point). The total follow-up will be 1 year for all patients and will be completed in 2017. The study was prematurely terminated for futility. The occurrence of the primary end point did not differ between groups receiving prasugrel and ticagrelor (4.0% and 4.1%, respectively; odds ratio, 0.98; 95% confidence interval, 0.55-1.73; P=0.939). No significant difference was found in any of the components of the primary end point. The occurrence of key secondary end point within 30 days, composed of cardiovascular death, nonfatal myocardial infarction, or stroke, did not show any significant difference between prasugrel and ticagrelor (2.7% and 2.5%, respectively; odds ratio, 1.06; 95% confidence interval, 0.53-2.15; P=0.864). This head-to-head comparison of prasugrel and ticagrelor does not support the hypothesis that one is more effective or safer than the other in preventing ischemic and bleeding events in the acute phase of myocardial infarction treated with a primary percutaneous coronary intervention strategy

  15. The Comprehensive Post-Acute Stroke Services (COMPASS) study: design and methods for a cluster-randomized pragmatic trial.

    Science.gov (United States)

    Duncan, Pamela W; Bushnell, Cheryl D; Rosamond, Wayne D; Jones Berkeley, Sara B; Gesell, Sabina B; D'Agostino, Ralph B; Ambrosius, Walter T; Barton-Percival, Blair; Bettger, Janet Prvu; Coleman, Sylvia W; Cummings, Doyle M; Freburger, Janet K; Halladay, Jacqueline; Johnson, Anna M; Kucharska-Newton, Anna M; Lundy-Lamm, Gladys; Lutz, Barbara J; Mettam, Laurie H; Pastva, Amy M; Sissine, Mysha E; Vetter, Betsy

    2017-07-17

    Patients discharged home after stroke face significant challenges managing residual neurological deficits, secondary prevention, and pre-existing chronic conditions. Post-discharge care is often fragmented leading to increased healthcare costs, readmissions, and sub-optimal utilization of rehabilitation and community services. The COMprehensive Post-Acute Stroke Services (COMPASS) Study is an ongoing cluster-randomized pragmatic trial to assess the effectiveness of a comprehensive, evidence-based, post-acute care model on patient-centered outcomes. Forty-one hospitals in North Carolina were randomized (as 40 units) to either implement the COMPASS care model or continue their usual care. The recruitment goal is 6000 patients (3000 per arm). Hospital staff ascertain and enroll patients discharged home with a clinical diagnosis of stroke or transient ischemic attack. Patients discharged from intervention hospitals receive 2-day telephone follow-up; a comprehensive clinic visit within 2 weeks that includes a neurological evaluation, assessments of social and functional determinants of health, and an individualized COMPASS Care Plan™ integrated with a community-specific resource database; and additional follow-up calls at 30 and 60 days post-stroke discharge. This model is consistent with the Centers for Medicare and Medicaid Services transitional care management services provided by physicians or advanced practice providers with support from a nurse to conduct patient assessments and coordinate follow-up services. Patients discharged from usual care hospitals represent the control group and receive the standard of care in place at that hospital. Patient-centered outcomes are collected from telephone surveys administered at 90 days. The primary endpoint is patient-reported functional status as measured by the Stroke Impact Scale 16. Secondary outcomes are: caregiver strain, all-cause readmissions, mortality, healthcare utilization, and medication adherence. The

  16. Does epicatechin contribute to the acute vascular function effects of dark chocolate? A randomized, crossover study.

    Science.gov (United States)

    Dower, James I; Geleijnse, Johanna M; Kroon, Paul A; Philo, Mark; Mensink, Marco; Kromhout, Daan; Hollman, Peter C H

    2016-11-01

    Cocoa, rich in flavan-3-ols, improves vascular function, but the contribution of specific flavan-3-ols is unknown. We compared the effects of pure epicatechin, a major cocoa flavan-3-ol, and chocolate. In a randomized crossover study, twenty healthy men (40-80 years) were supplemented with: (1) 70g dark chocolate (150 mg epicatechin) with placebo capsules; (2) pure epicatechin capsules (2 × 50 mg epicatechin) with 75g white chocolate; and (3) placebo capsules with 75 g white chocolate (0 mg epicatechin). Vascular function (flow-mediated dilation (FMD) and augmentation index (AIx)) were measured before and 2 hours after interventions. Epicatechin metabolites time-profiles were measured in blood to calculate the bioavailability. Pure epicatechin did not significantly improve FMD (+0.75%; p = 0.10) or AIx (-2.2%; p = 0.23) compared to placebo. Dark chocolate significantly improved FMD (+0.96%; p = 0.04) and AIx (-4.6%; p = 0.02). Differences in improvements in FMD (+ 0.21%; p = 0.65) or Aix (-2.4%; p = 0.20) between pure epicatechin and dark chocolate were not significant. The bioavailability of epicatechin did not differ between pure epicatechin and dark chocolate (p = 0.14). Despite differences in epicatechin dose, improvements in vascular function after pure epicatechin and chocolate were similar and the bioavailability did not differ, suggesting a role for epicatechin. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  17. A randomized trial of aripiprazole vs blonanserin for the treatment of acute schizophrenia and related disorders.

    Science.gov (United States)

    Kishi, Taro; Matsuda, Yuki; Matsunaga, Shinji; Mukai, Tomohiko; Moriwaki, Masatsugu; Tabuse, Hideaki; Fujita, Kiyoshi; Iwata, Nakao

    2016-01-01

    There has been no direct comparison of aripiprazole and blonanserin for schizophrenia treatment. We conducted a 24-week, rater-masked, randomized trial of aripiprazole (6-30 mg/d) vs blonanserin (4-24 mg/d) in schizophrenia patients who were not taking any antipsychotic medication for more than 2 weeks before enrollment (UMIN000011194). The primary outcome measure for efficacy was improvement of Positive and Negative Syndrome Scale (PANSS) total score at week 24. Secondary outcomes were PANSS subscale scores, 21-item Hamilton Rating Scale for Depression (HAMD-21) score, response rate, discontinuation rate, and individual adverse events. Forty-four patients were recruited. The discontinuation rate was 86.4% in the aripiprazole group and 68.2% in the blonanserin treatment group. There was no significant difference in mean time to discontinuation between the groups. Although both treatment groups showed significant reductions in the PANSS total score, PANSS subscale scores, and HAMD-21 scores at week 24, the magnitudes of the changes did not differ between the groups. There were no significant differences in the incidences of adverse events including somnolence, extrapyramidal symptoms, prolactin-related adverse events, and weight change between the groups. Our results suggest similar efficacy and safety profiles of aripiprazole and blonanserin in the patients with schizophrenia. Double-blind controlled studies are needed to further explore the efficacy and safety of aripiprazole and blonanserin in schizophrenia.

  18. Effect of Acute Noise Exposure on Salivary Cortisol: A Randomized Controlled Trial.

    Science.gov (United States)

    Pouryaghoub, Gholamreza; Mehrdad, Ramin; Valipouri, Alireza

    2016-10-01

    Cardiovascular adverse effects are interesting aspects of occupational noise exposure. One possible mechanism of these effects is an alternation in hypothalamic-pituitary-adrenal axis. Our aim was to measure salivary cortisol response to relatively high-intensity noise exposure in a controlled randomized trial study. We exposed 50 male volunteers to 90 dBA noise for 20 minutes and compared their level of salivary cortisol with 50 non-exposed controls. Salivary samples obtained before and after exposure. Before intervention means (SD) salivary cortisol level were 3.24 (0.47)ng/ml and 3.25 (0.41)ng/ml for exposed and non-exposed groups respectively. Mean salivary cortisol level increased to 4.17 ng/mlafter intervention in exposure group. This increment was statistically significant (P=0.00). Mean salivary cortisol level of the non-exposed group had statistically non-significant decrement after this period (0.2 ng/ml). The difference between salivary cortisol level of non-exposed and exposed groups after the intervention was statistically significant. Noise exposure may affect the hypothalamic-pituitary-adrenal axis activity, and this may be one of the mechanisms of noise exposure cardiovascular effects.

