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Sample records for acute decompensation randomized

  1. Interleukin-1 Blockade in Acute Decompensated Heart Failure: A Randomized, Double-Blinded, Placebo-Controlled Pilot Study.

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    Van Tassell, Benjamin W; Abouzaki, Nayef A; Oddi Erdle, Claudia; Carbone, Salvatore; Trankle, Cory R; Melchior, Ryan D; Turlington, Jeremy S; Thurber, Clinton J; Christopher, Sanah; Dixon, Dave L; Fronk, Daniel T; Thomas, Christopher S; Rose, Scott W; Buckley, Leo F; Dinarello, Charles A; Biondi-Zoccai, Giuseppe; Abbate, Antonio

    2016-06-01

    Heart failure is an inflammatory disease. Patients with acute decompensated heart failure (ADHF) exhibit significant inflammatory activity on admission. We hypothesized that Interleukin-1 blockade, with anakinra (Kineret, Swedish Orphan Biovitrum), would quench the acute inflammatory response in patients with ADHF. We randomized 30 patients with ADHF, reduced left ventricular ejection fraction (Interleukin-1 blockade with anakinra reduces the systemic inflammatory response in patients with ADHF. Further studies are warranted to determine whether this anti-inflammatory effect translates into improved clinical outcomes.

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

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

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    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.

  4. Diuretic strategies in patients with acute decompensated heart failure.

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    Felker, G Michael; Lee, Kerry L; Bull, David A; Redfield, Margaret M; Stevenson, Lynne W; Goldsmith, Steven R; LeWinter, Martin M; Deswal, Anita; Rouleau, Jean L; Ofili, Elizabeth O; Anstrom, Kevin J; Hernandez, Adrian F; McNulty, Steven E; Velazquez, Eric J; Kfoury, Abdallah G; Chen, Horng H; Givertz, Michael M; Semigran, Marc J; Bart, Bradley A; Mascette, Alice M; Braunwald, Eugene; O'Connor, Christopher M

    2011-03-03

    Loop diuretics are an essential component of therapy for patients with acute decompensated heart failure, but there are few prospective data to guide their use. In a prospective, double-blind, randomized trial, we assigned 308 patients with acute decompensated heart failure to receive furosemide administered intravenously by means of either a bolus every 12 hours or continuous infusion and at either a low dose (equivalent to the patient's previous oral dose) or a high dose (2.5 times the previous oral dose). The protocol allowed specified dose adjustments after 48 hours. The coprimary end points were patients' global assessment of symptoms, quantified as the area under the curve (AUC) of the score on a visual-analogue scale over the course of 72 hours, and the change in the serum creatinine level from baseline to 72 hours. In the comparison of bolus with continuous infusion, there was no significant difference in patients' global assessment of symptoms (mean AUC, 4236±1440 and 4373±1404, respectively; P=0.47) or in the mean change in the creatinine level (0.05±0.3 mg per deciliter [4.4±26.5 μmol per liter] and 0.07±0.3 mg per deciliter [6.2±26.5 μmol per liter], respectively; P=0.45). In the comparison of the high-dose strategy with the low-dose strategy, there was a nonsignificant trend toward greater improvement in patients' global assessment of symptoms in the high-dose group (mean AUC, 4430±1401 vs. 4171±1436; P=0.06). There was no significant difference between these groups in the mean change in the creatinine level (0.08±0.3 mg per deciliter [7.1±26.5 μmol per liter] with the high-dose strategy and 0.04±0.3 mg per deciliter [3.5±26.5 μmol per liter] with the low-dose strategy, P=0.21). The high-dose strategy was associated with greater diuresis and more favorable outcomes in some secondary measures but also with transient worsening of renal function. Among patients with acute decompensated heart failure, there were no significant differences

  5. [Therapeutic strategies in acute decompensated heart failure and cardiogenic shock].

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    Buerke, M; Lemm, H; Russ, M; Schlitt, A; Werdan, K

    2010-08-01

    As the population of elderly people is increasing, the number of patients requiring hospitalization for acute exacerbations is rising. Traditionally, these episodes of hemodynamic instability were viewed as a transient event characterized by systolic dysfunction, low cardiac output, and fluid overload. Diuretics, along with vasodilator and inotropic therapy, eventually became elements of standard care. In a multicenter observational registry (ADHERE--Acute Decompensated Heart Failure National Registry) of more than 275 hospitals, patients with acute decompensated heart failure were analyzed for their characteristics and treatments options. These data have shown that this population consists of multiple types of heart failure, various forms of acute decompensation, combinations of comorbidities, and varying degrees of disease severity. The challenges in the treatment require multidisciplinary approaches since patients typically are elderly and have complex combinations of comorbidities. So far only a limited number of drugs is currently available to treat the different groups. Over the past years it was shown that even "standard drugs" might be deleterious by induction of myocardial injury, worsening of renal function or increasing mortality upon treatment. Therefore, based on pathophysiology, different types of acute decompensated heart failure require specialized treatment strategies.

  6. [Acute delirium in decompensated schizophrenia and bipolar disorder].

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    Faget-Agius, Catherine; Lançon, Christophe

    2015-02-01

    Acute delirium is common in decompensated schizophrenia and bipolar disor- der: more 50% in two years after the first episode of schizophrenia and 90% of patients with a diagnosis of bipolar disorder. Early signs precede in more 50% of cases the delirious exacerbation of 6 months. These non-specific signs are a change in the mood, an increase of anxiety, sleep and food disorders and suicidal ideation. After this prodromal phase, a persecutory delusion and hallucinations are often present in decompensated schizophrenia. In decompensated bipolar disorder, the delusional syndrome is congruent with the mood. The care should be the earliest possible. The treatment by antipsychotic or mood stabilizer must be increased or re-introduced and maintained during a long time in order to prevent a relapse. In parallel, a psychosocial care must be instituted.

  7. Rational use of diuretics in acute decompensated heart failure.

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    Goebel, Jason A; Van Bakel, Adrian B

    2008-09-01

    Chronic heart failure poses an enormous health care burden to the United States and other developed countries. Acute decompensated heart failure (ADHF) accounts for nearly half of the morbidity and expense of treating this disease. Most patients presenting with ADHF have symptomatic vascular congestion. Diuretics, especially loop diuretics, are the primary pharmacologic intervention used in this population. Despite their widespread use, scant data from randomized clinical trials are available to guide therapeutic choices. In addition, data from several large registries examining weight loss during hospitalization for ADHF suggest that efficacy with diuretic treatment is far from universal. Aggressive diuresis carries a significant risk of electrolyte and volume depletion, with subsequent arrhythmias, hypotension, and worsening renal function. These complications often translate into worse prognosis. Diuretic regimens used to treat ADHF must be individualized based on general knowledge of potency and pharmacokinetic and pharmacodynamic considerations. This article summarizes older and more recent literature to provide a framework for making rational treatment choices in this difficult patient population.

  8. Serum levels of soluble Fas, nitric oxide and cytokines in acute decompensated cirrhotic patients

    Institute of Scientific and Technical Information of China (English)

    Christoph Elsing; Sabine Harenberg; Wolfgang Stremmel; Thomas Herrmann

    2007-01-01

    AIM: To evaluate plasma levels of nitrite/nitrate (NOx),soluble Fas (sFas) antigen, tumor necrosis factor alpha(TNF-α) and interleukin-6 (TL-6) in patients with compensated and acute decompensated cirrhosis and to evaluate mediators causing acute decompensation in liver cirrhosis.METHODS: This prospective study was conducted in the medical intensive care unit of an academic tertiary center. Fifty-five patients with acute decompensation (gastrointestinal hemorrhage, encephalopathy, hydropic decompensation) and twenty-five patients with compensated liver cirrhosis were included. Blood samples were taken for analyses of sfas, Nox, TL-6, TNF-α. Liver enzymes and kidney functions were also tested.RESULTS: In patients with acute decompensation, plasma sfas levels were higher than in non-decompensated patients (15305±4646 vs 12458 ± 4322 pg/mL, P <0.05). This was also true for the subgroup of patients with alcoholic liver cirrhosis (P < 0.05). The other mediators were not different and none of the parameters predicted survival, except for ALT (alanine-aminotransferase). In patients with portal-hypertension-induced acute hemorrhage, NOx levels were significantly lower than in patients with other forms of decompensation (70.8 ±48.3 vs 112.9 ± 74.9 pg/mL, P < 0.05). When NOx levels were normalized to creatinine levels, the difference disappeared. IL-6, TNF-α and sfas were not different between bleeders and non-bleeders. In decompensated patients sfas, IL-6 and NOx levels correlated positively with creatinine levels, while IL-6 levels were dependent on Child class.CONCLUSION: In acute decompensated cirrhotic patients sFas is increased, suggesting a role of apoptosis in this process and patients with acute bleeding have lower NOx levels. However, in this acute complex clinical situation, kidney function seems to have a predominant influence on mediator levels.

  9. Effects of Nesiritide and Predictors of Urine Output in Acute Decompensated Heart Failure Results From ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure)

    NARCIS (Netherlands)

    Gottlieb, Stephen S.; Stebbins, Amanda; Voors, Adriaan A.; Hasselblad, Vic; Ezekowitz, Justin A.; Califf, Robert M.; O'Connor, Christopher M.; Starling, Randall C.; Hernandez, Adrian F.

    2013-01-01

    Objectives This study sought to determine if nesiritide increases diuresis in congestive heart failure patients. Background In the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure), 7,141 patients hospitalized with acute decompensated heart failure

  10. 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)

    NARCIS (Netherlands)

    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.

    2014-01-01

    Background-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. Methods

  11. 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)

    NARCIS (Netherlands)

    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.

    2014-01-01

    Background-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. Methods

  12. Effects of Nesiritide and Predictors of Urine Output in Acute Decompensated Heart Failure Results From ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure)

    NARCIS (Netherlands)

    Gottlieb, Stephen S.; Stebbins, Amanda; Voors, Adriaan A.; Hasselblad, Vic; Ezekowitz, Justin A.; Califf, Robert M.; O'Connor, Christopher M.; Starling, Randall C.; Hernandez, Adrian F.

    2013-01-01

    Objectives This study sought to determine if nesiritide increases diuresis in congestive heart failure patients. Background In the ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide and Decompensated Heart Failure), 7,141 patients hospitalized with acute decompensated heart failure (ADHF

  13. 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 requ

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

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    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

  15. Substantial Discrepancy Between Fluid and Weight Loss During Acute Decompensated Heart Failure Treatment.

    Science.gov (United States)

    Testani, Jeffrey M; Brisco, Meredith A; Kociol, Robb D; Jacoby, Daniel; Bellumkonda, Lavanya; Parikh, Chirag R; Coca, Steven G; Tang, W H Wilson

    2015-07-01

    Net fluid and weight loss are used ubiquitously to monitor diuretic response in acute decompensated heart failure research and patient care. However, the performance of these metrics has never been evaluated critically. The weight and volume of aqueous fluids such as urine should be correlated nearly perfectly and with very good agreement. As a result, significant discrepancy between fluid and weight loss during the treatment of acute decompensated heart failure would indicate measurement error in 1 or both of the parameters. The correlation and agreement (Bland-Altman method) between diuretic-induced fluid and weight loss were examined in 3 acute decompensated heart failure trials and cohorts: (1) Diuretic Optimization Strategies Evaluation (DOSE) (n = 254); (2) Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE) (n = 348); and (3) Penn (n = 486). The correlation between fluid and weight loss was modest (DOSE r = 0.55; ESCAPE r = 0.48; Penn r = 0.51; P fluid than weight loss was found across populations (-0.74 to -2.1 kg-L, P ≤ .002). A consistent pattern of baseline characteristics or in-hospital treatment parameters that could identify patients at risk of discordant fluid and weight loss was not found. Considerable discrepancy between fluid balance and weight loss is common in patients treated for acute decompensated heart failure. Awareness of the limitations inherent to these commonly used metrics and efforts to develop more reliable measures of diuresis are critical for both patient care and research in acute decompensated heart failure. Copyright © 2015 Elsevier Inc. All rights reserved.

  16. Loop Diuretics in Acute Decompensated Heart Failure: Necessary? Evil? A Necessary Evil?

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    Felker, G. Michael; O’Connor, Christopher M.; Braunwald, Eugene

    2009-01-01

    Acute decompensated heart failure (ADHF) is a common and highly morbid cardiovascular disorder. Most hospitalizations for ADHF are related to symptoms of congestion, and the vast majority of ADHF patients are treated with intravenous loop diuretics. Despite this nearly ubiquitous use, data supporting the safety and efficacy of loop diuretics in ADHF are limited, and controversy exists about the best way to use loop diuretics with regard to both dosing and means of administration (continuous infusion vs. intermittent boluses). We reviewed the data supporting the safety and efficacy of loop diuretics in patients with ADHF. A large body of observational literature suggests that loop diuretics, especially at higher doses, may be associated with increased mortality in patients with heart failure even after detailed adjustment for other measures of disease severity. Additionally, multiple small underpowered trials suggest that continuous infusion may be equivalent or superior to intermittent bolus dosing. In summary, there is a critical need to develop more robust data on the use of loop diuretics in ADHF. In that context, the NIH Heart Failure Clinical Research Network has begun the Diuretics Optimization Strategies Evaluation (DOSE) study, a multi-center, double-blind, randomized controlled trial that will enroll 300 patients with ADHF. The DOSE study will randomize patients using a 2 × 2 factorial design to low dose vs. high dose furosemide, and intermittent bolus vs. continuous infusion. Successful completion of the DOSE study will provide important data on the optimal clinical use of loop diuretics in ADHF. PMID:19750134

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

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    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.)

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

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    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.

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

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    Estrada, Chelsea; Patel, Sagar; Weisfelner Bloom, Michelle; Wadhwa, Nand K.

    2013-01-01

    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. PMID:24829808

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

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    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.

  1. Hepatic encephalopathy in patients with acute decompensation of cirrhosis and acute-on-chronic liver failure.

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    Romero-Gómez, Manuel; Montagnese, Sara; Jalan, Rajiv

    2015-02-01

    Hepatic encephalopathy in a hospitalized cirrhotic patient is associated with a high mortality rate and its presence adds further to the mortality of patients with acute-on-chronic liver failure (ACLF). The exact pathophysiological mechanisms of HE in this group of patients are unclear but hyperammonemia, systemic inflammation (including sepsis, bacterial translocation, and insulin resistance) and oxidative stress, modulated by glutaminase gene alteration, remain as key factors. Moreover, alcohol misuse, hyponatremia, renal insufficiency, and microbiota are actively explored. HE diagnosis requires exclusion of other causes of neurological, metabolic and psychiatric dysfunction. Hospitalization in the ICU should be considered in every patient with overt HE, but particularly if this is associated with ACLF. Precipitating factors should be identified and treated as required. Evidence-based specific management options are limited to bowel cleansing and non-absorbable antibiotics. Ammonia lowering drugs, such as glycerol phenylbutyrate and ornithine phenylacetate show promise but are still in clinical trials. Albumin dialysis may be useful in refractory cases. Antibiotics, prebiotics, and treatment of diabetes reduce systemic inflammation. Where possible and not contraindicated, large portal-systemic shunts may be embolized but liver transplantation is the most definitive step in the management of HE in this setting. HE in patients with ACLF appears to be clinically and pathophysiologically distinct from that of acute decompensation and requires further studies and characterization.

  2. Intra-abdominal Hypertension: An Important Consideration for Diuretic Resistance in Acute Decompensated Heart Failure.

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    Nguyen, Vinh Q; Gadiraju, Taraka V; Patel, Hiren; Park, Minnsun; Le Jemtel, Thierry H; Jaiswal, Abhishek

    2016-01-01

    Fluid accumulation is the hallmark of heart failure decompensation. Fluid overload and congestion are associated with recurrent hospitalizations, poor quality of life, and increased mortality in heart failure. Despite the use of high-dose intravenous loop diuretic therapy, acutely decompensated heart failure patients may develop diuretic resistance. Diuretic refractoriness can be a result of elevated intra-abdominal pressure (IAP) in acutely decompensated heart failure. Increased renal venous and interstitial pressures in patients with elevated IAP may lead to renal impairment and diuretic resistance. Routine approaches such as sequential nephron blockade with a combination of loop and thiazide or thiazide-like diuretics, continuous diuretic infusion, and ultrafiltration may not be sufficient. Presented here is a case illustrating the importance of recognizing intra-abdominal hypertension in patients with diuretic resistance. Lowering IAP improves renal perfusion, renal filtration, and diuresis. When elevated, IAP is an easily reversible cause of diuretic resistance. Additionally, abdominal perfusion pressure can be used to guide therapy to reverse end-organ damage and avoid permanent renal replacement therapy.

  3. Efficacy and safety of continuous hemodiafiltration for acute decompensated heart failure.

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    Shiomi, Hiroki; Matsubara, Kinya; Ariyoshi, Makoto; Iwamura, Yumi; Fukui, Kensuke; Sakamoto, Tomoko; Sawanishi, Takayoshi; Shima, Masami; Furukawa, Keizo

    2010-07-01

    The mortality of heart failure patients with renal insufficiency is high, and these patients tend to develop diuretic resistance. Under these conditions, continuous hemodiafiltration (CHDF) is a possible alternative volume reduction therapy to diuretics. However, its efficacy and safety are not clear. Between April 2005 and March 2008, 248 patients with acute decompensated heart failure were admitted to the CCU of Kyoto City Hospital. Of those patients, 31 (20 volume overloaded heart failure, 11 cardiogenic shock) received CHDF therapy, and their weight loss, acute hemodynamic changes, and clinical outcome were assessed to evaluate the efficacy and safety of CHDF therapy. CHDF was performed for 6.5 +/- 6.5 days. There was no significant change in acute hemodynamics after CHDF initiation. In the volume overloaded heart failure (VH) group, significant weight loss was observed at 24 hours and 48 hours after CHDF initiation (P shock (CS) group were 10.0% and 54.5%, respectively. CHDF for acute decompensated heart failure (ADHF) is a safe, effective, and reliable volume reduction therapy for volume overloaded heart failure. Further investigation is required to assess the effectiveness of CHDF for cardiogenic shock.

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

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    João Pedro Ferreira

    2015-04-01

    Full Text Available 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 < 0.05. Baseline MMP2, NT-pro BNP and weight did not differ between spironolactone and control groups. A trend towards a more pronounced decrease in MMP2 from baseline to day 3 was observed in the spironolactone group (-21 [-50 to 19] vs 1.5 [-26 to 38] ng/mL, p = 0.06. NT-pro BNP and weight also had a greater decrease in the spironolactone group. The proportion of patients with a decrease in MMP2 levels from baseline to day 3 was also likely to be greater in the spironolactone group (50% vs 66.7%, but without statistical significance. Correlations between MMP2, NT-pro BNP and weight variation were not statistically significant. Conclusion: MMP2 levels are increased in ADHF. Patients treated with spironolactone may have a greater reduction in MMP2 levels.

  5. Extracorporal hemodialysis with acute or decompensated chronical hepatic failure

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    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

  6. Acute decompensated heart failure is routinely treated as a cardiopulmonary syndrome.

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    Kumar Dharmarajan

    Full Text Available BACKGROUND: Heart failure as recognized and treated in typical practice may represent a complex condition that defies discrete categorizations. To illuminate this complexity, we examined treatment strategies for patients hospitalized and treated for decompensated heart failure. We focused on the receipt of medications appropriate for other acute conditions associated with shortness of breath including acute asthma, pneumonia, and exacerbated chronic obstructive pulmonary disease. METHODS AND RESULTS: Using Premier Perspective(®, we studied adults hospitalized with a principal discharge diagnosis of heart failure and evidence of acute heart failure treatment from 2009-2010 at 370 US hospitals. We determined treatment with acute respiratory therapies during the initial 2 days of hospitalization and daily during hospital days 3-5. We also calculated adjusted odds of in-hospital death, admission to the intensive care unit, and late intubation (intubation after hospital day 2. Among 164,494 heart failure hospitalizations, 53% received acute respiratory therapies during the first 2 hospital days: 37% received short-acting inhaled bronchodilators, 33% received antibiotics, and 10% received high-dose corticosteroids. Of these 87,319 hospitalizations, over 60% continued receiving respiratory therapies after hospital day 2. Respiratory treatment was more frequent among the 60,690 hospitalizations with chronic lung disease. Treatment with acute respiratory therapy during the first 2 hospital days was associated with higher adjusted odds of all adverse outcomes. CONCLUSIONS: Acute respiratory therapy is administered to more than half of patients hospitalized with and treated for decompensated heart failure. Heart failure is therefore regularly treated as a broader cardiopulmonary syndrome rather than as a singular cardiac condition.

  7. Effect of recombinant human brain natriuretic peptide combined with sodium nitroprusside therapy on hemodynamics and cardiac in patients with acute decompensated heart failure

    Institute of Scientific and Technical Information of China (English)

    Qiao-Li Xing; Xian-Hong Ma; Lu Wang

    2016-01-01

    Objective:To evaluate the effect of recombinant human brain natriuretic peptide combined with sodium nitroprusside therapy on hemodynamics and cardiac function levels in patients with acute decompensated heart failure.Methods:A total of 118 patients with acute decompensated heart failure were randomly divided into observation group and the control group (n=59). Control group received clinical conventional therapy for heart failure, observation group received recombinant human brain natriuretic peptide combined with sodium nitroprusside therapy, and the differences in hemodynamics, cardiac function and circulation factor levels were compared between two groups after 12 hours of treatment. Results: After 12 hours of treatment, central venous pressure, right atrial pressure and pulmonary capillary wedge pressure values as well as circulating blood IL-6, hsCRP, ST2, NT-proBNP and cTnⅠlevels of observation group were lower than those of control group, and left heart GLS, GCS, GSRs, GSRe, GSRa, ROT and ROTR levels were higher than those of control group (P<0.05).Conclusions:Recombinant human brain natriuretic peptide combined with sodium nitroprusside therapy for patients with acute decompensated heart failure has significant advantages in optimizing hemodynamics, cardiac function and other aspects.

  8. Citric acid as the last therapeutic approach in an acute life-threatening metabolic decompensation of propionic acidaemia.

    Science.gov (United States)

    Siekmeyer, Manuela; Petzold-Quinque, Stefanie; Terpe, Friederike; Beblo, Skadi; Gebhardt, Rolf; Schlensog-Schuster, Franziska; Kiess, Wieland; Siekmeyer, Werner

    2013-01-01

    The tricarboxylic acid (TCA) cycle represents the key enzymatic steps in cellular energy metabolism. Once the TCA cycle is impaired in case of inherited metabolic disorders, life-threatening episodes of metabolic decompensation and severe organ failure can arise. We present the case of a 6 ½-year-old girl with propionic acidaemia during an episode of acute life-threatening metabolic decompensation and severe lactic acidosis. Citric acid given as an oral formulation showed the potential to sustain the TCA cycle flux. This therapeutic approach may become a treatment option in a situation of acute metabolic crisis, possibly preventing severe disturbance of energy metabolism.

  9. 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

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

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    Barkoudah Ebrahim

    2015-05-01

    Full Text Available Introduction: 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. Objective: 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. Methods: 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. Results: 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 < 0.001 more than those who received standard 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. Conclusion: 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.

  11. 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 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 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 também apresentaram maior diminuição no grupo espironolactona. A proporção de pacientes com redução nos níveis de MMP2 do basal para o dia 3 também foi maior no grupo espironolactona (50% vs 66,7%), embora sem significado estatístico. As correlações entre as variações de MMP2, NT-pro BNP e peso não apresentaram significado estatístico. Conclusões: Os níveis de MMP2 acham-se aumentados na ICAD. Pacientes tratados com espironolactona podem apresentar maior redução nos níveis de MMP2.

  12. Plasma asymmetric dimethylarginine and cardiovascular events in patients with acute decompensated heart failure.

    Science.gov (United States)

    Dückelmann, Christina; Mittermayer, Friedrich; Haider, Dominik G; Altenberger, Johann; Wolzt, Michael

    2008-07-01

    This prospective study investigated whether plasma asymmetric dimethylarginine (ADMA) concentrations are related to cardiovascular events in patients with acute heart failure. It has been reported that increased plasma ADMA concentrations are associated with adverse cardiovascular outcome in chronic heart failure. In 118 patients with acute decompensated heart failure and impaired left ventricular function, ADMA and N-terminal pro-brain natriuretic peptide (NT-proBNP) were assessed by high-performance liquid chromatography and by an enzyme-linked immunosorbent assay, respectively. Venous blood was collected at admission and after 1 week, and clinical events were observed during follow-up. All patients (median age 73 years, 96 males) were followed up for a median of 10.7 months. A clinical endpoint (cardiac decompensation, major adverse cardiovascular event, or all-cause mortality) occurred in 66 patients. In 81 patients, changes (Delta) in ADMA or NT-proBNP between admission and a median of 7 days were available. ADMA, NT-proBNP at admission, and DeltaADMA or DeltaNT-proBNP were comparable in patients with and without a clinical endpoint. In contrast to ADMA, NT-proBNP concentrations above the median were associated with higher adjusted hazard ratio for occurrence of an endpoint (HR 2.1; 95% confidence interval 1.2-3.9; P = 0.013). An inverse relationship was observed between DeltaNT-proBNP and endpoints before (P = 0.010) and after (P = 0.015) adjustment for confounders. In patients with acute heart failure, ADMA did not detect patients at future cardiovascular risk.

  13. The Predictive Value of Short-Term Changes in Hemoglobin Concentration in Patients Presenting With Acute Decompensated Heart Failure

    NARCIS (Netherlands)

    van der Meer, Peter; Postmus, Douwe; Ponikowski, Piotr; Cleland, John G.; O'Connor, Christopher M.; Cotter, Gad; Metra, Marco; Davison, Beth A.; Givertz, Michael M.; Mansoor, George A.; Teerlink, John R.; Massie, Barry M.; Hillege, Hans L.; Voors, Adriaan A.

    2013-01-01

    Objectives The study sought to investigate the clinical correlates and prognostic role of anemia and changes in hemoglobin in patients hospitalized for acute decompensated heart failure (AHF). Background Anemia is related to a poor outcome in patients with heart failure. In addition, an increase in

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

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    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

  15. 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.

  16. Effects of the Adenosine A(1) Receptor Antagonist Rolofylline on Renal Function in Patients With Acute Heart Failure and Renal Dysfunction Results From PROTECT (Placebo-Controlled Randomized Study of the Selective A(1) Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized With Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function)

    NARCIS (Netherlands)

    Voors, Adriaan A.; Dittrich, Howard C.; Massie, Barry M.; DeLucca, Paul; Mansoor, George A.; Metra, Marco; Cotter, Gad; Weatherley, Beth D.; Ponikowski, Piotr; Teerlink, John R.; Cleland, John G. F.; O'Connor, Christopher M.; Givertz, Michael M.

    2011-01-01

    Objectives This study sought to assess the effects of rolofylline on renal function in patients with acute heart failure (AHF) and renal dysfunction randomized in PROTECT (Placebo-Controlled Randomized Study of the Selective A(1) Adenosine Receptor Antagonist Rolofylline for Patients Hospitalized Wi

  17. 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.

  18. The glucocorticoid in acute decompensated heart failure: Dr Jekyll or Mr Hyde?

    Science.gov (United States)

    Massari, Francesco; Mastropasqua, Filippo; Iacoviello, Massimo; Nuzzolese, Vincenzo; Torres, Daniele; Parrinello, Gaspare

    2012-03-01

    Glucocorticoid administration is not recommended in patients with heart failure because of its related sodium and fluid retention. However, previous experimental and clinical studies have demonstrated that glucocorticoids can also induce a diuretic effect and improve renal function in patients with acute decompensated heart failure (ADHF) with refractory diuretic resistance. We report the case of a 65-year-old man with a known diagnosis of aortic stenosis, systolic ventricular dysfunction, and chronic obstructive pulmonary disease who was admitted for ADHF. After 3 days, during which resistance to conventional therapy was observed, intravenous methylprednisolone (60 mg/d) was added to ongoing medical treatment. Three days after the onset of glucocorticoid therapy, daily urine volume progressively increased (up to 5.8 L/d). Concurrently, signs and symptoms of congestion improved, the weight and brain natriuretic peptide plasma levels decreased (−7 kg and −46%, respectively) and glomerular filtration rate increased (+26%). Bioimpedance vector analysis showed a net reduction of fluid content (from 88.4% to 73.6% of hydration at discharge). In conclusion, this case report suggests that in a patient with ADHF and congestion resistant to diuretic therapy, glucocorticoid administration is safe and associated with improvement in congestion, neurohormonal status, and renal function. These data support the possible usefulness of glucocorticoids in this setting.

  19. Decongestive treatment of acute decompensated heart failure: cardiorenal implications of ultrafiltration and diuretics.

    Science.gov (United States)

    Freda, Benjamin J; Slawsky, Mara; Mallidi, Jaya; Braden, Gregory L

    2011-12-01

    In patients with acute decompensated heart failure (ADHF), treatment aimed at adequate decongestion of the volume overloaded state is essential. Despite diuretic therapy, many patients remain volume overloaded and symptomatic. In addition, adverse effects related to diuretic treatment are common, including worsening kidney function and electrolyte disturbances. The development of decreased kidney function during treatment affects the response to diuretic therapy and is associated with important clinical outcomes, including mortality. The occurrence of diuretic resistance and the morbidity and mortality associated with diuretic therapy has stimulated interest to develop effective and safe treatment strategies that maximize decongestion and minimize decreased kidney function. During the last few decades, extracorporeal ultrafiltration has been used to remove fluid from diuretic-refractory hypervolemic patients. Recent clinical studies using user-friendly machines have suggested that ultrafiltration may be highly effective for decongesting patients with ADHF. Many questions remain regarding the comparative impact of diuretics and ultrafiltration on important clinical outcomes and adverse effects, including decreased kidney function. This article serves as a summary of key clinical studies addressing these points. The overall goal is to assist practicing clinicians who are contemplating the use of ultrafiltration for a patient with ADHF.

  20. Quantitative Assessment of Fluid Accumulation Using Bioelectrical Impedance Analysis in Patients With Acute Decompensated Heart Failure.

    Science.gov (United States)

    Sakaguchi, Taiki; Yasumura, Kaori; Nishida, Hiroki; Inoue, Hiroyuki; Furukawa, Tetsuo; Shinouchi, Kazuya; Miura, Hiroyuki; Miyazaki, Koichi; Hamano, Gou; Koide, Masao; Abe, Haruhiko; Date, Motoo; Hirooka, Keiji; Koretsune, Yukihiro; Kusuoka, Hideo; Yasumura, Yoshio

    2015-01-01

    Acute decompensated heart failure (ADHF) is generally considered to be a problem of fluid volume overload, therefore accurately quantifying the degree of fluid accumulation is of critical importance in assessing whether adequate decongestion has been achieved. The aim of this study was to develop and validate a method to quantify the degree of fluid accumulation in patients with ADHF. Using multi-frequency bioelectrical impedance analysis (BIA), we measured extracellular water (ECW) volume in 130 ADHF patients on admission and at discharge. We also predicted optimal ECW volume using original equations based on data from 60 control subjects without the signs of HF. Measured/predicted (M/P) ratio of ECW in ADHF patients was observed to decrease from 1.26±0.25 to 1.04±0.17 during hospitalization (P<0.001). The amount of ECW volume reduction was significantly correlated with reduction in body weight (r=0.766, P<0.001). On multivariate analysis, higher M/P ratio of ECW at discharge was associated with increased risk of ADHF readmission or cardiac death within 6 months after discharge. Multi-frequency BIA-measured ECW was found to offer valuable information for analyzing the pathophysiology of ADHF, and may be a useful guide in the management of this disease.

  1. Incremental value of natriuretic peptide measurement in acute decompensated heart failure (ADHF): a systematic review.

    Science.gov (United States)

    Santaguida, Pasqualina L; Don-Wauchope, Andrew C; Ali, Usman; Oremus, Mark; Brown, Judy A; Bustamam, Amy; Hill, Stephen A; Booth, Ronald A; Sohel, Nazmul; McKelvie, Robert; Balion, Cynthia; Raina, Parminder

    2014-08-01

    The aim of this systematic review was to determine whether B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) independently add incremental value for predicting mortality and morbidity in patients with acute decompensated heart failure (ADHF). Medline(®), Embase™, AMED, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and CINAHL were searched from 1989 to June 2012. We also searched reference lists of included articles, systematic reviews, and the gray literature. Studies were screened for eligibility criteria and assessed for risk of bias. Data were extracted on study design, population demographics, assay cutpoints, prognostic risk prediction model covariates, statistical methods, outcomes, and results. From 183 citations, only seven studies (5 BNP and 2 NT-proBNP) considered incremental value in ADHF subjects admitted to acute care centers. Admission assay levels and length of follow-up varied for BNP studies (31 days to 12 months) and for NT-proBNP studies (25-82 months). All studies presented at least one estimate of incremental value of BNP/NT-proBNP relative to the base prognostic model. Using discrimination or likelihood statistics, these studies consistently showed that BNP or NT-proBNP increased model performance. Three studies used reclassification and model validation computations to establish incremental value; these studies showed less consistency with respect to added value. In conclusion, the literature assessing incremental value of BNP/NT-proBNP in ADHF populations is limited to seven studies evaluating only mortality outcomes and at moderate risk of bias. Although there were differences in the base risk prediction models, assay cutpoints, and lengths of follow-up, there was consistency in BNP/NT-proBNP adding incremental value in prediction models in ADHF patients.

  2. 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

    NARCIS (Netherlands)

    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

    Background 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, m

  3. Impact of onset time of acute kidney injury on outcomes in patients with acute decompensated heart failure.

    Science.gov (United States)

    Takaya, Yoichi; Yoshihara, Fumiki; Yokoyama, Hiroyuki; Kanzaki, Hideaki; Kitakaze, Masafumi; Goto, Yoichi; Anzai, Toshihisa; Yasuda, Satoshi; Ogawa, Hisao; Kawano, Yuhei

    2016-01-01

    Since acute kidney injury (AKI) is not always related to mortality in patients with acute decompensated heart failure (ADHF), the aim of this study was to focus on onset time of AKI and its clinical importance. A total of 371 ADHF patients were included. The impact of AKI (≥ 0.3 mg/dl or 1.5-fold increase in serum creatinine level within 48 h) with early onset (≤ 4 days from admission) or late onset (≥ 5 days from admission) was assessed. AKI occurred in 99 patients, who were divided into two groups according to the median onset time of AKI: 50 with early onset of AKI and 49 with late onset of AKI. The maximum increase in serum creatinine level from admission was greater in patients with late onset of AKI than in patients with early onset of AKI (p = 0.012). Patients with late onset of AKI had a higher 12-month mortality rate than that in patients with early onset of AKI (log-rank test, p = 0.014). Late onset of AKI was an independent predictor of mortality (hazard ratio: 3.39, 95 % confidence interval: 1.84-6.18, p time of AKI may be useful for risk stratification of mortality in ADHF patients developing AKI.

  4. Fluid loss, venous congestion, and worsening renal function in acute decompensated heart failure.

    Science.gov (United States)

    Aronson, Doron; Abassi, Zaid; Allon, Eyal; Burger, Andrew J

    2013-06-01

    To investigate the relationship between decongestion, central venous pressure, and risk of worsening renal function (WRF) in patients with acute decompensated heart failure (ADHF). We studied 475 patients with ADHF, of whom 238 underwent right heart catheterization. Right atrial pressure (RAP) was measured at baseline and at 24 h. Net fluid loss was recorded in the first 24 h. WRF was defined as a >0.3 mg/dL increase in serum creatinine above baseline. WRF occurred in 84 catheterized patients (35.3%). There was a weak correlation between baseline RAP and baseline estimated glomerular filtration rate (r = -0.17, P = 0.009). The amount of fluid removed during the first 24 h did not correlate with the magnitude of RAP reduction (r = 0.06, P = 0.35). No association was observed between WRF and baseline RAP [odds ratio (OR) 1.06, 95% confidence interval (CI) 0.80-1.41, P = 0.68 per 6.6 mmHg] or the decrease in RAP (adjusted OR 1.13, 95% CI 0.85-1.49, P = 0.40 per 5.3 mmHg reduction in RAP). In contrast, smaller net fluid loss was strongly associated with increased WRF risk. Compared with the first net fluid loss tertile, the adjusted OR was 1.85 (95% CI 0.90-3.80, P = 0.10) and 2.58 (95% CI 1.27-5.25; P = 0.009) for the second and third tertile, respectively (P for trend fluid loss is associated with increased risk for WRF. RAP is not a reliable surrogate of the magnitude of decongestion and risk of WRF. Future research is necessary to determine if targeting congestion may help prevent WRF.

  5. A retrospective characterization of worsening renal function in patients with acute decompensated heart failure receiving nesiritide

    Directory of Open Access Journals (Sweden)

    Starr JA

    2009-09-01

    Full Text Available Nesiritide is approved by Food and Drug Administration (FDA for the treatment of patients with acute decompensated heart failure (ADHF due its ability to rapidly reduce cardiac filling pressures and improve dyspnea. Numerous studies have shown that renal dysfunction is associated with unfavorable outcomes in patients with heart failure. In addition, there have been reports suggesting that nesiritide may adversely affect renal function and mortality. Objective: The purpose of this retrospective analysis was to assess the effect of dose and duration of nesiritide use and the dose and duration of diuretic therapy on worsening renal function and increased in-hospital mortality in this patient population.Methods: Seventy-five patients who were hospitalized for ADHF and who were treated with nesiritide for at least 12 hours were reviewed retrospectively. Results: The mean increase in SCr was 0.5 mg/dL (range 0 – 4.4 mg/dL. Thirty-six percent of patients (27/75 met the primary endpoint with an increase in SCr>0.5 mg/dL. Treatment dose and duration of nesiritide did not differ between those patients who had an increase in SCr>0.5 mg/dL and those who did not (p=0.44 and 0.61. Concomitant intravenous diuretics were used in 85% of patients with an increase in SCr >0.5 mg/dL compared to 90% of patients without an increase in SCr>0.5 mg/dL (p=0.57. The in-hospital mortality rate was also higher at 35% in those patients with an increase in creatinine >0.5 mg/dL compared to 11% in those without (p=0.01. Conclusion: Nesiritide was associated with an increase in SCr > 0.5 mg/dL in approximately one-third of patients. The increase occurred independently of dose, duration of nesiritide therapy, blood pressure changes, and concomitant intravenous diuretic use. However, the increase in SCr was associated with an increase in hospital stay and in hospital mortality consistent with previous reports in the literature.

  6. Management strategies to meet the core heart failure measures for acute decompensated heart failure: a nursing perspective.

    Science.gov (United States)

    Gardetto, Nancy J; Carroll, Karen C

    2007-01-01

    Despite enormous advances in the medical management of heart disease, heart failure (HF) persists as a leading cause of hospitalization in our elderly. In 2001, the American Heart Association and the American College of Cardiology published Guidelines for Secondary Prevention for Patients With Coronary and Other Atherosclerotic Vascular Disease. The guidelines proactively responded to a growing body of evidence confirming that comprehensive risk factor management and risk reduction improve quality of life and survival, while reducing recurrent cardiovascular events. In spite of the well-crafted, comprehensive HF guidelines, morbidity, mortality, and hospital readmission rates for acute decompensated heart failure remain high, and adherence to HF guidelines is not always optimal. The Joint Commission has implemented a number of quality care performance indicators based on the Guidelines for Secondary Prevention; among them are the Core HF Measures for hospitalized HF patients. The Core HF Measures are endorsed by the Center for Medicare and Medicaid and has been adopted as a national benchmark for measurement and public reporting of healthcare performance and for Medicare payments (Joint Commission). The implementation and monitoring of Core HF Measures has prioritized attention toward patient education and risk factor modification to prevent future hospitalization. Critical care nurses are on the frontline to champion uptake and adherence of Core HF Measures. The purpose of this article is to highlight the critical component that nursing care, guided by the Core HF Measures, can offer to improve the quality of patient care in acute decompensated heart failure.

  7. 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

  8. 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.

  9. 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.

  10. Device diagnostics and early identification of acute decompensated heart failure: a systematic review.

    Science.gov (United States)

    Blair, Tara Leslie

    2014-01-01

    Traditional methods of heart failure (HF) management are based on reactive strategies to treat late indicators of decompensated HF. Advances in monitoring methods have become available with the evolution of implantable cardioverter-defibrillators and cardiac-resynchronization therapy devices. These devices provide new diagnostic data and remote monitoring capabilities that allow clinicians to proactively monitor patients for earlier signs of worsening HF. The integration of data obtained from implantable cardioverter-defibrillator and cardiac-resynchronization therapy technology could improve outpatient HF care, potentially leading to decreased readmission rates and improved patient outcomes. This review will synthesize the literature regarding the efficacy of device diagnostic data and the usability of the data in the clinical setting. Articles for review were obtained using Cumulative Index to Nursing and Allied Health Literature, MEDLINE, PubMed, and ClinicalTrials.gov. Device diagnostics showed strong correlation with established HF biomarkers and hemodynamic measures. The findings from this review indicate that device diagnostic parameters predict impending HF much earlier than traditional methods of monitoring do. Device diagnostics are also more accurate in the early prediction of HF when compared with noninvasive objective measures, particularly when multiple parameters are combined and monitored for trends. Device diagnostics possess a distinct advantage over traditional methods of monitoring for HF because they allow clinicians to remotely monitor the status of their HF patients without relying on patient compliance for data entry and reporting. Studies regarding the efficacy of device diagnostic parameters suggest that their integration into clinical practice will provide a more accurate and reliable mechanism for assisting clinicians in risk stratifying and predicting potential episodes of decompensated HF.