  19. Conservative management equally effective to new suture anchor technique for acute mallet finger deformity: A prospective randomized clinical trial.

    Science.gov (United States)

    Batıbay, Sefa Giray; Akgül, Turgut; Bayram, Serkan; Ayık, Ömer; Durmaz, Hayati

    2017-09-28

    Prospective randomized controlled trial. This study was designed to compare our new suture anchor technique with conservative management in acute Wehbe-Schneider type I A-B and II A-B mallet fingers. Twenty nine patients who presented to our clinic between 2013 and 2015 were randomized for surgical or conservative treatment. Wehbe-Schneider subtype C fractures were excluded. Fourteen were treated with surgery, and 15 were treated with conservative treatment. Primary outcomes were visual analog scale score, active distal interphalangeal (DIP) joint flexion, return to work, extension deficit and DIP joint degeneration. Follow-up time was 12 months. The mean visual analog scale was 2.0, and return to work was on average in 63.2 days in the surgical group and 1.47 and 53.7 days in the conservative group. Extension deficit was 8.1° in the surgical group and 6.1° in the conservative group. The mean DIP flexion at final follow-up was 54.5° (40-65) in the surgery group and 58.3° (45-70) in the conservative group. DIP joint degeneration was observed with X-rays in 4 patients in surgical group, and none of the patients in the conservative group had DIP degeneration at 1 year after treatment. The therapeutic effectiveness of suture anchor technique was not statistically different from conservative treatment. Subluxation seen after fixation treatment with suture anchors may be due to inadequate anchor fixation. DIP joint degeneration was seen significantly more in the surgical group. Our study suggests that the new suture anchor technique is not superior to conservative treatment. Ib. Copyright © 2017 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

  20. A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel

    Science.gov (United States)

    Cruser, des Anges; Maurer, Douglas; Hensel, Kendi; Brown, Sarah K; White, Kathryn; Stoll, Scott T

    2012-01-01

    Objective Acute low back pain (ALBP) may limit mobility and impose functional limitations in active duty military personnel. Although some manual therapies have been reported effective for ALBP in military personnel, there have been no published randomized controlled trials (RCTs) of osteopathic manipulative treatment (OMT) in the military. Furthermore, current military ALBP guidelines do not specifically include OMT. Methods This RCT examined the efficacy of OMT in relieving ALBP and improving functioning in military personnel at Fort Lewis, Washington. Sixty-three male and female soldiers ages 18 to 35 were randomly assigned to a group receiving OMT plus usual care or a group receiving usual care only (UCO). Results The primary outcome measures were pain on the quadruple visual analog scale, and functioning on the Roland Morris Disability Questionnaire. Outcomes were measured immediately preceding each of four treatment sessions and at four weeks post-trial. Intention to treat analysis found significantly greater post-trial improvement in ‘Pain Now’ for OMT compared to UCO (P = 0·026). Furthermore, the OMT group reported less ‘Pain Now’ and ‘Pain Typical’ at all visits (P = 0·025 and P = 0·020 respectively). Osteopathic manipulative treatment subjects also tended to achieve a clinically meaningful improvement from baseline on ‘Pain at Best’ sooner than the UCO subjects. With similar baseline expectations, OMT subjects reported significantly greater satisfaction with treatment and overall self-reported improvement (P<0·01). Conclusion This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel. PMID:23372389

  1. Clinical and Morphological Changes Following 2 Rehabilitation Programs for Acute Hamstring Strain Injuries: A Randomized Clinical Trial

    Science.gov (United States)

    SILDER, AMY; SHERRY, MARC A.; SANFILIPPO, JENNIFER; TUITE, MICHAEL J.; HETZEL, SCOTT J.; HEIDERSCHEIT, BRYAN C.

    2013-01-01

    STUDY DESIGN Randomized, double-blind, parallel-group clinical trial. OBJECTIVES To assess differences between a progressive agility and trunk stabilization rehabilitation program and a progressive running and eccentric strengthening rehabilitation program in recovery characteristics following an acute hamstring injury, as measured via physical examination and magnetic resonance imaging (MRI). BACKGROUND Determining the type of rehabilitation program that most effectively promotes muscle and functional recovery is essential to minimize reinjury risk and to optimize athlete performance. METHODS Individuals who sustained a recent hamstring strain injury were randomly assigned to 1 of 2 rehabilitation programs: (1) progressive agility and trunk stabilization or (2) progressive running and eccentric strengthening. MRI and physical examinations were conducted before and after completion of rehabilitation. RESULTS Thirty-one subjects were enrolled, 29 began rehabilitation, and 25 completed rehabilitation. There were few differences in clinical or morphological outcome measures between rehabilitation groups across time, and reinjury rates were low for both rehabilitation groups after return to sport (4 of 29 subjects had reinjuries). Greater craniocaudal length of injury, as measured on MRI before the start of rehabilitation, was positively correlated with longer return-to-sport time. At the time of return to sport, although all subjects showed a near-complete resolution of pain and return of muscle strength, no subject showed complete resolution of injury as assessed on MRI. CONCLUSION The 2 rehabilitation programs employed in this study yielded similar results with respect to hamstring muscle recovery and function at the time of return to sport. Evidence of continuing muscular healing is present after completion of rehabilitation, despite the appearance of normal physical strength and function on clinical examination. LEVEL OF EVIDENCE Therapy, level 1b–. J Orthop

  2. A randomized, controlled trial of osteopathic manipulative treatment for acute low back pain in active duty military personnel.

    Science.gov (United States)

    Cruser, des Anges; Maurer, Douglas; Hensel, Kendi; Brown, Sarah K; White, Kathryn; Stoll, Scott T

    2012-02-01

    Acute low back pain (ALBP) may limit mobility and impose functional limitations in active duty military personnel. Although some manual therapies have been reported effective for ALBP in military personnel, there have been no published randomized controlled trials (RCTs) of osteopathic manipulative treatment (OMT) in the military. Furthermore, current military ALBP guidelines do not specifically include OMT. This RCT examined the efficacy of OMT in relieving ALBP and improving functioning in military personnel at Fort Lewis, Washington. Sixty-three male and female soldiers ages 18 to 35 were randomly assigned to a group receiving OMT plus usual care or a group receiving usual care only (UCO). The primary outcome measures were pain on the quadruple visual analog scale, and functioning on the Roland Morris Disability Questionnaire. Outcomes were measured immediately preceding each of four treatment sessions and at four weeks post-trial. Intention to treat analysis found significantly greater post-trial improvement in 'Pain Now' for OMT compared to UCO (P = 0·026). Furthermore, the OMT group reported less 'Pain Now' and 'Pain Typical' at all visits (P = 0·025 and P = 0·020 respectively). Osteopathic manipulative treatment subjects also tended to achieve a clinically meaningful improvement from baseline on 'Pain at Best' sooner than the UCO subjects. With similar baseline expectations, OMT subjects reported significantly greater satisfaction with treatment and overall self-reported improvement (P<0·01). This study supports the effectiveness of OMT in reducing ALBP pain in active duty military personnel.

  3. Radial Access Reduces Mortality in Patients With Acute Coronary Syndromes: Results From an Updated Trial Sequential Analysis of Randomized Trials.

    Science.gov (United States)

    Andò, Giuseppe; Capodanno, Davide

    2016-04-11

    The authors sought to investigate whether the cumulative evidence coming from randomized studies has reached the necessary power to consider radial access as a bleeding avoidance strategy that reduces mortality and ischemic endpoints in patients with acute coronary syndromes (ACS). Studies in ACS patients have reached conflicting conclusions about the impact of radial access in improving ischemic outcomes in addition to the established bleeding benefit. English-language publications and abstracts of major cardiovascular meetings until October 2015 were scrutinized. Study quality, patient characteristics, procedural data, and outcomes were extracted. Data were pooled in random effects meta-analyses with classic and trial sequential techniques. Trial sequential analysis combines the a priori information size calculation needed to allow for clinically meaningful statistical inference with the adjustment of thresholds for which results are considered significant. Seventeen studies, encompassing data from 19,328 patients, were pooled. Radial access was found to reduce mortality (relative risk [RR]: 0.73; 95% confidence interval [CI]: 0.60 to 0.88; p = 0.001), major adverse cardiovascular events (RR: 0.86; 95% CI: 0.77 to 0.95; p = 0.005), and major bleeding (RR: 0.60; 95% CI: 0.48 to 0.76; p < 0.001). Multiple sensitivity analyses showed consistent results, and trial sequential analysis suggested firm evidence for a meaningful reduction in mortality with radial access. Radial access reduces mortality compared with femoral access in ACS patients undergoing invasive management. This benefit is paralleled by consistent reductions in major adverse cardiovascular events and major bleeding, supporting radial access as the default strategy for cardiac catheterization in patients with ACS. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  4. Clinical and morphological changes following 2 rehabilitation programs for acute hamstring strain injuries: a randomized clinical trial.

    Science.gov (United States)

    Silder, Amy; Sherry, Marc A; Sanfilippo, Jennifer; Tuite, Michael J; Hetzel, Scott J; Heiderscheit, Bryan C

    2013-05-01

    Randomized, double-blind, parallel-group clinical trial. To assess differences between a progressive agility and trunk stabilization rehabilitation program and a progressive running and eccentric strengthening rehabilitation program in recovery characteristics following an acute hamstring injury, as measured via physical examination and magnetic resonance imaging (MRI). Determining the type of rehabilitation program that most effectively promotes muscle and functional recovery is essential to minimize reinjury risk and to optimize athlete performance. Individuals who sustained a recent hamstring strain injury were randomly assigned to 1 of 2 rehabilitation programs: (1) progressive agility and trunk stabilization or (2) progressive running and eccentric strengthening. MRI and physical examinations were conducted before and after completion of rehabilitation. Thirty-one subjects were enrolled, 29 began rehabilitation, and 25 completed rehabilitation. There were few differences in clinical or morphological outcome measures between rehabilitation groups across time, and reinjury rates were low for both rehabilitation groups after return to sport (4 of 29 subjects had reinjuries). Greater craniocaudal length of injury, as measured on MRI before the start of rehabilitation, was positively correlated with longer return-to-sport time. At the time of return to sport, although all subjects showed a near-complete resolution of pain and return of muscle strength, no subject showed complete resolution of injury as assessed on MRI. The 2 rehabilitation programs employed in this study yielded similar results with respect to hamstring muscle recovery and function at the time of return to sport. Evidence of continuing muscular healing is present after completion of rehabilitation, despite the appearance of normal physical strength and function on clinical examination. Therapy, level 1b-.

  5. Comparing Adrenaline with Tranexamic Acid to Control Acute Endobronchial Bleeding: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Mitra Samareh Fekri

    2017-03-01

    Full Text Available Background: Hemoptysis occurs due to either pulmonary diseases or bronchoscopy interventions. The aim of the present study was to compare the efficacy of the endobronchial instillation of adrenaline with that of tranexamic acid. Methods: Fifty patients were randomly selected as 2 double-blinded sample groups (n=25. In these patients, bleeding could not be controlled with cold saline lavage during bronchoscopy and they, therefore, required prescription of another medicine. Adrenaline (1 mg in one group and tranexamic acid (500 mg in the other group were diluted in 20 mL of normal saline and instilled through the bronchoscope. This technique was repeated 3 times at 90-second intervals, if necessary. In the case of persistent bleeding, 90 seconds after the last dose, a second medicine was given for bleeding control. Observation of clot through the bronchoscope meant that the bleeding had stopped. The efficacy of tranexamic acid and adrenaline was evaluated and then compared using the Mann–Whitney test. Results: The time of bleeding control had no significant difference between tranexamic acid and adrenaline (P=0.908. Another analysis was done to evaluate bleeding control with a second medicine; the results showed that 1 (4% patient in the tranexamic acid and 8 (32% in the adrenaline group needed the second medicine and there was no significant difference between the 2 groups (P=0.609. Conclusion: Our results suggested that tranexamic acid by endobronchial instillation was as efficient as adrenaline in controlling hemoptysis and required less frequent use of a second medicine. Trial Registration Number: IRCT2014120220188

  6. A multicenter, randomized, double-blind, controlled trial of nebulized epinephrine in infants with acute bronchiolitis.

    Science.gov (United States)

    Wainwright, Claire; Altamirano, Luis; Cheney, Marise; Cheney, Joyce; Barber, Scott; Price, Darrell; Moloney, Sue; Kimberley, Ann; Woolfield, Nick; Cadzow, Susan; Fiumara, Frank; Wilson, Peter; Mego, Steve; VandeVelde, Dianne; Sanders, Sharon; O'Rourke, Peter; Francis, Paul

    2003-07-03

    The treatment of infants with bronchiolitis is largely supportive. The role of bronchodilators is controversial. Most studies of the use of bronchodilators have enrolled small numbers of subjects and have examined only short-term outcomes, such as clinical scores. We conducted a randomized, double-blind, controlled trial comparing nebulized single-isomer epinephrine with placebo in 194 infants admitted to four hospitals in Queens-land, Australia, with a clinical diagnosis of bronchiolitis. Three 4-ml doses of 1 percent nebulized epinephrine or three 4-ml doses of normal saline were administered at four-hour intervals after hospital admission. Observations were made at admission and just before, 30 minutes after, and 60 minutes after each dose. The primary outcome measures were the length of the hospital stay and the time until the infant was ready for discharge. The secondary outcome measures were the degree of change in the respiratory rate, the heart rate, and the respiratory-effort score and the time that supplemental oxygen was required. There were no significant overall differences between the groups in the length of the hospital stay (P=0.16) or the time until the infant was ready for discharge (P=0.86). Among infants who required supplemental oxygen and intravenous fluids, the time until the infant was ready for discharge was significantly longer in the epinephrine group than in the placebo group (P=0.02). The need for supplemental oxygen at admission had the greatest influence on the score for severity of illness and strongly predicted the length of the hospital stay and the time until the infant was ready for discharge (Pepinephrine (P=0.02 to Pnebulized epinephrine did not significantly reduce the length of the hospital stay or the time until the infant was ready for discharge among infants admitted to the hospital with bronchiolitis. Copyright 2003 Massachusetts Medical Society

  7. Acute toxicity profile and compliance to accelerated radiotherapy plus carbogen and nicotinamide for clinical stage T2-4 laryngeal cancer: results of a phase III randomized trial.