  11. 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.

  12. Decrease in serum adiponectin levels in response to treatment predicts good prognosis in acute decompensated heart failure.

    Science.gov (United States)

    Matsumoto, Mika; Lee-Kawabata, Masaaki; Tsujino, Takeshi; Naito, Yoshiro; Ezumi, Akira; Sakoda, Tsuyoshi; Ohyanagi, Mitsumasa; Shimomura, Iichiro; Masuyama, Tohru

    2010-11-01

    Adiponectin is a cardioprotective adipocytokine. Serum adiponectin concentration decreases in patients who are obese but increases in patients with chronic heart failure (CHF). The aim of this study was to explore the temporal changes in serum adiponectin concentration following treatment for acute decompensated heart failure (ADHF). Serum adiponectin was measured on admission and at discharge in 95 patients who were admitted to our hospital with ADHF. Ten patients without heart failure (HF) served as controls. Serum adiponectin concentration was higher on admission in HF patients than in the controls (22.6±13.3 μg/mL vs 9.3±3.9 μg/mL, P<.01). Serum adiponectin concentration decreased after treatment in HF patients (18.0±11.7 μg/mL vs 22.6±13.3 μg/mL, P<.01). The larger temporal decrease in adiponectin level in ADHF was associated with the lower incidence of cardiac death or HF hospitalizations (log-rank, P<.05). Serum adiponectin concentration was elevated in ADHF and decreased following the treatment. How much serum adiponectin decreases in response to treatment in ADHF is an important determinant of the prognosis. © 2010 Wiley Periodicals, Inc.

  13. Recurrent Acute Decompensated Heart Failure Owing to Severe Iron Deficiency Anemia Caused by Inappropriate Habitual Bloodletting

    Science.gov (United States)

    Lim, Woo-Hyun; Kim, Hack-Lyoung; Kim, Ki-Hwan; Na, Sang Hoon; Lee, Hyun-Jung; Kang, Eun Gyu; Seo, Jae-Bin; Chung, Woo-Young; Zo, Joo-Hee; Hong, Jung Ae; Kim, Kwangyoun; Kim, Myung-A

    2015-01-01

    A 68-year-old woman visited the emergency department twice with symptoms of acute heart failure including shortness of breath, general weakness, and abdominal distension. Laboratory findings showed extremely low level of serum hemoglobin at 1.4 g/dL. Echocardiographic examination demonstrated dilated left ventricular cavity with systolic dysfunction and moderate amount of pericardial effusion. In this patient, acute heart failure due to severe iron deficiency anemia was caused by inappropriate habitual bloodletting. PMID:26755934

  14. Acute Heart Failure Registry: Risk Assessment Model in Decompensated Heart Failure

    Science.gov (United States)

    Delgado, Anne; Rodrigues, Bruno; Nunes, Sara; Baptista, Rui; Marmelo, Bruno; Moreira, Davide; Gama, Pedro; Nunes, Luís; Santos, Oliveira; Cabral, Costa

    2016-01-01

    Background Heart failure (HF) is a highly prevalent syndrome. Although the long-term prognostic factors have been identified in chronic HF, this information is scarcer with respect to patients with acute HF. despite available data in the literature on long-term prognostic factors in chronic HF, data on acute HF patients are more scarce. Objectives To develop a predictor of unfavorable prognostic events in patients hospitalized for acute HF syndromes, and to characterize a group at higher risk regarding their clinical characteristics, treatment and outcomes. Methods cohort study of 600 patients admitted for acute HF, defined according to the European Society of Cardiology criteria. Primary endpoint for score derivation was defined as all-cause mortality and / or rehospitalization for HF at 12 months. For score validation, the following endpoints were used: all-cause mortality and / or readmission for HF at 6, 12 and 24 months. The exclusion criteria were: high output HF; patients with acute myocardial infraction, acute myocarditis, infectious endocarditis, pulmonary infection, pulmonary artery hypertension and severe mitral stenosis. Results 505 patients were included, and prognostic predicting factors at 12 months were identified. One or two points were assigned according to the odds ratio (OR) obtained (p < 0.05). After the total score value was determined, a 4-point cut-off was determined for each ROC curve at 12 months. Two groups were formed according to the number of points, group A < 4 points, and group B = 4 points. Group B was composed of older patients, with higher number of comorbidities and predictors of the combined endpoint at 6, 12 and 24 months, as linearly represented in the survival curves (Log rank). Conclusions This risk score enabled the identification of a group with worse prognosis at 12 months.

  15. 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 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 hepatic encephalopathy.

  16. Acute-on-chronic and Decompensated Chronic Liver Failure: Definitions, Epidemiology, and Prognostication.

    Science.gov (United States)

    Olson, Jody C

    2016-07-01

    Chronic liver disease is the fifth leading cause of death worldwide and represents a major burden for the health care community. Cirrhosis is a progressive disease resulting in end-stage liver failure, which in the absence of liver transplantation is fatal. Acute-on-chronic liver failure carries high short-term mortality but is potentially reversible. Viral hepatitis, alcohol, and nonalcoholic fatty liver disease remain the principal causes of liver disease. Though treatments exist for hepatitis B and C, they remain unavailable to many with these diseases. This article reviews the epidemiology of advanced liver disease and the concept of acute-on-chronic liver failure.

  17. Ularitide for the treatment of acute decompensated heart failure: from preclinical to clinical studies

    OpenAIRE

    Anker, Stefan D.; Ponikowski, Piotr; Mitrovic, Veselin; Peacock, W. Frank; Filippatos, Gerasimos

    2015-01-01

    The short- and long-term morbidity and mortality in acute heart failure is still unacceptably high. There is an unmet need for new therapy options with new drugs with a new mode of action. One of the drugs currently in clinical testing in Phase III is ularitide, which is the chemically synthesized form of the human natriuretic peptide urodilatin. Urodilatin is produced in humans by differential processing of pro-atrial natriuretic peptide in distal renal tubule cells. Physiologically, urodila...

  18. Acute Decompensation in Pediatric Cardiac Patients: Outcomes After Rapid Response Events.

    Science.gov (United States)

    Bavare, Aarti C; Rafie, Kimia S; Bastero, Patricia X; Hagan, Joseph L; Checchia, Paul A

    2017-05-01

    We studied rapid response events after acute clinical instability outside ICU settings in pediatric cardiac patients. Our objective was to describe the characteristics and outcomes after rapid response events in this high-risk cohort and elucidate the cardiac conditions and risk factors associated with worse outcomes. A retrospective single-center study was carried out over a 3-year period from July 2011 to June 2014. Referral high-volume pediatric cardiac center located within a tertiary academic pediatric hospital. All rapid response events that occurred during the study period were reviewed to identify rapid response events in cardiac patients. None. We reviewed 1,906 rapid response events to identify 152 rapid response events that occurred in 127 pediatric cardiac patients. Congenital heart disease was the baseline diagnosis in 74% events (single ventricle, 28%; biventricle physiology, 46%). Seventy-four percent had a cardiac surgery before rapid response, 37% had ICU stay within previous 7 days, and acute kidney injury was noted in 41% post rapid response. Cardiac and/or pulmonary arrest occurred during rapid response in 8.5%. Overall, 81% were transferred to ICU, 22% had critical deterioration (ventilation or vasopressors within 12 hr of transfer), and 56% received such support and/or invasive procedures within 72 hours. Mortality within 30 days post event was 14%. Significant outcome associations included: single ventricle physiology-increased need for invasive procedures and mortality (adjusted odds ratio, 2.58; p = 0.02); multiple rapid response triggers-increased ICU transfer and interventions at 72 hours; critical deterioration-cardiopulmonary arrest and mortality; and acute kidney injury-cardiopulmonary arrest and need for hemodynamic support. Congenital heart disease, previous cardiac surgery, and recent discharge from ICU were common among pediatric cardiac rapid responses. Progression to cardiopulmonary arrest during rapid response, need for ICU

  19. Sustained Increase in the Incidence of Acute Decompensated Heart Failure After the 2011 Japan Earthquake and Tsunami.

    Science.gov (United States)

    Nakamura, Motoyuki; Tanaka, Fumitaka; Komi, Ryousuke; Tanaka, Kentarou; Onodera, Masayuki; Kawakami, Mikio; Koeda, Yorihiko; Sakai, Toshiaki; Tanno, Kozo; Onoda, Toshiyuki; Matsura, Yuki; Komatsu, Takashi

    2016-11-01

    This study investigated the long-term impact of the 2011 Japan earthquake and tsunami on the incidence of acute decompensated heart failure (HF) in the disaster area. This was a population-based study using comprehensive registration for all hospitals within the study area. The standardized incidence ratio (SIR) and 95% confidence interval (CI) for new onset of HF during the disaster year (2011) and postdisaster years (2012 to 2014) were determined. When SIR were compared between the low- and high-impact areas, as defined by the extent of tsunami inundation in residential areas, SIR showed a significant increase in high-impact areas in 2011 (1.67, 95% CI 1.45 to 1.88) and tended to return to baseline in 2012, the first postdisaster year (1.25, 95% CI 1.06 to 1.43). The rate again increased in 2013 (1.38, 95% CI 1.18 to 1.57) and 2014 (1.55, 95% CI 1.35 to 1.75). In low-impact areas, no such increase was apparent during either the disaster year or the postdisaster years. Mean postdisaster period SIR for municipalities significantly correlated with the percentage of tsunami flooding in residential areas (r = 0.52, p tsunami but not the earthquake per se resulted in a prolonged increase in the incidence of HF among the general population living in tsunami-stricken areas. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

  20. 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% (p<0.001); IV nitrates 4.5% v. 6.7% (p=0.39). There were significant differences in rate of admission (50.6% v. 95.2%, p<0.001) and length of stay in ED (6.7 v. 3.0 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.

  1. Clinical Implications of Cluster Analysis-Based Classification of Acute Decompensated Heart Failure and Correlation with Bedside Hemodynamic Profiles.

    Science.gov (United States)

    Ahmad, Tariq; Desai, Nihar; Wilson, Francis; Schulte, Phillip; Dunning, Allison; Jacoby, Daniel; Allen, Larry; Fiuzat, Mona; Rogers, Joseph; Felker, G Michael; O'Connor, Christopher; Patel, Chetan B

    2016-01-01

    Classification of acute decompensated heart failure (ADHF) is based on subjective criteria that crudely capture disease heterogeneity. Improved phenotyping of the syndrome may help improve therapeutic strategies. To derive cluster analysis-based groupings for patients hospitalized with ADHF, and compare their prognostic performance to hemodynamic classifications derived at the bedside. We performed a cluster analysis on baseline clinical variables and PAC measurements of 172 ADHF patients from the ESCAPE trial. Employing regression techniques, we examined associations between clusters and clinically determined hemodynamic profiles (warm/cold/wet/dry). We assessed association with clinical outcomes using Cox proportional hazards models. Likelihood ratio tests were used to compare the prognostic value of cluster data to that of hemodynamic data. We identified four advanced HF clusters: 1) male Caucasians with ischemic cardiomyopathy, multiple comorbidities, lowest B-type natriuretic peptide (BNP) levels; 2) females with non-ischemic cardiomyopathy, few comorbidities, most favorable hemodynamics; 3) young African American males with non-ischemic cardiomyopathy, most adverse hemodynamics, advanced disease; and 4) older Caucasians with ischemic cardiomyopathy, concomitant renal insufficiency, highest BNP levels. There was no association between clusters and bedside-derived hemodynamic profiles (p = 0.70). For all adverse clinical outcomes, Cluster 4 had the highest risk, and Cluster 2, the lowest. Compared to Cluster 4, Clusters 1-3 had 45-70% lower risk of all-cause mortality. Clusters were significantly associated with clinical outcomes, whereas hemodynamic profiles were not. By clustering patients with similar objective variables, we identified four clinically relevant phenotypes of ADHF patients, with no discernable relationship to hemodynamic profiles, but distinct associations with adverse outcomes. Our analysis suggests that ADHF classification using simultaneous

  2. Ventricular conduction abnormalities as predictors of long‐term survival in acute de novo and decompensated chronic heart failure

    Science.gov (United States)

    Siirila‐Waris, Krista; Harjola, Veli‐Pekka; Marono, David; Parenica, Jiri; Kreutzinger, Philipp; Nieminen, Tuomo; Pavlusova, Marie; Tarvasmaki, Tuukka; Twerenbold, Raphael; Tolonen, Jukka; Miklik, Roman; Nieminen, Markku S.; Spinar, Jindrich; Mueller, Christian; Lassus, Johan

    2016-01-01

    Abstract Aims Data on the prognostic role of left and right bundle branch blocks (LBBB and RBBB), and nonspecific intraventricular conduction delay (IVCD; QRS ≥ 110 ms, no BBB) in acute heart failure (AHF) are controversial. Our aim was to investigate electrocardiographic predictors of long‐term survival in patients with de novo AHF and acutely decompensated chronic heart failure (ADCHF). Methods and Results We analysed the admission electrocardiogram of 982 patients from a multicenter European cohort of AHF with 3.9 years' mean follow‐up. Half (51.5%, n = 506) of the patients had de novo AHF. LBBB, and IVCD were more common in ADCHF than in de novo AHF: 17.2% vs. 8.7% (P < 0.001) and 20.6% vs. 13.2% (P = 0.001), respectively, and RBBB was almost equally common (6.9% and 8.1%; P = 0.5), respectively. Mortality during the follow‐up was higher in patients with RBBB (85.4%) and IVCD (73.7%) compared with patients with normal ventricular conduction (57.0%); P < 0.001 for both. The impact of RBBB on prognosis was prominent in de novo AHF (adjusted HR 1.93, 1.03–3.60; P = 0.04), and IVCD independently predicted death in ADCHF (adjusted HR 1.79, 1.28–2.52; P = 0.001). Both findings were pronounced in patients with reduced ejection fraction. LBBB showed no association with increased mortality in either of the subgroups. The main results were confirmed in a validation cohort of 1511 AHF patients with 5.9 years' mean follow‐up. Conclusions Conduction abnormalities predict long‐term survival differently in de novo AHF and ADCHF. RBBB predicts mortality in de novo AHF, and IVCD in ADCHF. LBBB has no additive predictive value in AHF requiring hospitalization. PMID:27774265

  3. [Hepatorenal syndrome in decompensated cirrhosis : A special form of acute renal failure].

    Science.gov (United States)

    Lenz, K; Buder, R; Lohr, G; Piringer, P; Voglmayr, M

    2016-06-01

    Renal failure is a serious complication in patients with advanced cirrhosis. It occurs in about 20 % of patients hospitalized with cirrhosis. In about 70 % it is caused by prerenal failure, and in 30 % it is due to intrarenal causes. In about 70 % of patients with rperenal failure, renal function can be restored with fluid replacement, but the remaining 30 % are unresponsive to volume expansion. Minor increase in serum creatinine have been shown to be clinically relevant and can adversely affect survival. Therefore early efforts should be made to avoid precipitation of renal failure.Hepatorenal syndrome (HRS) is a  fully reversible impairment of renal function in patients with cirrhosis unresponsive to volume expansion characterized by an acute progressive decrease in kidney function (serumcreatinin > 1,5 mg/dl) - type 1 HRS, whereas type 2 HRS features a decrease in kidney function over a long time, mostly in patients with refractory ascites. Therapy with vasoconstrictors like terlipressin to reverse splanchnic vasodilation, together with albumin is effective in 30-50 % of patients with HRS 1 and improves survival. The only effective longterm therapy is livertransplantation. An improvement of kidney fuction before transplantation is associated with a better outcome and posttransplant kidney function.

  4. Impact of decreased serum albumin levels on acute kidney injury in patients with acute decompensated heart failure: a potential association of atrial natriuretic peptide.

    Science.gov (United States)

    Takaya, Yoichi; Yoshihara, Fumiki; Yokoyama, Hiroyuki; Kanzaki, Hideaki; Kitakaze, Masafumi; Goto, Yoichi; Anzai, Toshihisa; Yasuda, Satoshi; Ogawa, Hisao; Kawano, Yuhei; Kangawa, Kenji

    2017-02-07

    Although hypoalbuminemia at admission is a risk for acute kidney injury (AKI) and mortality in patients with acute decompensated heart failure (ADHF), the clinical significance of decreased serum albumin levels (DAL) during ADHF therapy has not been elucidated. This study aimed to evaluate whether DAL was associated with AKI, and whether intravenous atrial natriuretic peptide (ANP) administration, which provides an effective treatment for ADHF but promotes albumin extravasation, was associated with DAL and AKI. A total of 231 consecutive patients with ADHF were enrolled. AKI was defined as ≥0.3 mg/dl absolute or 1.5-fold increase in serum creatinine levels within 48 h. AKI occurred in 73 (32%) of the 231 patients during ADHF therapy. The median value of decreases in serum albumin levels was 0.3 g/dl at 7 days after admission. When DAL was defined as ≥0.3 g/dl decrease in serum albumin levels, DAL occurred in 113 patients, and was independently associated with AKI. Of the 231 patients, 73 (32%) were treated with intravenous ANP. DAL occurred more frequently in patients receiving ANP than in those not receiving ANP (77 vs. 36%, p < 0.001), and ANP was independently associated with DAL. The incidence of AKI was higher in patients receiving ANP than in those not receiving ANP (48 vs. 24%, p < 0.001). ANP was independently associated with AKI. In conclusion, DAL is associated with AKI. Intravenous ANP administration may be one of the promoting factors of DAL, which leads to AKI, indicating a possible novel mechanism of AKI.

  5. Impact of dopamine infusion on renal function in hospitalized heart failure patients: results of the Dopamine in Acute Decompensated Heart Failure (DAD-HF) Trial.

    Science.gov (United States)

    Giamouzis, Gregory; Butler, Javed; Starling, Randall C; Karayannis, George; Nastas, John; Parisis, Charalambos; Rovithis, Dimitrios; Economou, Dimitrios; Savvatis, Konstantinos; Kirlidis, Themistoklis; Tsaknakis, Themistoklis; Skoularigis, John; Westermann, Dirk; Tschöpe, Carsten; Triposkiadis, Filippos

    2010-12-01

    Worsening renal function (WRF) and hypokalemia related to diuretic use for acute decompensated heart failure (ADHF) are common and associated with poor prognosis. Low-dose dopamine infusion improves renal perfusion; its effect on diuresis or renal function specifically in ADHF is not known. Sixty consecutive ADHF patients (age 75.7 ± 11.2 years; 51.7% female; left ventricular ejection fraction 35.3 ± 12.1%) were randomized, after receiving a 40 mg intravenous furosemide bolus, to either high-dose furosemide (HDF, 20 mg/h continuous infusion for 8 hours) or low-dose furosemide combined with low-dose dopamine (LDFD, furosemide 5 mg/h plus dopamine 5 μg kg(-1) min(-1) continuous infusion for 8 hours). Both strategies were compared for total diuresis, WRF (defined as a rise in serum creatinine of >0.3 mg/dL from baseline to 24 hours), electrolyte balance, and 60-day postdischarge outcomes. Mean hourly excreted urine volume (272 ± 149 mL in HDF vs 278 ± 186 mL in LDFD group; P = .965) and changes in dyspnea score (Borg index: -4.4 ± 2.1 in HDF group vs -4.7 ± 2.0 in LDFD group; P = .575) during the 8 hours of protocol treatment were similar in the two groups. WRF was more frequent in the HDF (n = 9; 30%) than in the LDFD group (n = 2; 6.7%; P = .042). Serum potassium changed from 4.3 ± 0.5 to 3.9 ± 0.4 mEq/L at 24 hours (P = .003) in the HDF group and from 4.4 ± 0.5 to 4.2 ± 0.5 mEq/L at 24 hours (P = .07) in the LDFD group. Length of stay and 60-day mortality or rehospitalization rates (all-cause, cardiovascular, and worsening HF) were similar in the two groups. In ADHF patients, the combination of low-dose furosemide and low-dose dopamine is equally effective as high-dose furosemide but associated with improved renal function profile and potassium homeostasis. Copyright © 2010 Elsevier Inc. All rights reserved.

  6. Arrival by ambulance in acute heart failure: insights into the mode of presentation from Acute Studies of Nesiritide in Decompensated Heart Failure (ASCEND-HF).

    Science.gov (United States)

    Ezekowitz, Justin A; Podder, Mohua; Hernandez, Adrian F; Armstrong, Paul W; Starling, Randall C; O'Connor, Christopher M; Califf, Robert M

    2016-03-17

    Limited data exist assessing the relationship between ambulance versus self-presentation and outcomes in patients with acute heart failure (AHF). Clinical trial sites in North America. 1068 patients enrolled in the Acute Studies of Nesiritide in Decompensated Heart Failure (ASCEND-HF) trial. The association between ambulance use and dyspnoea improvement, 30-day mortality or HF rehospitalisation and 180-day mortality. Of the 1068 patients in the substudy, 832 (78%) self-presented (SP) and 236 (22%) patients presented via ambulance. Patients presenting via ambulance were older, more likely to be female, have a higher ejection fraction but similar natriuretic peptide levels as patients who SP. Patients presenting by ambulance (compared with SP) trended towards more dyspnoea improvement at 6 (p=0.09) and 24 h (p=0.10). The co-primary end point (30-day mortality or HF rehospitalisation) was similar between groups (ambulance 12.2% vs SP 11.4%, p=0.74). Patients who presented by ambulance had a higher 30-day and 180-day mortality rate than those who SP (30-day: 4.3% vs 2.2%, p=0.08; 180-day: 15.1% vs 10.3%, p=0.04). After adjustment for baseline characteristics, patients arriving by ambulance (compared with SP) had a 2-fold high risk of 30-day mortality (OR 2.12, 95% CI 0.94 to 4.79), but no relationship to the composite of 30-day mortality/HF rehospitalisation (OR 1.01, 95% CI 0.63 to 1.63). Among patients with AHF, 30-day and 180-day mortality is 1.5-2 times higher for those with presenting via ambulance compared with patients who self-present. Understanding patient-related and system-related factors of ambulance use for patients with AHF is important. NCT00475852. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. 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.

  8. Hyperkalemia after acute metabolic decompensation in two children with vitamin B12-unresponsive methylmalonic acidemia and normal renal function.

    Science.gov (United States)

    Pela, I; Gasperini, S; Pasquini, E; Donati, M A

    2006-07-01

    The patients affected by vitamin B12-unresponsive methylmalonic acidemia (MMA) on the long run develop chronic renal disease with interstitial nephropathy and progressive renal insufficiency. The mechanism of nephrotoxicity in vitamin B12-unresponsive MMA is not yet known. Chronic hyporeninemic hypoaldosteronism has been found in many cases of methylmalonic acidemia, hyperkalemia and renal tubular acidosis type 4. We report 2 patients affected by B12-unresponsive methylmalonic acidemia diagnosed at the age of 23 months and 5 years, respectively, with normal glomerular filtration and function. They showed hyporeninemic hypoaldosteronism and significant hyperkalemia requiring sodium potassium exchange resin (Kayexalate) therapy after an episode of metabolic decompensation leading to diagnosis of MMA. In both children, hyporeninemic hypoaldosteronism and hyperkalemia disappeared after 6 months of good metabolic control.

  9. 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)

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

    2014-01-01

    Background and objectives 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. Design, setting, participants, & measurements 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. Results 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; P<0.01). In patients with reduced ejection fraction, adjusted analysis showed that a significantly higher risk of the primary end point was associated with renal 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; P<0.001). Conclusions The findings show that renal dysfunction combined with anemia is associated with an

  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. A case of marked diuresis by combined dopamine and atrial natriuretic peptide administration without renal injury in acute decompensated heart failure.

    Science.gov (United States)

    Kamiya, Masataka; Sato, Naoki; Akiya, Mai; Okazaki, Hirotake; Takahashi, Yasuhiro; Mizuno, Kyoichi

    2013-01-01

    Renal injury is an important factor for worsening outcome in acute decompensated heart failure (ADHF). An 81-year-old woman was admitted due to ADHF with dyspnea and mild peripheral edema. The patient was managed with intravenous administration of atrial natriuretic peptide (ANP) at a dose of 0.0125 μg/kg/minute, which did not control volume overload even at an increased dose of 0.025 μg/kg/minute. After a low dose of dopamine (DA) of 1.0 μg/kg/ minute was added, urine output increased markedly to 120 from 30 mL/hour. Furthermore, her heart rate decreased to 80-100 from 120 bpm and the congestion improved with a reduced brain natriuretic peptide level. Interestingly, the combination of ANP and DA therapy reduced serum creatinine as well as the levels of urinary liver-type fatty acid binding protein, a novel reno-tubular stress marker, by 98.9%, and an oxidative stress marker, urinary 8-hydroxydeoxyguanosine, by 88.2% from baseline levels. Thus, this ADHF patient, a nonresponder to ANP alone, improved without renal injury when administered combination therapy consisting of low doses of ANP and DA, suggesting that this combined therapy might be useful for better management of ADHF in patients without diuretic responses with ANP alone. Further prospective studies are warranted.

  12. Diuretic response in patients with acute decompensated heart failure : characteristics and clinical outcome-an analysis from RELAX-AHF

    NARCIS (Netherlands)

    Voors, Adriaan A.; Davison, Beth A.; Teerlink, John R.; Felker, G. Michael; Cotter, Gad; Filippatos, Gerasimos; Greenberg, Barry H.; Pang, Peter S.; Levin, Bruce; Hua, Tsushung A.; Severin, Thomas; Ponikowski, Piotr; Metra, Marco

    2014-01-01

    AimsWe studied the characteristics and clinical outcome related to diuretic response and the effects of serelaxin in patients hospitalized for acute heart failure (AHF). Methods and resultsRELAX-AHF was a double-blind, placebo-controlled trial, enrolling 1161 patients admitted to hospital for AHF wh

  13. 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 C...

  14. Prognostic value of new-onset anemia as a marker of hemodilution in patients with acute decompensated heart failure and severe renal dysfunction.

    Science.gov (United States)

    Hong, Namki; Youn, Jong-Chan; Oh, Jaewon; Lee, Hye Sun; Park, Sungha; Choi, Donghoon; Kang, Seok-Min

    2014-07-01

    In patients with acute decompensated heart failure (ADHF), the prognostic value of new-onset anemia with regard to renal function has not been investigated. Consecutive 299 ADHF patients (162 men, 62 ± 14 years) were enrolled. Cardiovascular (CV) events composite of CV mortality and rehospitalization occurred in 113 patients (37.8%) during 2 years of follow-up. Baseline anemia was prevalent (n = 124, 41.5%) and 43 patients (14.4%) had new-onset anemia at 1 month after discharge. Baseline anemia was strongly associated with CV events risk in overall [hazard ratio (HR): 1.79, 95% CI: 1.17-2.74, p = 0.006] and those with preserved renal function [estimated glomerular filtration rate (eGFR)≥ 45 mL/min/1.73 m(2)] (HR: 1.81, 95% CI: 1.05-3.12, p = 0.031). In patients with severe renal dysfunction (eGFRanemia independently predicted CV events (HR: 2.72, 95% CI: 1.09-6.76, p = 0.031) whereas baseline anemia did not (HR: 1.28, 95% CI: 0.61-2.65, p = 0.505). New-onset anemia was significantly associated with hemodilution, which may reflect inadequate decongestion in ADHF patients. Baseline anemia was an independent prognostic factor in overall ADHF patients and those with preserved renal function. New-onset anemia as a surrogate for hemodilution better predicted CV events than baseline anemia in ADHF patients with severe renal dysfunction. Copyright © 2013. Published by Elsevier Ltd.

  15. Clinical analysis of treating acute decompensated heart failure by recombinant human brain natriuretic peptide and nitroglycerin%重组人脑利钠肽和硝酸甘油治疗急性失代偿性心力衰竭的临床分析

    Institute of Scientific and Technical Information of China (English)

    孙晶

    2015-01-01

    Objective: research clinical effects of treating acute decompensated heart failure by recombinant human brain natriuretic peptide and nitroglycerin. Method: choose 86 cases patients with acute or chronic heart failure received in our hospital, and randomly divided them into control and treatment group, 43 cases in each. Apply nitroglycerin for control group patients and recombinant human brain natriuretic peptide and nitroglycerin for treatment group. Compare patients of two groups before and after treatment with index of improvement magnitude of respiration and heart rate level, treatment effect of acute decompensated heart failure, number of adverse reactions during treatment, heart failure symptoms remission time, ECG recovery time to normal level, total time of heart disease medication therapy treatment. Result:improvement magnitude of respiration and heart rate level of treatment group patients is signiifcantly bettern than that of control group, difference is signiifcant between groups (P0.05);and heart failure symptoms remission time, ECG recovery time to normal level, total time of heart disease medication therapy treatment is obviously shorter than that of control group, difference between groups is signiifcant (P0.05);心衰症状缓解时间、心电图表现恢复正常时间、心衰疾病用药治疗总时间明显短于对照组,组间差异显著(P<0.05)。结论应用硝酸甘油与重组人脑利钠肽联合对患有急性失代偿性心力衰竭疾病的患者实施治疗的临床效果非常明显。

  16. Renal neurohormonal regulation in heart failure decompensation.

    Science.gov (United States)

    Jönsson, Sofia; Agic, Mediha Becirovic; Narfström, Fredrik; Melville, Jacqueline M; Hultström, Michael

    2014-09-01

    Decompensation in heart failure occurs when the heart fails to balance venous return with cardiac output, leading to fluid congestion and contributing to mortality. Decompensated heart failure can cause acute kidney injury (AKI), which further increases mortality. Heart failure activates signaling systems that are deleterious to kidneys such as renal sympathetic nerve activity (RSNA), renin-angiotensin-aldosterone system, and vasopressin secretion. All three reduce renal blood flow (RBF) and increase tubular sodium reabsorption, which may increase renal oxygen consumption causing AKI through renal tissue hypoxia. Vasopressin contributes to venous congestion through aquaporin-mediated water retention. Additional water retention may be mediated through vasopressin-induced medullary urea transport and hyaluronan but needs further study. In addition, there are several systems that could protect the kidneys and reduce fluid retention such as natriuretic peptides, prostaglandins, and nitric oxide. However, the effect of natriuretic peptides and nitric oxide are blunted in decompensation, partly due to oxidative stress. This review considers how neurohormonal signaling in heart failure drives fluid retention by the kidneys and thus exacerbates decompensation. It further identifies areas where there is limited data, such as signaling systems 20-HETE, purines, endothelin, the role of renal water retention mechanisms for congestion, and renal hypoxia in AKI during heart failure.

  17. 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 dopamine (5μg/kg/min) combined with furosemide (5mg/h). Echocardiographic assessments were performed at 0 and 24h. 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, pDopamine-furosemide combination had a borderline effect on creatinine (p=0.08) and led to significant improvements in e', E/e' ratio (p=0.015 and p=0.009 respectively) and VAC (value closer to 1). VAC improvement correlated with EE and creatinine improvement, regardless of treatment, supporting a potential role for VAC status assessment and improvement in acute 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.

  18. 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

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

    Science.gov (United States)

    De Vecchis, Renato; Di Maio, Marco; Di Biase, Giuseppina; Ariano, Carmelina

    2016-01-01

    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 having a 30

  20. 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

  1. 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.

    2013-01-01

    Aims 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. Methods 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). Results 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%, χ2 = 70.1; p < 0.001) and 1-year adverse outcomes (67.5 vs. 31.0%, χ2 = 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, χ2 = 5.6; p = 0.02) as well as for KDIGO and WRF at 1 year (AUC 0.67 vs. 0.65, χ2 = 4.8; p = 0.03). Conclusion 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. PMID:23801998

  2. Management options in decompensated cirrhosis

    Directory of Open Access Journals (Sweden)

    Shah NL

    2015-07-01

    Full Text Available Neeral L Shah,1 Yasmin Pourkazemi Banaei,2 Kristen L Hojnowski,2 Scott L Cornella3 1Division of Gastroenterology and Hepatology, 2School of Medicine, 3Department of Medicine, University of Virginia, Charlottesville, VA, USA Abstract: Chronic injury to the liver from a variety of different sources can result in irreversible scarring of the liver, known as cirrhosis. Cirrhosis is a major cause of morbidity and mortality in the USA, and according to the Centers for Disease Control and Prevention was responsible for 31,903 deaths in 2010 alone. It is thus of the utmost importance to appropriately manage these patients in the inpatient and outpatient setting to improve morbidity and mortality. In this review, we address four major areas of cirrhosis management: outpatient management of portal hypertension with decompensation, hepatic encephalopathy, hepatorenal syndrome, and bleeding/coagulation issues. Outpatient management covers recommendations for health care maintenance and screening. Hepatic encephalopathy encompasses a brief review of pathophysiology, treatment in the acute setting, and long-term prevention. Hepatorenal syndrome is discussed in regards to pathophysiology and treatment in the hospital setting. Finally, a discussion of the assessment of coagulation profiles in cirrhosis and recommendations for bleeding and thrombosis complications is included. These topics are not all encompassing with regard to this complicated population, but rather an overview of a few medical problems that are commonly encountered in their care. Keywords: portal hypertension, hepatic encephalopathy, hepatorenal, coagulation

  3. Improving Survival in Decompensated Cirrhosis

    Directory of Open Access Journals (Sweden)

    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.

  4. preliminary study of prednisone applied in cardio-renal syndrome of acute decompensated heart failure%强的松在急性失代偿性心力衰竭伴心肾综合征中的应用

    Institute of Scientific and Technical Information of China (English)

    张天元; 王海洪

    2014-01-01

    Objective To investigate prednisone improving the heart function and renal function and potentiating diu-retic effects of patients with acute decompensated heart failure. Methods 45 cases of patients with acute decompensated heart failure took orally prednisone 40 ~ 60mg/ day besides conventional therapy,dose of prednisone decreased 5mg/ week. At the course of therapy,the renal function and body weight change were measured periodically,and changes of vital sign,edema,and side effects were observed as well. Results 14 days after the treatment with prednisone,the heart function and renal function of the patients with acute heart failure improved,the levels of serum creatinine and uric acid were lowered,the differences were statistically significant(P ﹤ 0. 05). There was a remarkable reduction(4. 2 ± 2. 5kg)in body weight,the differences were sta-tistically significant(P ﹤ 0. 01). Serum electrolyte level was no significant different compared with baseline(P ﹥ 0. 05). Con-clusion Prednisone can improve the heart function and renal function and potentiate diuretic effect in patients with acute de-compensated heart failure.%目的:探讨强的松对急性失代偿性心力衰竭患者心功能和肾功能的改善及其利尿作用。方法45例急性失代偿性心力衰竭患者在常规治疗的基础上加用糖皮质激素强的松40~60mg/ d,2周后强的松逐渐减量,每周减5mg。治疗过程中定期测肾功能、体质量变化、观察生命体征、水肿、尿量等变化及有无不良反应,并于治疗前后检查 X 线胸片和超声心动图评价心肾功能改善程度。结果强的松治疗14d 后,45例心力衰竭患者心功能改善,血肌酐和血尿酸水平治疗后较治疗前降低,差异有统计学意义(P ﹤0.05)。患者尿量连续增加,体质量明显下降(4.2±2.5)kg,差异有统计学意义(P ﹤0.01),而血电解质治疗前后比较无明显变化(P ﹥0.05)。结论强的松能改

  5. Clinical observation of lyophilized recombinant human brain natriuretic peptide for the treatment of acute decompensated heart failure%冻干重组人脑利钠肽治疗急性失代偿性心力衰竭临床观察

    Institute of Scientific and Technical Information of China (English)

    王沐; 魏盟

    2014-01-01

    目的:研究冻干重组人脑利钠肽治疗急性代偿性心力衰竭的临床效果。方法选择急性失代偿性心力衰竭患者90例,随机分成观察组(45例)和对照组(45例)。对2组患者均进行常规治疗,观察组同时静脉注射冻干重组人脑利钠肽;对照组则静脉注射硝酸甘油。结果治疗前观察组和对照组左心室舒张末期内径(LVEDD)及左心室射血分数(LVEF)差异无统计学意义(P>0.05)。治疗后观察组LVEDD显著小于对照组(P<0.01),LVEF显著高于对照组(P<0.01)。治疗前2组患者动脉血二氧化碳分压(PaCO2)、时间肺活量、收缩压及动脉血氧饱和度比较差异均无统计学意义(P>0.05)。治疗后观察组PaCO2、收缩压显著低于对照组(P<0.01),时间肺活量和动脉血氧饱和度显著高于对照组(P<0.01)。结论冻干重组人脑利钠肽可以有效改善急性失代偿性心力衰竭患者的心脏功能以及呼吸功能。%Objective To study the clinical effect of lyophilized recombinant human brain natriuretic peptide for the treatment of acute decompensated heart failure .Methods 90 patients with acute decompensated heart failure were ran-domly divided into observation group (n=45) and control group (n=45).The patients in both groups received routine treatment .The patients in the observation group received lyophilized recombinant human brain natriuretic peptide intrave -nous injection .The patients in the control group received intravenous injection of nitroglycerin .Results Before treat-ment, the left ventricular end diastolic diameter (LVEDD) and left ventricular ejection fraction (LVEF) between the two groups showed no statistical difference (P>0.05).After treatment, the LVEDD in the observation group were signifi-cantly less than that in the control group (P0.05).After treatment, the PaCO2 and systolic blood pressure were significantly lower in the

  6. A Clinical Study of Recombinant Human Brain Natriuretic Peptide on Patients with Acute Decompensated Heart Failure%重组人脑利钠肽治疗急性心力衰竭的疗效观察

    Institute of Scientific and Technical Information of China (English)

    周秀金; 卢竟前

    2013-01-01

    Objective:To observe the clinic efficacy and safety of used recombinant human brain natriuretie peptide (rh-BNP)on patients with acute decompensated heart failure.Methods:48 patients who suffered from acute decompensated heart failure patients were divided into rh-BNP group(n=22)and control group(n=26).The rh-BNP group received rh-BNP made by China and traditional heart failure treatment; the control group was treated with traditional heart failure treatment.The changes of the clinical efficacy, left ventricular ejection fraction (LVEF)and brain natriuretie peptide test parameters were observed. Results:After 7 days treatment, clinical efficacy improvements were more significant in rh-BNP group compared control group (81.7% vs 61.6,P<0.05).LVEF were improved in rh-BNP group compared with control group((51±6)%vs(46±5)%,P<0.01).and BNP level were decreased obviously in rh-BNP group than control group((498±209)pg/ml vs(642±318)pg/ml,P<0.01),and there had positive relation in BNP decrease and LVEF increased(P<0.05).Conclusion:The use of rh-BNP is efficient and safe for acute decompensated heart failure patient.And BNP test can provide a dog marker for diagnosis and prognostic.%目的:探讨在监测血清脑钠肽水平下,短期使用注射用重组人脑利钠肽治疗急性心力衰竭或慢性心力衰竭急性发作的临床效果。方法:48例急性心力衰竭患者根据是否使用注射用重组人脑利钠肽分为常规组和注射用重组人脑利钠肽组,对比两组治疗的临床效果和超声心动图情况,并监测BNP水平。结果:治疗7 d后,注射用重组人脑利钠肽组临床有效率明显好于常规组(81.7%vs61.6%,P<0.05),左室射血分数明显高于常规组(51±6)%vs(46±5)%,(P<0.01),且血清脑钠肽水平明显降低(498±209)pg/mL vs(642±318)pg/mL,(P<0.01),血清脑钠肽下降水平和左室射血分数提高水平差异有统计学意义(P<0.05),有

  7. Clinical features of 100 patients with acute exacerbation of cirrhosis with liver function decompensation%失代偿期肝硬化患者肝损伤急性加重100例临床分析

    Institute of Scientific and Technical Information of China (English)

    周静; 苏菲

    2016-01-01

    目的:探讨失代偿期肝硬化肝损伤急性加重患者在肝衰竭分型中的合理定位,为临床诊治提供参考依据。方法采用回顾性分析法,纳入我院失代偿期肝硬化肝损伤急性加重患者100例和慢加急性肝衰竭(ACLF)患者200例,使用罗氏COBAS INTEGRA 800检测血生化指标;采用摆动磁珠凝固法检测凝血指标。应用SPSS16.0软件对两组患者临床资料进行分析。结果在300例患者中,由肝炎病毒活动性复制引起的急性肝损伤220例(73.3%),其他诱因引起者80例(26.7%);肝硬化组血清白蛋白和血钠分别为(27.2±4.2)g/l和130.5(90.1,143.8) mmol/l,显著低于肝衰竭组的(29.5±4.5)g/l和134.2(78.7,143.0)mmol/l(P<0.05);肝硬化组肝肾综合征、自发性腹膜炎、低钠血症发生率分别为26.0%、57.0%、75.0%,均显著高于肝衰竭组的13.0%、42.0%、53.0%(P<0.05);肝硬化组好转率为10.0%,显著低于肝衰竭组的25.5%(P<0.05)。结论在失代偿期肝硬化基础上因某种诱因导致肝损伤急性加重患者具有与ACLF患者相似的急性肝功能失代偿表现,同时也存在门脉高压为主的表现,其在肝衰竭分型中的合理定位尚需扩大病例数,进一步深入临床研究。%Objective To investigate the reasonable diagnosis of patients with acute exacerbated liver function in patients with decompensated liver cirrhosis. Methods 100 patients with acute exacerbated liver function with underlying decompensated cirrhosis and 200 patients with acute on chronic liver failure (ACLF) were retrospectively analyzed in our hospital. Blood biochemical parameters and blood coagulation function index were routinely detected. SPSS 16.0 software was used to analyze the clinical materials. Results Active replication of hepatitis B virus-induced acute liver injuries accounted for (73.3%),and other causes for (26.7%) in the 300 patients;serum levels of

  8. 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

    Directory of Open Access Journals (Sweden)

    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

  9. Nightmares and psychotic decompensation: a case study.

    Science.gov (United States)

    Levin, R; Daly, R S

    1998-01-01

    There have been numerous reports in the literature on the descriptive similarities between a severe nightmare and an acute psychotic episode. Nightmares may be a prelude to psychotic decompensation, and it has been suggested that frequent lifelong nightmares may even be diagnostic of an underlying vulnerability to psychosis. In this report, we present a case study of a 40-year old female experiencing chronic paranoid schizophrenia, whose two witnessed psychotic relapses in the hospital were immediately preceded by intense and vivid nightmare attacks. Significantly, the content of these nocturnal dreams was thematically consistent with her waking hallucinations, suggesting a direct continuity between these experiences. We propose that further systematic study of the dreams and nightmares of individuals diagnosed with schizophrenia may be particularly useful in understanding their phenomenological experience.

  10. Management of Coagulopathy in Patients with Decompensated Liver Cirrhosis

    Directory of Open Access Journals (Sweden)

    Pooja D. Amarapurkar

    2011-01-01

    Full Text Available Patients with decompensated liver cirrhosis have significantly impaired synthetic function. Many proteins involved in the coagulation process are synthesized in the liver. Routinely performed tests of the coagulation are abnormal in patients with decompensated liver cirrhosis. This has led to the widespread belief that decompensated liver cirrhosis is prototype of acquired hemorrhagic coagulopathy. If prothrombin time is prolonged more than 3 seconds over control, invasive procedures like liver biopsy, splenoportogram, percutaneous cholangiography, or surgery were associated with increased risk of bleeding, and coagulopathy should be corrected with infusion of fresh frozen plasma. These practices were without any scientific evidence and were associated with significant hazards of fresh frozen plasma transfusion. Now, it is realized that coagulation is a complex process involving the interaction of procoagulation and anticoagulation factors and the fibrinolytic system. As there is reduction in both anti and procoagulant factors, global tests of coagulation are normal in patients with acute and chronic liver disease indicating that coagulopathy in liver disease is more of a myth than a reality. In the last few years, surgical techniques have substantially improved, and complex procedures like liver transplantation can be done without the use of blood or blood products. Patients with liver cirrhosis may also be at increased risk of thrombosis. In this paper, we will discuss coagulopathy, increased risk of thrombosis, and their management in decompensated liver cirrhosis.

  11. Management of coagulopathy in patients with decompensated liver cirrhosis.

    Science.gov (United States)

    Amarapurkar, Pooja D; Amarapurkar, Deepak N

    2011-01-01

    Patients with decompensated liver cirrhosis have significantly impaired synthetic function. Many proteins involved in the coagulation process are synthesized in the liver. Routinely performed tests of the coagulation are abnormal in patients with decompensated liver cirrhosis. This has led to the widespread belief that decompensated liver cirrhosis is prototype of acquired hemorrhagic coagulopathy. If prothrombin time is prolonged more than 3 seconds over control, invasive procedures like liver biopsy, splenoportogram, percutaneous cholangiography, or surgery were associated with increased risk of bleeding, and coagulopathy should be corrected with infusion of fresh frozen plasma. These practices were without any scientific evidence and were associated with significant hazards of fresh frozen plasma transfusion. Now, it is realized that coagulation is a complex process involving the interaction of procoagulation and anticoagulation factors and the fibrinolytic system. As there is reduction in both anti and procoagulant factors, global tests of coagulation are normal in patients with acute and chronic liver disease indicating that coagulopathy in liver disease is more of a myth than a reality. In the last few years, surgical techniques have substantially improved, and complex procedures like liver transplantation can be done without the use of blood or blood products. Patients with liver cirrhosis may also be at increased risk of thrombosis. In this paper, we will discuss coagulopathy, increased risk of thrombosis, and their management in decompensated liver cirrhosis.

  12. 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

  13. The risk factors associated with intraoperative acute cardiac decompensation in patients undergoing off-pump coronary artery bypass grafting%非体外循环冠状动脉旁路移植术患者术中急性心功能失代偿的危险因素

    Institute of Scientific and Technical Information of China (English)

    董秀华; 卢家凯; 卿恩明; 王义军; 王学勇

    2010-01-01

    目的 筛选非体外循环冠状动脉旁路移植术(OPCABG)患者术中发生急性心功能失代偿的危险因素.方法 选择本院2007年11月至2009年2月行OPCABG的患者2379例,记录术前、术中与急性心功能失代偿可能有关的因素.根据是否发生急性心功能失代偿,分为2组:急性心功能失代偿组和非急性心功能失代偿组.采用1ogistic多元回归分析,筛选发生急性心功能失代偿的危险因素.结果 术中发生急性心功能失代偿368例(发生率15.5%),无一例患者死亡.logistic多元回归分析显示,室壁瘤、术中房颤、术中频发性室性期前收缩、术前射血分数<40%、术前室性期前收缩、合并瓣膜病、心肌梗死史、入室心动过速、急诊手术、左主干病变为术中发生急性心功能失代偿的危险因素.结论 术前合并室壁瘤、瓣膜病变、左主干病变、心肌梗死史、术前室性期前收缩、射血分数<40%,术中房颤、频发性室性期前收缩、入室心动过速和急诊手术为OPCABG患者术中发生急性心功能失代偿的危险因素.%Objective To identify the risk factors associated with intraoperative acute cardiac decompensation in patients undergoing off-pump coronary artery bypass grafting (OPCABG). Methods From November 2007 to February 2009, 2379 OPCABGs were performed in our hospital. The possible risk factors associated with intraoperative cardiac decompensation were retrospectively analyzed. The preoperative patient demographics and intraoperative characteristics were correlated with intraoperative acute cardiac decompensation.The possible risk factors included sex, age, body weight, cardiac function (NYHA classification), the associated diseases (hypertension, diabetes mellitus, liver-kidney dysfunction), history of myocardial infarct, ventricular aneurysm, preoperative treatment with β-blocker and/or calcium channel blocking agent, ventricular extrasystole,atrial fibrillation, duration of

  14. 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.)

  15. 人重组B型利钠肽治疗高龄急性失代偿性心力衰竭患者的疗效和安全性%Efficacy and safety of recombinant human B-type natriuretic peptide in patients with advanced age and acute decompensated heart failure

    Institute of Scientific and Technical Information of China (English)

    付士辉; 朱兵; 王浩; 王亮; 刘源; 叶平; 骆雷鸣

    2011-01-01

    目的:探讨人重组B型利钠肽(rhBNP)治疗高龄急性失代偿性心力衰竭患者的疗效和安全性.方法:试验设计为随机对照试验,对象为2008年1月至2010年12月解放军总医院连续收住的高龄急性失代偿性心力衰竭患者80例,以抽签的方式随机分配到常规心力衰竭治疗组(常规组)和常规+rhBNP治疗组(rhBNP组),每组40例.2组患者均接受抗心力衰竭规范治疗,rhBNP组每天再给予rhBNP 0.5~1.0 mg(溶于50 ml生理盐水),以0.0075~0.0150 μg·kg-1·min-1速度经泵持续静脉输入10~15 h.疗程均为13 d.比较2组患者治疗前和治疗第4、8、14天的呼吸困难评分、水肿评分、净水分丢失情况、心率、血压和血肌酐水平.结果:常规组男性37例,女性3例,平均年龄(88±4)岁;rhBNP组男性38例,女性2例,平均年龄(86±5)岁.2组患者治疗前的基本临床特征和抗心力衰竭药物使用情况差异均无统计学意义.rhBNP组患者治疗第4天呼吸困难评分与常规组比较差异无统计学意义(P>0.05),第8和14天均明显低于常规组(均P<0.05).rhBNP组患者水肿评分第4、8和14天均明显低于常规组(均P<0.05).净水分丢失量第4、8和14天均明显多于常规组[中位数(最小值,最大值):263.5(-793,2184)ml比-129.0(-1249,3636)ml,239.5(-754,1370)ml比-29.5(-1364,2242)ml,386.5(-564,1490)m比71.0(-2274,1660)ml,均P<0.05].心率第4、8天均明显低于常规组[(73±13)次/min比(81±17)次/min,(70±10)次/min比(79±16)次/min,均P<0.05].2组治疗后不同时点血压和血肌酐差异均无统计学意义.结论:常规治疗加用rhBNP对高龄急性失代偿性心力衰竭患者具有较佳疗效和安全性.%Objective : To explore the efficacy and safety of recombjnant human brain natriuretic peptide ( thBNP) in patients with advanced age and acute decompensated heart failure.Methods : A randomized controlled trials was performed.From January 2008 to December 2010, 80 hospitalized patients with

  16. Change of Serum BNP Between Admission and Discharge After Acute Decompensated Heart Failure Is a Better Predictor of 6-Month All-Cause Mortality Than the Single BNP Value Determined at Admission

    Science.gov (United States)

    De Vecchis, Renato; Ariano, Carmelina; Giandomenico, Giuseppe; Di Maio, Marco; Baldi, Cesare

    2016-01-01

    Background B-type natriuretic peptide (BNP) is regarded as a reliable predictor of outcome in patients with acute decompensated heart failure (ADHF). However, according to some scholars, a single isolated measurement of serum BNP at the time of hospital admission would not be sufficient to provide reliable prognostic information. Methods A retrospective study was carried out on patients hospitalized for ADHF, who had then undergone follow-up of at least 6 months, in order to see if there was any difference in midterm mortality among patients with rising BNP at discharge as compared to those with decreasing BNP at discharge. Medical records had to be carefully examined to divide the case records into two groups, the former characterized by an increase in BNP during hospitalization, and the latter showing a decrease in BNP from the time of admission to the time of discharge. Results Ultimately, 177 patients were enrolled in a retrospective study. Among them, 53 patients (29.94%) had increased BNPs at the time of discharge relative to admission, whereas 124 (70.06%) exhibited decreases in serum BNP during their hospital stay. The group with patients who exhibited BNP increases at the time of discharge had higher degree of congestion evident in the higher frequency of persistent jugular venous distention (odds ratio: 3.72; P = 0.0001) and persistent orthopnea at discharge (odds ratio: 2.93; P = 0.0016). Moreover, patients with increased BNP at the time of discharge had a lower reduction in inferior vena cava maximum diameter (1.58 ± 2.2 mm vs. 6.32 ± 1.82 mm; P = 0.001 (one-way ANOVA)). In contrast, there was no significant difference in weight loss when patients with increased BNP at discharge were compared to those with no such increase. A total of 14 patients (7.9%) died during the 6-month follow-up period. Cox proportional hazard analysis revealed that BNP increase at the time of discharge was an independent predictor of 6-month all-cause mortality after

  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. N-carbamylglutamate protects patients with decompensated propionic aciduria from hyperammonaemia.

    Science.gov (United States)

    Gebhardt, B; Dittrich, S; Parbel, S; Vlaho, S; Matsika, O; Bohles, H

    2005-01-01

    In patients with propionic aciduria, the accumulating metabolite propionyl-CoA causes a disturbance of the urea cycle via the inhibition of N-acetylglutamate synthesis. Lack of this allosteric activator results in an inhibition of carbamoylphosphate synthase (CPS). This finally leads to hyperammonaemia. In two patients with decompensated propionic aciduria the CPS activator carbamylglutamate was tested for its ability to antagonize the propionyl-CoA associated hyperammonaemia. Oral carbamyl glutamate administration resulted in a significant increase in ammonia detoxification and could avoid further dialysis therapy. Safe, fast and easy to administer, carbamyl glutamate improves the acute therapy of decompensated propionic aciduria by increasing ammonia detoxification and avoiding hyperammonaemia.

  19. N-carbamylglutamate enhances ammonia detoxification in a patient with decompensated methylmalonic aciduria.

    Science.gov (United States)

    Gebhardt, Boris; Vlaho, Stefan; Fischer, Doris; Sewell, Adrian; Böhles, Hansjosef

    2003-08-01

    In patients with methylmalonic aciduria (MMA), the accumulating metabolite propiony-CoA results in an inhibition of the urea circle via the decreased synthesis of N-acetylglutamate, an essential activator of carbamylphosphat synthetase (CPS). This results in one of the major clinical problems which is hyperammonaemia. In a patient with decompensated MMA, the CPS activator carbamylglutamate was tested for its ability to antagonize the propionyl-CoA-induced hyperammonaemia. Oral carbamylgutamate administration resulted in an impressive increase in ammonia detoxification compared to peritoneal dialysis. Safe, fast and easy to administer, carbamylglutamate improves the acute therapy of decompensated MMA by increasing ammonia detoxification and avoiding hyperammonaemia.

  20. Randomized Clinical evaluatiON of wireless fluid monitoriNg and rEmote ICD managemenT using OptiVol alert-based predefined management to reduce cardiac decompensation and health care utilization: the CONNECT-OptiVol study.

    Science.gov (United States)

    Zabel, Markus; Vollmann, Dirk; Lüthje, Lars; Seegers, Joachim; Sohns, Christian; Zenker, Dieter; Hasenfuss, Gerd

    2013-01-01

    The CONNECT-OptiVol study is designed to investigate whether wireless fluid monitoring using OptiVol alerts as well as implantable cardioverter-defibrillator (ICD) remote monitoring (RM) reduces cardiac decompensations and health care utilization in ICD patients, as compared to standard clinical care. Patients undergoing implantation of wireless telemetry-enabled dual chamber (ICD-DR) or cardiac resynchronization therapy/defibrillator (CRT-D) devices with the OptiVol feature are eligible for the study. In a randomized fashion, OptiVol function, its audible alert as well as its remote alert, and other ICD RM alerts are switched ON or OFF. The primary study objective is to estimate an improvement of heart failure status. The primary endpoint is measured as a prolongation of the time to first hospitalization due to worsened heart failure. The secondary objectives are to estimate: a reduction of the time from event to clinical decision, a reduction of the rate of health care utilization, and improved quality of life (QoL) measures (secondary endpoints). The study is designed as a single center pilot study with 180 patients randomized 1:1 to the two study arms. The CONNECT-OptiVol study aims to answer whether wireless fluid monitoring integrated into RM may reduce cardiac decompensations and health care utilization in ICD patients. The results can be used to adequately power future studies evaluating the benefit of these features. Study enrollment has been completed, and follow-up is expected to be finished in September 2012. Copyright © 2012 Elsevier Inc. All rights reserved.

  1. The role of B-type natriuretic peptide in the diagnosis and treatment of decompensated heart failure

    Institute of Scientific and Technical Information of China (English)

    Michael J. Gallagher; Peter A. McCullough

    2004-01-01

    Heart failure (HF) is a common disease associated with increasing age. B-type natriuretic peptide (BNP), is a cardiac neurohormone, and is released as prepro BNP and then enzyrnatically cleaved to the Ntenninal-proBNP (NT-proBNP) and BNP upon ventricular myocyte stretch. Blood measurements of BNP have been used to identify patients with I-IF. The BNP assay is currently used as a diagnostic and prognostic aid in HF. In general, a BNP level below 100 pg/mL excludes acutely decompensated HF and levels > 500 pg/ml indicate decompensation. Recombinant human BNP (hBNP, nesiritide) is an approved intravenous treatment for acute,decompensated -HF. Nesiritide given in supraphysiologic doses causes vasodilation, natriuresis, diuresis, and improved symptoms over the course of a 48-hour infusion. This paper will sort out the literature concerning the use of this peptide both as a diagnostic test and as an intravenous therapy.

  2. [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.

  3. Rifaximin has no effect on hemodynamics in decompensated cirrhosis

    DEFF Research Database (Denmark)

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

    2017-01-01

    , P = 0.14, or vasoactive hormones were found. Subgroup analyses on patients with increased lipopolysaccharide binding protein and systemic vascular resistance below the mean (1,011 dynes × s/cm(5) ) revealed no effect of rifaximin. CONCLUSION: Four weeks of treatment with rifaximin did not reduce......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...

  4. 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 cort

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

    OpenAIRE

    Cătălin Pleșea Condratovici; Vladimir Bacarea; Núria Piqué

    2016-01-01

    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 xylo...

  6. 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

  7. 低糖血症与急性失代偿性肝硬化患者 病死率增加的相关性研究%Correlation between hypoglycemia and increased mortality of patients with acute decompensated liver cirrhosis

    Institute of Scientific and Technical Information of China (English)

    刘润田; 白云; 安聪静; 李秋生; 郑建兴; 张海燕

    2015-01-01

    Objective To explore the correlation between hypoglycemia and the increased mortality of patients with acute decompensated liver cirrhosis.Methods A retrospective study was conducted on the clinical data of 120 patients with acute decompensated liver cirrhosis admitted to the Department of Hepatobiliary Surgery of the Second Hospital of Hebei Medical University from December 2011 to December 2014. The patients were divided into three groups: hypoglycemia group (glucose 10.0 mmol/L, 15 cases). The differences in hepatic carcinoma, decompensation symptoms, the incidence of known glycometabolic disorder, hospitalization situation, indicators of liver function and indexes of blood gas analysis were compared among three groups. The patients' age, hepatic carcinoma, ascites, hepatorenal syndrome, encephalopathy, bleeding, jaundice and glycometabolic disorder, etc were analyzed by the univariate analysis. The resulting risk factors with statistically significant differences were analyzed by multivariate logistic regression method in order to screen out the risk factors of increased mortality.Results The incidences of hepatorenal syndrome [42.9% (9/21) vs. 22.6% (19/84), 33.3% (5/15)] and jaundice [38.1% (7/21) vs. 20.2% (17/84), 13.3% (2/15)], rate of admission into intensive care unit (ICU) [14.3% (3/21) vs. 10.7% (9/84), 13.3% (2/15)] and in-hospital mortality [23.8% (5/21) vs. 10.7% (9/84), 20.0% (3/15)] in the hypoglycemia group were significantly higher than those in the normoglycemia group and hyperglycemia group (P 0.05). Univariate analysis showed that advanced age, hepatic carcinoma, hepatorenal syndrome, bleeding, jaundice and glycometabolic disorder hypoglycemia were the risk factors of the death in patients with acute decompensated liver cirrhosis (P 10.1 mmol/L,15例),比较3组患者肝癌、代偿失调症状、已知糖代谢紊乱发生率及住院情况、肝功能指标和血气分析指标的差异,对患者的年龄、肝癌、腹水、肝肾综合

  8. Prednisone lowers serum uric acid levels in patients with decompensated heart failure by increasing renal uric acid clearance.

    Science.gov (United States)

    Liu, Chao; Zhen, Yuzhi; Zhao, Qingzhen; Zhai, Jian-Long; Liu, Kunshen; Zhang, Jian-Xin

    2016-07-01

    Clinical studies have shown that large doses of prednisone could lower serum uric acid (SUA) in patients with decompensated heart failure (HF); however, the optimal dose of prednisone and underlying mechanisms are unknown. Thirty-eight patients with decompensated HF were randomized to receive standard HF care alone (n = 10) or with low-dose (15 mg/day, n = 8), medium-dose (30 mg/day, n = 10), or high-dose prednisone (60 mg/day, n = 10), for 10 days. At the end of the study, only high-dose prednisone significantly reduced SUA, whereas low- and medium-dose prednisone and standard HF care had no effect on SUA. The reduction in SUA in high-dose prednisone groups was associated with a significant increase in renal uric acid clearance. In conclusion, prednisone can reduce SUA levels by increasing renal uric acid clearance in patients with decompensated HF.

  9. Efficacy of toivaptan for delusional hyponatremia in decompensated liver cirrhosis

    Institute of Scientific and Technical Information of China (English)

    阚晓

    2014-01-01

    Objective To investigate the efficacy and safety of vasopressin receptor antagonist tolvaptan for treating dilutional hyponatremia casused by decompensated liver cir-rhosis.Methods Ninety-six subjects with decompensated liver cirrhosis complicated by dilutional hyponatremia were divided into test group(n=56)and control group(n=40)by double blind method.

  10. Inflammasome activation in decompensated liver cirrhosis

    Institute of Scientific and Technical Information of China (English)

    2016-01-01

    Inflammation participates in the pathogenesis of many liver diseases, including liver cirrhosis. Certaininflammatory citokines, such as interleukin (IL)-1β andIL-18, are produced after the activation of a multiproteincomplex known as the inflammasome. Activation of theinflammasome has been documented in several liverdiseases, but its role in the development and progressionof liver cirrhosis or the complications associated withthis disease is still largely unknown. We have recentlystudied the impact of the inflammasome in the sterileinflammatory response that takes place in the asciticfluid of patients with decompensated cirrhosis, providingevidence that activation of the absent in melanoma2 (AIM2) inflammasome is an important response inthese patients. Ascitic fluid-derived macrophages wereable to mount a very robust AIM2-mediated responseeven in the absence of a priming signal, which is usuallyrequired for the full activation of all the inflammasomes.In addition, high level of inflammasome activation inthese patients was associated with a higher degree ofliver disease and an increased incidence of spontaneousbacterial peritonitis. These results may help explain theexacerbated inflammatory response that usually occursin patients with decompensated cirrhosis in the absenceof detectable infections. Thus, inflammasomes shouldbe considered as possible therapeutic targets in sterileinflammatory complications in patients with cirrhosis.

  11. [Management of avoidable acute transfers from an intermediate care geriatric facility to acute hospitals: critical aspects of an intervention protocol].

    Science.gov (United States)

    Colprim, Daniel; Casco, Mónica; Malumbres, Jennifer; Rodríguez, Ginés; Inzitari, Marco

    The unplanned transfers (UT) from post-acute intermediate care facilities, are associated with adverse outcomes for patients, and a significant cost to the system. We present a practical protocol and the design of an intervention study aimed at reducing avoidable UT from a geriatric post-acute rehabilitation setting to acute care hospitals. A quasi-experimental non randomized study. The intervention consists in: 1) protocol for early detection of symptoms in order to conduct a pro-active management of decompensation; 2) an advanced care planning structured protocol for the acute decompensations. We will compare the intervention group with a parallel and a historical cohort for demographic, functional, cognitive, comorbidity and social variables. number of UT to acute care hospitals. This is a quasi-experimental study, focused on everyday care practice that intends to assess the impact of multi-disciplinary and multi-factorial intervention to reduce UT from a post-acute rehabilitation unit. We expect that the project results will be useful for future randomized and controlled studies. Copyright © 2016 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.

  12. The first use of N-carbamylglutamate in a patient with decompensated maple syrup urine disease.

    Science.gov (United States)

    Kalkan Ucar, Sema; Coker, Mahmut; Habif, Sara; Saz, Eylem Ulas; Karapinar, Bulent; Ucar, Hakan; Kitis, Omer; Duran, Marinus

    2009-09-01

    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 hyperleucinaemia with hyperammonaemia. The oral administration of the N-acetylglutamate analogue, N-carbamylglutamate (NCG), 200 mg/kg/day as a loading dose, and 100 mg/kg/day as a maintenance dose, in combination with standard therapy resulted in a significant decrease of plasma ammonia levels. This observation suggests that NCG may be an important adjunct to standard therapy in the management of decompensated MSUD patients with high leucine and ammonia levels. Supportive evidence from either randomized controlled trials or a large prospective cohort study is needed to confirm this interesting finding.

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

    DEFF Research Database (Denmark)

    Mett, A.; Tfelt-Hansen, P.

    2008-01-01

    (1) A wide array of data regarding acute migraine treatment are available, but few trials strictly adhere to International Headache Society guidelines for patient inclusion criteria. (2) Triptans appear to have similar efficacy profiles, but among newer triptans, almotriptan offers improved...... 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...

  14. 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.

  15. Correlation between tricuspid annular plane systolic excursion and glomerular filtration rate in patients with acute decompensated heart failure%急性失代偿型心力衰竭患者三尖瓣收缩期位移与肾小球滤过率的关系

    Institute of Scientific and Technical Information of China (English)

    李邵琳; 张菲斐

    2016-01-01

    目的:探讨急性失代偿型心力衰竭患者三尖瓣收缩期位移(TAPSE)变化及其与肾小球滤过率的关系。方法选取慢性收缩性心力衰竭急性失代偿入院患者102例,经胸超声心动图检测TASPE、左室射血分数(LVEF)及肺动脉收缩压(PASP),静脉采血测定B型氨基端利钠肽原(NT- proBNP)、电解质、血尿素氮(BUN)及血肌酐,采用改良的MDRD方程计算肾小球滤过率(eGFR),将eGFR0.05)。在肾功能不全组中肾小球滤过率分别与TASPE、NT- proBNP、PASP、LVEF进行相关性分析,显示只有TASPE与肾小球滤过率呈显著相关(=0.62,%Objective To explore the change of tricuspid annular plane systolic excursion (TAPSE) and its corre-lation with glomerular filtration rate (GFR) in patients with acute decompensated heart failure (ADHF). Methods One hundred and two consecutive patients with acute decompensated heart failure and left ventricular ejection fraction (LVEF) below 50% on echocardiogram were enrolled. The value of TASPE, LVEF and pulmonary arterial systolic pressure (PASP) were measured by the transthoracic echocardiography. Blood test was conducted to determine NT-proBNP, electrolytes, BUN and creatinine. The estimated GFR (eGFR) was calculated on the basis of simplified Modification of Diet in Renal Disease (MDRD). According to the eGFR, the patients were divided into preserved re-nal function (PRF) group [eGFR≥60 ml/(min·1.73m2), =54] and renal dysfunction (RDSF) group [eGFR﹤60 ml/(min·1.73m2), = 48]. The echocardiographic parameters and serum indexes were compared between the two groups. The correlations between TASPE and echocardiographic parameters, serum indexes in the RDSF group were analyzed. Results TASPE in the PRF group [(16.4 ± 4.0) mm] was significantly lower than that in the RDSF group [(18.9 ± 3.8) mm, ﹤ 0.001], but no significant difference in NT-proBNP, PASP or LVEF was observed between the two groups ( ﹥ 0

  16. Immunogenicity of hepatitis A vaccination in decompensated cirrhotic patients.

    Science.gov (United States)

    Arguedas, M R; Johnson, A; Eloubeidi, M A; Fallon, M B

    2001-07-01

    Hepatitis A virus (HAV) vaccination is recommended in chronic liver disease because of an increased morbidity and mortality associated with HAV superinfection. However, data regarding the efficacy of HAV vaccination in patients with advanced chronic liver disease is limited. We assessed the efficacy of a standard HAV vaccination schedule in decompensated chronic liver disease in comparison with compensated disease and defined clinical predictors associated with seroconversion. Eighty-four anti-HAV antibody-negative patients, 49 with compensated liver disease, and 35 with decompensated disease were enrolled. Seroconversion was measured by qualitative and quantitative anti-HAV antibody measurements 1 month after each vaccine dose, and univariate/multivariate analysis was performed to define clinical predictors associated with seroconversion. One month after the primary dose, 71.4% of patients with compensated liver disease had detectable anti-HAV antibody compared with 37.1% with decompensated liver disease (P decompensated disease (P decompensated disease. On multivariate analysis, Child-Pugh class was the only factor predicting response to vaccination. Seroconversion after HAV vaccination was significantly less common in decompensated liver disease and the presence of advanced disease (Child-Pugh class B/C) predicted a lower response rate. These findings indicate that the response to HAV vaccination in chronic liver disease is optimal when targeted to patients before the development of hepatic decompensation.

  17. 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.

  18. Entecavir for Patients with Hepatitis B Decompensated Cirrhosis in China: a meta-analysis.

    Science.gov (United States)

    Wang, F Y; Li, B; Li, Y; Liu, H; Qu, W D; Xu, H W; Qi, J N; Qin, C Y

    2016-09-07

    Evidence about the clinical effects of entecavir (ETV) for patients with hepatitis B decompensated cirrhosis remain controversial. Therefore, we perform this meta-analysis to assess the treatment outcomes of ETV in participants with hepatitis B decompensated cirrhosis. Relevant studies were identified by searching databases until the March 2016. A random-effects model was used to estimate summary relative risks (RRs) and 95% confidence intervals (CIs). GRADEprofiler3.6 was used to evaluate the quality of the evidence. A total of 26 studies (involving 2040 patients) were included. The quality of the evidence was classified from very low to high by the GRADED approach for all included RCTs. Meta-analysis showed that patients were more likely to experience HBV-DNA loss (RR:1.85, 95%CIs: 1.41 to 2.43, P < 0.0001 at 48 weeks), have normalized alanine aminotransferase levels (ALT) (P = 0.003 at 24 weeks, P = 0.02 at 48 weeks), and have a low mortality rate at 24 weeks (P = 0.003) when treated with ETV. There was no significant different between ETV and the control groups at the total mortality (P = 0.06) and HBeAg seroconversion (P = 0.14). In conclusion, ETV could be the first line therapy for patients with HBV related decompensated cirrhosis, because ETV could reduce the early mortality and move HBV DNA load down.

  19. 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 reconst...

  20. 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.

  1. 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. 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 proto

  2. Effect of fluvastatin on ischaemia following acute myocardial infarction : a randomized trial

    NARCIS (Netherlands)

    Liem, AH; van Boven, AJ; Veeger, NJGM; Withagen, AJ; de Medina, RMR; Tijssen, JGP; van Veldhuisen, DJ

    2002-01-01

    Alms Residual ischaemia following acute myocardial infarction (AMI) is related to an adverse outcome, although the effect of early initiation of statin therapy is unknown. Methods A randomized, placebo-controlled, double-blind, parallel study was performed, which compared fluvastatin 80 mg daily

  3. Nesiritide for pulmonary arterial hypertension with decompensated cor pulmonale.

    Science.gov (United States)

    Kingman, Martha S; Thompson, Brenda S; Newkirk, Trixie; Torres, Fernando

    2005-01-01

    Pulmonary arterial hypertension complicated by decompensated cor pulmonale is a challenging clinical problem with few effective therapeutic options. B-type natriuretic peptide is a pluripotent hormone that promotes diuresis and natriuresis, vasodilates systemic and pulmonary vessels, and reduces circulating levels of endothelin and aldosterone. It may represent a possible therapeutic strategy for decompensated cor pulmonale in the same manner that it is used to treat decompensated left heart failure. The authors report their experience with B-type natriuretic peptide as adjunctive therapy for pulmonary arterial hypertension complicated by decompensated cor pulmonale. A detailed case report is presented followed by the evaluation of a series of 11 cases occurring in eight patients from December 2002 through April 2004.

  4. 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

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

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    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.

  6. 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

    BACKGROUND: Acute cholecystitis can be the result of retention of bile in the gallbladder with possible secondary infection and ischaemia. The aim of the present study was to investigate whether internal drainage of the gallbladder could protect against the development of acute cholecystitis...... in a pig model. MATERIALS AND METHODS: Twenty pigs were randomized to either internal drainage (drained) or not (undrained). Day 0 acute cholecystitis was induced by ligation of the cystic artery and duct together with inoculation of bacteria. Four days later the pigs were killed and the gallbladders were...... 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...

  7. Criteria for decompensation in binocular vision.

    Science.gov (United States)

    Jenkins, T C; Pickwell, L D; Yekta, A A

    1989-04-01

    Two groups of patients, one under 40 years of age and the other 40 years and over, were divided into subgroups according to whether they had symptoms associated with near vision. A method developed in 'signal detection theory' was used to determine whether a value could be found for heterophoria, or associated heterophoria, which would predict which patients had symptoms due to decompensated heterophoria in normal routine investigation. Receiver operator characteristic curves (ROC curves) were constructed to look for these cut-off values between patients with, and without, symptoms. No value for dissociated heterophoria was found that would discriminate between the symptomatic and asymptomatic patients. It is concluded that heterophoria measurement is not useful as a routine procedure. In the case of associated heterophoria, for the under 40 years age group, patients with a value of 1 prism dioptre or more are more likely to have symptoms than not, and one-third of patients with close work problems have a value of 2 prism dioptres or more. It was rare to find any asymptomatic patient with a value as high as this. In the 40 years and over age group those with an associated heterophoria of 2 prism dioptres or more are more likely to have symptoms than not. One-third of patients in the latter age group, with symptoms, have a value of 3 prism dioptres or more whilst it is rare to find an asymptomatic patient with a value as large as this.

  8. 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

    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...... during follow-up. CONCLUSIONS: There was no effect of IV immunoglobulin (IVIG) on long-term visual function following acute optic neuritis, nor was there an effect of IVIG treatment in reducing latency on visual evoked potentials and thus preserving function of axons of the optic nerve...

  9. A phase 3 randomized trial comparing inolimomab vs usual care in steroid-resistant acute GVHD.

    Science.gov (United States)

    Socié, Gérard; Vigouroux, Stéphane; Yakoub-Agha, Ibrahim; Bay, Jacques-Olivier; Fürst, Sabine; Bilger, Karin; Suarez, Felipe; Michallet, Mauricette; Bron, Dominique; Gard, Philippe; Medeghri, Zakaria; Lehert, Philippe; Lai, Chinglin; Corn, Tim; Vernant, Jean-Paul

    2017-02-02

    Treatment of steroid-resistant acute graft-versus-host disease (GVHD) remains an unmet clinical need. Inolimomab, a monoclonal antibody to CD25, has shown encouraging results in phase 2 trials. This phase 3 randomized, open-label, multicenter trial compared inolimomab vs usual care in adult patients with steroid-refractory acute GVHD. Patients were randomly selected to receive treatment with inolimomab or usual care (the control group was treated with antithymocyte globulin [ATG]). The primary objective was to evaluate overall survival at 1 year without changing baseline allocated therapy. A total of 100 patients were randomly placed: 49 patients in the inolimomab arm and 51 patients in the ATG arm. The primary criteria were reached by 14 patients (28.5%) in the inolimomab and 11 patients (21.5%) in the ATG arms, with a hazard ratio of 0.874 (P = .28). With a minimum follow-up of 1 year, 26 (53%) and 31 (60%) patients died in the inolimomab and ATG arms, respectively. Adverse events were similar in the 2 arms, with fewer viral infections in the inolimomab arm compared with the ATG arm. The primary end point of this randomized phase 3 trial was not achieved. The lack of a statistically significant effect confirms the need for development of more effective treatments for acute GVHD. This trial is registered to https://www.clinicaltrialsregister.eu/ctr-search/search as EUDRACT 2007-005009-24.

  10. 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 viral bronchiolitis.

  11. Using Animation to Improve Recovery from Acute Coronary Syndrome: A Randomized Trial.

    Science.gov (United States)

    Jones, Annie Selina Kozlowski; Ellis, Christopher J; Nash, Martyn; Stanfield, Brad; Broadbent, Elizabeth

    2016-02-01

    Background: Recovery from myocardial infarction has been associated with patients' perceptions of damage to their heart. New technologies offer a way to show patients animations that may foster more accurate perceptions and encourage medication adherence, increased exercise and faster return to activities. The purpose of this study was to investigate the effects of a brief animated intervention delivered at the patients' bedside on perceptions and recovery in acute coronary syndrome patients. Seventy acute coronary syndrome patients were randomly assigned to the intervention or standard care alone. Illness perceptions, medication beliefs and recovery outcomes were measured. Post-intervention, the intervention group had significantly increased treatment control perceptions and decreased medication harm beliefs and concerns. Seven weeks later, intervention participants had significantly increased treatment control and timeline beliefs, decreased symptoms, lower cardiac avoidance, greater exercise and faster return to normal activities compared to control patients. A brief animated intervention may be clinically effective for acute coronary syndrome patients (Trial-ID: ACTRN12614000440628).

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

    Science.gov (United States)

    Mahapatro, Samarendra; Mahilary, Nijwm; Satapathy, Amit Kumar

    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). PMID:28331496

  13. 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.

  14. Graft irradiation in the treatment of acute rejection of renal transplants: a randomized study

    Energy Technology Data Exchange (ETDEWEB)

    Pilepich, M.V.; Anderson, C.B.; Etheredge, E.E.; Sicard, G.A.; Melzer, J.S.; Blum, J.

    1982-05-01

    A randomized study of graft irradiation in the treatment of acute rejection of renal transplants was conducted from 1978 to 1981. Patients developing clinical signs of an acute graft rejection received customary antirejection treatment in the form of intravenous administration of high-dose (1 gm per day) of methylprednisolone. They were at the same time randomized to either receive therapeutic irradiation (175 rad every other day to a total of 525 rad) or sham irradiation. Neither the patient nor the Transplant Service surgeons knew at any time whether the radiation treatment had been given. Eighty-three rejection episodes occurring in 64 grafts were entered into the study. Acute rejection was reversed in 84.5% of grafts in the control and 75% in the treated group. The incidence of recurrent rejection was higher in the treated group (66 vs. 46%) and graft survival was lower (22% vs. 54%). The study failed to demonstrate a beneficial effect of graft irradiation in the treatment of acute renal allograft rejection, when used in conjunction with high dose steriods.

  15. Treatment of Hepatitis B in Decompensated Liver Cirrhosis

    Directory of Open Access Journals (Sweden)

    Richard Guan

    2011-01-01

    Full Text Available Chronic hepatitis B infection progresses from an asymptomatic persistently infected state to chronic hepatitis, cirrhosis, decompensated liver disease, and/or hepatocellular carcinoma. About 3% of patients with chronic hepatitis develop cirrhosis yearly, and about 5% of individuals with hepatitis B cirrhosis become decompensated annually. The outcome for patients with decompensated cirrhosis is bleak. Lamivudine, the first oral antiviral agent available for hepatitis B treatment is safe and effective and can improve or stabilize liver disease in patients with advanced cirrhosis and viraemia. Viral resistance restricts its prolonged use. Entecavir and tenofovir are newer agents with excellent resistance profile to date. These and some other antiviral agents are being investigated for optimal use in this rather challenging patient group.

  16. 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.

  17. 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

  18. Serum ferritin predicts early mortality in patients with decompensated cirrhosis.

    Science.gov (United States)

    Maiwall, Rakhi; Kumar, Suman; Chaudhary, A K; Maras, Jaswinder; Wani, Zeeshan; Kumar, Chandan; Rastogi, A; Bihari, C; Vashisht, Chitranshu; Sarin, S K

    2014-07-01

    Serum ferritin is a known marker of hepatic necro-inflammation and has been studied to predict 1 year mortality and post-transplant survival in decompensated cirrhotics. However, there are no studies evaluating ferritin as a predictor of early mortality. We investigated whether serum ferritin levels could predict 15 day and 30 day mortality in patients with decompensated cirrhosis. 318 patients with decompensated cirrhosis were included. Patients of decompensated cirrhosis [257 males, mean age of 51 [±13]years, were followed for a median of 31 days. Serum ferritin levels were significantly different between survivors and non-survivors [pserum sodium [pSerum ferritin, etiology, MELD, HE, CTP score, sodium, TLC, and ACLF grades were significant predictors of mortality on univariate analysis. Ferritin [p=0.04, HR 1.66 95% CI (1.02-2.73)] was a significant predictor of early mortality on multivariate analysis along with HE [p=0.006, HR 3.47 95% CI (2.13-8.41)] (Model 1), TLC [p=0.02, HR 1.81 95% CI (1.06-3.07)] (Model 2), ACLF grades [p=0.018, HR 2.013,95% CI (1.126-3.60)], and CTP score [pSerum ferritin levels correlate with severity of hepatic decompensation and are associated with early liver related death independent of the MELD score in hospitalized patients with decompensated cirrhosis. This could also have a potential therapeutic implication. Copyright © 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

  19. 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

  20. 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.

  1. Ketamine Patient Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active Comparator Controlled, Blinded, Pilot Trial

    Science.gov (United States)

    2017-01-11

    AFRL-SA-WP-SR-2017-0003 Ketamine Patient-Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active Comparator...June 2013 – December 2016 4. TITLE AND SUBTITLE Ketamine Patient-Controlled Analgesia for Acute Pain in Trauma Patients: A Randomized, Active...in trauma patients while reducing opioid consumption in the traumatically injured patient. The objective of this study was to compare differences in

  2. 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.

  3. 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.

  4. Recombinant streptokinase vs phenylephrine-based suppositories in acute hemorrhoids, randomized, controlled trial (THERESA-3).