    Science.gov (United States)

    Janssens, Geert O; Terhaard, Chris H; Doornaert, Patricia A; Bijl, Hendrik P; van den Ende, Piet; Chin, Alim; Pop, Lucas A; Kaanders, Johannes H

    2012-02-01

    To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. From April 2001 to February 2008, 345 patients with cT2-4 squamous cell laryngeal cancer were randomized to AR (n = 174) and ARCON (n = 171). Acute toxicity was scored weekly until Week 8 and every 2-4 weeks thereafter. Compliance to carbogen and nicotinamide was reported. Between both treatment arms (AR vs. ARCON) no statistically significant difference was observed for incidence of acute skin reactions (moist desquamation: 56% vs. 58%, p = 0.80), acute mucosal reactions (confluent mucositis: 79% vs. 85%, p = 0.14), and symptoms related to acute mucositis (severe pain on swallowing: 53% vs. 58%, p = 0.37; nasogastric tube feeding: 28% vs. 28%, p = 0.98; narcotic medicines required: 58% vs. 58%, p = 0.97). There was a statistically significant difference in median duration of confluent mucositis in favor of AR (2.0 vs 3.0 weeks, p = 0.01). There was full compliance with carbogen breathing and nicotinamide in 86% and 80% of the patients, with discontinuation in 6% and 12%, respectively. Adjustment of antiemesis prophylaxis was needed in 42% of patients. With the exception of a slight increase in median duration of acute confluent mucositis, the present data reveal a similar acute toxicity profile between both regimens and a good compliance with ARCON for clinical stage T2-4 laryngeal cancers. Treatment outcome and late morbidity will determine the real therapeutic benefit. Copyright © 2012 Elsevier Inc. All rights reserved.

  8. Acute Toxicity Profile and Compliance to Accelerated Radiotherapy Plus Carbogen and Nicotinamide for Clinical Stage T2-4 Laryngeal Cancer: Results of a Phase III Randomized Trial

    Energy Technology Data Exchange (ETDEWEB)

    Janssens, Geert O., E-mail: g.janssens@rther.umcn.nl [Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, Nijmegen (Netherlands); Terhaard, Chris H. [Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands); Doornaert, Patricia A. [Department of Radiation Oncology, VU University Medical Center, Amsterdam (Netherlands); Bijl, Hendrik P. [Department of Radiation Oncology, University Medical Center Groningen, Groningen (Netherlands); Ende, Piet van den [Department of Radiation Oncology, Maastricht University Medical Centre, Maastricht (Netherlands); Chin, Alim [Department of Clinical Oncology, Leiden University Medical Centre, Leiden (Netherlands); Pop, Lucas A.; Kaanders, Johannes H. [Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, Nijmegen (Netherlands)

    2012-02-01

    Purpose: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. Methods and Materials: From April 2001 to February 2008, 345 patients with cT2-4 squamous cell laryngeal cancer were randomized to AR (n = 174) and ARCON (n = 171). Acute toxicity was scored weekly until Week 8 and every 2-4 weeks thereafter. Compliance to carbogen and nicotinamide was reported. Results: Between both treatment arms (AR vs. ARCON) no statistically significant difference was observed for incidence of acute skin reactions (moist desquamation: 56% vs. 58%, p = 0.80), acute mucosal reactions (confluent mucositis: 79% vs. 85%, p = 0.14), and symptoms related to acute mucositis (severe pain on swallowing: 53% vs. 58%, p = 0.37; nasogastric tube feeding: 28% vs. 28%, p = 0.98; narcotic medicines required: 58% vs. 58%, p = 0.97). There was a statistically significant difference in median duration of confluent mucositis in favor of AR (2.0 vs 3.0 weeks, p = 0.01). There was full compliance with carbogen breathing and nicotinamide in 86% and 80% of the patients, with discontinuation in 6% and 12%, respectively. Adjustment of antiemesis prophylaxis was needed in 42% of patients. Conclusion: With the exception of a slight increase in median duration of acute confluent mucositis, the present data reveal a similar acute toxicity profile between both regimens and a good compliance with ARCON for clinical stage T2-4 laryngeal cancers. Treatment outcome and late morbidity will determine the real therapeutic benefit.

  9. Acute Achilles tendon rupture - Minimally invasive surgery versus nonoperative treatment with immediate full weightbearing - Randomized controlled trial

    NARCIS (Netherlands)

    Metz, Roderick; Verleisdonk, Egbert-Jan M. M.; van der Heijden, Geert J. -M. -G.; Clevers, Geert-Jan; Hammacher, Erik R.; Verhofstad, Michiel H. J.; van der Werken, Christiaan

    Background: Surgical repair of acute Achilles tendon ruptures is considered superior to nonoperative treatment, but complications other than rerupture range up to 34%. Nonoperative treatment by functional bracing seems a promising alternative. Hypothesis: Nonoperative treatment of acute Achilles

  10. Efficacy and safety of ticagrelor in patients with acute coronary syndrome: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Jing, Yunyan; Ni, Bin; Zhou, Donglai; Zhang, Xingwei; Liu, Shanxin

    2017-09-25

    Acute coronary syndrome (ACS) is a dangerous and urgent clinical pattern of coronary artery disease. Aspirin and adenosine diphosphate P2Y12 receptor antagonists are the standard dual anti-platelet therapy for patients with ACS. Ticagrelor is a new oral antagonist of the adenosine diphosphate P2Y12 receptor. Randomized controlled trials (RCTs) have evaluated the efficacy and safety of ticagrelor compared to clopidogrel or prasugrel in patients with ACS, obtaining conflicting results. Thus, we conducted a meta-analysis of these RCTs to determine the efficacy and safety of ticagrelor in patients with ACS. Results of the meta-analysis indicate that ticagrelor decreased the risk of major adverse cardiovascular events (MACE) and all-cause death, but increased the risk of bleeding events. In Asiatic patients, analysis indicates that ticagrelor did not decrease the risk of MACE and all-cause death, while increasing the risk of bleeding events. Together, this meta-analysis suggests that ticagrelor was more effective, but less safe than clopidogrel and prasugrel in patients with ACS. Subgroup analysis indicates that ticagrelor was not more effective, although less safe than clopidogrel in Asiatic patients, thus more evidence is needed to further evaluate the efficacy and safety of ticagrelor in Asiatic patients. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  11. Acute effects of single and multiple level thoracic manipulations on chronic mechanical neck pain: a randomized controlled trial

    Science.gov (United States)

    Puntumetakul, Rungthip; Suvarnnato, Thavatchai; Werasirirat, Phurichaya; Uthaikhup, Sureeporn; Yamauchi, Junichiro; Boucaut, Rose

    2015-01-01

    Background Thoracic spine manipulation has become a popular alternative to local cervical manipulative therapy for mechanical neck pain. This study investigated the acute effects of single-level and multiple-level thoracic manipulations on chronic mechanical neck pain (CMNP). Methods Forty-eight patients with CMNP were randomly allocated to single-level thoracic manipulation (STM) at T6–T7 or multiple-level thoracic manipulation (MTM), or to a control group (prone lying). Cervical range of motion (CROM), visual analog scale (VAS), and the Thai version of the Neck Disability Index (NDI-TH) scores were measured at baseline, and at 24-hour and at 1-week follow-up. Results At 24-hour and 1-week follow-up, neck disability and pain levels were significantly (Pneck disability, pain level at rest, and CROM between the STM and MTM groups. Conclusion These results suggest that both single-level and multiple-level thoracic manipulation improve neck disability, pain levels, and CROM at 24-hour and 1-week follow-up in patients with CMNP. PMID:25624764

  12. High-dose Oral Ambroxol for Early Treatment of Pulmonary Acute Respiratory Distress Syndrome: an Exploratory, Randomized, Controlled Pilot Trial.

    Science.gov (United States)

    Baranwal, Arun K; Murthy, Aparna S; Singhi, Sunit C

    2015-10-01

    To evaluate efficacy of high-dose oral ambroxol in acute respiratory distress syndrome (ARDS) with respect to ventilator-free days (VFD). Prospective, randomized, placebo-controlled, blinded pilot trial. Sixty-six mechanically ventilated patients (1 month to 12 years) with ARDS who were hand-ventilated for ambroxol (40 mg/kg/day, in four divided doses) (n = 32) or placebo (n = 34) until 10 days, extubation or death whichever is earlier. Majority (91%) had pneumonia and bronchiolitis. Two study groups were similar in baseline characteristics. Mean partial pressure of arterial oxygen/fraction of inspired oxygen and oxygenation index were >175 and ambroxol. Among ventilated pulmonary ARDS patients with oxygenation index of Ambroxol did not improve VFD. Study with higher and more frequently administered doses of ambroxol in larger sample is suggested after having generated relevant pharmacokinetic data among critically ill children. © The Author [2015]. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  13. A randomized, controlled trial of nebulized terbutaline for the first acute bronchiolitis in infants less than 12-months-old.