    Science.gov (United States)

    Hernández-Bernal, Francisco; Castellanos-Sierra, Georgina; Valenzuela-Silva, Carmen M; Catasús-Álvarez, Karem M; Valle-Cabrera, Roselin; Aguilera-Barreto, Ana; López-Saura, Pedro A

    2014-02-14

    To compare the efficacy and safety of recombinant streptokinase (rSK) and phenylephrine-based suppositories in acute hemorrhoidal disease. A multicenter (14 sites), randomized (1:1), open, parallel groups, active controlled trial was done. After inclusion, subjects with acute symptoms of hemorrhoids, who gave their written, informed consent to participate, were centrally randomized to receive, as outpatients, rSK (200000 IU) or 0.25% phenylephrine suppositories, which had different organoleptic characteristics. Treatment was administered by the rectal route, one unit every 6 h during 48 h for rSK, and up to a maximum of 5 d (20 suppositories) for phenylephrine. Evaluations were performed at 3, 5 and 10 d post-inclusion. The main end-point was the 5(th)-day complete clinical response (disappearance of pain and edema, and ≥ 70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were evaluated too. 5(th) day complete response rates were 83/110 (75.5%) and 36/110 (32.7%) with rSK and phenylephrine suppositories, respectively. This 42.7% difference (95%CI: 30.5-54.2) was highly significant (P suppositories showed a significant advantage over a widely used over-the-counter phenylephrine preparation for the treatment of acute hemorrhoidal illness, with an adequate safety profile.

  5. 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 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.

  6. Safflower yellow for acute ischemic stroke: A systematic review of randomized controlled trials.

    Science.gov (United States)

    Fan, Siyuan; Lin, Nan; Shan, Guangliang; Zuo, Pingping; Cui, Liying

    2014-04-01

    Stroke is one of the most common causes of mortality worldwide. Safflower yellow is widely used for the treatment of acute ischemic stroke in China. Several trials comparing safflower yellow and placebo or no intervention were unavailable for prior meta-analysis. Here, we present an updated and expanded systematic review, including four new trials, to evaluate the efficacy and safety of safflower yellow for the treatment of acute ischemic stroke. A comprehensive search was performed in Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, the Allied and Complementary Medicine Database (AMED), China National Knowledge Infrastructure (CNKI), China Biological Medicine Database (CBM), CQVIP Information and Wanfang Database until January 2013. Only randomized controlled trials (RCTs) evaluating the efficacy and safety of safflower yellow for acute ischemic stroke were included. Two researchers (Fan, S.Y. and Lin, N.) independently extracted data, assessed the study quality, and selected trials for inclusion. 7 RCTs with 762 participants were included. None of the included studies were of high methodological quality. The meta-analysis showed that safflower yellow was more effective assessed by neurological improvement rate [odds ratio (OR), 3.11; 95% confidence interval (CI) 2.06-4.68, Pacute ischemic stroke. However, RCTs of high methodological quality are warranted before drawing any conclusion on the efficacy or safety of safflower yellow for acute ischemic stroke. Copyright © 2014 Elsevier Ltd. All rights reserved.

  7. 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......-depressed acute coronary syndrome patients to escitalopram (n = 120) or matching placebo (n = 120). The main outcomes were mean scores on Short Form 36 Health Survey (SF-36) domains, and diagnosis of depression was adjusted for baseline SF-36 scores. RESULTS: Escitalopram did not yield different SF-36...... 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...

  8. Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized Trial.

    Science.gov (United States)

    Rainer, Timothy Hudson; Cheng, Chi Hung; Janssens, Hein J E M; Man, Chi Yin; Tam, Lai Shan; Choi, Yu Fai; Yau, Wah Hon; Lee, Ka Hing; Graham, Colin Alexander

    2016-04-05

    Two recent double-blind, randomized, controlled trials (RCTs) showed that oral steroids and nonsteroidal anti-inflammatory drugs have similar analgesic effectiveness for management of gout, but the trials had small sample sizes and other methodological limitations. To compare the effectiveness and safety of oral prednisolone versus oral indomethacin in patients presenting to emergency departments (EDs) with acute gout. Multicenter, double-blind, randomized equivalence trial. Patients were randomly assigned (1:1 ratio) to receive either indomethacin or prednisolone. (ISRCTN registry number: ISRCTN45724113). Four EDs in Hong Kong. 416 patients aged 18 years or older. Analgesic effectiveness was defined as changes in pain (at rest or with activity) greater than 13 mm on a 100-mm visual analogue scale. Outcomes were measured during the first 2 hours in the ED and from days 1 to 14. 376 patients completed the study. Equivalent and clinically significant within-group reductions in mean pain score were observed with indomethacin and prednisolone in the ED (approximately 10 mm [rest] and 20 mm [activity]) and from days 1 to 14 (approximately 25 mm [rest] and 45 mm [activity]). No major adverse events occurred during the study. During the ED phase, patients in the indomethacin group had more minor adverse events than those in the prednisolone group (19% vs. 6%; P gout was usually based on clinical criteria rather than examination of joint fluid. Oral prednisolone and indomethacin had similar analgesic effectiveness among patients with acute gout. Prednisolone is a safe, effective first-line option for treatment of acute gout. Health and Health Services Research Grant Committee of the Hong Kong Government.

  9. Midazolam-Droperidol, Droperidol, or Olanzapine for Acute Agitation: A Randomized Clinical Trial.

    Science.gov (United States)

    Taylor, David McD; Yap, Celene Y L; Knott, Jonathan C; Taylor, Simone E; Phillips, Georgina A; Karro, Jonathan; Chan, Esther W; Kong, David C M; Castle, David J

    2017-03-01

    We aim to determine the most efficacious of 3 common medication regimens for the sedation of acutely agitated emergency department (ED) patients. We undertook a randomized, controlled, double-blind, triple-dummy, clinical trial in 2 metropolitan EDs between October 2014 and August 2015. Patients aged 18 to 65 years and requiring intravenous medication sedation for acute agitation were enrolled and randomized to an intravenous bolus of midazolam 5 mg-droperidol 5 mg, droperidol 10 mg, or olanzapine 10 mg. Two additional doses were administered, if required: midazolam 5 mg, droperidol 5 mg, or olanzapine 5 mg. The primary outcome was the proportion of patients adequately sedated at 10 minutes. Three hundred forty-nine patients were randomized to the 3 groups. Baseline characteristics were similar across the groups. Ten minutes after the first dose, significantly more patients in the midazolam-droperidol group were adequately sedated compared with the droperidol and olanzapine groups: differences in proportions 25.0% (95% confidence interval [CI] 12.0% to 38.1%) and 25.4% (95% CI 12.7% to 38.3%), respectively. For times to sedation, the differences in medians between the midazolam-droperidol group and the droperidol and olanzapine groups were 6 (95% CI 3 to 8) and 6 (95% CI 3 to 7) minutes, respectively. Patients in the midazolam-droperidol group required fewer additional doses or alternative drugs to achieve adequate sedation. The 3 groups' adverse event rates and lengths of stay did not differ. Midazolam-droperidol combination therapy is superior, in the doses studied, to either droperidol or olanzapine monotherapy for intravenous sedation of the acutely agitated ED patient. Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  10. Pentoxifylline Treatment in Severe Acute Pancreatitis: A Pilot, Double-Blind, Placebo-Controlled, Randomized Trial.

    Science.gov (United States)

    Vege, Santhi Swaroop; Atwal, Tegpal; Bi, Yan; Chari, Suresh T; Clemens, Magdalen A; Enders, Felicity T

    2015-08-01

    In acute pancreatitis (AP) tumor necrosis factor-α mediates multi-organ failure; in animal models its blockade with pentoxifylline ameliorates AP. The efficacy of pentoxifylline in predicted severe AP (pSAP) was tested in a double-blinded, randomized, control trial. Twenty-eight patients with pSAP were randomized within 72 hours of diagnosis to pentoxifylline or placebo. Baseline characteristics were similar in both groups. The pentoxifylline group had fewer intensive care unit admissions and shorter intensive care unit and hospital stays of longer than 4 days (all P < .05). Patients receiving pentoxifylline had no adverse effects. Pentoxifylline within 72 hours of pSAP is safe; a larger study of pentoxifylline in AP is needed to confirm efficacy. ClinicalTrials.gov number: NCT01292005. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

  11. 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.

  12. Portal vein thrombosis, mortality and hepatic decompensation in patients with cirrhosis: A meta-analysis

    Institute of Scientific and Technical Information of China (English)

    Jonathan; G; Stine; Puja; M; Shah; Scott; L; Cornella; Sean; R; Rudnick; Marwan; S; Ghabril; George; J; Stukenborg; Patrick; G; Northup

    2015-01-01

    AIM: To determine the clinical impact of portal vein thrombosis in terms of both mortality and hepatic decompensations(variceal hemorrhage, ascites, portosystemic encephalopathy) in adult patients with cirrhosis.METHODS: We identified original articles reported through February 2015 in MEDLINE, Scopus, Science Citation Index, AMED, the Cochrane Library, and relevant examples available in the grey literature. Two independent reviewers screened all citations for inclusion criteria and extracted summary data. Random effects odds ratios were calculated to obtain aggregate estimates of effect size across included studies, with 95%CI.RESULTS: A total of 226 citations were identified and reviewed, and 3 studies with 2436 participants were included in the meta-analysis of summary effect. Patients with portal vein thrombosis had an increased risk of mortality(OR = 1.62, 95%CI: 1.11-2.36, P = 0.01). Portal vein thrombosis was associated with an increased risk of ascites(OR = 2.52, 95%CI: 1.63-3.89, P < 0.001). There was insufficient data available to determine the pooled effect on other markers of decompensation including gastroesophageal variceal bleeding or hepatic encephalopathy. CONCLUSION: Portal vein thrombosis appears to increase mortality and ascites, however, the relatively small number of included studies limits more generalizable conclusions. More trials with a direct comparison group are needed.

  13. Intraarticular lidocaine versus intravenous analgesic for reduction of acute anterior shoulder dislocations. A prospective randomized study.

    Science.gov (United States)

    Matthews, D E; Roberts, T

    1995-01-01

    We performed a prospective, randomized study to evaluate the use of injected lidocaine as an anesthetic for closed reduction of acute anterior shoulder dislocations. Thirty consecutive patients who presented at the emergency department with acute anterior shoulder dislocations were randomly placed in one of two groups. One group received an intraarticular injection of 20 ml of 1% lidocaine and the other group, intravenous injections of morphine sulfate and midazolam. The groups were compared regarding time of reduction maneuver, difficulty of reduction, subjective pain, complications, and total time spent in the emergency department. The lidocaine provided adequate anesthesia and secondary relief of muscle spasm in 15 of 15 (100%) patients. When compared with the intravenous sedation group, the lidocaine group showed no statistically significant difference in time for reduction maneuver, difficulty of reduction, or subjective pain. The lidocaine group had no complications and had a statistically significant shorter emergency department visit when compared with the intravenous sedation group (mean, 78 minutes versus 186 minutes; P = 0.004). Lidocaine provides excellent anesthesia for patients with uncomplicated anterior shoulder dislocations and can be very beneficial when sedation is contraindicated. Lidocaine injections also proved to be cost effective in our institution, reducing total costs by as much as 62%.

  14. 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.

  15. 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.)

  16. 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.

  17. Efficacy and safety of 2-hour urokinase regime in acute pulmonary embolism: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Huang Kewu

    2009-12-01

    Full Text Available Abstract Backgrounds Urokinase (UK 2 200 U/kg·h for 12 hours infusion(UK-12 his an ACCP recommended regimen in treating acute pulmonary embolism (PE. It is unclear whether this dose and time can be reduced further. We compared the efficacy and safety of 20, 000 U/kg for 2 hours (UK-2 h with the UK-12 h regime in selected PE patients. Methods A randomized trial involving 129 patients was conducted. Patients with acute PE were randomly assigned to receive either UK-12 h (n = 70, or UK-2 h (n = 59. The efficacy was determined by the improvement of right heart dysfunction and perfusion defect at 24 h and 14 d post UK treatment. The bleeding incidence, death rate and PE recurrence were also evaluated. Results Similarly significant improvements in right heart dysfunction and lung perfusion defects were observed in both groups. Overall bleeding incidents were low in both groups. Major bleeding directly associated with UK infusion occurred in one patient in the UK-2 h group and one in the UK-12 h group. Mortality rates were low, with one reported fatal recurrent in the UK-12 h group and none in the UK-2 h group. When the rate of bleeding, death and PE recurrence were compared separately in the hemodynamic instability and the massive anatomic obstruction subgroups, no significant difference was found. Conclusions The UK-2 h regimen exhibits similar efficacy and safety as the UK-12 h regimen for acute PE. Trial Registration Clinical trial registered with http://clinicaltrials.gov/ct2/show/NCT00799968 (Identifier: NCT 00799968

  18. Recombinant streptokinase vs hydrocortisone suppositories in acute hemorrhoids: A randomized controlled trial.

    Science.gov (United States)

    Hernández-Bernal, Francisco; Castellanos-Sierra, Georgina; Valenzuela-Silva, Carmen M; Catasús-Álvarez, Karem M; Martínez-Serrano, Osmany; Lazo-Diago, Odalys C; Bermúdez-Badell, Cimara H; Causa-García, José R; Domínguez-Suárez, Juan E

    2015-06-21

    To compare the efficacy and safety of recombinant streptokinase (rSK) vs hydrocortisone acetate-based suppositories in acute hemorrhoidal disease. A multicenter (11 sites), randomized (1:1:1), open, controlled trial with parallel groups was performed. All participating patients gave their written, informed consent. After inclusion, patients with acute symptoms of hemorrhoids were centrally randomized to receive, as outpatients, by the rectal route, suppositories of rSK 200000 IU of one unit every 8 h (first 3 units) and afterwards every 12 h until 8 administrations were completed (schedule A), one unit every 8 h until 6 units were completed (schedule B), or 25 mg hydrocortisone acetate once every 8 h up to a maximum of 24 administrations. Evaluations were performed at 3, 5, and 10 d post-inclusion. The main end-point was the 5(th)-day response (disappearance of pain and bleeding, and ≥ 70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were also evaluated. Groups were homogeneous with regards to demographic and baseline characteristics. Fifth day complete response rates were 156/170 (91.8%; 95%CI: 87.3-96.2), 155/170 (91.2%; 95%CI: 86.6%-95.7%), and 46/170 (27.1%; 95%CI: 20.1%-34.0%) with rSK (schedule A and B) and hydrocortisone acetate suppositories, respectively. These 64.6% and 63.9% differences (95%CI: 56.7%-72.2% and 55.7%-72.0%) were highly significant (P suppositories showed a significant advantage over a widely-used over-the-counter hydrocortisone acetate preparation for the treatment of acute hemorrhoidal illness, as well as having an adequate safety profile.

  19. Strengthening self-management improves treatment compliance and outcome in hepatitis B patients with decompensated cirrhosis treated with entecavir

    Directory of Open Access Journals (Sweden)

    CUI Yuhua

    2014-10-01

    Full Text Available ObjectiveTo investigate the effect of strengthening self-management on the treatment compliance and outcome in hepatitis B patients with decompensated cirrhosis treated with entecavir. MethodsA total of 120 hepatitis B patients with decompensated cirrhosis, who received antiviral therapy with entecavir in our hospital from January 2010 to January 2012, were randomly divided into control group (n=60 and intervention group (n=60. Both groups received routine nursing care; in addition, regular telephone follow-up was performed for the intervention group to provide guidance for the self-management during the comprehensive prevention and treatment of decompensated cirrhosis. The two groups were compared in terms of withdrawal rate, rehospitalization rate, hepatitis B virus (HBV DNA negative conversion rate, incidence of primary liver cancer, and mortality one year later. Continuous data were analyzed by t test, and categorical data by chi-square test or Fisher′s exact test. ResultsThe withdrawal rate and rehospitalization rate in the intervention group were 0 and 183%, respectively, versus 8.3% and 35% in the control group (P<0.05 for both. The HBV DNA negative conversion rate, incidence of primary liver cancer, and mortality in the intervention group were 90%, 3.3%, and 5.3%, versus 88.3%, 5%, and 6.7% in the control group (P>0.05 for all. ConclusionStrengthening self-management, as well as regular health education, can improve treatment compliance and promote recovery in hepatitis B patients with decompensated cirrhosis treated with entecavir.

  20. A Cluster-Randomized Trial of Decision Support Strategies for Reducing Antibiotic Use for 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

    2013-01-01

    Background National quality indicators show little change in the overuse of antibiotics for uncomplicated acute bronchitis. We compared the impact of two decision support strategies on antibiotic treatment of uncomplicated acute bronchitis. Methods We conducted a three-arm, cluster-randomized trial among 33 primary care practices belonging to an integrated health care system in central Pennsylvania. The printed intervention arm (n=11 practices) received decision support for acute cough illness through a print-based strategy, the computerized intervention group (n=11) received decision support through an electronic medical record-based strategy, and third group of practices (n=11) served as the control arm. Both intervention groups also received provider education and feedback on prescribing practices, and patient education brochures at check-in. Antibiotic prescription rates for uncomplicated acute bronchitis in the winter period (October 2009 – March 2010) following introduction of the intervention were compared with the previous three winter periods in an intent-to-treat analysis. Results Compared with the baseline period, the percentage of adolescents and adults prescribed antibiotics during the intervention period decreased at the printed (from 80.0% to 68.3%) and computerized 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 provider characteristics, and clustering of observations by provider and practice site, the differences for the intervention groups were statistically significant from control (control vs. printed P=0.003; control vs. computerized P=0.014) but no among themselves (printed vs. computerized P=0.67). Changes in total visits, proportion diagnosed as uncomplicated acute bronchitis and thirty-day return visit rates were similar between study groups. Conclusions Implementation of a decision support strategy for acute bronchitis can help reduce overuse

  1. 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

  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. Steroid treatment of acute graft versus host disease grade I: a randomized trial.

    Science.gov (United States)

    Bacigalupo, Andrea; Milone, Giuseppe; Crupi, Alessandra; Severino, Alessandro; Fagioli, Franca; Berger, Massimo; Santarone, Stella; Chiusolo, Patrizia; Sica, Simona; Mammoliti, Sonia; Sorasio, Roberto; Massi, Daniela; van Lint, Maria Teresa; Raiola, Anna Maria; Gualandi, Francesca; Selleri, Carmine; Sormani, Maria Pia; Signori, Alessio; Risitano, Antonio; Bonifazi, Francesca

    2017-09-29

    Patients with acute graft versus host disease (GvHD) grade I, were randomized, to an observation arm (n=85) or to a treatment arm (n=86), consisting of 6-methylprednisolone 1 mg/kg/day , after stratification for age and donor type. The primary end point was development of grade II-IV GvHD. The cumulative incidence of GvHD grade II-IV, was 50% in the observation and 33% in the treatment arm (p=0.005). However, grade III-IV GvHD was comparable (13% vs 10% respectively; p=0.6), and this was true for sibling and alternative donor transplants. Moderate/severe chronic GvHD was also comparable (17% vs 19%). In multivariate analysis, an early interval between transplant and randomization (< day +20) , was the only negative predictor of GvHD grade III-IV .Patients in the observation arm had less infectious bacterial episodes (12 vs 25, p=0.04), less severe infectious fungal episodes (0 vs 3; p=0.04), and less severe adverse events (3 vs 11 p=0.07). At 5 years, non relapse mortality was 20% (observation) vs 26% (treatment) (p=0.2), relapse related death 25% vs 21%, and actuarial survival was 51% vs 41% respectively (p=0.3). In multivariate analysis, advanced disease phase, older age and an early onset of GvHD, were significant negative predictors of survival, independent of the randomization arm. In conclusion, steroids treatment of acute GvHD grade I prevents progression to grade II but not to grade III-IV GvHD, and there is no effect on non relapse mortality and survival; patients treated with steroids, are at a higher risk of develping infections and have more adverse events. (This trial is registered as EUDTRACT 2008-000413-29). Copyright © 2017, Ferrata Storti Foundation.

  4. Autologous bone marrow transplantation in decompensated liver: Systematic review and meta-analysis.

    Science.gov (United States)

    Pankaj, Prasoon; Zhang, Qi; Bai, Xue-Li; Liang, Ting-Bo

    2015-07-28

    To evaluate the efficacy of autologous bone marrow mononuclear cell transplantation in decompensated liver disease. Medline, EMBASE, PubMed, Science Direct, and the Cochrane Library were searched for relevant studies. Retrospective case-control studies were included along with randomized clinical trials. Meta-analysis was performed in line with recommendations from the Cochrane Collaboration software review manager. Heterogeneity was assessed using a random-effects model. Four randomized controlled trials and four retrospective studies were included. Cell transplantation increased serum albumin level by 1.96 g/L (95%CI: 0.74-3.17; P = 0.002], 2.55 g/L (95%CI: 0.32-4.79; P = 0.03), and 3.65 g/L (95%CI: 0.76-6.54; P = 0.01) after 1, 3, and 6 mo, respectively. Patients who had undergone cell transplantation also had a lower level of total bilirubin [mean difference (MD): -1.37 mg/dL; 95%CI: -2.68-(-0.06); P = 0.04] after 6 mo. This decreased after 1 year when compared to standard treatment (MD: -1.26; 95%CI: -2.48-(-0.03); P = 0.04]. A temporary decrease in alanine transaminase and aspartate transaminase were significant in the cell transplantation group. However, after 6 mo treatment, patients who had undergone cell transplantation had a slightly longer prothrombin time (MD: 5.66 s, 95%CI: 0.04-11.28; P = 0.05). Changes in the model for end-stage liver disease score and Child-Pugh score were not statistically significant. Autologous bone marrow transplantation showed some benefits in patients with decompensated liver disease. However, further studies are still needed to verify its role in clinical treatment for end-stage liver disease.

  5. Erythromycin infusion prior to endoscopy for acute nonvariceal upper gastrointestinal bleeding: a pilot randomized controlled trial.

    Science.gov (United States)

    Na, Hee Kyong; Jung, Hwoon-Yong; Seo, Dong Woo; Lim, Hyun; Ahn, Ji Yong; Lee, Jeong Hoon; Kim, Do Hoon; Choi, Kee Don; Song, Ho June; Lee, Gin Hyug; Kim, Jin-Ho

    2017-03-28

    The aim of this study was to compare the effects of erythromycin infusion and gastric lavage in order to improve the quality of visualization during emergency upper endoscopy. We performed a prospective randomized pilot study. Patients presented with hematemesis or melena within 12 hours and were randomly assigned to the erythromycin group (intravenous infusion of erythromycin), gastric lavage group (nasogastric tube placement with gastric lavage), or erythromycin + gastric lavage group (both erythromycin infusion and gastric lavage). The primary outcome was satisfactory visualization. Secondary outcomes included identification of a bleeding source, the success rate of hemostasis, duration of endoscopy, complications related to erythromycin infusion or gastric lavage, number of transfused blood units, rebleeding rate, and bleeding-related mortality. A total of 43 patients were randomly assigned: 14 patients in the erythromycin group; 15 patients in the gastric lavage group; and 14 patients in the erythromycin + gastric lavage group. Overall satisfactory visualization was achieved in 81% of patients: 92.8% in the erythromycin group; 60.0% in the gastric lavage group; and 92.9% in the erythromycin + gastric lavage group, respectively (p = 0.055). The identification of a bleeding source was possible in all cases. The success rate of hemostasis, duration of endoscopy, and number of transfused blood units did not significantly differ between groups. There were no complications. Rebleeding occurred in three patients (7.0%). Bleeding-related mortality was not reported. Intravenous erythromycin infusion prior to emergency endoscopy for acute nonvariceal upper gastrointestinal bleeding seems to provide satisfactory endoscopic visualization.

  6. ROLE OF ORAL MONTELUKAST IN ACUTE ASTHMA EXACERBATIONS : A RANDOMIZED PLACEBO CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    Gaude

    2015-08-01

    Full Text Available 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. The present study was done to evaluate the clinical efficacy of oral Montelukast as an add on therapy to the usual standard therapy of acute attack of bronchial asthma. MATERIALS AND METHODS: A randomized single blinded controlled study was conducted in a tertiary car e teaching hospital. A total of 320 patients with age >18 years of acute exacerbations due to bronchial asthma were included in the study. The patients were randomized into two study and control groups. The study group patients received oral Montelukast (1 0mg once daily for 2 weeks, while the control group received a placebo. All the patients received standard therapy according to GINA guidelines. Improvements in lung function tests, clinical symptoms and relapse rates were monitored at baseline, at discha rge and at 2 weeks. Side effects profile was also monitored. RESULTS: A total of 255 patients were finally assessed. One hundred thirty patients belonged to study group and 125 in the control group. Baseline characteristics were similar and well matched in both the groups. Mean age was 39.9±15.8 years in study group and 42.8±12.8 in the control group and majority were female patients in both the groups. At the end of 2 weeks, it was observed that there were no significant improvements in FEV 1 and FVC as com pared to the control group. However, there was significant improvement in PEFR at 2 weeks (0.4 L/sec, 12% as compared to the control group (p <0.0376. Length of hospital stay was similar in both the groups. No serious adverse effects were noted during th e course of the study. CONCLUSIONS: In acute asthma exacerbations, the present study showed that additional administration of oral Montelukast resulted in significantly higher PEFR at 2 weeks as compared to the standard

  7. Randomized controlled study of icodextrin on the treatment of peritoneal dialysis patients during acute peritonitis.

    Science.gov (United States)

    Chow, Kai Ming; Szeto, Cheuk Chun; Kwan, Bonnie Ching Ha; Pang, Wing Fai; Ma, Terry; Leung, Chi Bon; Law, Man Ching; Li, Philip Kam-Tao

    2014-07-01

    The clinical benefits of using icodextrin during acute peritonitis in peritoneal dialysis are uncertain. On the premise that high glucose concentration might jeopardize the peritoneal defense during peritonitis, icodextrin administration during acute peritonitis could have the potential to improve the peritonitis outcome whilst improving ultrafiltration. We conducted a single-center, open-label, randomized controlled trial in which 53 adult continuous ambulatory peritoneal dialysis patients underwent randomization to receive either icodextrin or original glucose-based dialysis solution. The primary outcome measure was the peritoneal dialyzate white cell count on Day 3. Secondary outcome measures comprised the need of additional hypertonic exchanges, fluid control as denoted by changes in body weight, and the clinical outcome of peritonitis including 30-day and 120-day all-cause mortality. Between icodextrin and control treatment groups, there were no statistically significant differences in the peritoneal dialyzate white cell count on day (1829 versus 987/mm(3), P = 0.13). There was neither improvement in primary cure rate (31.8 versus 32.3%, P = 1.00), nor was there any change in 120-day mortality after icodextrin use (13.6 versus 12.9%, P = 1.00). However, requirement of hypertonic dialysis exchange was much more frequent in the control group than in those randomized to icodextrin (35.5 versus 0%, P = 0.001). Body weight did not change significantly in the icodextrin group, but body weight in the control group increased from 63.3 ± 14.5 kg at baseline to 64.2 ± 14.2 kg at Day 5 (P = 0.0002) and 65.2 ± 14.1 kg at Day 10 (P icodextrin achieved better ultrafiltration and fluid control during acute peritonitis complicating continuous ambulatory peritoneal dialysis, although we found no evidence of a worthwhile clinical benefit on peritonitis resolution. (ClinicalTrial.gov number, NCT0104446 [ClinicalTrial.gov].). © The Author 2014. Published by Oxford University

  8. 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.

  9. Spontaneous expulsive suprachoroidal hemorrhage caused by decompensated liver disease

    Directory of Open Access Journals (Sweden)

    Krishnagopal Srikanth

    2013-01-01

    Full Text Available Expulsive suprachoroidal hemorrhage can be surgical or spontaneous. Spontaneous expulsive suprachoroidal hemorrhage (SESCH is a rare entity. Most of the reported cases of SESCH were caused by a combination of corneal pathology and glaucoma. We are reporting a rare presentation of SESCH with no pre-existing glaucoma or corneal pathology and caused by massive intra- and peri-ocular hemorrhage due to decompensated liver disease.

  10. Lamivudine treatment for decompensated cirrhosis resulting from chronic hepatitis B.

    Science.gov (United States)

    Villeneuve, J P; Condreay, L D; Willems, B; Pomier-Layrargues, G; Fenyves, D; Bilodeau, M; Leduc, R; Peltekian, K; Wong, F; Margulies, M; Heathcote, E J

    2000-01-01

    The prognosis of decompensated cirrhosis resulting from chronic hepatitis B is poor, and the benefits of treatment with interferon are outweighed by serious side effects and by the risk of fatal exacerbation of disease activity. Lamivudine rapidly reduces hepatitis B virus (HBV)-DNA in serum to undetectable levels. We have treated 35 patients with chronic hepatitis B and decompensated cirrhosis with lamivudine 100 mg or 150 mg orally once daily. Pretreatment, all were positive for HBV-DNA in serum. Ten had Child-Pugh class B and 25 had Child-Pugh class C liver disease. Seven patients underwent liver transplantation within 6 months of treatment initiation, 5 patients died within 6 months, and 23 patients were treated for at least 6 months (mean = 19 months). In a majority of these 23 cases, there was a slow but marked improvement in liver function, which was most apparent after 9 months of treatment, with a decrease in serum bilirubin from 67 +/- 13 to 30 +/- 4 micromol/L (P decompensated HBV cirrhosis, but the long-term benefits remain uncertain.

  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. Topical corticosteroids in the treatment of acute sunburn - A randomized, double-blind clinical trial

    DEFF Research Database (Denmark)

    Faurschou, A.; Wulf, Hans Chr.

    2008-01-01

    Objective: To examine the effect of topical corticosteroid treatment on acute sunburn. Design: Randomized, double-blind clinical trial. Setting: University dermatology department. Patients: Twenty healthy volunteers with Fitzpatrick skin types I (highly sensitive, always burns easily, tans...... minimally) through III (sun-sensitive skin, sometimes burns, slowly tans to light brown). Intervention: Seven 34-cm(2) areas were marked on the upper aspect of the back of each participant. An untreated area was tested to determine UV sensitivity. Two areas were treated with excess amounts (2 mg/cm(2......) was determined by the following equation: SIF=MED(minimal erythema dose) on treated skin/MED on nontreated skin. An SIF greater than 1 indicated an effect of topical corticosteroids in sunburn relief. Results: The SIFs in the areas treated with either topical corticosteroid 30 minutes before UV-B exposure...

  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. Intranasal midazolam compared with intravenous diazepam in patients suffering from acute seizure: a randomized clinical trial.

    Science.gov (United States)

    Javadzadeh, Mohsen; Sheibani, Kourosh; Hashemieh, Mozhgan; Saneifard, Hedyeh

    2012-03-01

    Acute seizure attack is a stressful experience both for health care personnel and parents. These attacks might cause morbidity and mortality among patients, so reliable methods to control the seizure preferably at home should be developed. This study was performed to measure the time needed to control seizure attacks using intranasal midazolam compared to the common treatment (intravenous diazepam) and to evaluate its probable side effects. This study was conducted as a not blind randomized clinical trial among 60 patients coming to Imam Ali Hospital, Zahedan, Iran. The patients were 2 months to 15 years old children coming to our emergency department suffering from an acute seizure episode. Intranasal midazolam was administered 0.2 mg/kg equally dropped in both nostrils for case group and intravenous diazepam was administered 0.3mg/kg via IV line for control group. After both treatments the time needed to control the seizure was registered by the practitioner. Pulse rate and O2 saturation were recorded at patients' entrance and in minutes 5 and 10 after drug administration. The time needed to control seizure using intranasal midazolam (3.16±1.24) was statistically shorter than intravenous diazepam (6.42±2.59) if the time needed to establish IV line in patients treated by intravenous diazepam is taken into account (P<0.001). The readings for O2 saturation or heart rate did not indicate a statistically significant difference between two groups of patients either at entrance or 5 and 10 minutes after drug administration. Considering the shorter time needed to control acute seizure episodes compared to intravenous diazepam and its safety record, intranasal midazolam seems to be a good candidate to replace diazepam, as the drug of choice, in controlling this condition.

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

    Institute of Scientific and Technical Information of China (English)

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

    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 Ioperamide in the outpatient treatment of acute diarrhea in adults.METHODS: A two-center, randomized, parallel-group,single-blind study was carried out to compare the efficacy,tolerability, and safety of racecadotril (100 mg thrics daily)and Ioperamide (2.0 mg 2 twics 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.RESULTS: The clinical success rates for these antidiarrheal treatments were 95.7% and 92.0% for racecadotril and Ioperamide respectively. Patients on racecadotril had a median duration of diarrhea of 19.5 h compared with a median of 13 h for patients on Ioperamide.Rapid improvement in anal burn and nausea was found for each drug. However, more patients on Ioperamide 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.CONCLUSION: Racecadotril and Ioperamide are rapid,equally effective treatments for acute diarrhea in adults,but Ioperamide treatment is associated with a higher incidence of treatment-related constipation.

  16. Lifestyle referral assessment in an acute cardiology setting: study protocol for a randomized controlled feasibility trial.

    Science.gov (United States)

    Hill, Kate M; Walwyn, Rebecca E A; Camidge, Diana C; Meads, David M; Murray, Jenni Y; Reynolds, Greg; Farrin, Amanda J; House, Allan O

    2013-07-11

    Lifestyle and behaviour change are important factors in the prevention of cardiovascular disease and reduction of premature mortality. Public health initiatives have focused on opportunities for healthcare staff to deliver lifestyle advice routinely in primary and secondary care but there is no consistent approach to onward referrals and the rate of uptake of advice remains low. We do not know if advice is more effective in supporting behaviour change when a systematic approach is taken that includes identification of barriers to change, directing patients toward services, referral to services, and feedback on outcome. This is a single-centre, randomized, unblinded feasibility trial in an acute hospital setting which aims to assess the feasibility of a definitive trial and provide proof of concept for the systematic delivery of individualized lifestyle advice in patients managed through an acute cardiology in-patient service.Patients will be recruited before discharge and randomized to two groups. A control group will receive the usual lifestyle assessment and referral, while an intervention group will receive the usual assessment plus the new individualized lifestyle assessment and referral. The new assessment will inform assignment of each patient to one of three categories based on personal barriers to change. Patients may be referred to a formal lifestyle-change programme, through the 'Leeds Let's Change' website, or they may be guided in self-management, using goal setting, or they may be assigned to a 'deferment' category, for reassessment at follow-up. These latter patients will be given a contact card for the 'Leeds Let's Change' service. Lifestyle change is an important mechanism for improving health and wellbeing across the population but there are widely acknowledged difficulties in addressing lifestyle factors with patients and supporting behaviour change. A systematic approach to assessment would facilitate audit and provide an indicator of the quality

  17. Acute effects of massage or active exercise in relieving muscle soreness: randomized controlled trial.

    Science.gov (United States)

    Andersen, Lars L; Jay, Kenneth; Andersen, Christoffer H; Jakobsen, Markus D; Sundstrup, Emil; Topp, Robert; Behm, David G

    2013-12-01

    Massage is commonly believed to be the best modality for relieving muscle soreness. However, actively warming up the muscles with exercise may be an effective alternative. The purpose of this study was to compare the acute effect of massage with active exercise for relieving muscle soreness. Twenty healthy female volunteers (mean age 32 years) participated in this examiner-blind randomized controlled trial (ClinicalTrials.gov NCT01478451). The participants performed eccentric contractions for the upper trapezius muscle on a Biodex dynamometer. Delayed onset muscle soreness (DOMS) presented 48 hours later, at which the participants (a) received 10 minutes of massage of the trapezius muscle or (b) performed 10 minutes of active exercise (shoulder shrugs 10 × 10 reps) with increasing elastic resistance (Thera-Band). First, 1 treatment was randomly applied to 1 shoulder while the contralateral shoulder served as a passive control. Two hours later, the contralateral resting shoulder received the other treatment. The participants rated the intensity of soreness (scale 0-10), and a blinded examiner took measures of pressure pain threshold (PPT) of the upper trapezius immediately before treatment and 0, 10, 20, and 60 minutes after treatment 48 hours posteccentric exercise. Immediately before treatment, the intensity of soreness was 5.0 (SD 2.2) and PPT was 138 (SD 78) kPa. In response to treatment, a significant treatment by time interaction was found for the intensity of soreness (p < 0.001) and PPT (p < 0.05). Compared with control, both active exercise and massage significantly reduced the intensity of soreness and increased PPT (i.e., reduced pain sensitivity). For both types of treatment, the greatest effect on perceived soreness occurred immediately after treatment, whereas the effect on PPT peaked 20 minutes after treatment. In conclusion, active exercise using elastic resistance provides similar acute relief of muscle soreness as compared with that using massage

  18. Effect of N-acetylcysteine on inflammation biomarkers in pediatric acute pyelonephritis: a randomized controlled trial.

    Science.gov (United States)

    Allameh, Zahra; Karimi, Abdollah; Rafiei Tabatabaei, Seddigheh; Sharifian, Mostafa; Salamzadeh, Jamshid

    2015-11-01

    This study was designed to investigate the effect of N-acetylcysteine (NAC), as a potent and safe antioxidant, on inflammatory biomarkers of acute pyelonephritis in pediatric patients. Children (pyelonephritis were recruited in a randomized placebo-controlled trial. They were randomly allocated to 2 groups and recieved placebo or NAC effervescent tablets with daily dose based on their weight, for 5 days. The children were evaluated for serum procalcitonin level, leukocyte count, C-reactive protein (CRP), serum creatinine, and clinical symptoms on the 1st and the 5th days. Seventy patients, 35 in each group, with a mean age of 5.54 ± 3.10 years completed the study. There was no significant difference between the two groups in the amount of changes in procalcitonin levels after 5 days (P = .90). Within-group analysis confirmed CRP reduction in both groups (P < .001); however, between-group analysis did not show significant difference in CRP reductions, either (P = .65). No significant differences were found between the two groups in the day of resolving pyuria (P = .46), day of resolving bacteriuria (P = .81), or reductions in leukocyte count (P = .64) and neutrophil count (P = .49). A short period of NAC administration with the recommended doses could not lead to a significant decrease in inflammation biomarkers. Studies on higher doses and longer duration of NAC administration along with evaluation of the long-term effects of the intervention by tools such as renal scntigraphy are suggested.

  19. 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

  20. Centers for Medicare and Medicaid Services' readmission reports inaccurately describe an institution's decompensated heart failure admissions.

    Science.gov (United States)

    Cox, Zachary L; Lai, Pikki; Lewis, Connie M; Lenihan, Daniel J

    2017-09-01

    Hospitals typically use Center for Medicare and Medicaid Services' (CMS) Hospital Readmission Reduction Program (HRRP) administrative reports as the standard of heart failure (HF) admission quantification. We aimed to evaluate the HF admission population identified by CMS HRRP definition of HF hospital admissions compared with a clinically based HF definition. We evaluated all hospital admissions at an academic medical center over 16 months in patients with Medicare fee-for service benefits and age ≥65 years. We compared the CMS HRRP HF definition against an electronic HF identification algorithm. Admissions identified solely by the CMS HF definition were manually reviewed by HF providers. Admissions confirmed with having decompensated HF as the primary problem by manual review or by the HF ID algorithm were deemed "HF positive," whereas those refuted were "HF negative." Of the 1672 all-cause admissions evaluated, 708 (42%) were HF positive. The CMS HF definition identified 440 admissions: sensitivity (54%), specificity (94%), positive predictive value (87%), negative predictive value (74%). The CMS HF definition missed 324 HF admissions because of inclusion/exclusion criteria (15%) and decompensated HF being a secondary diagnosis (85%). The CMS HF definition falsely identified 56 admissions as HF. The most common admission reasons in this cohort included elective pacemaker or defibrillator implantations (n = 13), noncardiac dyspnea (n = 9), left ventricular assist device complications (n = 8), and acute coronary syndrome (n = 6). The CMS HRRP HF report is a poor representation of an institution's HF admissions because of limitations in administrative coding and the HRRP HF report inclusion/exclusion criteria. © 2017 Wiley Periodicals, Inc.

  1. Predictors of fifty days in-hospital mortality in decompensated cirrhosis patients with spontaneous bacterial peritonitis

    Institute of Scientific and Technical Information of China (English)

    Chinmaya; Kumar; Bal; Ripu; Daman; Vikram; Bhatia

    2016-01-01

    AIM: To determine the predictors of 50 d in-hospital mortality in decompensated cirrhosis patients with spontaneous bacterial peritonitis(SBP).METHODS: Two hundred and eighteen patients admitted to an intensive care unit in a tertiary care hospital between June 2013 and June 2014 with the diagnosis of SBP(during hospitalization) and cirrhosis were retrospectively analysed. SBP was diagnosed by abdominal paracentesis in the presence of polymorphonuclear cell count ≥ 250 cells/mm3 in the peritoneal fluid. Student’s t test, multivariate logistic regression, cox proportional hazard ratio(HR), receiver operating characteristics(ROC) curves and Kaplan-Meier survival analysis were utilized for statistical analysis. Predictive abilities of several variables identified by multivariate analysis were compared using the area under ROC curve. P < 0.05 were considered statistical significant. RESULTS: The 50 d in-hospital mortality rate attributable to SBP is 43.11%(n = 94). Median survival duration for those who died was 9 d. In univariate analysis acute kidney injury(AKI), hepatic encephalopathy, septic shock, serum bilirubin, international normalized ratio, aspartate transaminase, and model for end-stage liver disease- sodium(MELD-Na) were significantly associated with in- hospital mortality in patients with SBP(P ≤ 0.001). Multivariate coxproportional regression analysis showed AKI(HR = 2.16, 95%CI: 1.36-3.42, P = 0.001) septic shock(HR = 1.73, 95%CI: 1.05-2.83, P = 0.029) MELD-Na(HR = 1.06, 95%CI: 1.02-1.09, P ≤ 0.001) was significantly associated with 50 d in-hospital mortality. The prognostic accuracy for AKI, MELD-Na and septic shock was 77%, 74% and 71% respectively associated with 50 d inhospital mortality in SBP patients.CONCLUSION: AKI, MELD-Na and septic shock were predictors of 50 d in-hospital mortality in decompensated cirrhosis patients with SBP.

  2. The effects of experimentally manipulated social status on acute eating behavior: A randomized, crossover pilot study.

    Science.gov (United States)

    Cardel, M I; Johnson, S L; Beck, J; Dhurandhar, E; Keita, A D; Tomczik, A C; Pavela, G; Huo, T; Janicke, D M; Muller, K; Piff, P K; Peters, J C; Hill, J O; Allison, D B

    2016-08-01

    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 ≤30kg/m(2)). 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 and

  3. 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.

  4. 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...

  5. 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...

  6. 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...

  7. 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.

  8. 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

  9. Representation of elderly persons and women in published randomized trials of acute coronary syndromes.

    Science.gov (United States)

    Lee, P Y; Alexander, K P; Hammill, B G; Pasquali, S K; Peterson, E D

    2001-08-08

    Elderly persons and women were underrepresented in randomized controlled trials (RCTs) prior to 1990. Since then, efforts have been made to correct these biases, but their effect is unclear. To determine whether the percentage of elderly persons and women in published clinical trials of acute coronary syndromes has increased and how this enrollment compared with disease prevalence. The MEDLINE and Cochrane databases were searched for English-language articles from January 1966 to March 2000 regarding myocardial infarction, unstable angina, or acute coronary syndromes. Additional data sources included meta-analyses, review articles, and cardiology textbooks. Estimates of community-based myocardial infarction rates came from the National Registry of Myocardial Infarction and the Worcester Heart Study. Published RCTs of acute coronary syndrome patients were included and trials enrolling 50 patients or fewer, those without clinical end points, papers published in a language other than English, and unpublished manuscripts were excluded. Of 7645 studies identified, 593 RCTs were selected for review. The RCTs were abstracted by 2 of the authors for year of publication, source of support (ie, funding), pharmacotherapy, study phase, number of study sites, trial location, number of patients, mean age of the study population, and any age exclusion criteria for enrollment. The number of published RCTs with explicit age exclusions has declined from 58% during 1966-1990 to 40% during 1991-2000. Trial enrollment of patients aged 75 years or older increased from 2% for studies published during 1966-1990 to 9% during 1991-2000, but remains well below their representation among all patients with myocardial infarction (37%) in the United States. Enrollment of women has risen from 20% for studies published between 1966-1990 to 25% during 1991-2000, but remains well below their proportion of all patients with myocardial infarction (43%) in the United States. Attempts at making

  10. Efficacy of Two Streptokinase Formulations in Acute Myocardial Infarction: A Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Navid Paydari

    2009-03-01

    Full Text Available Background: We sought to evaluate the efficacy and safety of the different trade forms of streptokinase available in our country, namely Heberkinasa (Heberbiotec, Havana, Cuba and Streptase (Aventis Behring GmbH, Marburg, Germany. Methods: We conducted a double-blind randomized clinical trial to compare the two streptokinase formulations, i.e. Heberkinasa (HBK or Streptase (STP, in patients with acute myocardial infarction who needed thrombolysis. Thrombolysis success was evaluated angiographically and/or clinically. Clinical follow-up was done 30 days after thrombolysis. Results: We randomly allocated 221 patients with a mean age of 56.9±10.8 years (males: 88.2% to HBK (n=119 and STP (n=102 groups. Baseline clinical and demographic characteristics were similar between the two groups, and the two groups were not significantly different in terms of door-to-needle and pain-to-needle intervals. The rate of complications was not significantly different between the groups (44.1% [HBK] vs. 42% [STP]. Angiography was done for 158 (71.5 % patients in the first 24 hours (9% and in the first 72 hours (38.8% after thrombolysis. Lesion morphology and lesion/patient ratio were not significantly different between the two groups (1.87[HBK] vs. 1.67[STP]. The two groups were similar with respect to angiographic patency rate (67.5% [HBK] vs. 67.6% [STP]. The study groups were also similar as regards clinical outcome and complications of both streptokinase formulations. Conclusion: The present study demonstrated that Heberkinasa is as effective and as safe as a standard streptokinase, namely Streptase, in a clinical setting.

  11. Effect of Intravenous Iron Supplementation on Acute Mountain Sickness: A Preliminary Randomized Controlled Study.

    Science.gov (United States)

    Ren, Xuewen; Zhang, Qiuying; Wang, Hao; Man, Chunyan; Hong, Heng; Chen, Li; Li, Tanshi; Ye, Ping

    2015-07-15

    The aim of this study was to assess the role of intravenous iron supplementation in the prevention of AMS. This was a randomized, double-blinded, placebo-controlled study. Forty-one (n=41) healthy Chinese low-altitude inhabitants living in Beijing, China (altitude of about 50 meters) were randomly assigned into intravenous iron supplementation (ISS group; n=21) and placebo (CON group; n=20) groups. Participants in the ISS group received iron sucrose supplement (200 mg) before flying to Lhasa, China (altitude of 4300 meters). Acute mountain sickness (AMS) severity was assessed with the Lake Louise scoring (LLS) system within 5 days after landing on the plateau (at high altitude). Routine check-ups, clinical biochemistry, and blood tests were performed before departure and 24 h after arrival. A total of 38 participants completed the study (ISS group: n=19; CON group: n=19). The rate of subjects with AMS (LLS>3) was lower in the ISS group compared with the CON group, but no significant differences were obtained (P>0.05). There were no differences in patients' baseline characteristics. The physiological indices were similar in both groups except for serum iron concentrations (19.44±10.02 vs. 85.10±26.78 μmol/L) and transferrin saturation rates (28.20±12.14 vs. 68.34±33.12%), which were significantly higher in the ISS group (Piron supplementation has no significant protective effect on AMS in healthy Chinese low-altitude inhabitants.

  12. Acute effects of aerosolized iloprost in COPD related pulmonary hypertension - a randomized controlled crossover trial.

    Science.gov (United States)

    Boeck, Lucas; Tamm, Michael; Grendelmeier, Peter; Stolz, Daiana

    2012-01-01

    Inhaled iloprost potentially improves hemodynamics and gas exchange in patients with chronic obstructive pulmonary disease (COPD) and secondary pulmonary hypertension (PH). To evaluate acute effects of aerosolized iloprost in patients with COPD-associated PH. A randomized, double blind, crossover study was conducted in 16 COPD patients with invasively confirmed PH in a single tertiary care center. Each patient received a single dose of 10 µg iloprost (low dose), 20 µg iloprost (high dose) and placebo during distinct study-visits. The primary end-point of the study was exercise capacity as assessed by the six minute walking distance. Both iloprost doses failed to improve six-minute walking distance (p = 0.36). Low dose iloprost (estimated difference of the means -1.0%, p = 0.035) as well as high dose iloprost (-2.2%, piloprost was associated with reduced peak oxygen consumption (-76 ml/min, p = 0.002), elevated partial pressure of carbon dioxide (0.27 kPa, p = 0.040) and impaired ventilation during exercise (-3.0l/min, piloprost inhalation in patients with COPD-associated mild to moderate PH is very unlikely. Controlled-Trials.com ISRCTN61661881.

  13. 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.

  14. 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....

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

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    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

  16. 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....

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

    DEFF Research Database (Denmark)

    Kavli, M; Strøm, T; Carlsson, M;

    2012-01-01

    with the Child-Pugh score. METHODS: A single-centre retrospective cohort analysis was conducted in a university-affiliated ICU. Eighty-seven adult patients with decompensated liver alcoholic cirrhosis were admitted from January 2007 to January 2010. RESULTS: The patients were severely ill with median scores......: 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......, SAPS II, and SOFA were better at predicting mortality than the Child-Pugh score. With three or more organ failures, the ICU mortality was > 90%. APACHE II > 30, SAPS II > 60, and SOFA at day 1 > 12 were all associated with a mortality of > 90%. Referral criteria of patients suffering from decompensated...

  18. Human umbilical cord mesenchymal stem cells improve liver function and ascites in decompensated liver cirrhosis patients.

    Science.gov (United States)

    Zhang, Zheng; Lin, Hu; Shi, Ming; Xu, Ruonan; Fu, Junliang; Lv, Jiyun; Chen, Liming; Lv, Sa; Li, Yuanyuan; Yu, Shuangjie; Geng, Hua; Jin, Lei; Lau, George K K; Wang, Fu-Sheng

    2012-03-01

    Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, mesenchymal stem cell (MSC) transfusion has been shown to lead to the regression of liver fibrosis in mice and humans. This study examined the safety and efficacy of umbilical cord-derived MSC (UC-MSC) in patients with decompensated LC. A total of 45 chronic hepatitis B patients with decompensated LC, including 30 patients receiving UC-MSC transfusion, and 15 patients receiving saline as the control, were recruited; clinical parameters were detected during a 1-year follow-up period. No significant side-effects and complications were observed in either group. There was a significant reduction in the volume of ascites in patients treated with UC-MSC transfusion compared with controls (P decompensated LC. UC-MSC transfusion, therefore, might present a novel therapeutic approach for patients with decompensated LC.

  19. Current and Future Percutaneous Strategies for the Treatment of Acute and Chronic Heart Failure.

    Science.gov (United States)

    Amat-Santos, Ignacio J; Varela-Falcón, Luis H; Abraham, William T

    2017-05-01

    The prevalence of heart failure (HF) has risen in parallel with improved survival in patients after a myocardial infarction and an aging population worldwide. In recent years, new percutaneous therapies have been developed to complement current established treatments for acute/decompensated and chronic HF and minimize risks. In acute presentations, the failure of medical treatment is no longer the end of the road in refractory circulatory shock; the use of mechanical circulatory support devices may be the next milestone in well-resourced health settings. Although evidence in this area is difficult to generate, research networks can facilitate the volume and quality of data needed to further augment the clinician's knowledge. Pulsatile (intra-aortic balloon pump), axial continuous (Impella), or centrifugal continuous pumps (TandemHeart; HeartMate PHP) together with percutaneously implanted extracorporeal membrane oxygenation are radically changing the prognosis of acute HF. Newer percutaneous therapies for chronic HF are based on attractive hypotheses, including left atrial decompression with shunting devices, left ventricle restoration through partitioning devices, or pressure-guided implantable therapies that may help to promptly treat decompensations. To date, only the last has been proved effective in a randomized study. Therefore, thorough research is still needed in this dynamic and promising field. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  20. 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

  1. A double-blind, randomized, multicenter, Italian study of frovatriptan versus rizatriptan for the acute treatment of migraine

    OpenAIRE

    Savi, Lidia; Omboni, Stefano; Lisotto, Carlo; Zanchin, Giorgio; Ferrari, Michel D.; Zava, Dario; Pinessi, Lorenzo

    2010-01-01

    The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1–3 attacks. The study had a multicenter, randomized, double-blind, cross-over design, with treatment pe...

  2. Safety and efficacy of vitamin-based antioxidant therapy in patients with severe acute pancreatitis: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dipika Bansal

    2011-01-01

    Full Text Available Background/Aim: Oxidative stress plays a major role in the pathogenesis of pancreatitis. Antioxidant therapy in the form of high-dose vitamin has been used for the treatment of severe acute pancreatitis with equivocal results. We wished to evaluate the efficacy and safety of antioxidant (vitamin A, vitamin C, vitamin E therapy in patients with severe acute pancreatitis. Setting and design: This was a single-center, prospective, randomized, open-label with blinded endpoint assessment study of antioxidant therapy, conducted in the emergency department attached to our hospital. Materials and Methods: Thirty-nine patients with severe acute pancreatitis were randomly assigned to antioxidant treatment group (n=19 or a control group (n=20 within 96 hours of developing symptoms. Patients in the antioxidant group received antioxidants (vitamin A, vitamin E, vitamin C in addition to the standard treatment provided to both the groups for a period of 14 days. The primary outcome variable was presence of organ dysfunction at day 7. The secondary outcome variables were length of hospital stay, multiorgan dysfunction (MODS at day 7, recovery at the end of 4 weeks, complications, and mortality. The change in markers of oxidative stress from baseline was also measured. Results: We demonstrated no significant difference in organ dysfunction (P=1.0, MODS (P=0.8, and length of hospital stay (P=0.29 between the two groups. All the patients survived in the antioxidant-treated group, whereas two patients died in the control group. The change in the levels of malondialdehyde, superoxide dismutase, and reduced glutathione were not significantly different in the two groups at day 7. Univariate analysis showed marginal benefit with antioxidant treatment (P=0.034 in patients with severe acute pancreatitis. Conclusions: This randomized study demonstrates that there is no significant benefit from antioxidant therapy in patients with established severe acute pancreatitis.

  3. 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.

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

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    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

  5. Acute effects of aerosolized iloprost in COPD related pulmonary hypertension - a randomized controlled crossover trial.

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    Lucas Boeck

    Full Text Available BACKGROUND: Inhaled iloprost potentially improves hemodynamics and gas exchange in patients with chronic obstructive pulmonary disease (COPD and secondary pulmonary hypertension (PH. OBJECTIVES: To evaluate acute effects of aerosolized iloprost in patients with COPD-associated PH. METHODS: A randomized, double blind, crossover study was conducted in 16 COPD patients with invasively confirmed PH in a single tertiary care center. Each patient received a single dose of 10 µg iloprost (low dose, 20 µg iloprost (high dose and placebo during distinct study-visits. The primary end-point of the study was exercise capacity as assessed by the six minute walking distance. RESULTS: Both iloprost doses failed to improve six-minute walking distance (p = 0.36. Low dose iloprost (estimated difference of the means -1.0%, p = 0.035 as well as high dose iloprost (-2.2%, p<0.001 significantly impaired oxygenation at rest. Peak oxygen consumption and carbon dioxide production differed significantly over the three study days (p = 0.002 and p = 0.003, accordingly. As compared to placebo, low dose iloprost was associated with reduced peak oxygen consumption (-76 ml/min, p = 0.002, elevated partial pressure of carbon dioxide (0.27 kPa, p = 0.040 and impaired ventilation during exercise (-3.0l/min, p<0.001. CONCLUSIONS: Improvement of the exercise capacity after iloprost inhalation in patients with COPD-associated mild to moderate PH is very unlikely. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN61661881.

  6. 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.

  7. Análise de custos do tratamento de episódios de descompensação aguda de insuficiência cardíaca: levosimendan versus dobutamina Cost analysis of the treatment of acute decompensated heart failure: levosimendan versus dobutamine

    Directory of Open Access Journals (Sweden)

    Mucio Tavares Oliveira Jr

    2005-07-01

    Full Text Available OBJETIVO: Verificar se o tratamento com levosimendan seria mais dispendioso que o usual com dobutamina, uma vez que o preço dos medicamentos não representa a maior despesa no tratamento da descompensação cardíaca. MÉTODOS: Comparou-se o custo do tratamento de 18 pacientes hospitalizados devido a descompensação cardíaca, 9 tratados com dobutamina (grupo dobuta e 9 com levosimendan (grupo levo. Os grupos foram semelhantes quanto à idade, sexo, classe funcional e função cardíaca. RESULTADOS: O custo do tratamento foi semelhante para os dois grupos. No grupo levo as despesas com medicamentos foram maiores, mas as relativas ao período de terapia intensiva e do material empregado foram menores. Levo - medicamentos: R$ 5.414,00; materiais: R$ 399,90; diárias hospitalares: R$ 5.061,20; serviços profissionais: R$ 3.241,80; final: R$ 14.117,00. Dobuta - medicamentos: R$ 2.320,10; materiais: R$ 1.665,70; diárias hospitalares: R$ 6.261,90; serviços profissionais: R$ 3.894,30; final: R$ 14.142,00. CONCLUSÃO: Apesar do preço mais elevado da droga, o custo global do tratamento foi semelhante para os pacientes tratados com dobutamina ou levosimendan. O paciente tratado com levosimendan permaneceu menos tempo em terapia intensiva.OBJECTIVE: To assess whether the treatment with levosimendan is more expensive than the usual one with dobutamine, since price of medications does not usually represent the greatest expense in the treatment of cardiac decompensation. METHODS: The cost of treatment of 18 inpatients with cardiac decompensation, 9 of which treated with dobutamine (dobuta group and 9 with levosimendan (levo group, was compared. Groups were similar concerning age, sex, functional class and cardiac function. RESULTS: Treatment costs were similar for both groups. In the levo group, the costs with the drug were higher than in the dobuta group, but those related to the length of stay in intensive care unit and to the material used during

  8. [A rare case of thalassemia concomitant with chronic decompensated tonsillitis].

    Science.gov (United States)

    Izvin, A I; Kuznetsova, N E; Siniakov, A Iu

    2014-01-01

    The present paper reports a rare combination of Cooley's disease (thalassemia B) and the decompensated variant of chronic tonsillitis in a 14-year old girl. The patient presented with the severe form of hypochromic anemia and degenerative changes of erythrocytes. She was treated by means of bilateral tonsillectomy associated with the high risk of postoperative hemorrhage. In the preoperative period, the child received drop intravenous infusion of tranexam at a dose of 15 mg/kg body weight together with hemostatic agents. Hemorrhage during the surgical intervention was stopped by pressing tampons impregnated with tranexamic acid known to exert local and systemic hemostatic and antifibrinolytic action. The patient was discharged from the hospital for the further treatment of the primary disease.

  9. 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.

  10. 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 suppleme

  11. 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.

  12. A randomized controlled trial on early physiotherapy intervention versus usual care in acute care unit for elderly: potential benefits in light of dietary intakes.

    NARCIS (Netherlands)

    Blanc-Bisson, C.; Dechamps, A.A.; Gouspillou, G.; Dehail, P.; Bourdel-Marchasson, I.

    2008-01-01

    OBJECTIVE: To evaluate effects of early intensive physiotherapy during acute illness on post hospitalization activity daily living autonomy (ADL). DESIGN: Prospective randomized controlled trial of intensive physiotherapy rehabilitation on day 1 to 2 after admission until clinical stability or usual

  13. 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...

  14. 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 t

  15. 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

  16. 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

    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 treat......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 supervised counseling and exercise program.Methods/design: 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......, 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...

  17. Lumiracoxib for acute postoperative dental pain: a systematic review of randomized clinical trials

    OpenAIRE

    Ricardo Carvalho Lopes Silva; Rachel Riera; Humberto Saconato

    2011-01-01

    CONTEXT AND OBJECTIVE: Lumiracoxib is an anti-inflammatory drug that has been used to treat acute dental pain, mainly in postsurgical settings, in which the greatest levels of pain and discomfort are experienced during the first 24 hours. This study aimed to assess the efficacy and safety of lumiracoxib for treating acute postsurgical dental pain. DESIGN AND SETTING: Systematic review developed at the Brazilian Cochrane Centre, Universidade Federal de São Paulo (UNIFESP). METHODS: An electron...

  18. 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): Probot-assisted treatment on hand 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.

  19. Combined MELD and blood lipid level in evaluating the prognosis of decompensated cirrhosis

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    AIM: To evaluate the prognostic value of the combined model for end-stage liver disease (MELD) and blood lipid level in patients with decompensated cirrhosis. METHODS: A total of 198 patients with decompensated cirrhosis were enrolled into the study. The values of triglyceride (TG), cholesterol (TC), high density lipoproteins (HDL) and low density lipoprotein (LDL) of each patient on the fi rst day of admission were retrieved from the medical records, and MELD was calculated. All the patients were followed ...

  20. Hepatic decompensation with sofosbuvir plus simeprevir in a patient with Child-Pugh B compensated cirrhosis.

    Science.gov (United States)

    Soriano, Vincent; Barreiro, Pablo; de Mendoza, Carmen; Peña, José M

    2016-01-01

    A 75-year-old male with compensated Child-Pugh B cirrhosis initiated sofosbuvir plus simeprevir, and developed hepatic decompensation and died a few days thereafter. High exposure to simeprevir leading to hepatotoxicity most likely explained this fatal outcome. This observation, along with similar cases recently reported in the literature, should raise awareness of the potential for decompensation in patients with advanced cirrhosis treated with simeprevir.

  1. 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 antibiotic therapy for uncomplicated appendicitis incurred lower costs than those who had surgery. © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

  2. Feasibility and preliminary effectiveness of ice therapy in patients with an acute tear in the gastrocnemius muscle: A pilot randomized controlled trial

    NARCIS (Netherlands)

    Prins, J.C.M.; Stubbe, J.H.; Meeteren, N.L.U. van; Scheffers, F.A.; Dongen, M.C.J.M. van

    2011-01-01

    Objective: To investigate the feasibility of a randomized controlled trial and the preliminary effectiveness of ice therapy in the acute phase of a gastrocnemius tear for the quality of functional recovery. Design: A pilot version of an intended prospective randomized controlled clinical trial was

  3. Randomized comparative study of moxalactam and cefazolin in the treatment of acute urinary tract infections in adults.

    OpenAIRE

    Lea, A.S.; Sudan, A W; Wood, B A; Gentry, L O

    1982-01-01

    Eighty-nine patients with clinical and laboratory evidence of acute urinary tract infection were randomized to therapy with either moxalactam (500 mg) or cefazolin (1 g) every 12 h. Escherichia coli was the predominant pathogen in both groups (92.6 versus 90.2%). Therapy was continued for 3 days after the patient defervesced. The minimum hospital stay was 5 days. Sequential urine cultures were obtained on day 3, at discharge, and 5 to 10 days after the cessation of therapy. THe average durati...

  4. 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 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 controlled trial of a “single-shot” of cognitive

  5. 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 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.

  6. 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...

  7. NOR-SASS (Norwegian Sonothrombolysis in Acute Stroke Study): Randomized Controlled Contrast-Enhanced Sonothrombolysis in an Unselected Acute Ischemic Stroke Population.

    Science.gov (United States)

    Nacu, Aliona; Kvistad, Christopher E; Naess, Halvor; Øygarden, Halvor; Logallo, Nicola; Assmus, Jörg; Waje-Andreassen, Ulrike; Kurz, Kathinka D; Neckelmann, Gesche; Thomassen, Lars

    2017-02-01

    The NOR-SASS (Norwegian Sonothrombolysis in Acute Stroke Study) aimed to assess effect and safety of contrast-enhanced ultrasound treatment in an unselected acute ischemic stroke population. Patients treated with intravenous thrombolysis within 4.5 hours after symptom onset were randomized 1:1 to either contrast-enhanced sonothrombolysis (CEST) or sham CEST. A visible arterial occlusion on baseline computed tomography angiography was not a prerequisite for inclusion. Pulse-wave 2 MHz ultrasound was given for 1 hour and contrast (SonoVue) as an infusion for ≈30 minutes. Magnetic resonance imaging and angiography were performed after 24 to 36 hours. Primary study end points were neurological improvement at 24 hours defined as National Institutes of Health Stroke Scale score 0 or reduction of ≥4 National Institutes of Health Stroke Scale points compared with baseline National Institutes of Health Stroke Scale and favorable functional outcome at 90 days defined as modified Rankin scale score 0 to 1. A total of 183 patients were randomly assigned to either CEST (93 patient) or sham CEST (90 patients). The rates of symptomatic intracerebral hemorrhage, asymptomatic intracerebral hemorrhage, or mortality were not increased in the CEST group. Neurological improvement at 24 hours and functional outcome at 90 days was similar in the 2 groups both in the intention-to-treat analysis and in the per-protocol analysis. CEST is safe among unselected ischemic stroke patients with or without a visible occlusion on computed tomography angiography and with varying grades of clinical severity. There was, however, statistically no significant clinical effect of sonothrombolysis in this prematurely stopped trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01949961. © 2016 The Authors.

  8. Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke : A Randomized Clinical Trial

    NARCIS (Netherlands)

    Fransen, Puck S S; Berkhemer, Olvert A; Lingsma, Hester F; Beumer, Debbie; van den Berg, Lucie A; Yoo, Albert J; Schonewille, Wouter J; Vos, Jan Albert; Nederkoorn, Paul J; Wermer, Marieke J H; van Walderveen, Marianne A A; Staals, Julie; Hofmeijer, Jeannette; van Oostayen, Jacques A; Lycklama À Nijeholt, Geert J; Boiten, Jelis; Brouwer, Patrick A; Emmer, Bart J; de Bruijn, Sebastiaan F; van Dijk, Lukas C; Kappelle, L Jaap; Lo, Rob H; van Dijk, Ewoud J; de Vries, Joost; de Kort, Paul L M; van den Berg, J S Peter; van Hasselt, Boudewijn A A M; Aerden, Leo A M; Dallinga, René J; Visser, Marieke C; Bot, Joseph C J; Vroomen, Patrick C; Eshghi, Omid; Schreuder, Tobien H C M L; Heijboer, Roel J J; Keizer, Koos; Tielbeek, Alexander V; den Hertog, Heleen M; Gerrits, Dick G; van den Berg-Vos, Renske M; Karas, Giorgos B; Steyerberg, Ewout W; Flach, H Zwenneke; Marquering, Henk A; Sprengers, Marieke E S; Jenniskens, Sjoerd F M; Beenen, Ludo F M; van den Berg, René; Koudstaal, Peter J; van Zwam, Wim H; Roos, Yvo B W E M; van Oostenbrugge, Robert J; Majoie, Charles B L M; van der Lugt, Aad; Dippel, Diederik W J

    2016-01-01

    Importance: Intra-arterial treatment (IAT) for acute ischemic stroke caused by intracranial arterial occlusion leads to improved functional outcome in patients treated within 6 hours after onset. The influence of treatment delay on treatment effect is not yet known. Objective: To evaluate the influe

  9. Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke : A Randomized Clinical Trial

    NARCIS (Netherlands)

    Fransen, Puck S S; Berkhemer, Olvert A; Lingsma, Hester F; Beumer, Debbie; van den Berg, Lucie A; Yoo, Albert J; Schonewille, Wouter J; Vos, Jan Albert; Nederkoorn, Paul J; Wermer, Marieke J H; van Walderveen, Marianne A A; Staals, Julie; Hofmeijer, Jeannette; van Oostayen, Jacques A; Lycklama À Nijeholt, Geert J; Boiten, Jelis; Brouwer, Patrick A; Emmer, Bart J; de Bruijn, Sebastiaan F; van Dijk, Lukas C; Kappelle, L Jaap; Lo, Rob H; van Dijk, Ewoud J; de Vries, Joost; de Kort, Paul L M; van den Berg, J S Peter; van Hasselt, Boudewijn A A M; Aerden, Leo A M; Dallinga, René J; Visser, Marieke C; Bot, Joseph C J; Vroomen, Patrick C; Eshghi, Omid; Schreuder, Tobien H C M L; Heijboer, Roel J J; Keizer, Koos; Tielbeek, Alexander V; den Hertog, Heleen M; Gerrits, Dick G; van den Berg-Vos, Renske M; Karas, Giorgos B; Steyerberg, Ewout W; Flach, H Zwenneke; Marquering, Henk A; Sprengers, Marieke E S; Jenniskens, Sjoerd F M; Beenen, Ludo F M; van den Berg, René; Koudstaal, Peter J; van Zwam, Wim H; Roos, Yvo B W E M; van Oostenbrugge, Robert J; Majoie, Charles B L M; van der Lugt, Aad; Dippel, Diederik W J

    2016-01-01

    IMPORTANCE: Intra-arterial treatment (IAT) for acute ischemic stroke caused by intracranial arterial occlusion leads to improved functional outcome in patients treated within 6 hours after onset. The influence of treatment delay on treatment effect is not yet known. OBJECTIVE: To evaluate the influe

  10. Acute neglect rehabilitation using repetitive prism adaptation: A randomized placebo-controlled trial

    NARCIS (Netherlands)

    Nys, G.M.S.; de Haan, E.H.F.; Kunneman, A.; de Kort, P.L.M.; Dijkerman, H.C.

    2008-01-01

    Purpose: At present, prism adaptation is probably the most promising rehabilitation procedure for hemi-neglect. However, randomised controlled trials are lacking and no data are available on the effectiveness of prism adaptation in the treatment of acute neglect. Methods: We followed sixteen neglect

  11. 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 p...

  12. Timing of laparoscopic cholecystectomy for acute cholecystitis: A prospective non randomized study

    Institute of Scientific and Technical Information of China (English)

    George Tzovaras; Dimitris Zacharoulis; Paraskevi Liakou; Theodoros Theodoropoulos; George Paroutoglou; Constantine Hatzitheofilou

    2006-01-01

    AIM: To study the timing of laparoscopic cholecystectomy for patients with acute cholecystitis.METHODS: Between January 2002 and December 2005,all American Society of Anesthesiologists classification (ASA) Ⅰ ,Ⅱand Ⅲ patients with acute cholecystitiswere treated laparoscopically during the urgent (index) admission. The patients were divided into three groups according to the timing of surgery: (1) within the first 3 d, (2) between 4 and 7 d and (3) beyond 7 d from the onset of symptoms. The impact of timing on the conversion rate, morbidity and postoperative hospital stay was studied.RESULTS: One hundred and twenty-nine patients underwent laparoscopic cholecystectomy for acute cholecystitis during the index admission. Thirty six were assigned to group 1, 58 to group 2, and 35 to group 3. The conversion rate and morbidity for the whole cohort of patients were 4.6% and 10.8%, respectively. There was no significant difference in the conversion rate, morbidity and postoperative hospital stay between the three groups.CONCLUSION: Laparoscopic cholecystectomy for acute cholecystitis during the index admission is safe, regardless of the time elapsed from the onset of symptoms. This policy can result in an overall shorter hospitalization.

  13. Tele-Interpersonal Psychotherapy Acutely Reduces Depressive Symptoms in Depressed HIV-Infected Rural Persons: A Randomized Clinical Trial.

    Science.gov (United States)

    Heckman, Timothy G; Heckman, Bernadette D; Anderson, Timothy; Lovejoy, Travis I; Markowitz, John C; Shen, Ye; Sutton, Mark

    2016-04-26

    Human immunodeficiency virus (HIV)-positive rural individuals carry a 1.3-times greater risk of a depressive diagnosis than their urban counterparts. This randomized clinical trial tested whether telephone-administered interpersonal psychotherapy (tele-IPT) acutely relieved depressive symptoms in 132 HIV-infected rural persons from 28 states diagnosed with Diagnostic and Statistical Manual of Mental Disorders-IV major depressive disorder (MDD), partially remitted MDD, or dysthymic disorder. Patients were randomized to either 9 sessions of one-on-one tele-IPT (n = 70) or standard care (SC; n = 62). A series of intent-to-treat (ITT), therapy completer, and sensitivity analyses assessed changes in depressive symptoms, interpersonal problems, and social support from pre- to postintervention. Across all analyses, tele-IPT patients reported significantly lower depressive symptoms and interpersonal problems than SC controls; 22% of tele-IPT patients were categorized as a priori "responders" who reported 50% or higher reductions in depressive symptoms compared to only 4% of SC controls in ITT analyses. Brief tele-IPT acutely decreased depressive symptoms and interpersonal problems in depressed rural people living with HIV.

  14. 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.

  15. Probiotics in addition to antibiotics for the treatment of acute tonsillitis: a randomized, placebo-controlled study.

    Science.gov (United States)

    Gilbey, P; Livshits, L; Sharabi-Nov, A; Avraham, Y; Miron, D

    2015-05-01

    Probiotics are live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. The probiotic Streptococcus salivarius has been shown to be effective in reducing the frequency of recurrent pharyngeal infections in children and adult populations. However, probiotics have not yet been evaluated in the treatment of acute pharyngotonsillitis in adults. We aimed to examine whether the addition of S. salivarius probiotics to the routine therapy of acute pharyngotonsillitis in adult patients may shorten disease duration and reduce symptom severity. This study was a prospective, randomized, placebo-controlled, double-blinded study comparing treatment with probiotics to placebo in addition to antibiotics in patients who were hospitalized with severe pharyngotonsillitis. Laboratory results, pain levels, body temperature, and daily volume of fluids consumed were recorded for both groups. Sixty participants were recruited, 30 for each group. No statistically significant differences between the two groups were observed regarding any of the major clinical and laboratory parameters examined. Supplement probiotic treatment with S. salivarius in patients with acute pharyngotonsillitis treated with penicillin is ineffective in relation to the parameters examined in this study and we cannot, therefore, recommend the use of S. salivarius during active pharyngotonsillar infection treated with penicillin.

  16. Role of glutamine versus placebo in prevention of acute gastrointestinal toxicity in pelvic radiotherapy: A randomized control study

    Directory of Open Access Journals (Sweden)

    Kazi Sazzad Manir

    2014-01-01

    Full Text Available Context: Nausea, vomiting, diarrhoea, abdominal cramping, ano-proctitis are common acute gastrointestinal (GI toxicities during pelvic radiotherapy (RT, having important impact on treatment outcome. Glutamine has a major role in mucosal growth and function. This phase III study is conducted to evaluate the role of prophylactic glutamine supplementation in prevention of acute GI toxicities during pelvic RT. Materials and Methods: Eighty five nonmetastatic patients with pelvic malignancy needing pelvic RT are included in this double blind randomized control trial. During RT 42 patients (Arm A received 10 g glutamine oral supplementation 1 h before every RT fraction. Forty three patients received glycine as placebo (Arm B in same schedule. Patients were assessed weekly for common acute RT induced GI toxicities. Toxicities were graded according to Common Terminology Criteria for Adverse Events version 4.02. Results: Two arms were well balanced with all baseline parameters. Median age was 57. 56.47% (n = 48 patients had cervical cancer. There was no significant difference between two arms in grade wise incidence of any of the GI toxicities. Trends of diarrhoea during weekly assessments also similar in both arms. Conclusion: There is no significant beneficial effect of glutamine during pelvic RT. As per our study data and our dose schedule glutamine should not be indicated in pelvic RT.

  17. Chinese Medicine Injection Qingkailing for Treatment of Acute Ischemia Stroke: A Systematic Review of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Fafeng Cheng

    2012-01-01

    Full Text Available Qingkailing (QKL injection was a famous traditional Chinese patent medicine, which was extensively used to treat the acute stages of cerebrovascular disease. The aim of this study was to assess the quantity, quality and overall strength of the evidence on QKL in the treatment of acute ischemic stroke. Methods. An extensive search was performed within MEDLINE, Cochrane, CNKI, Vip and Wan-Fang up to November 2011. Randomized controlled trails (RCTs on QKL for treatment of acute stroke were collected, irrespective of languages. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards, and RevMan5 was used for data analysis. Results. 7 RCTs (545 patients were included and the methodological quality was evaluated as generally low. The pooled results showed that QKL combined with conventional treatment was more effective in effect rate, and the score of MESSS and TNF-α level compared with conventional treatment alone, but there was no significant difference in mortality of two groups. Only one trial reported routine life status. There were four trials reported adverse events, and no obvious adverse event occurred in three trials while one reported adverse events described as eruption and dizziness.

  18. 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

  19. Recombinant streptokinase vs hydrocortisone suppositoriesin acute hemorrhoids: A randomized controlled trial

    National Research Council Canada - National Science Library

    2015-01-01

    .... After inclusion, patients with acutesymptoms of hemorrhoids were centrally randomized toreceive, as outpatients, by the rectal route, suppositoriesof rSK 200000 IU of one unit every 8 h (first 3 units...

  20. Motion style acupuncture treatment (MSAT for acute low back pain with severe disability: a multicenter, randomized, controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Shin Joon-Shik

    2011-12-01

    Full Text Available Abstract Background Acupuncture is widely-used to treat patients with low back pain, despite insufficient evidence of the technique's efficacy for acute back pain. Motion style acupuncture treatment (MSAT is a non-traditional acupuncture treatment requiring a patient to exercise while receiving acupuncture. In Korea, MSAT is used to reduce musculoskeletal pain and improve functional status. The study aims to evaluate the effect of MSAT on acute low back pain with severe disability. Methods/Design This study is a multicenter, randomized, active-controlled trial with two parallel arms. Participants with acute low back pain and severe functional disability, defined as an Oswestry Disability Index (ODI value > 60%, will be randomly allocated to the acupuncture group and the nonsteroidal anti-inflammatory drug (NSAID injection group. The acupuncture group will receive MSAT and the NSAID injection group will receive an intramuscular injection of diclofenac. All procedures will be limited to one session and the symptoms before and after treatment will be measured by assessors blinded to treatment allocation. The primary outcome will be measured at 30 minutes after treatment using the numerical rating scale (NRS of low back pain while the patient is moving. Secondary outcomes will be measured at 30 minutes after treatment using the NRS of leg pain, ODI, patient global impression of change, range of motion (ROM of the lumbar spine, and degrees of straight leg raising (SLR. Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment. Discussion The results of this trial will be discussed. Trial Registration ClinicalTrial.gov NCT01315561

  1. 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.

  2. Acute Effects of a Spinach Extract Rich in Thylakoids on Satiety: A Randomized Controlled Crossover Trial

    OpenAIRE

    Rebello, Candida J.; Chu, Jessica; Beyl, Robbie; Edwall, Dan; Erlanson-Albertsson, Charlotte; Frank L. Greenway

    2015-01-01

    Objective: By retarding fat digestion, thylakoids, the internal photosynthetic membrane system of green plants, promote the release of satiety hormones. This study examined the effect of consuming a single dose of concentrated extract of thylakoids from spinach on satiety, food intake, lipids, and glucose compared to a placebo. Design: Sixty overweight and obese individuals enrolled in a double-blind randomized crossover study consumed the spinach extract or placebo in random order at least a...

  3. Cost-effectiveness of entecavir versus adefovir for the treatment of chronic hepatitis B in patients with decompensated cirrhosis from a third-party US payer perspective

    Directory of Open Access Journals (Sweden)

    Tsai N

    2012-08-01

    Full Text Available Naoky Tsai,1 Lennox Jeffers,2 Lael Cragin,3 Sonja Sorensen,3 Wenqing Su,3 Lisa Rosenblatt,4 Hong Tang,4 Tony Hebden,4 Timothy Juday41John A Burns School of Medicine, University of Hawaii, Honolulu, HI, USA; 2University of Miami School of Medicine, Miami, FL, USA; 3United BioSource Corporation, Bethesda, MD, USA; 4Bristol-Myers Squibb Company, Plainsboro, NJ, USABackground: Decompensated cirrhosis is a serious clinical complication of chronic hepatitis B (CHB that places a large economic burden on the US health care system. Although entecavir has been shown to improve health outcomes in a cost-effective manner in mixed populations of CHB patients, the cost-effectiveness of entecavir has not been evaluated in CHB patients with decompensated cirrhosis.Methods: This study assessed the cost-effectiveness of entecavir versus adefovir, from a US payer perspective, in CHB patients with decompensated cirrhosis, using a health-state transition Markov model with four health states: hepatocellular carcinoma (HCC, HCC-free survival, post-liver transplant, and death. The model considered a hypothetical patient population similar to that included in a randomized controlled trial in the target population (ETV-048: predominantly male (74%, Asian (54%, mean age 52 years, hepatic decompensation (Child–Pugh score ≥ seven, hepatitis B e antigen-positive or -negative, treatment-naïve or lamivudine-experienced, and no liver transplant history. Clinical inputs were based on cumulative safety results for ETV-048 and published literature. Costs were obtained from published literature. Costs and outcomes were discounted at 3% per annum.Results: For 1000 patients over a 3-year time horizon, predicted overall survival and HCC-free survival were longer with entecavir than with adefovir (2.35 versus 2.30 years and 2.11 versus 2.03 years, respectively. Predicted total health care costs were $889 lower with entecavir than with adefovir ($91,878 versus $92,768. For

  4. Precipitating factors leading to decompensation of chronic heart failure in the elderly patient in South-American community hospital

    Institute of Scientific and Technical Information of China (English)

    Alejandro Diaz; Cleto Ciocchini; Mariano Esperatti; Alberto Becerra; Sabrina Mainardi; Alejandro Farah

    2011-01-01

    Background Exacerbations of heart failure appear frequently associated with precipitating factors not directly related to the evolution of cardiac disease. There still a paucity of data on the proportional distribution of precipitating factors specifically in elderly patients. The aim of this study was to examine prospectively the precipitating factors leading to hospitalization in elderly patients with heart failure in our community hospital. Methods We evaluate elderly patients who need admissions for decompensate heart failure. All patients were reviewed daily by the study investigators at the first 24 h and closely followed-up. Decompensafion was defined as the worsening in clinical NYHA class associated with the need for an increase in medical treatment (at minimum intravenously diuretics). Results We included 102 patients (mean age 79 ± 12 years). Precipitating factors were identified in 88.5%. The decompensation was sudden in 35% of the cases.Noncompliance with diet was identified in 52% of the patients, lack of adherence to the prescribed medications amounted to 30%. Others precipitating factors were infections (29%), arrhythmias (25%), acute coronary ischemia (22%), and uncontrolled hypertension (15%),miscellaneous causes were detected in 18% of the cases (progression of renal disease 60%, anemia 30% and iatrogenic factors 10%).Concomitant cause was not recognizable in 11.5%. Conclusions Large proportion heart failure hospitalizations are associated with preventable precipitating factors. Knowledge of potential precipitating factors may help to optimize treatment and provide guidance for patients with heart failure. The presence of potential precipitating factors should be routinely evaluated in patients presenting chronic heart failure.