    Science.gov (United States)

    Tinsa, Faten; Ben Rhouma, Anis; Ghaffari, Hadhami; Boussetta, Khadija; Zouari, Bechir; Brini, Ines; Karboul, Lotfi; Souid, Mahbouba; Bousnina, Souad

    2009-03-01

    Despite the common clinical practice, the available evidence on the efficacy of bronchodilators therapy for bronchiolitis is conflicting. The aim of this study is to evaluate the efficacy of nebulized terbutaline in bronchiolitis as measured by improvement in clinical score, oxygen saturation or reduction in duration of hospitalization. This prospective, double blind, placebo controlled, randomized clinical trial was performed at Children's Hospital of Tunis from December 2004 to April 2006. A total of 35 patients less than 12 months of age with diagnosis of moderately severe bronchiolitis were enrolled and assigned to receive nebulized terbutaline or normal saline placebo at admission (T0), at 30 minutes after admission (T30) and every four hours during a study period. Outcome measurements included: Respiratory Distress Assessment Instrument (RDAI) score, respiratory rate, oxygen saturation, heart rate and the duration of hospitalization. There were no significant difference between terbutaline and placebo at baseline, T30 min, T60 min, and T120 min after start study in RDAI score, oxygen saturation in room air, rate respiratory and heart rate. There was no difference in duration of hospitalization. Nebulized terbutaline therapy does not appear effective in treating moderately ill infants with the first acute bronchiolitis.

  14. Orange Pomace Improves Postprandial Glycemic Responses: An Acute, Randomized, Placebo-Controlled, Double-Blind, Crossover Trial in Overweight Men

    Directory of Open Access Journals (Sweden)

    C.-Y. Oliver Chen

    2017-02-01

    Full Text Available Orange pomace (OP, a fiber-rich byproduct of juice production, has the potential for being formulated into a variety of food products. We hypothesized that OP would diminish postprandial glycemic responses to a high carbohydrate/fat breakfast and lunch. We conducted an acute, randomized, placebo-controlled, double blind, crossover trial with 34 overweight men who consumed either a 255 g placebo (PLA, a low (35% OP (LOP, or a high (77% (HOP dose OP beverage with breakfast. Blood was collected at 0, 10, 20, 30, and 45 min and at 1, 1.5, 2, 3, 4, 5, 5.5, 6, 6.5, 7, and 8 h. Lunch was consumed after the 5.5-h blood draw. OP delayed the time (Tmax1 to the maximum concentration (Cmax1 of serum glucose during the 2-h period post breakfast by ≥36% from 33 (PLA to 45 (HOP and 47 (LOP min (p = 0.055 and 0.013, respectively. OP decreased post-breakfast insulin Cmax1 by ≥10% and LOP delayed the Tmax1 by 14 min, compared to PLA at 46 min (p ≤ 0.05. HOP reduced the first 2-h insulin area under concentration time curve (AUC by 23% compared to PLA. Thus, OP diminishes postprandial glycemic responses to a high carbohydrate/fat breakfast and the second meal in overweight men.

  15. [Use of a rapid rotavirus test in prescription of antibiotics in acute diarrhea in pediatrics: an observational, randomized, controlled study].

    Science.gov (United States)

    Bucher, Andrea; Rivara, Gustavo; Briceño, Diego; Huicho, Luis

    2012-01-01

    To determine the impact of a rapid and accurate rotavirus test in the emergency ward on the reduction of antibiotic prescription in children under 5 years old with acute diarrhea at "Arzobispo Loayza National Hospital", Lima, Peru. We performed an observational prospective randomized controlled study, from July 2008 to January 2009. Stool samples from patients with diarrhea lasting less than 5 days were analyzed. Out of 201 cases, 101 were classified in Group A (with fecal leukocytes test performed) and 100 in Group B (with fecal leukocytes test and rotavirus/adenovirus test performed). We aimed to associate the signs and symptoms with the decision of prescribing antibiotics and with hospitalization risk. Both groups were comparable with regard to age, weight and illness duration. In patients with rotavirus infection, fecal leukocytes were positive in 46.9% of cases. Frequency of antibiotic use was directly associated with the number of fecal leukocytes (Pdiarrhea-attributable deaths were reported. The use of rotavirus test in the pediatric emergency room decreased antibiotic prescription in children with diarrhea.

  16. A randomized placebo-controlled trial of progesterone with or without hypothermia in patients with acute severe traumatic brain injury.

    Science.gov (United States)

    Sinha, Sumit; Raheja, Amol; Samson, Neha; Goyal, Keshav; Bhoi, Sanjeev; Selvi, Arul; Sharma, Pushpa; Sharma, Bhawani Shankar

    2017-01-01

    Among newer neuroprotectant modalities, hypothermia and progesterone have shown a beneficial role in preliminary studies enrolling patients with severe traumatic brain injury (sTBI). The primary objective of this study was to evaluate the efficacy of progesterone with or without prophylactic hypothermia in acute sTBI patients. This is a prospective, outcome assessor, statistician blinded, randomized, and placebo-controlled phase II trial of progesterone with or without hypothermia (factorial design). All adult patients (18-65 years) with acute sTBI (Glasgow coma score of 4-8) and presenting to trauma center within 8 h after injury were included in the trial. Computer-generated randomization was done after exclusion; sequentially numbered, opaque, sealed envelope technique was used for allocation concealment. The enrollment duration was from January 2012 to October 2014. The primary endpoint was dichotomized Glasgow outcome score (GOS) [poor recovery = GOS 1-3; good recovery = GOS 4-5], and secondary endpoints were functional independence measure (FIM) score and mortality rate at 6 and 12 months follow-up after recruitment. A total of 107 patients were randomized into four groups (placebo [n = 27], progesterone [n = 26], hypothermia alone [n = 27], and progesterone + hypothermia [n = 27]). The study groups were comparable in baseline parameters except for a higher incidence of decompressive craniectomy in the placebo group (P = 0.001). The analysis of GOS at 6 months revealed statistically significant better outcome in the hypothermia group (82%; P = 0.01) and a weaker evidence for progesterone group (74%; P = 0.07) as compared with the placebo group (44%). However, the outcome benefit was marginal at 1-year follow-up for the hypothermia group (82% vs. 58%, P = 0.17). The adjusted odds ratio of poor recovery at 6 months in the hypothermia group was 0.21 (confidence interval = 0.05-0.84, P = 0.03), as compared with the placebo group. Although mean FIM scores at 6 and

  17. The role of oral ondansetron in children with vomiting as a result of acute gastritis/gastroenteritis who have failed oral rehydration therapy: a randomized controlled trial.