  5. Superinfection of hepatitis E Virus as a cause of decompen-sation in liver cirrhosis due to hepatitis B virus

    Institute of Scientific and Technical Information of China (English)

    Manisha Jain; Anita Chakravarti; P Kar Mbbs Md

    2009-01-01

    Objevtive:Super infection with hepatitis A virus (HAV)and hepatitis E virus (HEV)in the presence of un-derlying hepatocellular injury can cause severe illness.In endemic areas such as India,however most patients already have been exposed to HAV but could still be susceptible to HEV infection.In our study we determined the seroprevalence of anti-HAV IgMand anti-HEV IgMto assess the incidence of superinfection with these vi-ruses in cirrhotic patients with the goal of defining the need for protection against these viruses and further cor-relate the presence of these viruses with the clinical course.Methods:We studied 53 patients of cirrhosis as a result of Hepatitis B virus.Apparent causes of decompensation were ruled out before their inclusion in the study group.Serum sample from these patients was tested for HBsAg,anti HBc IgG,anti HEV IgMand anti HAV IgG and IgMby commercially available ELISA kit.Liver function test was done on all the patients and correlated with various serological markers.Results:anti HBc IgG was present in all the cases of cirrhosis. Hepatitis B surface antigen was present in 20 out of 53 cases of cirrhosis.None of the patients demonstrated anti-HAV IgM,however one patient had anti-HEV IgM.Conclusion:Superinfection with HAV in adult pa-tient is uncommon in India.Prevalence of acute HEV infection in decompensated cirrhosis is low in the present study but presence of HEV superinfection in one patient corroborates the apprehension of liver function deterio-ration following superinfection with HEV virus.

  6. Remote ischemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischemic stroke: a randomized trial.

    Science.gov (United States)

    Hougaard, Kristina Dupont; Hjort, Niels; Zeidler, Dora; Sørensen, Leif; Nørgaard, Anne; Hansen, Troels Martin; von Weitzel-Mudersbach, Paul; Simonsen, Claus Z; Damgaard, Dorte; Gottrup, Hanne; Svendsen, Kristina; Rasmussen, Peter Vestergaard; Ribe, Lars R; Mikkelsen, Irene K; Nagenthiraja, Kartheban; Cho, Tae-Hee; Redington, Andrew N; Bøtker, Hans Erik; Østergaard, Leif; Mouridsen, Kim; Andersen, Grethe

    2014-01-01

    Remote ischemic preconditioning is neuroprotective in models of acute cerebral ischemia. We tested the effect of prehospital rPerC as an adjunct to treatment with intravenous alteplase in patients with acute ischemic stroke. Open-label blinded outcome proof-of-concept study of prehospital, paramedic-administered rPerC at a 1:1 ratio in consecutive patients with suspected acute stroke. After neurological examination and MRI, patients with verified stroke receiving alteplase treatment were included and received MRI at 24 hours and 1 month and clinical re-examination after 3 months. The primary end point was penumbral salvage, defined as the volume of the perfusion-diffusion mismatch not progressing to infarction after 1 month. Four hundred forty-three patients were randomized after provisional consent, 247 received rPerC and 196 received standard treatment. Patients with a nonstroke diagnosis (n=105) were excluded from further examinations. The remaining patients had transient ischemic attack (n=58), acute ischemic stroke (n=240), or hemorrhagic stroke (n=37). Transient ischemic attack was more frequent (P=0.006), and National Institutes of Health Stroke Scale score on admission was lower (P=0.016) in the intervention group compared with controls. Penumbral salvage, final infarct size at 1 month, infarct growth between baseline and 1 month, and clinical outcome after 3 months did not differ among groups. After adjustment for baseline perfusion and diffusion lesion severity, voxelwise analysis showed that rPerC reduced tissue risk of infarction (P=0.0003). Although the overall results were neutral, a tissue survival analysis suggests that prehospital rPerC may have immediate neuroprotective effects. Future clinical trials should take such immediate effects, and their duration, into account. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00975962.

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

    Science.gov (United States)

    2015-10-01

    Injury PRINCIPAL INVESTIGATOR: Nicholas Theodore, MD CONTRACTING ORGANIZATION: Dignity Health San Francisco, CA 94107-1773 REPORT DATE: October 2015...TASK NUMBER E-Mail: Nicholas.Theodore@bnaneuro.net 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Dignity Health AND ADDRESS...patients aims to reduce cell death and axonal damage leading to improved neurological function in patients. 2. KEYWORDS acute spinal cord injury

  8. A Randomized Feasibility Trial of a New Lifestyle Referral Assessment Versus Usual Assessment in an Acute Cardiology Setting.

    Science.gov (United States)

    Hill, Kate; Walwyn, Rebecca; Camidge, Diana; Murray, Jenni; Meads, David; Reynolds, Greg; Farrin, Amanda; House, Allan

    A healthy diet, taking exercise, and not smoking or consuming alcohol in excess are important to reduce the risk of cardiovascular disease either alone or in combination with statin medication. Health education, including providing information to patients on healthy living and guidance on how to achieve it, is a key nursing function. This study aims first to assess the feasibility of conducting a full-scale trial of lifestyle referral assessment as shown by recruitment rate, data collection, and follow-up and second to assess proof of concept and explore possible mechanisms of change. This was a single-center, randomized, 2-arm, parallel-group, unblinded feasibility trial conducted in an acute teaching hospital trust. Participants were followed up at 3 and 6 months after randomization. Eight hundred eighty-seven patients were screened for eligibility, of whom 132 (15%) were randomized into the trial. Of the patients allocated to the individualized assessment, 27% accepted referral or self-referred by 3 months in comparison to 5% allocated to the usual assessment. We demonstrated that a full-scale trial is feasible and that an individualized approach increased the number of patients accepting referral to a formal program and initiating lifestyle change. However, we should consider the aim of the assessment and ways in which the process of change can be optimized in order to produce long-term benefit for patients. current controlled trials ISRCTN41781196.

  9. 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

  10. 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)

  11. Oral Prednisolone in the Treatment of Acute Gout: A Pragmatic, Multicenter, Double-Blind, Randomized Trial

    NARCIS (Netherlands)

    Rainer, T.H.; Cheng, C.H.; Janssens, H.J.; Man, C.Y.; Tam, L.S.; Choi, Y.F.; Yau, W.H.; Lee, K.H.; Graham, C.A.

    2016-01-01

    BACKGROUND: Two recent double-blind, randomized, controlled trials (RCTs) showed that oral steroids and nonsteroidal anti-inflammatory drugs have similar analgesic effectiveness for management of gout, but the trials had small sample sizes and other methodological limitations. OBJECTIVE: To compare

  12. 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) w

  13. 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.

  14. Low-dose Ketamine Versus Morphine for Acute Pain In the ED: A Randomized Controlled Trial

    Science.gov (United States)

    2015-03-01

    and Leeann Zarzabal for statistical support. References [1] Todd KH, Ducharme J, Choiniere M, Crandall CS, Fosnocht DE, Homel P, et al. Pain in the...model of acute pain. Am J Emerg Med 2001;19: 531–2. [8] Lester L, Braude DA, Niles C, Crandall CS. Low-dose ketamine for analgesia in the ED: a...retrospective case series. Am J Emerg Med 2010;28:820–7. [9] Lester L, Braude DA, Niles C, Crandall CS. Low-dose ketamine for analgesia in the ED: a

  15. REASSESSMENT OF DEFIBRASE IN TREATMENT OF ACUTE CEREBRAL INFARCTION: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED TRIAL

    Institute of Scientific and Technical Information of China (English)

    The Cooperative Group for Reassessment of Defibras

    2005-01-01

    Objective To evaluate the efficacy and safety of defibrase in patients with acute cerebral infarction by a large sample,multicenter, randomized, double-blind, placebo-controlled clinical trial.Methods Patients with acute cerebral infarction within 12 hours of stroke onset were randomly assigned to receive either an initial intravenous infusion of defibrase 15 U plus normal saline 250 Ml or 250 Ml of normal saline only.Subsequent infusions of defibrase 15 U or placebo (normal saline) were given on the 3rd, 5th, 7th, and 9th day, respectively.Both groups received standard care of acute cerebral infarction. The primary efficacy outcome was functional status(Barthel Index) at 3 months after treatment. Safety outcome were bleeding events and mortality rate. Secondary outcome included Chinese Stroke Scale (CSS) score at 14 days and recurrence rate of stroke at 1 year. Results A total of 1053 patients were enrolled at 46 centers from September 2001 to July 2003, and 527 patients were randomly assigned to receive defibrase and 526 to receive placebo. A similar proportion of patients in both groups completed a full course of treatment. There was a significantly greater proportion of favorable functional status (Barthel Index ≥95) in defibrase group than in placebo group at 3 months (52.2% vs. 42.8%, P < 0.01), and the proportion of dependent functional status (Barthel Index ≤60) was a little lower in defibrase group compared with placebo group(27.7%vs. 32.4%). These differences were more obvious among patients who were treated within 6 hours of stroke onset.Patients in defibrase group had better improvement with respect to CSS score than those in placebo group at 14 days (P <0.05). Recurrence rate of stroke at 1 year was lower in the defibrase group compared with placebo group (6.2% vs. 10.1%,P = 0.053). Patients in defibrase group had higher risk of extracranial bleeding events (4.7%vs. 1.5%, P< 0.01) and a tendency of higher risk of symptomatic intracranial hemorrhage

  16. Protective role of selective nitric oxide synthase inhibitor for treatment of decompensated hemorrhagic shock in normotensive and hypertensive rats.

    Science.gov (United States)

    Khazaei, Majid; Barmaki, Babak; Nasimi, Ali

    2012-01-01

    Different vasoactive factors can modulate cardiovascular adaptation to hemorrhagic shock including Nitric Oxide (NO). In this study we investigated the effect of the NO synthase inhibitor for treatment of decompensated hemorrhagic shock in normotensive and hypertensive rats. Twenty-four male Wistar rats were divided into two groups: The normotensive and hypertensive groups. Hypertension was induced by the DOCA-Salt method for eight weeks. Then, the animals were given hemorrhagic shock by continuously withdrawing blood until the mean arterial pressure (MAP) reached to 40 mmHg. The animals were maintained in the shock state for 120 minutes. Subsequently, they were randomly assigned to L-NAME-treated and non-treated groups and monitored for 60 minutes. The survival time was recorded. Blood samples were taken before and after the shock and 60 minutes after L-NAME administration. Infusion of L-NAME caused a significant increase in MAP in normotensive animals, however, slightly increased MAP in hypertensive animals. The heart rate did not significantly alter. Hemorrhage caused a marked increase in serum nitrite levels in both groups (P<0.05). L-NAME treatment significantly reduced the serum nitrite concentration in the normotensive group (P<0.05), without any change in the hypertensive group. All animals who received L-NAME treatment survived at the end of experiment. Fifty percent of the hypertensive animals died four hours after the experiment. The 72-hour survival rate was similar in the L-NAME treated groups. L-NAME infusion during decompensated hemorrhagic shock plays a protective role in the improvement of hemodynamic responses and short-term survival rate in normotensive animals.

  17. Intravenous iron supplementation may protect against acute mountain sickness: a randomized, double-blinded, placebo-controlled trial.

    Science.gov (United States)

    Talbot, Nick P; Smith, Thomas G; Privat, Catherine; Nickol, Annabel H; Rivera-Ch, Maria; León-Velarde, Fabiola; Dorrington, Keith L; Robbins, Peter A

    2011-01-01

    Acute mountain sickness (AMS) is a common and disabling condition that occurs in healthy individuals ascending to high altitude. Based on the ability of iron to influence cellular oxygen sensing pathways, we hypothesized that iron supplementation would protect against AMS. To examine this hypothesis, 24 healthy sea-level residents were randomized to receive either intravenous iron(III)-hydroxide sucrose (200 mg) or saline placebo, before ascending rapidly to Cerro de Pasco, Peru (4340 m). The Lake Louise scoring system was used to assess incidence and severity of AMS at sea level and on the first full day at altitude. No significant difference in absolute AMS score was detected between the two groups either at baseline or at high altitude. However, the mean increase in AMS score was 65% smaller in the iron group than in the saline group (pvolunteers.

  18. 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.

  19. Effect of coumarins started before coronary angioplasty on acute complications and long-term follow-up: a randomized trial.

    Science.gov (United States)

    ten Berg, J M; Kelder, J C; Suttorp, M J; Mast, E G; Bal, E; Ernst, S M; Verheugt, F W; Plokker, H W

    2000-07-25

    Coronary angioplasty frequently creates a thrombogenic surface, with subsequent mural thrombosis that may lead to acute complications and possibly stimulates the development of restenosis. Whether coumarins can prevent these complications is unclear. The objective of this open, randomized trial was to assess the clinical effect of coumarins started before coronary angioplasty and continued for 6 months. Before coronary angioplasty, 530 patients were randomly assigned to aspirin plus coumarins and 528 patients to aspirin alone. At the start of the angioplasty, the mean international normalized ratio was 2.7+/-1.1; during follow-up, it was 3.0+/-1.1. At 30 days, the composite end point of death, myocardial infarction, target-lesion revascularization, and stroke was observed in 18 patients (3.4%) treated with aspirin plus coumarin compared with 34 patients (6.4%) treated with aspirin alone (relative risk, 0.53; 95% CI, 0.30 to 0.92). At 1 year, these figures were 14.3% and 20.3%, respectively (relative risk, 0.71; 95% CI, 0.54 to 0.93). The incidence of major bleeding and false aneurysm during hospitalization was 3.2% and 1.0%, respectively (relative risk, 3.39; 95% CI, 1.26 to 9.11). The benefit of coumarins was observed in both stented and nonstented patients. Coumarins in addition to aspirin started before PTCA and continued for 6 months was more effective than aspirin alone in the prevention of acute and late complications after coronary angioplasty. This benefit was accompanied by a small but significant increase in bleeding complications.

  20. Effects of intracutaneous injections of sterile water in patients with acute low back pain: a randomized, controlled, clinical trial

    Directory of Open Access Journals (Sweden)

    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.

  1. Analgesic Effects and Safety of Desmopressin, Tramadol and Indomethacin in Patients with Acute Renal Colic; A Randomized Clinical Trial

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    Mehdi Shirazi

    2015-04-01

    Full Text Available Objective: To compare the efficacy of desmopressin (DDAVP, tramadol and indomethacin on pain intensity of patients with acute renal colic caused by urolithiasis. Methods: This prospective, randomized clinical trial was conducted between July 2005 and July 2006 including 120 patients (70 men and 50 women, mean age 38.2±5.8 years referring to emergency room of Shahid Faghihi hospital with renal colic caused by urolithiasis without any previous treatment. The patients were randomly assigned to three groups: group A received tramadol 50mg intramuscularly (n=40, group B received desmopressin 40 µg intranasally (n=40 and group C received indomethacin 100mg rectally (n=40. The pain was assessed both on admission and 30 minutes after the intervention. The pain intensity and the side effects were compared between two study groups. Results: There was no significant difference between two study groups regarding the baseline characteristics. The intensity of pain of presentation was almost similar in all groups. In group A, 30 patients (75%, in group B, 15 patients (37.5% and in group C, 19 patients (47.5% had complete pain relief. The pain intensity decreased significantly after the intervention within all three groups ( p<0.001. Conclusion: According to the results of the current study, rectal indomethacin, intramuscular tramadol and intranasal desmopressin are effective and safe routs of controlling pain in acute renal colic secondary to urolithiasis. Tramadol was the most effective agent in controlling the pain. Clinical Trial Registry: The current study is registered with Iranian Registry for Clinical Trials (www.irct.ir; IRCT2015030919470N18

  2. Oxidative stress markers in laparoscopic vs. open appendectomy for acute appendicitis: A double-blind randomized study

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    Recep Aktimur

    2016-01-01

    Full Text Available Background: Oxidative stress is a complicated process, which was defined as an increase in prooxidants and decrease in antioxidants caused by various mechanisms, including inflammation and surgical trauma. The association between acute appendicitis and oxidative stress has been showed in previous studies. However, comparison of oxidative stress in laparoscopic or open appendectomy (OA has not been established. Patients and Methods: Patients who were diagnosed as acute appendicitis between October 2012 and January 2013 were randomized to open (OA, n = 50 and laparoscopic appendectomy (LA, n = 50. Blood samples for oxidative stress markers (total oxidant status [TOS] and total antioxidant status [TAS], C-reactive protein (CRP and white blood cells (WBC's were collected just before the surgery and 24 h after surgery. Results: There were no differences in preoperative values of WBC and CRP between LA and OA groups (P = 0.523 and 0.424, however, in postoperative 24th h, CRP was reduced in LA group (P = 0.031. There were no differences in preoperative levels of TOS, TAS, and oxidative stress index (OSI between LA and OA groups. In the postoperative 24th h, TOS and OSI were found to be significantly higher in OA group when compared to LA group (P = 0.017 and 0.002 whereas no difference was detected in TAS level in the postoperative 24th h (P = 0.172. Conclusions: This double-blind, randomized clinical trial provides evidence that LA for uncomplicated appendicitis is associated with significantly lower oxidative stress compared with OA. Some of the advantages of LA may be attributed to the significant reduction of oxidative stress in these patients.

  3. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial.

    Science.gov (United States)

    Heiss, Wolf-Dieter; Brainin, Michael; Bornstein, Natan M; Tuomilehto, Jaakko; Hong, Zhen

    2012-03-01

    Cerebrolysin showed neuroprotective and neurotrophic properties in various preclinical models of ischemia and small clinical trials. The aim of this large double-blind, placebo-controlled randomized clinical trial was to test its efficacy and safety in patients with acute ischemic stroke. Patients with acute ischemic hemispheric stroke were randomized within 12 hours of symptoms onset to active treatment (30 mL Cerebrolysin daily) or placebo (saline solution) given as intravenous infusion for 10 days in addition to aspirin (100 mg daily). The patients were followed up to 90 days. The primary end point was the result of a combined global directional test of modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale. Adverse events were documented to assess safety. A total of 1070 patients were enrolled in this study. Five hundred twenty-nine patients were assigned to Cerebrolysin and 541 to placebo. The confirmatory end point showed no significant difference between the treatment groups. When stratified by severity however, a post hoc analysis of National Institutes of Health Stroke Scale and modified Rankin Scale showed a trend in favor of Cerebrolysin in patients with National Institutes of Health Stroke Scale >12 (National Institutes of Health Stroke Scale: OR, 1.27; CI lower bound, 0.97; modified Rankin Scale: OR, 1.27; CI lower bound, 0.90). In this subgroup, the cumulative mortality by 90 days was 20.2% in the placebo and 10.5% in the Cerebrolysin group (hazard ratio, 1.9661; CI lower bound, 1.0013). In this study, the confirmatory end point showed neutral results between the treatment groups. However, a favorable outcome trend was seen in the severely affected patients with ischemic stroke treated with Cerebrolysin. This observation should be confirmed by a further clinical trial. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00868283.

  4. 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.

  5. A randomized trial of washed red blood cell and platelet transfusions in adult acute leukemia [ISRCTN76536440

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    Rowe Jacob M

    2004-12-01

    Full Text Available Abstract Background Platelet transfusion is universally employed in acute leukemia. Platelet concentrate supernatants contain high concentrations of biologic mediators that might impair immunity. We investigated whether washed platelet and red cell transfusions could improve clinical outcomes in adult patients with acute leukemia. Methods A pilot randomized trial of washed, leukoreduced ABO identical transfusions versus leukoreduced ABO identical transfusions was conducted in 43 adult patients with acute myeloid or lymphoid leukemia during 1991–94. Primary endpoints to be evaluated were platelet transfusion refractoriness, infectious and bleeding complications and overall survival. Results There were no significant differences in infectious or major bleeding complications and only one patient required HLA matched platelet transfusions. Minor bleeding was more frequent in the washed, leukoreduced arm of the study. Confirmed transfusion reactions were more frequent in the leukoreduced arm of the study. Overall survival was superior in the washed arm of the study (40% versus 22% at 5 years, but this difference was not statistically significant (p = 0.36. A planned subset analysis of those ≤50 years of age found that those in the washed, leukoreduced arm (n = 12 had a 75% survival at five years compared with 30% in the leukoreduced arm (n = 10 (p = 0.037 Conclusion This study provides the first evidence concerning the safety and efficacy of washed platelets, and also raises the possibility of improved survival. We speculate that transfusion of stored red cell and platelet supernatant may compromise treatment, particularly in younger patients with curable disease. Larger trials will be needed to assess this hypothesis.

  6. Randomized Controlled Trial of Brief Mindfulness Training and Hypnotic Suggestion for Acute Pain Relief in the Hospital Setting.

    Science.gov (United States)

    Garland, Eric L; Baker, Anne K; Larsen, Paula; Riquino, Michael R; Priddy, Sarah E; Thomas, Elizabeth; Hanley, Adam W; Galbraith, Patricia; Wanner, Nathan; Nakamura, Yoshio

    2017-07-12

    Medical management of acute pain among hospital inpatients may be enhanced by mind-body interventions. We hypothesized that a single, scripted session of mindfulness training focused on acceptance of pain or hypnotic suggestion focused on changing pain sensations through imagery would significantly reduce acute pain intensity and unpleasantness compared to a psychoeducation pain coping control. We also hypothesized that mindfulness and suggestion would produce significant improvements in secondary outcomes including relaxation, pleasant body sensations, anxiety, and desire for opioids, compared to the control condition. This three-arm, parallel-group randomized controlled trial conducted at a university-based hospital examined the acute effects of 15-min psychosocial interventions (mindfulness, hypnotic suggestion, psychoeducation) on adult inpatients reporting "intolerable pain" or "inadequate pain control." Participants (N = 244) were assigned to one of three intervention conditions: mindfulness (n = 86), suggestion (n = 73), or psychoeducation (n = 85). Participants in the mind-body interventions reported significantly lower baseline-adjusted pain intensity post-intervention than those assigned to psychoeducation (p < 0.001, percentage pain reduction: mindfulness = 23%, suggestion = 29%, education = 9%), and lower baseline-adjusted pain unpleasantness (p < 0.001). Intervention conditions differed significantly with regard to relaxation (p < 0.001), pleasurable body sensations (p = 0.001), and desire for opioids (p = 0.015), but all three interventions were associated with a significant reduction in anxiety (p < 0.001). Brief, single-session mind-body interventions delivered by hospital social workers led to clinically significant improvements in pain and related outcomes, suggesting that such interventions may be useful adjuncts to medical pain management. Trial Registry: ClinicalTrials.gov ; registration ID number: NCT02590029 URL

  7. Randomized comparative study of moxalactam and cefazolin in the treatment of acute urinary tract infections in adults.

    Science.gov (United States)

    Lea, A S; Sudan, A W; Wood, B A; Gentry, L O

    1982-01-01

    Eighty-nine patients with clinical and laboratory evidence of acute urinary tract infection were randomized to therapy with either moxalactam (500 mg) or cefazolin (1 g) every 12 h. Escherichia coli was the predominant pathogen in both groups (92.6 versus 90.2%). Therapy was continued for 3 days after the patient defervesced. The minimum hospital stay was 5 days. Sequential urine cultures were obtained on day 3, at discharge, and 5 to 10 days after the cessation of therapy. THe average duration of hospital stay was 5.6 days for both groups of patients. THe incidence of recurrent infection was similar in uncomplicated patients (9.1 versus 10%) and in complicated patients with a condition predisposing them to urinary tract infections (43 versus 42%). Moxalactam-treated patients had a higher incidence of reversible hepatic enzyme elevation (36%) and Streptococcus faecalis superinfections (12.2%). Moxalactam is as effective as cefazolin for the elimination of gram-negative pathogens from the urine of patients with acute urinary tract infections, but it is associated with a higher incidence of reversible side effects. PMID:6214996

  8. 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.

  9. Successful pregnancy outcome in decompensated chronic liver disease with portal vein thrombosis: case report and review of literature.

    Science.gov (United States)

    Kumar, Mukesh; Kamani, Lubna; Hussain, Riaz; Siddique, Shoaib

    2011-07-01

    Pregnancy is rare in women with decompensated chronic liver disease. In this case report, we describe a case of a young woman who presented with hepatitis B-related decompensated chronic liver disease with portal vein thrombosis having successful full-term uneventful pregnancy.

  10. Randomized Trial of Two Dosages of Prophylactic Granulocyte Colony-Stimulating Factor after Induction Chemotherapy in Pediatric Acute Myeloid Leukemia

    Science.gov (United States)

    Inaba, Hiroto; Cao, Xueyuan; Pounds, Stanley; Pui, Ching-Hon; Rubnit, Jeffrey E.; Ribeiro, Raul C.; Razzouk, Bassem I.

    2010-01-01

    Background Granulocyte colony-stimulating factor (G-CSF) is effective in accelerating neutrophil recovery after intensive chemotherapy for acute myeloid leukemia (AML). However, the optimal G-CSF dosage for patients with AML has not been determined. To our knowledge, G-CSF dosages have not been compared in a randomized AML study. Methods Patients enrolled on the St. Jude AML97 protocol who remained on study after window therapy were eligible to participate. The effect of the dosage of G-CSF given after induction chemotherapy courses 1 and 2 was analyzed in 46 patients randomly assigned in a double-blinded manner to receive 5 or 10 μg/kg/day of G-CSF. The number of days of G-CSF treatment, neutropenia (absolute neutrophil count < 0.5 × 109/L), and hospitalization; the number of episodes of febrile neutropenia, grade 2-4 infection, and antimicrobial therapy; transfusion requirements; the cost of supportive care; and survival were compared between the two study arms. Results We found no statistically significant difference between the two arms in any of the endpoints measured. Conclusions The higher G-CSF dosage (10 μg/kg/day) offers no greater benefit than the lower dosage (5 μg/kg/day) in patients undergoing intensive chemotherapy for AML. PMID:21381017

  11. A double-blind, randomized, multicenter, Italian study of frovatriptan versus rizatriptan for the acute treatment of migraine.

    Science.gov (United States)

    Savi, Lidia; Omboni, Stefano; Lisotto, Carlo; Zanchin, Giorgio; Ferrari, Michel D; Zava, Dario; Pinessi, Lorenzo

    2011-04-01

    The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1-3 attacks. The study had a multicenter, randomized, double-blind, cross-over design, with treatment periods lasting rizatriptan (3.2±1.1). The rates of pain-free (33% frovatriptan vs. 39% rizatriptan) and pain relief (55 vs. 62%) episodes at 2 h were not significantly different between the two treatments. The rate of recurrent episodes was significantly (prizatriptan). No significant differences were observed in sustained pain-free episodes (26% frovatriptan vs. 22% rizatriptan). The number of patients with adverse events was not significantly different between rizatriptan (34) and frovatriptan (25, p=NS). The results suggest that frovatriptan has a similar efficacy to rizatriptan, but a more prolonged duration of action.

  12. 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.

  13. Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial

    Institute of Scientific and Technical Information of China (English)

    LI Ting; CHEN Shun-le; DAI Qing; HAN Xing-hai; LI Zhan-guo; WU Dong-hai; ZHANG Xiao

    2013-01-01

    Background Acute gout is an intensely painful,inflammatory arthritis.Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition,the efficacy is based on only a few studies,particularly in China.We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.Methods A randomized,double-blind,active comparator study was conducted at 10 sites in China.Patients (n=178; ≥18 years of age) with acute gouty attack (<48 hours) were treated for 5 days with etoricoxib (120 mg/d; n=89) or indometacin (75 mg twice daily; n=89).The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2-5.Secondary end points included investigator assessments of tenderness and swelling,patient/ investigator global assessments of response to therapy,and patients discontinuing treatment.Safety was assessed by adverse events (AEs).Results Etoricoxib and indometacin had comparable primary and secondary end points.Mean change difference from baseline from days 2-5 was 0.03 (95% confidence interval (Cl)-0.19 to 0.25; P=0.6364),which fell within the prespecified comparative bounds of-0.5 to 0.5.No severe AEs were associated with etoricoxib use.Non-severe AEs were mainly digestive and general,and most (73.7%) were mild,although they caused withdrawal of two subjects in the etoricoxib group,due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related).Overall,AEs were similar,although the absolute number of AEs in the etoricoxib group (n=31) was less than the indometacin group (n=34).Conclusions Etoricoxib (120 mg once daily) is effective in treating acute gout,is generally safe and well-tolerated,and is comparable in efficacy to indometacin (75 mg twice daily).

  14. A pilot randomized control trial: testing a transitional care model for acute psychiatric conditions.

    Science.gov (United States)

    Hanrahan, Nancy P; Solomon, Phyllis; Hurford, Matthew O

    2014-01-01

    People with multiple and persistent mental and physical health problems have high rates of transition failures when transferring from a hospital level of care to home. The transitional care model (TCM) is evidence-based and demonstrated to improve posthospital outcomes for elderly with physical health conditions, but it has not been studied in the population with serious mental illness. Using a randomized controlled design, 40 inpatients from two general hospital psychiatric units were recruited and randomly assigned to an intervention group (n = 20) that received the TCM intervention that was delivered by a psychiatric nurse practitioner for 90 days posthospitalization, or a control group (n = 20) that received usual care. Outcomes were as follows: service utilization, health-related quality of life, and continuity of care. The intervention group showed higher medical and psychiatric rehospitalization than the control group (p = .054). Emergency room use was lower for intervention group but not statistically significant. Continuity of care with primary care appointments were significantly higher for the intervention group (p = .023). The intervention group's general health improved but was not statistically significant compared with controls. A transitional care intervention is recommended; however, the model needs to be modified from a single nurse to a multidisciplinary team with expertise from a psychiatric nurse practitioner, a social worker, and a peer support specialist. A team approach can best manage the complex physical/mental health conditions and complicated social needs of the population with serious mental illness. © The Author(s) 2014.

  15. Restrictive vs Liberal Blood Transfusion for Acute Upper Gastrointestinal Bleeding: Rationale and Protocol for a Cluster Randomized Feasibility Trial

    Science.gov (United States)

    Jairath, Vipul; Kahan, Brennan C.; Gray, Alasdair; Doré, Caroline J.; Mora, Ana; Dyer, Claire; Stokes, Elizabeth A.; Llewelyn, Charlotte; Bailey, Adam A.; Dallal, Helen; Everett, Simon M.; James, Martin W.; Stanley, Adrian J.; Church, Nicholas; Darwent, Melanie; Greenaway, John; Le Jeune, Ivan; Reckless, Ian; Campbell, Helen E.; Meredith, Sarah; Palmer, Kelvin R.; Logan, Richard F.A.; Travis, Simon P.L.; Walsh, Timothy S.; Murphy, Michael F.

    2013-01-01

    Acute upper gastrointestinal bleeding (AUGIB) is the commonest reason for hospitalization with hemorrhage in the UK and the leading indication for transfusion of red blood cells (RBCs). Observational studies suggest an association between more liberal RBC transfusion and adverse patient outcomes, and a recent randomised trial reported increased further bleeding and mortality with a liberal transfusion policy. TRIGGER (Transfusion in Gastrointestinal Bleeding) is a pragmatic, cluster randomized trial which aims to evaluate the feasibility and safety of implementing a restrictive versus liberal RBC transfusion policy in adult patients admitted with AUGIB. The trial will take place in 6 UK hospitals, and each centre will be randomly allocated to a transfusion policy. Clinicians throughout each hospital will manage all eligible patients according to the transfusion policy for the 6-month trial recruitment period. In the restrictive centers, patients become eligible for RBC transfusion when their hemoglobin is bleeding, mortality, thromboembolic events, and infections. Quality of life will be measured using the EuroQol EQ-5D at day 28, and the costs associated with hospitalization for AUGIB in the UK will be estimated. Consent will be sought from participants or their representatives according to patient capacity for use of routine hospital data and day 28 follow up. The study has ethical approval for conduct in England and Scotland. Results will be analysed according to a pre-defined statistical analysis plan and disseminated in peer reviewed publications to relevant stakeholders. The results of this study will inform the feasibility and design of a phase III randomized trial. PMID:23706959

  16. Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Nascimento, L S; Santos, A C; Lucena, Jms; Silva, Lgo; Almeida, Aem; Brasileiro-Santos, M S

    2017-06-02

    Resistant hypertension is a specific condition that affects approximately 10% of subjects with hypertension, and is characterized by persistently high blood pressure levels even using therapy of three or more antihypertensive agents or with blood pressure control using therapy with four or more antihypertensive agents. Changes in lifestyle, such as physical exercise, are indicated for controlling blood pressure. However, investigating studies about this therapy in individuals with resistant hypertension are few. This is a randomized controlled clinical trial. Forty-eight patients with resistant hypertension will be submitted to perform four short-term interventions: aerobic exercise sessions (mild-, moderate- and high-intensity) and control session, in random order and on separate days. After the short-term sessions, the patients will be randomly allocated into four groups for 8 weeks of follow-up: mild-, moderate- and high-intensity aerobic exercise, and a control group. The primary outcome is the occurrence of blood pressure reduction (office and ambulatory analysis, and acute and chronic effects). Secondary outcomes are autonomic and hemodynamic mechanisms: cardiac and vasomotor autonomic modulation, spontaneous baroreflex sensitivity, forearm blood flow and vascular resistance. The importance of exercise for hypertension has been known for decades, but little is known about the effects on patients with resistant hypertension. This study will help to understand whether different aerobic exercise intensities can induce different responses, as well as by what mechanisms adjustments in blood pressure levels may occur. ClinicalTrials.gov, ID: NCT02670681 . Registered on 28 January 2016 (first version); Brazilian Registry Platform Clinical Trials: protocol RBR-5q24zh . Registered on 24 June 2015.

  17. 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

  18. 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

  19. A randomized trail comparing primary percutaneous coronary intervention with a strategy of short-acting thrombolysis and immediate planned primary percutaneous coronary intervention in acute myocardial infarction

    Institute of Scientific and Technical Information of China (English)

    傅向华

    2003-01-01

    A randomized trail comparing primary percutaneous coronary intervention with a strategy of short-acting thrombolysis and immediate planned primary percutaneous coronary intervention in acute myocardial infarction!050000$河北医科大学第二医院河北医科大学心脏介入中心@傅向华

  20. Effect of goal attainment theory based education program on cardiovascular risks, behavioral modification, and quality of life among patients with first episode of acute myocardial infarction: Randomized study.

    Science.gov (United States)

    Park, Moonkyoung; Song, Rhayun; Jeong, Jin-Ok

    2017-02-24

    Effect of goal-attainment-theory-based education program on cardiovascular risks, behavioral modification, and quality of life among patients with first episode of acute myocardial infarction: randomized study BACKGROUND: The behavioral modification strategies should be explored at the time of admission to lead the maximum effect of cardiovascular risk management.

  1. A randomized, double-blind, placebo-controlled, multicentre study to assess haemodynamic effects of serelaxin in patients with acute heart failure

    NARCIS (Netherlands)

    Ponikowski, Piotr; Mitrovic, Veselin; Ruda, Mikhail; Fernandez, Alberto; Voors, Adriaan A.; Vishnevsky, Alexander; Cotter, Gad; Milo, Olga; Laessing, Ute; Zhang, Yiming; Dahlke, Marion; Zymlinski, Robert; Metra, Marco

    The aim of this study was to evaluate the haemodynamic effects of serelaxin (30 g/kg/day 20-h infusion and 4-h post-infusion period) in patients with acute heart failure (AHF). This double-blind, multicentre study randomized 71 AHF patients with pulmonary capillary wedge pressure (PCWP) 18 mmHg,

  2. 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

    admitted with acute colitis (random...... forest analysis. Ponies and Icelandic horses made up 59% of the population, whilst the remaining 41% were horses. Blood lactate concentration at admission was the only individual parameter significantly associated with probability of survival to discharge (P 

  3. 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

  4. Prospective randomized clinical trial of aggressive rehabilitation after acute Achilles tendon ruptures repaired with Dresden technique.

    Science.gov (United States)

    De la Fuente, Carlos; Peña y Lillo, Roberto; Carreño, Gabriel; Marambio, Hugo

    2016-03-01

    Rupture of the Achilles tendon is a common injury during working years. Aggressive rehabilitation may provide better outcomes, but also a greater chance of re-rupture. To determine if aggressive rehabilitation has better clinical outcomes for Achilles tendon function, Triceps surae function, one-leg heel rise capacity and lower complication rate during twelve weeks after percutaneous Achilles tendon repair compared to conventional rehabilitation. Randomized controlled trial. Thirty-nine patients were prospectively randomized. The aggressive group (n=20, 41.4 ± 8.3 years) received rehabilitation from the first day after surgery. The conventional group (n=19, 41.7 ± 10.7 years) rested for 28 days, before rehabilitation started. The statistical parameters were the Achilles tendon rupture score (ATRS), verbal pain scale, time to return to work, pain medication consumption, Achilles tendon strength, dorsiflexion range of motion (RoM), injured-leg calf circumference, calf circumference difference, one-leg heel rise repetition and difference, re-rupture rate, strength deficit rate, and other complication rates. Mixed-ANOVA and Bonferroni's post hoc test were performed for multiple comparisons. Student's t-test was performed for parameters measured on the 12th week. The aggressive group with respect to the conventional group had a higher ATRS; lower verbal pain score; lower pain medication consumption; early return to work; higher Achilles tendon strength; higher one-leg heel rise repetitions; and lower one-leg heel rise difference. The re-rupture rate was 5% and 5%, the strength deficit rate was 42% and 5%, and other complications rate was 11% and 15% in the conventional and aggressive group, respectively. Patients with Dresden repair and aggressive rehabilitation have better clinical outcomes, Achilles tendon function and one-leg heel rise capacity without increasing the postoperative complications rate after 12 weeks compared to rehabilitation with immobilization and

  5. 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

  6. The effect of antiemetics and reduced radiation fields on acute gastrointestinal morbidity of adjuvant radiotherapy in Stage I seminoma of the testis: a randomized pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Khoo, V.S.; Rainford, K.; Horwich, A.; Dearnaley, D.P. [Royal Marsden NHS Trust, Sutton (United Kingdom)

    1997-12-31

    The purpose of this pilot study was to evaluate the acute gastrointestinal morbidity of adjuvant radiotherapy (RT) for Stage I seminoma of the testis. Ten Stage I patients receiving para-aortic and ipsilateral pelvic nodal (dog-leg) RT provided a toxicity baseline (group A). Twenty Stage I patients randomized to dog-let RT or para-aortic RT (10 per group) were further randomized to received prophylactic ondansetron or expectant therapy with metoclopramide (group B). Daily patient-completed questionnaires evaluated acute toxicity. Dog-leg RT for Stage I seminomas is associated with readily demonstrable gastrointestinal tract (GIT) toxicity. The number of patients in this study is too small to produce definitive results, but there appears to be reduced GIT toxicity with prophylactic antiemetics. The effect of reduced RT fields has been assessed further in the MRC randomized tiral of field sizes (TE10). (Author).

  7. A Randomized Controlled Trial of Intravenous Magnesium Sulphate as an Adjunct to Standard Therapy in Acute Severe Asthma

    Directory of Open Access Journals (Sweden)

    Singh Anupam Kumar

    2008-12-01

    Full Text Available Though intravenous (IV Magnesium Sulphate (MgS04 has additive effect to beta-2 agonists, its additive benefit in face of combination therapy with beta-2-agonists and ipratropium (standard therapy of severe acute exacerbation of asthma remains unaddressed. The aim of this investigation was to evaluate the role of IV MgSO4 when used as an adjunct to standard therapy of severe exacerbations of asthma. Randomized, single blinded, placebo-controlled study was carried out in Emergency Department (ED. Patients aged 18-60 years presenting with acute asthma and FEV1 In group1 (controls, patients were nebulised with salbutamol and ipratropium thrice at 20 minutes interval and were given 2g IV MgSO4 at 30 minutes. In group2 patients were nebulised similarly, but were given IV normal saline at 30 minutes for blinding. FEV1 was evaluated at baseline and at 30 minutes intervals. The primary efficacy end point was FEV1%pred. at 120 mins and pooled discharge rate (derived from comparing proportion of groups attaining PEFR >60%pred. and relief in dyspnea at 30, 60, 90, 120 minutes. Both groups of 30 patients each, were matched with respect to demographic and pulmonary parameters (Baseline FEV1% :22.0+5.1% in group2 vs.22.07+5.2% in group1, p=0.87.At 120 minutes, there was a higher mean FEV1 %pred (62.84+4.73% vs. 56.7+4.5% and %improvement from baseline of (40.7+9.2%vs34.77+7.3%, in group 2 as compared to group1 (Mean Difference= 6.07%, C.I.1.87-10.62., pMagnesium sulfate as an adjunct to standard therapy in patients with severe exacerbation of asthma could cause improvement in pulmonary function and decrease in hospital admission.

  8. Early Administration of Selenium in Patients with Acute Traumatic Brain Injury: A Randomized Double-blinded Controlled Trial.

    Science.gov (United States)

    Moghaddam, Omid Moradi; Lahiji, Mohammad Niakan; Hassani, Valiollah; Mozari, Shakiba

    2017-02-01

    The present study was carried out to examine this hypothesis that administration of selenium can prevent the development of injuries by brain trauma and thus can modulate patients' functional recovery and also improve posttraumatic outcome. This double-blinded controlled trial was carried out on 113 patients who were hospitalized following traumatic brain injury (TBI) with Glasgow Coma Scale score of 4-12 that were randomly assigned to receive selenium within 8 h after injury plus standard treatment group or routine standard treatment alone as the control. The primary endpoint was to assess patients' functional recovery at 2 months after the injury based on extended Glasgow Outcome Scale score (GOS-E). Secondary outcomes included the changes in Full Outline of Unresponsiveness score (FOUR) score, Sequential Organ Failure Assessment (SOFA) score, and acute physiology and chronic health evaluation (APACHE) III score, side effects of selenium, length of Intensive Care Unit (ICU) stay, and length of hospital stay. There was no difference in the length of ICU and hospital stay, the trend of the change in FOUR and SOFA scores within 15 days of first interventions, and the mean APACHE III score on the 1(st) and 15(th) days between the two groups. Mortality was 15.8% in selenium group and 19.6% in control group with no between-group difference. No difference was revealed between the two groups in appropriate outcome according to GOS-E score at 60 ± 10 days and also 30 ± 5 days according to the severity of TBI. This human trial study could not demonstrate beneficial effects of intravenous infusion of selenium in the improvement of outcomes in patients with acute TBI.

  9. 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; Pacute 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.

  10. Early application of citicoline in the treatment of acute stroke: A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Shi, Pei-yu; Zhou, Xiao-cui; Yin, Xiao-xue; Xu, Liang-liang; Zhang, Xing-ming; Bai, Hong-ying

    2016-04-01

    This study was to evaluate the efficacy and safety of early application of citicoline in the treatment of patients with acute stroke by meta-analysis. Randomized controlled trials published until May 2015 were electronically searched in MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, WHO International Clinical Trial Registration Platform, Clinical Trial.gov, and China Biology Medicine disc. Two reviewers independently screened the articles and extracted the data based on the inclusion and exclusion criteria. The quality of included articles was evaluated by using Revman5.0, and meta-analysis was performed. The results showed that 1027 articles were obtained in initial retrieval, and finally 7 articles, involving a total of 4039 cases, were included for analysis. The meta-analysis showed that no significant differences were found in the long-term mortality (OR=0.91, 95% CI 0.07 to 1.09, P=0.30), the rate of dependency (OR=1.02, 95% CI 0.87 to 1.24, P=0.85), and the effective rate (OR=0.98, 95% CI 0.84 to 1.14, P=0.82) between citicoline group and control group. The overall rate of adverse events in citicoline group was not significantly different from that in control group (P=0.30). The quality of included articles reached moderate-low level. In conclusion, citicolne cannot reduce long-term mortality and dependence rate in the treatment of acute stroke, and the effective rate of citivoline may be not better than that of controls but with reliable safety.

  11. 1H NMR-based serum metabolic profiling in compensated and decompensated cirrhosis

    Institute of Scientific and Technical Information of China (English)

    Su-Wen Qi; Zhi-Guang Tu; Wu-Jian Peng; Lin-Xian Wang; Xin Ou-Yang; An-Ji Cai; Yong Dai

    2012-01-01

    AIM: To study the metabolic profiling of serum samples from compensated and decompensated cirrhosis patients.METHODS: A pilot metabolic profiling study was conducted using three groups: compensated cirrhosis patients (n = 30), decompensated cirrhosis patients (n = 30) and healthy controls (n = 30). A 1H nuclear magnetic resonance (NMR)-based metabonomics approach was used to obtain the serum metabolic profiles of the samples. The acquired data were processed by multivariate principal component analysis and orthogonal partial least-squares discriminant analysis (OPLS-DA). RESULTS: The OPLS-DA model was capable of distinguishing between decompensated and compensated cirrhosis patients, with an R2Y of 0.784 and a Q2Y of 0.598. Twelve metabolites, such as pyruvate, phenylalanine and succinate, were identified as the most influential factors for the difference between the two groups. The validation of the diagnosis prediction showed that the accuracy of the OPLSDA model was 85% (17/20). CONCLUSION: 1H NMR spectra combined with pattern recognition analysis techniques offer a new way to diagnose compensated and decompensated cirrhosis in the future.

  12. Hagen-Poiseuille's law: The link between cirrhosis, liverstiffness, portal hypertension and hepatic decompensation

    Institute of Scientific and Technical Information of China (English)

    Gerond Lake-Bakaar; Muneeb Ahmed; Amy Evenson; Alan Bonder; Salomao Faintuch; Vinay Sundaram

    2015-01-01

    The onset of hepatic decompensation in cirrhosisheralds an accelerated downhill course with pooroutcome. The sole predictor of this decompensation in cirrhosis is increased hepatic vein to portal veingradient hepatic venous pressure gradient (HVPG).Surrogate markers of liver function or hepatic reserveappear to be less relevant. The hepatic sinusoidsbecome less elastic and more rigid as liver fibrosisand cirrhosis progress. We propose that the Hagen-Poiseuille's law, which applies to rigid, but not elasticvessels, determines the pressure-flow characteristicsin the sinusoids. In the rigid cirrhotic liver, HVPG risesdramatically with any change in net surface areaor radius, r4 of the vasculature that follows surgicalresection. This review relates liver stiffness to therisk of decompensation in patients with cirrhosis. Theliver has a unique dual blood supply comprising a lowpressure portal vein and high pressure hepatic artery.We compare the complexity of autoregulation in thenormal elastic liver with that in the rigid cirrhotic liver.Therapeutic modalities to reduce portal pressure mayreduce the risk of hepatic decompensation and improveoutcomes in cirrhosis.

  13. Budd-Chiari like syndrome in decompensated alcoholic steatohepatitis and liver cirrhosis

    Institute of Scientific and Technical Information of China (English)

    Carlos Robles-Medranda; Hannah Lukashok; Beatriz Biccas; Vera L Pannain; Homero S Fogaca

    2006-01-01

    A rare case of pseudo-Budd-Chiari Syndrome in a patient with decompensated alcoholic liver disease is reported.Although clinical and radiological findings suggested Budd-Chiari Syndrome, the liver biopsy revealed micronodular cirrhosis and absence of histological signs of hepatic outflow obstruction.

  14. 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.

  15. 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 was ...

  16. Mechanical instability after acute ankle ligament injury: randomized prospective comparison of two forms of conservative treatment

    Directory of Open Access Journals (Sweden)

    Marcelo Pires Prado

    2013-08-01

    Full Text Available OBJECTIVE: This trial has the objective to investigate the incidence of mechanical ankle instability after the conservative treatment of first episode, severe ankle ligamentar lesions. This common lesion affects young, professional and physical active patients, causing important personal and economic consequences. There are difficulties related to adequate diagnosis and treatment for these lesions. METHOD: 186 patients with severe ankle ligament lesions were included in this trial. They were randomized in two treatment options. In group A patients were treated using ankle long orthoosis, weight bearing allowed as confortable, pain care, ice, elevation with restricted joint mobilization for three weeks. After that they were maintained in short, functional orthosis (air cast, starting the reabilitation program. In group B patients were immobilized using a functional orthosis (air cast, following the same other sequences that patients in group A. RESULTS: We did not find significant differences in relation to the residual mechanical ankle instability between both groups. We did not find differences in the intensity of pain, but the functional evaluation using AOFAS score system showed better results in the functional treatment group. CONCLUSION: The functional treatment (Group B had better AOFAS score and few days off their professional activities, comparing with patients treated with rigid orthosis (Group A, without increased chance in developing ankle mechanical instability.

  17. 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.

  18. Random Lead Time of the acute ghrelin response to a psychological stress

    Directory of Open Access Journals (Sweden)

    Geetha.T

    2014-12-01

    Full Text Available Ghrelin is a growth hormone and cortisol secretagogue that plays an important role in appetite and weight regulation. It is not known whether ghrelin is involved in the eating response to stress in humans. In the present study we examined the effects of psychologically induced stress on plasma ghrelin levels in patients with bingeeating disorder (BED and in healthy subjects of normal or increased body mass index (BMI. Volunteers were subjected to the standardized trier social stress test (TSST. Basal ghrelin levels in patients were at an intermediate level between thin and healthy obese subjects, but this difference did not attain statistical significance. There were no differences in ghrelin levels throughout the test among the groups after correction for BMI, age and gender. A significant difference in the trend time of ghrelin was revealed when the three groups were analyzed according to their cortisol response to stress. Ghrelin levels increased in cortisol responders whereas no change or a decrease in ghrelin levels occurred in cortisol non-responders. We also found Optimal time T*, Minimal Repair δ and Random Lead Time g to minimize the ghrelin level.

  19. 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.

  20. 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.

  1. 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.

  2. 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

  3. Comparison of oral montelukast with oral zileuton in acute asthma: A randomized, double-blind, placebo-controlled study

    Science.gov (United States)

    Magazine, Rahul; Shahul, Hameed Aboobackar; Chogtu, Bharti; Kamath, Asha

    2016-01-01

    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. PMID:27185992

  4. Results of Membrane-Activated Chelator Stroke Intervention randomized trial of DP-b99 in acute ischemic stroke.

    Science.gov (United States)

    Lees, Kennedy R; Bornstein, Natan; Diener, Hans-Christoph; Gorelick, Philip B; Rosenberg, Gilad; Shuaib, Ashfaq

    2013-03-01

    DP-b99, a lipophilic moderate-affinity chelator of zinc, was postulated to improve recovery after acute ischemic stroke. We evaluated the safety and therapeutic effects of DP-b99 in patients with acute hemispheric ischemic stroke. The Membrane-Activated Chelator Stroke Intervention trial was a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial of intravenous DP-b99 administered for 4 consecutive days (NCT00893867). Acute ischemic stroke patients within 9 hours of onset, but untreated by alteplase, with a baseline National Institutes of Health Stroke Scale score of 10 to 16, and evidence of language dysfunction, visual field defect, and neglect were eligible. The primary efficacy analysis compared distributions of functional status measured by modified Rankin score in the intent-to-treat population of patients with any post-treatment outcome, adjusted for initial severity. Functional and neurological recovery were secondary measures. Home time was an exploratory end point. Enrollment terminated at n=446 after the planned interim analysis determined futility; follow-up continued. Final modified Rankin score distributions were equal between DP-b99 and placebo-treated groups (P=0.10; P(adj) adjusted for baseline age and National Institutes of Health Stroke Scale=0.21). Fewer patients recovered to modified Rankin score ≤1 in the DP-b99-treated group (45/218; 20.6%) than after placebo (63/219; 28.8%) (P=0.05; P(adj)=0.10). Similarly, fewer patients attained National Institutes of Health Stroke Scale ≤1 after DP-b99 (42/218; 19.3%) than placebo (56/219; 25.6%; P=0.10; P(adj)=0.26). Mortality was similar between DP-b99 and placebo intent-to-treat groups (36/218; 16.5% vs 33/219; 15.1%; P=0.68). Home time was unchanged by treatment (median 36 vs 36.5 days; P=0.25). Despite encouraging preclinical and phase II trial data, DP-b99 shows no evidence of efficacy in treating human ischemic stroke.

  5. 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

  6. Efficacy and feasibility of radiofrequency ablation for decompensated cirrhotic patients with hepatocellular carcinoma

    Institute of Scientific and Technical Information of China (English)

    WU Jin-yu; YANG Wei; CUI Ming; YIN Shan-shan; GAO Wen; WU Wei; YAN Kun; CHEN Min-hua

    2010-01-01

    Background Most HCC patients with decompensation of liver function lost the chance of surgical and/or interventional treatment. The aim of this study was to evaluate feasibility and outcome of radiofrequency ablation (RFA) in treating hepatocellular carcinoma (HCC) patients with poor liver function (Child-Pugh class C), who are not suitable for surgery or hepatic artery chemo-embolization.Methods Thirteen HCC patients (the number of tumors was 17) with liver function of Child-Pugh C (scores: 10.2±0.4)were included in the study. Among the patients, 8 were male and 5 were female with the average age of (61.6±10.9)years old. The average size of HCC was (3.8±1.0) cm. Two patients were recurrent HCC and 30.8% of the patients had multiple tumors (2-3 tumors). All the patients were treated with RFA.Results There were 22 RFA sessions (1-4 sessions per patient) in all, average ablations per tumor at first session was 3.1. One week after RFA, the liver enzymes elevated in 9 patients (69.2%), in 7 of them, the liver enzyme returned to pre-RFA level in 1-3 months. One month after RFA, the Child-Pugh grading was 10.3±0.8 (Child-Pugh C), while that of pre-RFA was 10.2±0.4 (Child-Pugh C), with no significant difference. Computer tomography (CT) one month after RFA showed that the tumor necrosis rate was 88.2% (15/17). Five patients had 2-4 repeated RFA due to HCC recurrence.During the follow-up of 2-69 months in this group, survival rate of one year was 53.8%, two years was 30.8%, and three year was 15.4%. The incidence of RFA-related complications was 13.6% (3/22 sessions), including 1 case of GI hemorrhage and 1 sub-capsular hemorrhage of the liver. One patient with HCC over 5 cm who had fever and liver abscess after RFA, and was dead 2 months later due to liver function failure.Conclusions Minimal invasive RFA provides possible treatment modality for HCC patients with poor liver function, who are not candidates for surgical and/or interventional therapy. For large HCC

  7. Acute Effects of Contract-Relax Stretching vs. TENS in Young Subjects With Anterior Knee Pain: A Randomized Controlled Trial.

    Science.gov (United States)

    Valenza, Marie C; Torres-Sánchez, Irene; Cabrera-Martos, Irene; Valenza-Demet, Gerald; Cano-Cappellacci, Marcelo

    2016-08-01

    Valenza, MC, Torres-Sánchez, I, Cabrera-Martos, I, Valenza-Demet, G, and Cano-Cappellacci, M. Acute effects of contract-relax stretching vs. TENS in young subjects with anterior knee pain: A randomized controlled trial. J Strength Cond Res 30(8): 2271-2278, 2016-The aim of this study was to examine the immediate effects on pressure point tenderness, range of motion (ROM), and vertical jump (VJ) of contract-relax stretching vs. transcutaneous electrical nerve stimulation (TENS) therapy in individuals with anterior knee pain (AKP). Eighty-four subjects with AKP were randomly assigned to 1 of 3 different intervention groups: a contract-relax stretching group (n = 28), a TENS intervention group (n = 28), and a control group (n = 28). The participants included in the sample were both sex (37.5% men vs. 62.5% women) at a mean age of 21 years, with mean values of height and weight of 169 cm and 64 kg, respectively. The main outcome measures were knee ROM, pressure pain threshold (PPT), and VJ. The participants were assessed at baseline and immediately after treatment. In the case of VJ, at baseline, immediately after the intervention, at 3 and at 6 minutes posttreatment. The data analysis showed that PPT scores of participants in the stretching and TENS group significantly increased from pretest to posttest (p ≤ 0.05). A significant increase pre- to posttreatment in ROM (p stretching groups showed significant differences between preintervention and all postintervention values (p ≤ 0.05), whereas no significant differences were found in the control group. In conclusion, the results show significant pre-to-post-treatment effects in PPT, ROM, and VJ from both contract-relax stretching and TENS in young subjects with AKP.

  8. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial

    Science.gov (United States)

    Roncalli, Jérôme; Mouquet, Frédéric; Piot, Christophe; Trochu, Jean-Noel; Le Corvoisier, Philippe; Neuder, Yannick; Le Tourneau, Thierry; Agostini, Denis; Gaxotte, Virginia; Sportouch, Catherine; Galinier, Michel; Crochet, Dominique P.; Teiger, Emmanuel; Richard, Marie-Jeanne; Polge, Anne-Sophie; Beregi, Jean-Paul; Manrique, Alain; Carrie, Didier; Susen, Sophie; Klein, Bernard; Parini, Angelo; Lamirault, Guillaume; Croisille, Pierre; Rouard, Hélène; Bourin, Philippe; Nguyen, Jean-Michel; Delasalle, Béatrice; Vanzetto, Gérald; Van Belle, Eric; Lemarchand, Patricia F.

    2011-01-01

    Aims Intracoronary administration of autologous bone marrow cells (BMCs) leads to a modest improvement in cardiac function, but the effect on myocardial viability is unknown. The aim of this randomized multicenter study was to evaluate the effect of BMC therapy on myocardial viability in patients with decreased left ventricular ejection fraction (LVEF) after acute myocardial infarction (AMI) and to identify predictive factors for improvement of myocardial viability. Methods and Results One-hundred one patients with AMI and successful reperfusion, LVEF ≤45%, and decreased myocardial viability (resting Tl201-SPECT) were randomized to either a control group (n=49) or a BMC group (n=52). Primary endpoint was improvement of myocardial viability 3 months after AMI. Baseline mean LVEF measured by radionuclide angiography was 36.3 ± 6.9%. BMC infusion was performed 9.3 ± 1.7 days after AMI. Myocardial viability improved in 16/47 (34%) patients in the BMC group compared to 7/43 (16%) in the control group (p = 0.06). The number of non-viable segments becoming viable was 0.8 ± 1.1 in the control group and 1.2 ± 1.5 in the BMC group (p = 0.13). Multivariate analysis including major post-AMI prognostic factors showed a significant improvement of myocardial viability in BMC vs. control group (p=0.03). Moreover, a significant adverse role for active smoking (p=0.04) and a positive trend for microvascular obstruction (p=0.07) were observed. Conclusions Intracoronary autologous BMC administration to patients with decreased LVEF after AMI was associated with improvement of myocardial viability in multivariate –but not in univariate – analysis. A large multicenter international trial is warranted to further document the efficacy of cardiac cell therapy and better define a group of patients that will benefit from this therapy. PMID:21127322

  9. Sucralfate versus mesalazine versus hydrocortisone in the prevention of acute radiation proctitis during conformal radiotherapy for prostate carcinoma. A randomized study

    Energy Technology Data Exchange (ETDEWEB)

    Sanguineti, G.; Franzone, P.; Marcenaro, M.; Vitale, V. [Dept. of Radiation Oncology, National Inst. for Cancer Research, Genova (Italy); Foppiano, F. [Dept. of Physics, National Inst. for Cancer Research, Genova (Italy)

    2003-07-01

    Purpose: To assess whether the topical use of steroids or 5-aminosalicylic acid (5-ASA) is superior to sucralfate in preventing acute rectal toxicity during three-dimensional conformal radiotherapy (3DCRT) to 76 Gy. Patients and Methods: Patients undergoing 3DCRT for prostate carcinoma at our institution were offered to be randomized to sucralfate 3 g in 15 ml suspension enema (Antepsin {sup trademark}), mesalazine 4 g gel enema (Enterasyn trademark), or hydrocortisone 100 mg foam enema (Colifoam {sup trademark}). Randomization was blind to the treating physician but not to the patient. Sucralfate was chosen as control arm. Topical treatment had to be performed once daily, starting on day 1 of 3DCRT. Acute rectal toxicity was scored weekly according to RTOG criteria. Time to occurrence of grade 2+ acute rectal toxicity was taken as endpoint. Results: The trial was opened in August 1999, and after the first 24 patients had been treated, arm 2 was discontinued because of eight patients receiving mesalazine, seven actually developed acute rectal toxicity (five patients grade 3 and two patients grade 2). Until May 2001, 134 consecutive patients were randomly assigned to sucralfate (63 patients), mesalazine (eight patients) or hydrocortisone (63 patients). The cumulative incidence of acute rectal toxicity at the end of treatment by arm is 61.9 {+-} 6.1%, 87.5 {+-} 11.7%, and 52.4 {+-} 6.2% for arms 1, 2, and 3, respectively. The difference between the mesalazine group and the sucralfate group is highly significant (hazard ratio [HR] 2.5, 95% confidence interval [CI] 1.1-5.7; p = 0.03). At both uni- and multivariate analysis taking into account several patients and treatment covariates, the difference between hydrocortisone and sucralfate is not significant (HR 0.7, 95% CI 0.5-1.2; p = 0.2). Conclusion: Topical mesalazine is contraindicated during radiotherapy. Hydrocortisone enema is not superior to sucralfate in preventing acute rectal toxicity. (orig.)

  10. Does breastfeeding reduce acute procedural pain in preterm infants in the neonatal intensive care unit? A randomized clinical trial.

    Science.gov (United States)

    Holsti, Liisa; Oberlander, Timothy F; Brant, Rollin

    2011-11-01

    Managing acute procedural pain effectively in preterm infants in the neonatal intensive care unit remains a significant problem. The objectives of this study were to evaluate the efficacy of breastfeeding for reducing pain and to determine if breastfeeding skills were altered after this treatment. Fifty-seven infants born at 30-36 weeks gestational age were randomized to be breastfed (BF) or to be given a soother during blood collection. Changes in the Behavioral Indicators of Infant Pain (BIIP) and in mean heart rate (HR) across 3 phases of blood collection were measured. In the BF group, the Premature Infant Breastfeeding Behaviors (PIBBS) scale was scored before and 24 hours after blood collection. Longitudinal regression analysis was used to compare changes in Lance/squeeze and Recovery phases of blood collection between groups, with gestational age at birth, baseline BIIP scores, and mean HR included as covariates. Differences in PIBBS scores were assessed using a paired t-test. Relationships between PIBBS scores, BIIP scores, and HR were evaluated with Pearson correlations. No differences between treatment groups were found: BIIP (P=0.44, confidence interval [CI] -1.60-0.69); HR (P=0.73, CI -7.0-10.0). Infants in the BF group showed improved PIBBS scores after the treatment (Ppain indices or interfere with the acquisition of breastfeeding skills. Exploratory analyses indicate there may be benefit for infants with mature breastfeeding abilities.

  11. Do alcohol-based hand rubs reduce the incidence of acute diarrhea during military deployments? A prospective randomized trial.

    Science.gov (United States)

    Succo, Tiphanie; De Laval, Franck; Sicard, Sébastien; Belleoud, Didier; Marimoutou, Catherine; Mayet, Aurélie; Sagaon-Teyssier, Luis; Michel, Rémy

    Acute diarrhea remains a public health concern in armed forces deployed in tropical areas where access to water and soap is limited. This study aims to assess the effectiveness of alcohol-based hand rubs (ABHR) on incidence of diarrhea in poor hygiene conditions. A prospective randomized trial was conducted between November 2014 and January 2015 among French military troops deployed in Africa to compare a group of soldiers receiving usual hand hygiene recommendations (control group), to a group of soldiers who received ABHR in addition to usual hand hygiene recommendations (intervention group). Data on diarrhea and hygiene behaviors were collected using self-questionnaires. The incidence rate of diarrhea episodes in groups was compared. Participation rate was 59% (236/400). The proportion of individuals who used ABHR was 97% in the intervention group and 62% in the control group. The overall incidence rate of diarrheal episodes was observed to be in the region of 60 per 100 persons-month without any significant difference between groups after adjustment on confounding factors (p = 0.93). Handwashing with soap was used on average 4 times a day in the control group and twice a day in the intervention group (p = 0.93). It was the only significant protective factor for diarrhea (p soap and good quality water should be a priority on the field. Copyright © 2016. Published by Elsevier Ltd.

  12. 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.

  13. Orange Pomace Improves Postprandial Glycemic Responses: An Acute, Randomized, Placebo-Controlled, Double-Blind, Crossover Trial in Overweight Men

    Science.gov (United States)

    Chen, C.-Y. Oliver; Rasmussen, Helen; Kamil, Alison; Du, Peng; Blumberg, Jeffrey B.

    2017-01-01

    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. PMID:28208806

  14. [Study on clinical effectiveness of acupuncture and moxibustion on acute Bell's facial paralysis: randomized controlled clinical observation].

    Science.gov (United States)

    Wu, Bin; Li, Ning; Liu, Yi; Huang, Chang-qiong; Zhang, Yong-ling

    2006-03-01

    To investigate the adverse effects of acupuncture on the prognosis, and effectiveness of acupuncture combined with far infrared ray in the patient of acute Bell's facial paralysis within 48 h. Clinically randomized controlled trial was used, and the patients were divided into 3 groups: group A (early acupuncture group), group B (acupuncture combined with far infrared ray) and group C (acupuncture after 7 days). The facial nerve functional classification at the attack, 7 days after the attack and after treatment, the clinically cured rate of following-up of 6 months, and the average cured time, the cured time of complete facial paralysis were observed in the 3 groups. There were no significant differences among the 3 groups in the facial nerve functional classification 7 days after the attack, the clinically cured rate of following-up of 6 months and the average cured time (P > 0.05), but the cured time of complete facial paralysis in the group A and the group B were shorter than that in the group C (P facial paralysis can be treated with acupuncture and moxibustion, and traditional moxibustion can be replaced by far infrared way.

  15. A Randomized Controlled Trial of Defervescent Efficacy of Oral versus Rectal Paracetamol in a Pediatric Acute Care Setting

    Directory of Open Access Journals (Sweden)

    Chulathida Chomchai

    2016-01-01

    Full Text Available Objective: To assess the comparative efficacy of oral versus rectal paracetamol in reducing fever in a pediatric acute care setting. Methods: 200 children with body temperature >39oc were randomized to receive oral or rectal paracetamol, together with tepid sponging. Their body temperatures were measured at enrollment, after fever reduction protocol had been completed and at 30-minute and 60-minute intervals. General linear model was used to assess the effect of time and type of medication on fever reduction. Results: Mean log [temperature] differed significantly between time intervals (F(1.275, 248.576 = 32.766, p<0.001 and the test of between subject effects showed that there was a significant effect of antipyretic types on mean body temperature of children at different time intervals (F(1,995 = 4.040, p<0.05. Conclusion: Rectal paracetamol was shown to be more effective overall at lowering body temperature, especially at the termination of fever reduction protocol, and at 60 minutes.

  16. 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

    2008-01-01

    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 ten

  17. Effect of paracetamol (acetaminophen) on body temperature in acute ischemic stroke: a double-blind, randomized phase II clinical trial

    NARCIS (Netherlands)

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

    2001-01-01

    textabstractBACKGROUND AND PURPOSE: Body temperature is a strong predictor of outcome in acute stroke. However, it is unknown whether antipyretic treatment leads to early and clinically worthwhile reduction of body temperature in patients with acute stroke, especially w

  18. Short-term effect of levosimendan on free light chain kappa and lambda levels in patients with decompensated chronic heart failure.

    Science.gov (United States)

    Kurt, Ibrahim Halil; Yavuzer, Kemal; Batur, Mustafa Kemal

    2010-09-01

    To investigate the effects of levosimendan, a positive inotropic agent, on the new heart failure markers immunoglobulin free light chains kappa and lambda (FLC-kappa and FLC-lambda) in decompensated chronic heart failure (HF), 59 patients with New York Heart Association (NYHA) class III-IV HF were enrolled. Patients were randomized into levosimendan (n = 31) and standard HF treatment (n = 29) groups. Serum FLC-kappa and FLC-lambda, brain natriuretic peptide (BNP), and ejection fraction (EF) were measured before treatment and on the 5th day of treatment initiation. Forty-two percent of subjects were females (n = 25) and overall mean age was 64.1 +/- 10.7 years. FLC-kappa (P lambda (P kappa/FLC-lambda ratios in both groups were similar, whereas FLC-kappa and FLC-lambda levels and the FLC-kappa/FLC-lambda ratio showed no significant correlation with NYHA class, brain natriuretic peptide (BNP) and ejection fraction (EF) levels; and BNP and EF changes after the treatment. Symptomatic improvement in the levosimendan group according to the NYHA class was significantly better than in the standard treatment group (P = 0.044). While 55.2% of patients in the levosimendan group showed a 1-degree shift to lower NYHA classes, 10.3% showed a 2-degree decrease. In conclusion, levosimendan caused short-term hemodynamic and symptomatic improvements, with a more pronounced decrease in FLC levels in patients with advanced decompensated HF.

  19. 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.

  20. 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.

  1. A conceptual model of compensation/decompensation in lumbar segmental instability.

    Science.gov (United States)

    Barz, T; Melloh, M; Lord, S J; Kasch, R; Merk, H R; Staub, L P

    2014-09-01

    Lumbar spinal instability (LSI) is a common spinal disorder and can be associated with substantial disability. The concept of defining clinically relevant classifications of disease or 'target condition' is used in diagnostic research. Applying this concept to LSI we hypothesize that a set of clinical and radiological criteria can be developed to identify patients with this target condition who are at high risk of 'irreversible' decompensated LSI for whom surgery becomes the treatment of choice. In LSI, structural deterioration of the lumbar disc initiates a degenerative cascade of segmental instability. Over time, radiographic signs become visible: traction spurs, facet joint degeneration, misalignment, stenosis, olisthesis and de novo scoliosis. Ligaments, joint capsules, local and distant musculature are the functional elements of the lumbar motion segment. Influenced by non-functional factors, these functional elements allow a compensation of degeneration of the motion segment. Compensation may happen on each step of the degenerative cascade but cannot reverse it. However, compensation of LSI may lead to an alleviation or resolution of clinical symptoms. In return, the target condition of decompensation of LSI may cause the new occurrence of symptoms and pain. Functional compensation and decompensation are subject to numerous factors that can change which makes estimation of an individual's long-term prognosis difficult. Compensation and decompensation may influence radiographic signs of degeneration, e.g. the degree of misalignment and segmental angulation caused by LSI is influenced by the tonus of the local musculature. This conceptual model of compensation/decompensation may help solve the debate on functional and psychosocial factors that influence low back pain and to establish a new definition of non-specific low back pain. Individual differences of identical structural disorders could be explained by compensated or decompensated LSI leading to changes

  2. A double blind, placebo-controlled, randomized crossover study of the acute metabolic effects of olanzapine in healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Vance L Albaugh

    Full Text Available Atypical antipsychotics exhibit metabolic side effects including diabetes mellitus and obesity. The adverse events are preceded by acute worsening of oral glucose tolerance (oGTT along with reduced plasma free fatty acids (FFA and leptin in animal models. It is unclear whether the same acute effects occur in humans.A double blind, randomized, placebo-controlled crossover trial was conducted to examine the potential metabolic effects of olanzapine in healthy volunteers. Participants included male (8 and female (7 subjects [18-30 years old, BMI 18.5-25]. Subjects received placebo or olanzapine (10 mg/day for three days prior to oGTT testing. Primary endpoints included measurement of plasma leptin, oral glucose tolerance, and plasma free fatty acids (FFA. Secondary metabolic endpoints included: triglycerides, total cholesterol, high- and low-density lipoprotein cholesterol, heart rate, blood pressure, body weight and BMI. Olanzapine increased glucose Area Under the Curve (AUC by 42% (2808±474 vs. 3984±444 mg/dl·min; P = 0.0105 during an oGTT. Fasting plasma leptin and triglycerides were elevated 24% (Leptin: 6.8±1.3 vs. 8.4±1.7 ng/ml; P = 0.0203 and 22% (Triglycerides: 88.9±10.1 vs. 108.2±11.6 mg/dl; P = 0.0170, whereas FFA and HDL declined by 32% (FFA: 0.38±0.06 vs. 0.26±0.04 mM; P = 0.0166 and 11% (54.2±4.7 vs. 48.9±4.3 mg/dl; P = 0.0184, respectively after olanzapine. Other measures were unchanged.Olanzapine exerts some but not all of the early endocrine/metabolic changes observed in rodent models of the metabolic side effects, and this suggest that antipsychotic effects are not limited to perturbations in glucose metabolism alone. Future prospective clinical studies should focus on identifying which reliable metabolic alterations might be useful as potential screening tools in assessing patient susceptibility to weight gain and diabetes caused by atypical antipsychotics.ClinicalTrials.gov NCT00741026.

  3. 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.

  4. Ischemic electrocardiographic abnormalities and prognosis in decompensated heart failure.

    Science.gov (United States)

    Greig, Douglas; Austin, Peter C; Zhou, Limei; Tu, Jack V; Pang, Peter S; Ross, Heather J; Lee, Douglas S

    2014-11-01

    Identification of coronary ischemia may enable targeted diagnostic and therapeutic strategies for acute heart failure. We determined the risk of 30-day mortality associated with ischemic ECG abnormalities in patients with acute heart failure. Among 8772 patients (53.4% women, median 78 years [Q1, Q3: 68,84]) presenting with acute heart failure to 86 hospital emergency departments in Ontario, Canada, Q-waves, T-wave inversion, or ST-depression were present in 51.8% of subjects. However, presence of ST-depression was the only finding associated with 30-day mortality with adjusted odds ratio 1.24 (95% confidence interval [CI], 1.02-1.50). Using continuous net reclassification improvement, addition of ST-depression to the Emergency Heart failure Mortality Risk Grade model reclassified 16.9% of patients overall, and 29.3% of those with a history of ischemic heart disease (both P<0.001). By adding ST-depression to the model, the Emergency Heart failure Mortality Risk Grade was extended to predict 30-day death with high discrimination (c-statistic 0.801), with 0.57% mortality rate in the lowest risk decile. Adjusted odds ratios for 30-day mortality were 2.81 (95% CI, 1.48-5.31; P=0.002) in quintile 2, 7.41 (95% CI, 4.13-13.30; P<0.001) in quintile 3, and 14.47 (95% CI, 8.20-25.54; P<0.001) in quintile 4 compared with the lowest risk quintile. When the highest risk quintile was subdivided into 2 equally sized risk strata (deciles 9 and 10), the adjusted odds ratios for 30-day mortality were 27.20 (95% CI, 15.33-48.27; P<0.001) in decile 9 and 58.96 (95% CI, 33.54-103.65; P<0.001) in highest risk decile 10. Presence of ST-depression on the ECG reclassified risk of 30-day mortality in patients with acute heart failure, identifying both high- and low-risk subsets. © 2014 American Heart Association, Inc.

  5. 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

  6. Dual or mono antiplatelet therapy for patients with acute ischemic stroke or transient ischemic attack: systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Geeganage, Chamila M; Diener, Hans-Christoph; Algra, Ale; Chen, Christopher; Topol, Eric J; Dengler, Reinhard; Markus, Hugh S; Bath, Matthew W; Bath, Philip M W

    2012-04-01

    Antiplatelets are recommended for patients with acute noncardioembolic stroke or transient ischemic attack. We compared the safety and efficacy of dual versus mono antiplatelet therapy in patients with acute ischemic stroke or transient ischemic attack. Completed randomized controlled trials of dual versus mono antiplatelet therapy in patients with acute (≤3 days) ischemic stroke/transient ischemic attack were identified using electronic bibliographic searches. The primary outcome was recurrent stroke (ischemic, hemorrhagic, unknown; fatal, nonfatal). Comparison of binary outcomes between treatment groups was analyzed with random effect models and described using risk ratios (95% CI). Twelve completed randomized trials involving 3766 patients were included. In comparison with mono antiplatelet therapy, dual therapy (aspirin+dipyridamole and aspirin+clopidogrel) significantly reduced stroke recurrence, dual 58 (3.3%) versus mono 91 (5.0%; risk ratio, 0.67; 95% CI, 0.49-0.93); composite vascular event (stroke, myocardial infarction, vascular death), dual 74 (4.4%) versus mono 106 (6%; risk ratio, 0.75; 95% CI, 0.56-0.99); and the combination of stroke, transient ischemic attack, acute coronary syndrome, and all death, dual 100 (1.7%) versus mono 136 (9.1%; risk ratio, 0.71; 95% CI, 0.56-0.91); dual therapy was also associated with a nonsignificant trend to increase major bleeding, dual 15 (0.9%) versus mono 6 (0.4%; risk ratio, 2.09; 95% CI, 0.86-5.06). Dual antiplatelet therapy appears to be safe and effective in reducing stroke recurrence and combined vascular events in patients with acute ischemic stroke or transient ischemic attack as compared with mono therapy. These results need to be tested in prospective studies.

  7. 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 costs related to LBP were collected monthly and valued using standard costs. The incremental cost-effectiveness ratio was computed as incremental total costs divided by incremental QALYs. 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.

  8. A phase 2/3 multicenter randomized clinical trial of ABX-CBL versus ATG as secondary therapy for steroid-resistant acute graft-versus-host disease.

    Science.gov (United States)

    Macmillan, Margaret L; Couriel, Daniel; Weisdorf, Daniel J; Schwab, Gisela; Havrilla, Nancy; Fleming, Thomas R; Huang, Saling; Roskos, Lorin; Slavin, Shimon; Shadduck, Richard K; Dipersio, John; Territo, Mary; Pavletic, Steve; Linker, Charles; Heslop, Helen E; Deeg, H Joachim; Blazar, Bruce R

    2007-03-15

    Treatment for steroid-resistant acute graft-versus-host disease (GVHD) has had limited success. ABX-CBL is a hybridoma-generated murine IgM monoclonal antibody against the CD147 antigen, weakly expressed on human leukocytes and up-regulated on activated lymphocytes. A prospective, multicenter, open-label, randomized clinical trial comparing ABX-CBL to antithymocyte globulin (ATG) for treatment of steroid-resistant acute GVHD was conducted in 95 patients at 21 centers. Forty-eight patients received ABX-CBL daily for 14 consecutive days followed by up to 6 weeks of ABX-CBL twice weekly. Forty-seven patients received equine ATG, 30 mg/kg every other day for a total of 6 doses with additional courses as needed. By day 180, overall improvement was similar in the patients receiving ABX-CBL and in those receiving ATG (56% versus 57%, P = .91). Patient survival at 18 months was less favorable on ABX-CBL than on ATG (35% versus 45%), with the 95% confidence interval ruling out that ABX-CBL provides at least a 10.4% improvement. Data from this trial suggest that ABX-CBL does not offer an improvement over ATG in the treatment of acute steroid-resistant GVHD. This prospective, multicenter, randomized clinical trial for steroid-resistant acute GVHD serves as a model for future evaluation of new agents.

  9. 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

  10. Acute Achilles tendon rupture: minimally invasive surgery versus non operative treatment, with immediate full weight bearing. Design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Verleisdonk Egbert-Jan MM

    2007-11-01

    Full Text Available Abstract Background We present the design of an open randomized multi-centre study on surgical versus conservative treatment of acute Achilles tendon ruptures. The study is designed to evaluate the effectiveness of conservative treatment in reducing complications when treating acute Achilles tendon rupture. Methods/Design At least 72 patients with acute Achilles tendon rupture will be randomized to minimally invasive surgical repair followed by functional rehabilitation using tape bandage or conservative treatment followed by functional rehabilitation with use of a functional bracing system. Both treatment arms use a 7 weeks post-rupture rehabilitation protocol. Four hospitals in the Netherlands will participate. Primary end-point will be reduction in complications other than re-rupture. Secondary end-point will be re-rupturing, time off work, sporting activity post rupture, functional outcome by Leppilahti score and patient satisfaction. Patient follow-up will be 12 month. Discussion By making this design study we wish to contribute to more profound research on AT rupture treatment and prevent publication bias for this open-labelled randomized trial. Trial registration ISRCTN50141196

  11. Lysine clonixinate versus dipyrone (metamizole) for the acute treatment of severe migraine attacks: a single-blind, randomized study.

    Science.gov (United States)

    Krymchantowski, Abouch Valenty; Carneiro, Henrique; Barbosa, Jackeline; Jevoux, Carla

    2008-06-01

    Nonsteroidal anti-inflammatory drugs (NSAID) are effective to treat migraine attacks. Lysine clonixinate (LC) and dipyrone (metamizol) have been proven effective to treat acute migraine. The aim of this study was to evaluate the efficacy and tolerability of the intravenous formulations of LC and dipyrone in the treatment of severe migraine attacks. Thirty patients (28 women, 2 men), aged 18 to 48 years with migraine according the International Headache Society (IHS) (2004) were studied. The patients were randomized into 2 groups when presenting to an emergency department with a severe migraine attack. The study was single-blind. Headache intensity, nausea, photophobia and side effects were evaluated at 0, 30, 60 and 90 minutes after the drug administration. Rectal indomethacin as rescue medication (RM) was available after 2 hours and its use compared between groups. All patients completed the study. At 30 minutes, 0% of the dipyrone group 13% of the LC group were pain free (p=0.46). At 60 and 90 minutes, 2 (13%) and 5 (33%) patients from the dipyrone group and 11 (73%) and 13 (86.7%) patients from the LC group were pain free (p<0.001). At 60 minutes, significantly more patients from the LC group were nausea-free (p<0.001). Regarding photophobia, there were no differences between groups at 60 minutes (p=0.11). The use of RM at 2 hours did not differ among groups (p=0.50). Pain in the site of the injection was reported by more patients of the LC group compared to the dipyrone group (p<0.0001). LC is significantly superior to dipyrone in treating severe migraine attacks. LC promotes significantly more burning at the site of the injection.