    Science.gov (United States)

    Roslund, Gregory; Hepps, Terri S; McQuillen, Kemedy K

    2008-07-01

    We hypothesize that ondansetron will facilitate oral rehydration therapy in children with acute gastritis or acute gastroenteritis and mild to moderate dehydration who fail initial oral rehydration therapy. We hypothesize that subjects receiving ondansetron will tolerate oral rehydration and that a lower proportion will require intravenous hydration than subjects receiving placebo, with a clinically important difference of at least 30% when comparing 2 groups of patients presenting to the ED with acute gastritis/acute gastroenteritis. Secondarily, we hypothesize that subjects receiving ondansetron will have a lower proportion requiring admission, fewer episodes of vomiting and diarrhea, and fewer revisits. This double-blind, placebo-controlled, prospective, randomized trial enrolled a convenience sample of subjects 1 to 10 years old, with acute gastritis or acute gastroenteritis, who failed oral rehydration therapy in the emergency department (ED). Subjects received a weight-based dose of ondansetron (0.15 mg/kg of the orally dissolving tablet) or placebo, and oral rehydration therapy was reattempted 30 minutes later. If a subject vomited or refused to drink, he or she was considered a failed oral rehydration therapy and received IV hydration [corrected] If a subject tolerated adequate oral rehydration therapy, he or she was discharged. Parents completed symptom diaries and were contacted by telephone for follow-up. We used the chi(2) test to compare the proportions of subjects requiring IV hydration [corrected] in each group. We enrolled 106 subjects: 51 received ondansetron and 55 received placebo. Eleven of 51 (21.6%; 95% confidence interval [CI] 11.3% to 35.3%) of subjects who received ondansetron required intravenous hydration and 30 of 55 (54.5%; 95% CI 40.6% to 68%) of placebo subjects required intravenous hydration (p acute gastritis/acute gastroenteritis and mild to moderate dehydration who failed initial oral rehydration therapy, the proportion of

  18. Duration of bed occupancy as calculated at a random chosen day in an acute care ward. Implications for the use of scarce resources in psychiatric care

    Directory of Open Access Journals (Sweden)

    Restan Asbjørn

    2005-05-01

    Full Text Available Abstract Background Psychiatric acute wards are obliged to admit patients without delay according to the Act on Compulsive Psychiatric Care. Residential long term treatment facilities and rehabilitation facilities may use a waiting list. Patients, who may not be discharged from the acute ward or should not wait there, then occupy acute ward beds. Materials and methods Bed occupancy in one acute ward at a random day in 2002 was registered (n = 23. Successively, the length of stay of all patients was registered, together with information on waiting time after a decision was made on further treatment needs. Eleven patients waited for further resident treatment. The running cost of stay was calculated for the acute ward and in the different resident follow-up facilities. Twenty-three patients consumed a total of 776 resident days. 425 (54.8% of these were waiting days. Patients waited up to 86 days. Results Total cost of treatment was 0.69 million Euro (0.90 mill. $, waiting costs were 54.8% of this, 0.38 million Euro (0.50 million $. The difference between acute care costs and the costs in the relevant secondary resident facility was defined as the imputed loss. Net loss by waiting was 0.20 million Euro (0.26 million $ or 28.8% of total cost. Discussion This point estimate study indicates that treating patients too sick to be released to anything less than some other intramural facility locks a sizable amount of the resources of a psychiatric acute ward. The method used minimized the chance of financially biased treatment decisions. Costs of frustration to staff and family members, and delayed effect of treatment was set to zero. Direct extrapolation to costs per year is not warranted, but it is suggested that our findings would be comparable to other acute wards as well. The study shows how participant observation and cost effectiveness analysis may be combined.

  19. Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2 trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    McAuley Daniel F

    2012-09-01

    Full Text Available Abstract Background Acute lung injury (ALI is a common devastating clinical syndrome characterized by life-threatening respiratory failure requiring mechanical ventilation and multiple organ failure. There are in vitro, animal studies and pre-clinical data suggesting that statins may be beneficial in ALI. The Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2 trial is a multicenter, prospective, randomized, allocation concealed, double-blind, placebo-controlled clinical trial which aims to test the hypothesis that treatment with simvastatin will improve clinical outcomes in patients with ALI. Methods/Design Patients fulfilling the American-European Consensus Conference Definition of ALI will be randomized in a 1:1 ratio to receive enteral simvastatin 80 mg or placebo once daily for a maximum of 28 days. Allocation to randomized groups will be stratified with respect to hospital of recruitment and vasopressor requirement. Data will be recorded by participating ICUs until hospital discharge, and surviving patients will be followed up by post at 3, 6 and 12 months post randomization. The primary outcome is number of ventilator-free days to day 28. Secondary outcomes are: change in oxygenation index and sequential organ failure assessment score up to day 28, number of non pulmonary organ failure free days to day 28, critical care unit mortality; hospital mortality; 28 day post randomization mortality and 12 month post randomization mortality; health related quality of life at discharge, 3, 6 and 12 months post randomization; length of critical care unit and hospital stay; health service use up to 12 months post-randomization; and safety. A total of 540 patients will be recruited from approximately 35 ICUs in the UK and Ireland. An economic evaluation will be conducted alongside the trial. Plasma and urine samples will be taken up to day 28 to investigate potential mechanisms

  20. A randomized controlled trial comparing intranasal fentanyl to intravenous morphine for managing acute pain in children in the emergency department.

    Science.gov (United States)

    Borland, Meredith; Jacobs, Ian; King, Barbara; O'Brien, Debra

    2007-03-01

    We compare the efficacy of intranasal fentanyl versus intravenous morphine in a pediatric population presenting to an emergency department (ED) with acute long-bone fractures. We conducted a prospective, randomized, double-blind, placebo-controlled, clinical trial in a tertiary pediatric ED between September 2001 and January 2005. A convenience sample of children aged 7 to 15 years with clinically deformed closed long-bone fractures was included to receive either active intravenous morphine (10 mg/mL) and intranasal placebo or active intranasal concentrated fentanyl (150 microg/mL) and intravenous placebo. Exclusion criteria were narcotic analgesia within 4 hours of arrival, significant head injury, allergy to opiates, nasal blockage, or inability to perform pain scoring. Pain scores were rated by using a 100-mm visual analog scale at 0, 5, 10, 20, and 30 minutes. Routine clinical observations and adverse events were recorded. Sixty-seven children were enrolled (mean age 10.9 years [SD 2.4]). Fractures were radius or ulna 53 (79.1%), humerus 9 (13.4%), tibia or fibula 4 (6.0%), and femur 1 (1.5%). Thirty-four children received intravenous (i.v.) morphine and 33 received intranasal fentanyl. Statistically significant differences in visual analog scale scores were not observed between the 2 treatment arms either preanalgesia or at 5, 10, 20, or 30 minutes postanalgesia (P=.333). At 10 minutes, the difference in mean visual analog scale between the morphine and fentanyl groups was -5 mm (95% confidence interval -16 to 7 mm). Reductions in combined pain scores occurred at 5 minutes (20 mm; P=.000), 10 minutes (4 mm; P=.012), and 20 minutes (8 mm; P=.000) postanalgesia. The mean total INF dose was 1.7 microg/kg, and the mean total i.v. morphine dose was 0.11 mg/kg. There were no serious adverse events. Intranasal fentanyl delivered as 150 microg/mL at a dose of 1.7 microg/kg was shown to be an effective analgesic in children aged 7 to 15 years presenting to an ED with

  1. Dark chocolate attenuates intracellular pro-inflammatory reactivity to acute psychosocial stress in men: A randomized controlled trial.

    Science.gov (United States)

    Kuebler, Ulrike; Arpagaus, Angela; Meister, Rebecca E; von Känel, Roland; Huber, Susanne; Ehlert, Ulrike; Wirtz, Petra H

    2016-10-01

    Flavanol-rich dark chocolate consumption relates to lower risk of cardiovascular mortality, but underlying mechanisms are elusive. We investigated the effect of acute dark chocolate consumption on inflammatory measures before and after stress. Healthy men, aged 20-50years, were randomly assigned to a single intake of either 50g of flavanol-rich dark chocolate (n=31) or 50g of optically identical flavanol-free placebo-chocolate (n=34). Two hours after chocolate intake, both groups underwent the 15-min Trier Social Stress Test. We measured DNA-binding-activity of the pro-inflammatory transcription factor NF-κB (NF-κB-BA) in peripheral blood mononuclear cells, as well as plasma and whole blood mRNA levels of the pro-inflammatory cytokines IL-1β and IL-6, and the anti-inflammatory cytokine IL-10, prior to chocolate intake as well as before and several times after stress. We also repeatedly measured the flavanol epicatechin and the stress hormones epinephrine and cortisol in plasma and saliva, respectively. Compared to the placebo-chocolate-group, the dark-chocolate-group revealed a marginal increase in IL-10 mRNA prior to stress (p=0.065), and a significantly blunted stress reactivity of NF-κB-BA, IL-1β mRNA, and IL-6 mRNA (p's⩽0.036) with higher epicatechin levels relating to lower pro-inflammatory stress reactivity (p's⩽0.033). Stress hormone changes to stress were controlled. None of the other measures showed a significant chocolate effect (p's⩾0.19). Our findings indicate that acute flavanol-rich dark chocolate exerts anti-inflammatory effects both by increasing mRNA expression of the anti-inflammatory cytokine IL-10 and by attenuating the intracellular pro-inflammatory stress response. This mechanism may add to beneficial effects of dark chocolate on cardiovascular health. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Regulation of Lipolysis and Adipose Tissue Signaling during Acute Endotoxin-Induced Inflammation: A Human Randomized Crossover Trial.

    Directory of Open Access Journals (Sweden)

    Nikolaj Rittig

    Full Text Available Lipolysis is accelerated during the acute phase of inflammation, a process being regulated by pro-inflammatory cytokines (e.g. TNF-α, stress-hormones, and insulin. The intracellular mechanisms remain elusive and we therefore measured pro- and anti-lipolytic signaling pathways in adipocytes after in vivo endotoxin exposure.Eight healthy, lean, male subjects were investigated using a randomized cross over trial with two interventions: i bolus injection of saline (Placebo and ii bolus injection of lipopolysaccharide endotoxin (LPS. A 3H-palmitate tracer was used to measure palmitate rate of appearance (Rapalmitate and indirect calorimetry was performed to measure energy expenditures and lipid oxidation rates. A subcutaneous abdominal fat biopsy was obtained during both interventions and subjected to western blotting and qPCR quantifications.LPS caused a mean increase in serum free fatty acids (FFA concentrations of 90% (CI-95%: 37-142, p = 0.005, a median increase in Rapalmitate of 117% (CI-95%: 77-166, p<0.001, a mean increase in lipid oxidation of 49% (CI-95%: 1-96, p = 0.047, and a median increase in energy expenditure of 28% (CI-95%: 16-42, p = 0.001 compared with Placebo. These effects were associated with increased phosphorylation of hormone sensitive lipase (pHSL at ser650 in adipose tissue (p = 0.03, a trend towards elevated pHSL at ser552 (p = 0.09 and cAMP-dependent protein kinase A (PKA phosphorylation of perilipin 1 (PLIN1 (p = 0.09. Phosphatase and tensin homolog (PTEN also tended to increase (p = 0.08 while phosphorylation of Akt at Thr308 tended to decrease (p = 0.09 during LPS compared with Placebo. There was no difference between protein or mRNA expression of ATGL, G0S2, and CGI-58.LPS stimulated lipolysis in adipose tissue and is associated with increased pHSL and signs of increased PLIN1 phosphorylation combined with a trend toward decreased insulin signaling. The combination of these mechanisms appear to be the driving forces

  3. Repeated measurements of blood lactate concentration as a prognostic marker in horses with acute colitis evaluated with classification and regression trees (CART) and random forest analysis

    DEFF Research Database (Denmark)

    Petersen, Mette Bisgaard; Tolver, Anders; Husted, Louise

    2016-01-01

    -off value of 7 mmol/L had a sensitivity of 0.66 and a specificity of 0.92 in predicting survival. In independent test data, the sensitivity was 0.69 and the specificity was 0.76. At the observed survival rate (38%), the optimal decision tree identified horses as non-survivors when the Lac at admission...... admitted with acute colitis (trees, as well as random...

  4. A randomized clinical trial of chiropractic treatment and self-management in patients with acute musculoskeletal chest pain: 1-year follow-up.

    Science.gov (United States)

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner; Høilund-Carlsen, Poul F; Haghfelt, Torben; Hartvigsen, Jan

    2012-05-01

    We have previously reported short-term follow-up from a pragmatic randomized clinical trial comparing 2 treatments for acute musculoskeletal chest pain: (1) chiropractic treatment and (2) self-management. Results indicated a positive effect in favor of the chiropractic treatment after 4 and 12 weeks. The current article investigates the hypothesis that the advantage observed at 4 and 12 weeks would be sustained after 1 year. In addition, we describe self-reported consequences of acute musculoskeletal chest pain at 1-year follow-up. In a nonblinded, randomized controlled trial undertaken at an emergency cardiology department and 4 outpatient chiropractic clinics, 115 consecutive patients with acute chest pain of musculoskeletal origin were included. After the baseline evaluation, patients were randomized to 4 weeks of either chiropractic treatment or self-management, with posttreatment questionnaire follow-up 52 weeks later. The primary outcome measures were change in pain intensity (11-point box numerical rating scale) and self-perceived change in pain (7-point ordinal scale). Both groups experienced decreases in pain, positive global, self-perceived treatment effect, and increases in the 36-Item Short Form Health Survey scores. No statistically significant differences were observed between groups at the 1-year follow-up, and we could not deduce a common trend in favor of either intervention. At the 1-year follow-up, we found no difference between groups in terms of pain intensity and self-perceived change in chest pain in the first randomized clinical trial assessing chiropractic treatment vs minimal intervention for patients with acute musculoskeletal chest pain. Further research into health care utilization and use of prescriptive medication is warranted. Copyright © 2012 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  5. Effects of procalcitonin-guided treatment on antibiotic use and need for mechanical ventilation in patients with acute asthma exacerbation: Meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Wanis H. Ibrahim

    2017-12-01

    Full Text Available Objective: The primary outcome was to determine whether serum procalcitonin-guided antibiotic therapy can reduce antibiotic exposure in patients with an acute exacerbation of asthma presenting to the primary care facility or emergency department, or during hospital admission. The secondary outcome was the need for mechanical ventilation. Methods: An extensive literature search was performed to identify randomized controlled clinical trials (published in English that compared serum procalcitonin-guided antibiotic therapy versus antibiotic use according to physician’s discretion for adult participants with mild, moderate, or severe acute asthma exacerbations. Results: Four randomized controlled trials evaluating 457 patients were included in this meta-analysis, with significant homogeneity observed among these studies. Procalcitonin-based protocols decreased antibiotic prescriptions (relative risk 0.58, 95% confidence interval 0.50–0.67. The conclusion regarding the difference between the two groups in the need for mechanical ventilation (relative risk 1.10, 95% confidence interval 0.62–1.94 was guarded due to inadequate power and the potential for type II error. The overall quality of evidence was also limited by the lack of double-blinding. Conclusions: These data suggest a potential benefit for the use of serum procalcitonin in guiding antibiotic therapy in patients with an acute asthma exacerbation and advocates the need for more randomized controlled trials. Keywords: Procalcitonin, Asthma, Antibiotic, Exacerbation, Guided

  6. Effects of procalcitonin-guided treatment on antibiotic use and need for mechanical ventilation in patients with acute asthma exacerbation: Meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Ibrahim, Wanis H; Mushtaq, Kamran; Raza, Tasleem; Kartha, Anand; Saleh, Ahmed O; Malik, Rayaz A

    2017-12-01

    The primary outcome was to determine whether serum procalcitonin-guided antibiotic therapy can reduce antibiotic exposure in patients with an acute exacerbation of asthma presenting to the primary care facility or emergency department, or during hospital admission. The secondary outcome was the need for mechanical ventilation. An extensive literature search was performed to identify randomized controlled clinical trials (published in English) that compared serum procalcitonin-guided antibiotic therapy versus antibiotic use according to physician's discretion for adult participants with mild, moderate, or severe acute asthma exacerbations. Four randomized controlled trials evaluating 457 patients were included in this meta-analysis, with significant homogeneity observed among these studies. Procalcitonin-based protocols decreased antibiotic prescriptions (relative risk 0.58, 95% confidence interval 0.50-0.67). The conclusion regarding the difference between the two groups in the need for mechanical ventilation (relative risk 1.10, 95% confidence interval 0.62-1.94) was guarded due to inadequate power and the potential for type II error. The overall quality of evidence was also limited by the lack of double-blinding. These data suggest a potential benefit for the use of serum procalcitonin in guiding antibiotic therapy in patients with an acute asthma exacerbation and advocates the need for more randomized controlled trials. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  7. Tanreqing injection for acute bronchitis disease: A systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Wang, Pei; Liao, Xing; Xie, Yan-Ming; Chai, Yan; Li, Ling-Hui

    2016-04-01

    Acute bronchitis (AB) is one of the common diseases. Tanreqing injection (TRQ) was widely used to treat patients with acute bronchitis, and many randomized controlled trials have been conducted to investigate its efficacy. The purpose of this systematic review is to evaluate the efficacy and safety of TRQ for AB. Eight English and Chinese electronic databases, up to October 2014, were searched to identify randomized controlled trials on TRQ for AB. Two reviewers independently extracted data and assessed the quality of each trial by using Cochrane handbook. Meta-analysis was carried out by using Review Manager software. A total of 49 trials with 5131 participants were collected. Data of three main outcomes were pooled and analyzed as following: (1) effective rates: TRQ versus antibiotics (RR 1.12; 95% CI 1.05, 1.18; P=0.0002); TRQ plus antiviral drugs versus antiviral drugs (RR: 5.12; 95% CI 3.03, 8.66; P<0.00001); TRQ plus antibiotics versus antibiotics (RR 3.46; 95% CI 2.59, 4.62; P<0.00001); TRQ versus antibiotics plus antiviral drugs (RR 2.03; 95% CI 1.10, 3.74; P=0.02); TRQ plus conventional therapy versus conventional therapy alone (RR 1.21; 95% CI 1.15, 1.27; P<0.00001). (2) Time for fever resolution: TRQ plus antiviral drugs versus antiviral drugs (MD: -1.08; 95% CI -1.59, -0.57; P<0.00001); TRQ plus antibiotics versus antibiotics (MD -1.33; 95% CI -1.81, -0.86; P<0.00001); TRQ versus antibiotics plus antiviral drugs (MD -0.88; 95% CI -1.25, -0.51; P<0.00001); TRQ plus conventional therapy versus conventional therapy alone (MD -1.06; 95% CI -1.13, -0.98; P<0.00001). (3) Resolution of cough: TRQ plus antiviral drugs versus antiviral drugs (MD: -2.09; 95% CI -3.11, -1.43; P<0.00001); TRQ plus antibiotics versus antibiotics (MD: -2.65; 95% CI -2.88, -2.42; P<0.00001); TRQ plus conventional therapy versus conventional therapy alone (MD -1.84; 95% CI -2.85, -0.83; P=0.0003). Four trials described the adverse drug reactions of TRQ, while no severe adverse drug

  8. Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial

    Science.gov (United States)

    2011-01-01

    Background Vomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT). Physicians who provide care to paediatric patients in the emergency department (ED) usually prescribe intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking. Objectives To compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed ORT. Methods/Design Multicentre, double-blind randomized controlled trial conducted in paediatric EDs. Children aged from 1 to 6 years who vomiting, with a presumptive clinical diagnosis of AG, and without severe dehydration will be included. After the failure of a initial ORS administration in ED, eligible children will be randomized to receive: 1) ondansetron syrup (0,15 mg/Kg of body weight); 2) domperidone syrup (0,5 mg/Kg of body weight); 3) placebo. The main study outcome will be the percentage of patients needing nasogastric or IVT after symptomatic oral treatment failure, defined as vomiting or fluid refusal after a second attempt of ORT. Data relative to study outcomes will be collected at 30 minute intervals for a minimum of 6 hours. A telephone follow up call will be made 48 hours after discharge. A total number of 540 children (i.e. 180 patients in each arm) will be enrolled. Discussion The trial results would provide evidence on the efficacy of domperidone, which is largely used in clinical practice

  9. Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Urbino Antonio

    2011-02-01

    Full Text Available Abstract Background Vomiting in children with acute gastroenteritis (AG is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT. Physicians who provide care to paediatric patients in the emergency department (ED usually prescribe intravenous fluid therapy (IVT for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking. Objectives To compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed ORT. Methods/Design Multicentre, double-blind randomized controlled trial conducted in paediatric EDs. Children aged from 1 to 6 years who vomiting, with a presumptive clinical diagnosis of AG, and without severe dehydration will be included. After the failure of a initial ORS administration in ED, eligible children will be randomized to receive: 1 ondansetron syrup (0,15 mg/Kg of body weight; 2 domperidone syrup (0,5 mg/Kg of body weight; 3 placebo. The main study outcome will be the percentage of patients needing nasogastric or IVT after symptomatic oral treatment failure, defined as vomiting or fluid refusal after a second attempt of ORT. Data relative to study outcomes will be collected at 30 minute intervals for a minimum of 6 hours. A telephone follow up call will be made 48 hours after discharge. A total number of 540 children (i.e. 180 patients in each arm will be enrolled. Discussion The trial results would provide evidence on the efficacy of domperidone, which is largely used in

  10. Enhanced depression care for patients with acute coronary syndrome and persistent depressive symptoms: coronary psychosocial evaluation studies randomized controlled trial.

    Science.gov (United States)

    Davidson, Karina W; Rieckmann, Nina; Clemow, Lynn; Schwartz, Joseph E; Shimbo, Daichi; Medina, Vivian; Albanese, Gabrielle; Kronish, Ian; Hegel, Mark; Burg, Matthew M

    2010-04-12

    Depressive symptoms are an established predictor of mortality and major adverse cardiac events (defined as nonfatal myocardial infarction or hospitalization for unstable angina or urgent/emergency revascularizations) in patients with acute coronary syndrome (ACS). This study was conducted to determine the acceptability and efficacy of enhanced depression treatment in patients with ACS. A 3-month observation period to identify patients with ACS and persistent depressive symptoms was followed by a 6-month randomized controlled trial. From January 1, 2005, through February 29, 2008, 237 patients with ACS from 5 hospitals were enrolled, including 157 persistently depressed patients randomized to intervention (initial patient preference for problem-solving therapy and/or pharmacotherapy, then a stepped-care approach; 80 patients) or usual care (77 patients) and 80 nondepressed patients who underwent observational evaluation. The primary outcome was patient satisfaction with depression care. Secondary outcomes were depressive symptom changes (assessed with the Beck Depression Inventory), major adverse cardiac events, and death. At the end of the trial, the proportion of patients who were satisfied with their depression care was higher in the intervention group (54% of 80) than in the usual care group (19% of 77) (odds ratio, 5.4; 95% confidence interval [CI], 2.2-12.9 [P < .001]). The Beck Depression Inventory score decreased significantly more (t(155) = 2.85 [P = .005]) for intervention patients (change, -5.7; 95% CI, -7.6 to -3.8; df = 155) than for usual care patients (change, -1.9; 95% CI, -3.8 to -0.1; df = 155); the depression effect size was 0.59 of the standard deviation. At the end of the trial, 3 intervention patients and 10 usual care patients had experienced major adverse cardiac events (4% and 13%, respectively; log-rank test, chi(2)(1) = 3.93 [P = .047]), as well as 5 nondepressed patients (6%) (for the intervention vs nondepressed cohort, chi(2)(1) = 0