  12. The Role of Omega-3 Fatty Acids in Acute Pancreatitis: A Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Qiu Cheng Lei

    2015-03-01

    Full Text Available To determine whether treatment with omega-3 fatty acids (ω-3 FA provides benefits to patients with acute pancreatitis (AP. The Cochrane Library, PubMed, Embase, Web of Science, and Chinese Biomedical Literature Database were searched. Data analysis was performed using Revman 5.2 software. A total of eight randomized controlled trials (RCTs were included. Overall, ω-3 FA treatment resulted in a significantly reduced risk of mortality (RR 0.35; 95% CI 0.16 to 0.75, p < 0.05, infectious complications (RR 0.54; 95% CI 0.34 to 0.85, p < 0.05 and length of hospital stay (MD –6.50; 95% CI −9.54 to −3.46, p < 0.05, but not length of ICU stay (MD −1.98; 95% CI −6.92 to 2.96, p > 0.05. In subgroup analysis, only patients who received ω-3 FA parenterally had some statistically significant benefits in terms of mortality (risk ratio (RR 0.37; 95% confidence interval (CI 0.16 to 0.86, p < 0.05, infectious complications (RR 0.5; 95% CI 0.28 to 0.9, p < 0.05 and length of hospital stay (mean difference (MD −8.13; 95% CI −10.39 to −5.87, p < 0.001. The administration of ω-3 FA may be beneficial for decreasing mortality, infectious complications, and length of hospital stay in AP, especially when used parenterally. Large and rigorously designed RCTs are required to elucidate the efficacy of parenteral or enteral ω-3 FA treatment in AP.

  13. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial.

    Science.gov (United States)

    Boonen, Steven; Van Meirhaeghe, Jan; Bastian, Leonard; Cummings, Steven R; Ranstam, Jonas; Tillman, John B; Eastell, Richard; Talmadge, Karen; Wardlaw, Douglas

    2011-07-01

    Vertebral fractures are often painful and lead to reduced quality of life and disability. We compared the efficacy and safety of balloon kyphoplasty to nonsurgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n = 149) or nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short-Form 36 (SF-36) Physical Component Summary (PCS) scores when averaged across the 24-month follow-up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47-5.01, p = .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13-5.64, p = .003) but not at 12 months (1.70 points, 95% CI -0.59 to 3.98, p = .15) or 24 months (1.68 points, 95% CI -0.63 to 3.99, p = .15). Greater improvement in back pain was observed over 24 months for kyphoplasty (overall treatment effect -1.49 points, 95% CI -1.88 to -1.10, p kyphoplasty, 44.1% for control) with new radiographic vertebral fractures; fewer fractures occurred (~18%) within the second year. Compared with nonsurgical management, kyphoplasty rapidly reduces pain and improves function, disability, and quality of life without increasing the risk of additional vertebral fractures. The differences from nonsurgical management are statistically significant when averaged across 24 months. Most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all time points.

  14. Remote ischemic preconditioning for prevention of acute kidney injury: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Yang, Yi; Lang, Xia-Bing; Zhang, Ping; Lv, Rong; Wang, Yong-Fei; Chen, Jiang-Hua

    2014-10-01

    Remote ischemic preconditioning (RIPC) to prevent acute kidney injury (AKI) following cardiac and vascular interventions is a controversial practice. We conducted a systematic review and meta-analysis using the MEDLINE database (1966 through November 2013), EMBASE (1988 through November 2013), and Cochrane Library database. Patients undergoing cardiac and vascular interventions. Randomized controlled trials comparing patient outcome with or without RIPC for prevention of AKI following cardiac and vascular interventions. RIPC using an inflatable tourniquet around the limb or cross-clamping the iliac arteries versus non-RIPC. AKI, need for renal replacement therapy, postoperative kidney biomarkers, in-hospital mortality, and length of intensive care unit and hospital stay. 13 trials (1,334 participants) were included. RIPC decreased the risk of AKI for patients undergoing cardiac and vascular interventions compared with the control group (11 trials; 1,216 participants; risk ratio [RR], 0.70; 95% CI, 0.48-1.02; P = 0.06; I(2) = 45%) with marginal statistical significance. There were no differences in levels of postoperative kidney biomarkers (serum creatinine and glomerular filtration rate), incidence of renal replacement therapy, in-hospital mortality, hospital stay, or intensive care unit stay between the 2 groups. Metaregression analysis indicated that contrast intervention was not a covariate contributing significantly to heterogeneity on the risk estimate for AKI incidence; also, there was no dose effect of RIPC using tourniquet cuff around the limb on AKI prevention based on different ischemia duration. Different AKI definitions adopted in the trials included. RIPC might be beneficial for the prevention of AKI following cardiac and vascular interventions, but the current evidence is not robust enough to make a recommendation. Adequately powered trials are needed to provide more evidence in the future. Copyright © 2014 National Kidney Foundation, Inc. Published

  15. Effects of electroacupuncture therapy for Bell's palsy from acute stage: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Liu, Zhi-dan; He, Jiang-bo; Guo, Si-si; Yang, Zhi-xin; Shen, Jun; Li, Xiao-yan; Liang, Wei; Shen, Wei-dong

    2015-08-25

    Although many patients with facial paralysis have obtained benefits or completely recovered after acupuncture or electroacupuncture therapy, it is still difficult to list intuitive evidence besides evaluation using neurological function scales and a few electrophysiologic data. Hence, the aim of this study is to use more intuitive and reliable detection techniques such as facial nerve magnetic resonance imaging (MRI), nerve electromyography, and F waves to observe changes in the anatomic morphology of facial nerves and nerve conduction before and after applying acupuncture or electroacupuncture, and to verify their effectiveness by combining neurological function scales. A total of 132 patients with Bell's palsy (grades III and IV in the House-Brackmann [HB] Facial Nerve Grading System) will be randomly divided into electroacupuncture, manual acupuncture, non-acupuncture, and medicine control groups. All the patients will be given electroacupuncture treatment after the acute period, except for patients in the medicine control group. The acupuncture or electroacupuncture treatments will be performed every 2 days until the patients recover or withdraw from the study. The primary outcome is analysis based on facial nerve functional scales (HB scale and Sunnybrook facial grading system), and the secondary outcome is analysis based on MRI, nerve electromyography and F-wave detection. All the patients will undergo MRI within 3 days after Bell's palsy onset for observation of the signal intensity and facial nerve swelling of the unaffected and affected sides. They will also undergo facial nerve electromyography and F-wave detection within 1 week after onset of Bell's palsy. Nerve function will be evaluated using the HB scale and Sunnybrook facial grading system at each hospital visit for treatment until the end of the study. The MRI, nerve electromyography, and F-wave detection will be performed again at 1 month after the onset of Bell's palsy. Chinese Clinical Trials

  16. Loop diuretics in acute heart failure: beyond the decongestive relief for the kidney.

    Science.gov (United States)

    Palazzuoli, Alberto; Ruocco, Gaetano; Ronco, Claudio; McCullough, Peter A

    2015-09-03

    Current goals in the acute treatment of heart failure are focused on pulmonary and systemic decongestion with loop diuretics as the cornerstone of therapy. Despite rapid relief of symptoms in patients with acute decompensated heart failure, after intravenous use of loop diuretics, the use of these agents has been consistently associated with adverse events, including hypokalemia, azotemia, hypotension, and increased mortality. Two recent randomized trials have shown that continuous infusions of loop diuretics did not offer benefit but were associated with adverse events, including hyponatremia, prolonged hospital stay, and increased rate of readmissions. This is probably due to the limitations of congestion evaluation as well as to the deleterious effects linked to drug administration, particularly at higher dosage. The impaired renal function often associated with this treatment is not extensively explored and could deserve more specific studies. Several questions remain to be answered about the best diuretic modality administration, global clinical impact during acute and post-discharge period, and the role of renal function deterioration during treatment. Thus, if loop diuretics are a necessary part of the treatment for acute heart failure, then there must be an approach that allows personalization of therapy for optimal benefit and avoidance of adverse events.

  17. Corneal decompensation following filtering surgery with the Ex-PRESS® mini glaucoma shunt device

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    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 

  18. Stages of decompensation in combat-related posttraumatic stress disorder: a new conceptual model.

    Science.gov (United States)

    Wang, S; Wilson, J P; Mason, J W

    1996-01-01

    This conceptual article presents a model of severe, chronic combat-related PTSD based on several years of longitudinal clinical observations of Vietnam veterans. The model describes a repeating cycle of decompensation that profoundly disrupts the veteran's life. There appear to be "stages" of decompensation that can be described clinically and may be distinct physiologically. The stages describe a wide range of functioning, from adaptive to totally dysfunctional PTSD core symptoms, as well as several other dimensions of clinical functioning, such as affect regulation, defenses, ego states, interactions with the environment, capacity for self-destruction/suicide and capacity for attachment and insight are described for each stage. Clinical and research implications are discussed.

  19. Role of TIPS in Improving Survival of Patients with Decompensated Liver Disease

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    Sundeep J. Punamiya

    2011-01-01

    Full Text Available Liver cirrhosis is associated with higher morbidity and reduced survival with appearance of portal hypertension and resultant decompensation. Portal decompression plays a key role in improving survival in these patients. Transjugular intrahepatic portosystemic shunts are known to be efficacious in reducing portal venous pressure and control of complications such as variceal bleeding and ascites. However, they have been associated with significant problems such as poor shunt durability, increased encephalopathy, and unchanged survival when compared with conservative treatment options. The last decade has seen a significant improvement in these complications, with introduction of covered stents, better selection of patients, and clearer understanding of procedural end-points. Use of TIPS early in the period of decompensation also appears promising in further improvement of survival of cirrhotic patients.

  20. Orthodontic decompensation in skeletal Class III malocclusion: redefining the amount of movement assessed by Cone-Beam Computed Tomography

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    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.

  1. Impact of physician specialty on quality care for patients hospitalized with decompensated cirrhosis.

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    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.

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

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    Hansen Jørgen

    2009-04-01

    Full Text Available Abstract Background The prevalence of depression in patients with acute coronary syndrome, i.e. myocardial infarction and unstable angina, is higher than in the general population. The prevalence of anxiety is higher as well. Both depression and anxiety are associated with poor cardiac outcomes and higher mortality. Comorbid depression in patients with acute coronary syndrome often goes undiagnosed, and it is therefore a challenging task to prevent this risk factor. The study of DEpression in Coronary ARtery Disease (DECARD is designed to examine if it is possible to prevent depression in patients 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 of depression and Hamilton Depression Scale are the primary outcome measures. Discussion This is the first study of prevention of depression in patients after acute coronary syndrome with a selective serotonin reuptake inhibitor. Trial Registration http://www.ClinicalTrials.gov. Identifier: NCT00140257

  3. Direct antiviral agent treatment of decompensated hepatitis C virus-induced liver cirrhosis

    Institute of Scientific and Technical Information of China (English)

    Shogo; Ohkoshi; Haruka; Hirono; Satoshi; Yamagiwa

    2015-01-01

    Recently, direct antiviral agents(DAAs) have been increasingly used for the treatment of chronic hepatitis C virus(HCV) infections, replacing interferon-based regimens that have severe adverse effects and low tolerability. The constant supply of new DAAs makes shorter treatment periods with enhanced safety possible. The efficacy of DAAs for treatment of compensated liver cirrhosis(LC) is not less than that for treatment of non-cirrhotic conditions. These clinical advantages have been useful in pre- and post-liver transplantation(LT) settings. Moreover, DAAs can be used to treat decompensated HCV-induced LC in elderly patients or those with severe complications otherwise having poor prognosis. Although encouraging clinical data are beginning to appear, the actual efficacy of DAAs for suppressing disease progression, allowing delisting for LT and, most importantly, improving prognosis of patients with decompensated HCV-LC remains unknown. Casecontrol studies to examine the short- or long-term effects of DAAs for treatment of decompensated HCV-LC are urgently need.

  4. Endothelial keratoplasty for corneal decompensation leaded by a dexamethasone implant dislocation in anterior chamber

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    Fernanda Pacella

    2016-06-01

    Full Text Available Background: Dexamethasone intravitreal implant (DEX largely showed his safety and efficacy for the treatment of cases of macular edema. Even if uncommon, delivery dislocation in anterior chamber has been described in Literaure as complication of the injection procedure, leading to irreversible endothelial cell loss in the majority of cases. We report a case of a 66-year-old man with pain and vision loss in his left eye. The anamnesis revealed a recent intravitreal injection of DEX implant for a persistent cystoid macular edema related to central retinal vein occlusion. Anterior segment examination showed corneal edema and the rod implant adherent to corneal endothelium. A large peripheral iridectomy was evident with retroillumination and IOL appeared good centered in the bag. The implant was removed but corneal decompensation was irreversible. One month later, an endothelial keratoplasty was successfully performed restoring corneal transparency. DEX intravitreal implant can migrate from vitreous cavity to anterior chamber and lead to irreversible corneal decompensation by mechanical and chemical toxicity on corneal endothelium. Removeal of the implant is necessary to avoid total endothelial decompensation. Despite this, in some cases endothelial keratoplasty had to be performed.

  5. A Self-Administered Method of Acute Pressure Block of Sciatic Nerves for Short-Term Relief of Dental Pain: A Randomized Study

    Science.gov (United States)

    Wang, Xiaolin; Zhao, Wanghong; Wang, Ye; Hu, Jiao; Chen, Qiu; Yu, Juncai; Wu, Bin; Huang, Rong; Gao, Jie; He, Jiman

    2014-01-01

    Objectives While stimulation of the peripheral nerves increases the pain threshold, chronic pressure stimulation of the sciatic nerve is associated with sciatica. We recently found that acute pressure block of the sciatic nerve inhibits pain. Therefore, we propose that, the pain pathology-causing pressure is chronic, not acute. Here, we report a novel self-administered method: acute pressure block of the sciatic nerves is applied by the patients themselves for short-term relief of pain from dental diseases. Design This was a randomized, single-blind study. Setting Hospital patients. Patients Patients aged 16–60 years with acute pulpitis, acute apical periodontitis, or pericoronitis of the third molar of the mandible experiencing pain ≥3 on the 11-point numerical pain rating scale. Interventions Three-minute pressure to sciatic nerves was applied by using the hands (hand pressure method) or by having the patients squat to force the thigh and shin as tightly as possible on the sandwiched sciatic nerve bundles (self-administered method). Outcomes The primary efficacy variable was the mean difference in pain scores from the baseline. Results One hundred seventy-two dental patients were randomized. The self-administered method produced significant relief from pain associated with dental diseases (P ≤ 0.001). The analgesic effect of the self-administered method was similar to that of the hand pressure method. Conclusions The self-administered method is easy to learn and can be applied at any time for pain relief. We believe that patients will benefit from this method. PMID:24400593

  6. Acute effects of single and multiple level thoracic manipulations on chronic mechanical neck pain: a randomized controlled trial

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    Puntumetakul R

    2015-01-01

    Full Text Available Rungthip Puntumetakul,1,2 Thavatchai Suvarnnato,1,3 Phurichaya Werasirirat,1 Sureeporn Uthaikhup,2 Junichiro Yamauchi,4,5 Rose Boucaut6 1School of Physical Therapy, Faculty of Associated Medical Sciences, 2Research Center in Back, Neck, Other Joint Pain and Human Performance, 3Physical Therapy Unit, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 4Graduate School of Human Health Sciences, Tokyo Metropolitan University, 5Future Institute for Sport Sciences, Tokyo, Japan; 6School of Health Sciences (Physiotherapy, University of South Australia, Adelaide, SA, Australia 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 (P<0.05 improved in the STM and MTM groups compared with the control group. CROM in flexion and left lateral flexion were increased significantly (P<0.05 in the STM group when compared with the control group at 1-week follow-up. The CROM in right rotation was increased significantly after MTM compared to the control group (P<0.05 at 24-hour follow-up. There were no statistically significant differences in neck 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

  7. Enhanced Medical Rehabilitation increases therapy intensity and engagement and improves functional outcomes in post-acute rehabilitation of older adults: a randomized controlled trial

    Science.gov (United States)

    Lenze, Eric J.; Host, Helen H.; Hildebrand, Mary W.; Morrow-Howell, Nancy; Carpenter, Brian; Freedland, Kenneth E.; Baum, Carolyn A.; Dixon, David; Doré, Peter; Wendleton, Leah; Binder, Ellen F.

    2012-01-01

    Objectives For millions of disabled older adults each year, post-acute care in skilled nursing facilities (SNFs) is a brief window of opportunity to regain enough function to return home and live independently. Too often this goal is not achieved, possibly due to therapy that is inadequately intense or engaging. This study tested Enhanced Medical Rehabilitation, an intervention designed to increase patient engagement in, and intensity of, daily physical and occupational therapy sessions in post-acute care rehabilitation. Design Randomized controlled trial of Enhanced Medical Rehabilitation versus standard-of-care rehabilitation. Setting Post-acute care unit of a skilled nursing facility in St Louis, MO. Participants 26 older adults admitted from a hospital for post-acute rehabilitation. Intervention Based on models of motivation and behavior change, Enhanced Medical Rehabilitation is a set of behavioral skills for physical and occupational therapists (PT/OT) that increase patient engagement and intensity, with the goal of improving functional outcome, through: (1) a patient-directed, interactive approach, (2) increased rehabilitation intensity, and (3) frequent feedback to patients on their effort and progress. Measurements Therapy intensity: assessment of patient active time in therapy sessions. Therapy engagement: Rehabilitation Participation Scale. Functional and performance outcomes: Barthel Index, gait speed, and six-minute walk. Results Participants randomized to Enhanced Medical Rehabilitation had higher intensity therapy and were more engaged in their rehabilitation sessions; they had more improvement in gait speed (improving from 0.08 to 0.38 meter/sec vs. 0.08 to 0.22 in standard of care,p=0.003) and six-minute walk (from 73 to 266 feet vs. 40 to 94 feet in standard of care, p=0.026), with a trend for better improvement of Barthel Index (+43 points vs. 26 points in standard of care, p=0.087), compared to participants randomized to standard

  8. Eye movement training results in changes in qEEG and NIH stroke scale in subjects suffering from acute middle cerebral artery ischemic stroke: a randomized control trial

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    Frederick Robert Carrick

    2016-01-01

    Full Text Available Context:Eye-movement training (EMT can induce altered brain activation and change the functionality of saccades with changes of the brain in general. Objective:To determine if EMT would result in changes in qEEG and NIH Stroke Scales (NIHSS in patients suffering from acute middle cerebral artery (MCA infarction. Our hypothesis is that there would be positive changes in qEEG and NIHSS after EMT in patients suffering from acute MCA ischemic stroke.Design:Double blind randomized controlled trial.Setting and Participants:34 subjects with acute MCA ischemic stroke at university affiliated hospital intensive care unit.Interventions:Subjects were randomized into a control group treated only with aspirin (125 mg/day and a treatment group treated with aspirin (125 mg/day and a subject specific EMT. Main Outcome measures: Delta-Alpha Ratio, Power Ratio Index and the Brain Symmetry Index calculated by quantitative electroencephalograms, and NIHSS. Results:There was strong statistical and substantive significant improvement in all outcome measures for the group of stroke patients undergoing EMT. Such improvement was not observed for the control group and there were no adverse effects.Conclusions:The addition of EMT to a MCA ischemic stroke treatment paradigm has demonstrated statistically significant changes in outcome measures and is a low cost, safe and effective complement to standard treatment.

  9. A Randomized Controlled Trial of Puncturing and Bloodletting at Twelve Hand Jing Points to Treat Acute Carbon Monoxide Poisoning as Adjunct to First Aid Treatment: A Study Protocol

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    Ying Yue

    2015-01-01

    Full Text Available Background. Acute carbon monoxide poisoning (ACOP is a significant cause of morbidity and mortality in many countries. Twelve Hand Jing Points (THJP have been believed to be effective to treat all kinds of emergency calls in traditional Chinese medicine (TCM for more than 3000 years. This randomized controlled trial (RCT is designed to evaluate the effectiveness of THJP in curing acute carbon monoxide poisoning in first aid treatment. This paper reports the protocol of the trial. Methods/Design. This RCT is a multicenter, randomized, controlled study undergoing in China. The compliant patients are divided into the bloodletting group and standard of care group. With first aid treatments given to both of the groups, the bloodletting group is bleeding at THJP upon being hospitalized. Primary outcomes and secondary outcomes will be measured and compared between these two groups. Before treatment, immediately after treatment, and 30 minutes, 1 hour, and 4 hours after treatment, patients’ basic vital signs and state of consciousness were observed. Before treatment and 1 and 4 hours after treatment, carboxyhemoglobin concentration in venous blood samples was detected. Discussion. The objective of this study is to provide convincing evidence to clarify the efficacy and safety of THJP for early treatment of acute carbon monoxide poisoning.

  10. A randomized trial comparing hypofractionated and conventionally fractionated three-dimensional external-beam radiotherapy for localized prostate adenocarcinoma. A report on acute toxicity

    Energy Technology Data Exchange (ETDEWEB)

    Norkus, Darius; Miller, Albert; Kurtinaitis, Juozas; Valuckas, Konstantinas Povilas [Dept. of Radiotherapy, Inst. of Oncology, Vilnius Univ. (Lithuania); Haverkamp, Uwe [Dept. of Radiology, Clemenshospital, Muenster (Germany); Popov, Sergey [Dept. of Radiotherapy, Riga Eastern Hospital, Latvian Oncology Center, Riga (Latvia); Prott, Franz-Josef [Inst. of Radiology and Radiotherapy (RNS), St. Josefs Hospital, Wiesbaden (Germany)

    2009-11-15

    Purpose: to compare acute gastrointestinal (GI) and genitourinary (GU) toxicity between patient groups with localized prostate adenocarcinoma, treated with conventionally fractionated (CFRT) and hypofractionated (HFRT) three-dimensional conformal external-beam radiotherapy (3D-CRT). Patients and methods: 91 patients were enrolled into a randomized study with a minimum follow-up of 3 months. 44 men in the CFRT arm were irradiated with 74 Gy in 37 fractions at 2 Gy per fraction for 7.5 weeks. 47 men in the HFRT arm were treated with 57 Gy in 17 fractions for 3.5 weeks, given as 13 fractions of 3 Gy plus four fractions of 4.5 Gy. The clinical target volume (CTV) included the prostate and the base of seminal vesicles. The CTV-to-PTV (planning target volume) margin was 8-10 mm. Study patients had portal imaging and/or simulation performed on the first fractions and repeated at least weekly. Results: no acute grade 3 or 4 toxicities were observed. The grade 2 GU acute toxicity proportion was significantly lower in the HFRT arm: 19.1% versus 47.7% ({chi}{sup 2}-test, p = 0.003). The grade 2 GU acute toxicity-free survival was significantly better in the HFRT arm (log-rank test, p = 0.008). The median duration of overall GI acute toxicity was shorter with HFRT: 3 compared to 6 weeks with CFRT (median test, p = 0.017). Conclusion: in this first evaluation, the HFRT schedule is feasible and induces acceptable or even lower acute toxicity compared with the toxicities in the CFRT schedule. Extended follow-up is needed to justify this fractionation schedule's safety in the long term. (orig.)

  11. Admitting acute ischemic stroke patients to a stroke care monitoring unit versus a conventional stroke unit : a randomized pilot study

    NARCIS (Netherlands)

    Sulter, Geert; Elting, Jan Willem; Langedijk, Marc; Maurits, Natasha M; De Keyser, Jacques

    2003-01-01

    BACKGROUND AND PURPOSE: Pathophysiological considerations and observational studies indicate that elevated body temperature, hypoxia, hypotension, and cardiac arrhythmias in the acute phase of ischemic stroke may aggravate brain damage and worsen outcome. METHODS: Both units were organized with the

  12. Admitting acute ischemic stroke patients to a stroke care monitoring unit versus a conventional stroke unit : a randomized pilot study

    NARCIS (Netherlands)

    Sulter, Geert; Elting, Jan Willem; Langedijk, Marc; Maurits, Natasha M; De Keyser, Jacques

    2003-01-01

    BACKGROUND AND PURPOSE: Pathophysiological considerations and observational studies indicate that elevated body temperature, hypoxia, hypotension, and cardiac arrhythmias in the acute phase of ischemic stroke may aggravate brain damage and worsen outcome. METHODS: Both units were organized with the

  13. Results of a randomized trial in children with Acute Myeloid Leukaemia : Medical Research Council AML12 trial

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    Gibson, Brenda E. S.; Webb, David K. H.; Howman, Andrew J.; De Graaf, Siebold S. N.; Harrison, Christine J.; Wheatley, Keith

    2011-01-01

    The Medical Research Council Acute Myeloid Leukaemia 12 (MRC AML12) trial (children) addressed the optimal anthracenedione/anthracycline in induction and the optimal number of courses of consolidation chemotherapy. 504 children (

  14. Comprehensive Geriatric Assessment and Transitional Care in Acutely Hospitalized Patients The Transitional Care Bridge Randomized Clinical Trial

    NARCIS (Netherlands)

    Buurman, Bianca M.; Parlevliet, Juliette L.; Allore, Heather G.; Blok, Willem; van Deelen, Bob A. J.; van Charante, Eric P. Moll; de Haan, Rob J.; de Rooij, Sophia E.

    2016-01-01

    IMPORTANCE Older adults acutely hospitalized are at risk of disability. Trials on comprehensive geriatric assessment (CGA) and transitional care present inconsistent results. OBJECTIVE To test whether an intervention of systematic CGA, followed by the transitional care bridge program, improved activ

  15. Secondary Healing versus Delayed Excision and Direct Closure after Incision and Drainage of Acute Pilonidal Abscess: A Controlled Randomized Trial

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    Mahmoud F. Sakr

    2012-02-01

    Conclusions: Although there is more rapid healing and fewer visits for dressing with I and D and DE/DC of an acute pilonidal abscess, this is accompanied by a significantly higher overall complication rate than with I and D and secondary healing. Recurrence of an acute abscess or development of a chronic pilonidal sinus is similar with both procedures. [Arch Clin Exp Surg 2012; 1(1.000: 8-13

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

    OpenAIRE

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

    2013-01-01

    Background 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 r...

  17. Safety and efficacy of thrombectomy in patients undergoing primary percutaneous coronary intervention for Acute ST elevation MI: A Meta-Analysis of Randomized Controlled Trials

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    Grossman P Michael

    2010-02-01

    Full Text Available Abstract Background Clinical trials comparing thrombectomy devices with conventional percutaneous coronary interventions (PCI in patients with acute ST elevation myocardial infarction (STEMI have produced conflicting results. The objective of our study was to systematically evaluate currently available data comparing thrombectomy followed by PCI with conventional PCI alone in patients with acute STEMI. Methods Seventeen randomized trials (n = 3,909 patients of thrombectomy versus PCI were included in this meta-analysis. We calculated the summary odds ratios for mortality, stroke, post procedural myocardial blush grade (MBG, thrombolysis in myocardial infarction (TIMI grade flow, and post procedural ST segment resolution (STR using random-effects and fixed-effects models. Results There was no difference in risk of 30-day mortality (44/1914 vs. 50/1907, OR 0.84, 95% CI 0.54-1.29, P = 0.42 among patients randomized to thrombectomy, compared with conventional PCI. Thrombectomy was associated with a significantly greater likelihood of TIMI 3 flow (1616/1826 vs. 1533/1806, OR 1.41, P = 0.007, MBG 3 (730/1526 vs. 486/1513, OR 2.42, P Conclusions Thrombectomy devices appear to improve markers of myocardial perfusion in patients undergoing primary PCI, with no difference in overall 30-day mortality but an increased likelihood of stroke. The clinical benefits of thrombectomy appear to be influenced by the device type with a trend towards survival benefit with MAT and worsening outcome with mechanical devices.

  18. Influence of blood pressure at the beginning of decompensations in the prognosis of patients with heart failure.

    Science.gov (United States)

    Torrente Iranzo, Silvia; Garcés Horna, Vanesa; Josa Laorden, Claudia; Rubio Gracia, Jorge; Ruiz Laiglesia, Fernando José; Sánchez Marteles, Marta; Pérez Calvo, Juan Ignacio

    2017-08-22

    An inverse relationship has been described between blood pressure and the prognosis in heart failure (HF). The characteristics of this relationship are not well unknown. The objective of this study was to determine if this relationship is maintained in a non-selected cohort of patients with HF and if it can be modified by treatment. Prospective study of cohorts including patients hospitalized for decompensated HF in Internal Medicine departments and followed as outpatients in a monographic consultation. Patients were classified according to their levels of systolic (SBP) and diastolic blood pressure (DBP). Clinical characteristics, all-cause mortality and readmissions after the first, third and sixth month of follow-up were analysed. Two hundred and twenty-one patients were included after their admission to the hospital for acute HF. Mean patient age was 79.5 years(SD 8.09); 115 patients were male. No significant differences between SBP quartiles and basal characteristics were found. Patients with lower SBP (Q1) had higher mortality rates (20%, P<.05). No significant differences between mortality/readmissions and DBP were found. However, the Kaplan-Meier analysis showed higher all-cause mortality rates for the group of patients with lower SBP and DBP (log-rank=0.011 and 0.041, respectively). The pharmacological treatment did not differ significantly between both study groups. For non-selected patients suffering HF, higher SBP upon the admission is associated with significantly lower all-cause mortality rates during follow-up. Pharmacological treatment of HF does not seem to influence this inverse relationship between SBP at admission and patient mortality. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  19. Hiperpotassemia na vigência de espironolactona em pacientes com insuficiência cardíaca descompensada Hyperkalemia during spironolactone use in patients with decompensated heart failure

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    Marcelo Villaça Lima

    2008-09-01

    Full Text Available FUNDAMENTO: A incidência de hiperpotassemia relacionada à espironolactona é baixa na insuficiência cardíaca estável, entretanto não foi estudada durante a descompensação. OBJETIVO: Avaliar a influência da espironolactona na insuficiência cardíaca descompensada sobre o potássio sérico. MÉTODOS: Em um estudo de coorte, selecionamos pacientes hospitalizados por descompensação da insuficiência cardíaca, FEVE 6,0 mEq/l e uso de poliestireno de cálcio. Realizou-se a análise multivariada pela regressão logística, e p 60,5 mg/dl, durante a internação, apresenta risco relativo de 9,6 (IC 95% 8,03 - 11,20; p = 0,005 para a ocorrência de hiperpotassemia. CONCLUSÃO: A incidência de hiperpotassemia foi duas vezes maior com espironolactona, mas não estatisticamente significante. Elevação da uréia foi associada à hiperpotassemia. Estudos randomizados são necessários para esclarecer o assunto.BACKGROUND: The incidence of hyperkalemia related to spironolactone use is low in stable heart failure; however, it has not been studied during decompensation. OBJECTIVE: To evaluate the influence of spironolactone on serum potassium in decompensated heart failure (HF. METHODS: In a cohort study, patients that had been hospitalized due to decompensated HF, with left ventricular ejection fraction (LVEF 6.0 mEq/l and the use of calcium polystyrene. A multivariate analysis through logistic regression was carried out and values of p 60.5 mg/dl during the hospitalization presents a relative risk of 9.6 (95%CI 8.03 - 11.20; p = 0.005 for the occurrence of hyperkalemia. CONCLUSION: The incidence of hyperkalemia was two-fold higher with spironolactone use, but it was not statistically significant. The increase in urea levels was associated to the hyperkalemia. Randomized studies are necessary to clarify this issue.

  20. Viusid, a nutritional supplement, increases survival and reduces disease progression in HCV-related decompensated cirrhosis: a randomised and controlled trial

    Science.gov (United States)

    Sanchez Rodriguez, Yoan; Torres Gonzalez, Ana; Calzadilla Bertot, Luis; Arus Soler, Enrique; Martinez Perez, Yadina; Yasells Garcia, Ali; Abreu Vazquez, Maria del Rosario

    2011-01-01

    Objectives Viusid is a nutritional supplement with recognised antioxidant and immunomodulatory properties which could have beneficial effects on cirrhosis-related clinical outcomes such as survival, disease progression and development of hepatocellular carcinoma (HCC). This study evaluated the efficacy and safety of viusid in patients with HCV-related decompensated cirrhosis. Design A randomised double-blind and placebo-controlled study was conducted in a tertiary care academic centre (National Institute of Gastroenterology, Havana, Cuba). The authors randomly assigned 100 patients with HCV-related decompensated cirrhosis to receive viusid (three oral sachets daily, n=50) or placebo (n=50) during 96 weeks. The primary outcome of the study was overall survival at 96 weeks, and the secondary outcomes included time to disease progression, time to HCC diagnosis, time to worsening of the prognostic scoring systems Child–Pugh and Model for End-Stage Liver Disease, and time to a new occurrence or relapse for each one of the main clinical complications secondary to portal hypertension at 96 weeks. Results Viusid led to a significant improvement in overall survival (90%) versus placebo (74%) (HR 0.27, 95% CI 0.08 to 0.92; p=0.036). A similar improvement in disease progression was seen in viusid-treated patients (28%), compared with placebo-treated patients (48%) (HR 0.47, 95% CI 0.22 to 0.89; p=0.044). However, the beneficial effects of viusid were wholly observed among patients with Child–Pugh classes B or C, but not among patients with Child–Pugh class A. The cumulative incidence of HCC was significantly reduced in patients treated with viusid (2%) as compared with placebo (12%) (HR 0.15, 95% CI 0.019 to 0.90; p=0.046). Viusid was well tolerated. Conclusions The results indicate that treatment with viusid leads to a notable improvement in overall clinical outcomes such as survival, disease progression and development of HCC in patients with HCV

  1. Baseline MELD score predicts hepatic decompensation during antiviral therapy in patients with chronic hepatitis C and advanced cirrhosis.

    Directory of Open Access Journals (Sweden)

    Georg Dultz

    Full Text Available BACKGROUND AND AIMS: In patients with advanced liver cirrhosis due to chronic hepatitis C virus (HCV infection antiviral therapy with peginterferon and ribavirin is feasible in selected cases only due to potentially life-threatening side effects. However, predictive factors associated with hepatic decompensation during antiviral therapy are poorly defined. METHODS: In a retrospective cohort study, 68 patients with HCV-associated liver cirrhosis (mean MELD score 9.18 ± 2.72 were treated with peginterferon and ribavirin. Clinical events indicating hepatic decompensation (onset of ascites, hepatic encephalopathy, upper gastrointestinal bleeding, hospitalization as well as laboratory data were recorded at baseline and during a follow up period of 72 weeks after initiation of antiviral therapy. To monitor long term sequelae of end stage liver disease an extended follow up for HCC development, transplantation and death was applied (240 weeks, ± SD 136 weeks. RESULTS: Eighteen patients (26.5% achieved a sustained virologic response. During the observational period a hepatic decompensation was observed in 36.8%. Patients with hepatic decompensation had higher MELD scores (10.84 vs. 8.23, p14, respectively. Baseline MELD score was significantly associated with the risk for transplantation/death (p<0.001. CONCLUSIONS: Our data suggest that the baseline MELD score predicts the risk of hepatic decompensation during antiviral therapy and thus contributes to decision making when antiviral therapy is discussed in HCV patients with advanced liver cirrhosis.

  2. Comparison of Ertapenem and Ceftriaxone Therapy for Acute Pyelonephritis and Other Complicated Urinary Tract Infections in Korean Adults: A Randomized, Double-Blind, Multicenter Trial

    OpenAIRE

    PARK, DAE WON; Peck, Kyong Ran; Chung, Moon Hyun; Lee, Jin Seo; Park, Yoon Soo; Kim, Hyo Youl; Lee, Mi Suk; Kim, Jung Yeon; Yeom, Joon Sup; Kim, Min Ja

    2012-01-01

    The efficacy and safety of ertapenem, 1 g once daily, were compared with that of ceftriaxone, 2 g once daily, for the treatment of adults with acute pyelonephritis (APN) and complicated urinary tract infections (cUTIs) in a prospective, multicenter, double-blinded, randomized study. After ≥ 3 days of parenteral study therapy, patients could be switched to an oral agent. Of 271 patients who were initially stratified by APN (n = 210) or other cUTIs (n = 61), 66 (48.9%) in the ertapenem group an...

  3. Clinical Efficacy Comparison of Saccharomyces boulardii and Yogurt Fluid in Acute Non-Bloody Diarrhea in Children: A Randomized, Controlled, Open Label Study

    OpenAIRE

    Makbule EREN; Dinleyici, Ener C; Vandenplas,Yvan

    2010-01-01

    The purpose of this trial is to evaluate the clinical efficacy and cost/effectiveness of Saccharomyces boulardii compared with yogurt fluid (YF) in acute non-bloody diarrhea in children. This randomized, prospective open-label clinical trial includes 55 children (36 boys, 19 girls; mean age 21.2 ± 28.2 months). Group A (N = 28) received lyophilized S. boulardii and group B (N = 27) received YF. The duration of diarrhea was shorter with S. boulardii but the hospital stay was reduced with YF, a...

  4. Citicoline for Acute Ischemic Stroke: A Systematic Review and Formal Meta-analysis of Randomized, Double-Blind, and Placebo-Controlled Trials.

    Science.gov (United States)

    Secades, Julio J; Alvarez-Sabín, José; Castillo, José; Díez-Tejedor, Exuperio; Martínez-Vila, Eduardo; Ríos, José; Oudovenko, Natalia

    2016-08-01

    Citicoline is a drug approved for the treatment of acute ischemic stroke. Although evidence of its efficacy has been reported, recently published results of a large placebo-controlled clinical trial did not show differences. This study aims to assess whether starting citicoline treatment within 14 days after stroke onset improves the outcome in patients with acute ischemic stroke, as compared with placebo. A systematic search was performed to identify all published, unconfounded, randomized, double-blind, and placebo-controlled clinical trials of citicoline in acute ischemic stroke. Ten randomized clinical trials met our inclusion criteria. The administration of citicoline was associated with a significant higher rate of independence, independently of the method of evaluation used (odds ratio [OR] 1.56, 95% confidence interval [CI] = 1.12-2.16 under random effects; OR 1.20, 95% CI = 1.06-1.36 under fixed effects). After studying the cumulative meta-analysis, and with the results obtained with the subgroup of patients who were not treated with recombinant tissue plasminogen activator (rtPA) (OR 1.63, 95% CI = 1.18-2.24 under random effects; OR 1.42, 95% CI = 1.22-1.66 under fixed effects), our hypothesis of dilution of the effect of citicoline was confirmed. When we analyzed the effect of citicoline in patients who were not treated with rtPA and were receiving the highest dose of citicoline started in the first 24 hours after onset, based on more recent trials, there was no heterogeneity, and the size of the effect has an OR of 1.27 (95% CI = 1.05-1.53). This systematic review supports some benefits of citicoline in the treatment of acute ischemic stroke. But, on top of the best treatment available (rtPA), citicoline offers a limited benefit. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  5. Effectiveness of herbal acupuncture of Carthami semen(Honghwa vs its cotreatment with spiral taping for the treatment of acute low back pain : A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jeong, Minsu

    2002-12-01

    Full Text Available Spiral taping shows great effectiveness in relieving musculoskeletal pains. The purpose of this research is to compare effectiveness of herbal acupuncture of Carthami semen(Honghwa vs its cotreatment with spiral taping for the treatment of acute low back pain. The target patients were those who satisfied with all of the following conditions. 1. Those who suffered from acute low back pain but without past history of the pain in the last six weeks. 2. The pain wasn't radiated to the lower limbs and were without any neurotic symptoms. A computerized randomization was used to set the patients in two groups. The control group was consisted of 41 patients and treated with herbal acupuncture. The experimental group was consisted of 49 patients and treated with spiral taping as well as herbal acupuncture. The treatment was given two times a week and the nurses measured the ROM and VAS evaluation before every treatment. The patients wrote ODI by themselves before the first treatment and after the 3rd treatment. After three months, an interview of the patients' condition through a follow up survey was done. In terms of acute low back pain in both the control group and experimental group, significant treatment effects were found by assessing VAS, ROM and ODI. By comparing the control group and the experimental group, there was more significant improvement in the experimental group than the control group of VAS and ROM, but no significant effect was found between the groups of ODI. This study shows that the herbal acupuncture of Carthami Semen plays a significant role in relieving acute low back pain. It also shows that spiral taping of the experimental group was more highly effective. As a result, spiral taping can be used with acupunture of Carthami Semen for a highly effective treatment for acute low back pain.

  6. the Pathogenesis of acute on Chronic Hepatitis B liver Failure

    Institute of Scientific and Technical Information of China (English)

    2014-01-01

    Acute-on-chronic liver failure is a characteristic clinical liver syndrome, which should be differentiated from acute liver failure, acute decompensated liver cirrhosis and chronic liver failure. The pathogenesis of ACLF is not fully understood yet. Viral factors and immune injury have been reported to be the two major pathogenesis. This paper reviewed the researches on the pathogenesis of acute on chronic hepatitis B liver failure in recent years, to provide theoretical basis for prompt and accurate diagnosis and treatment of this syndrome. This would beneift for the prognosis and raise the survival rate of patients.

  7. Simeprevir, daclatasvir and sofosbuvir for hepatitis C virus-infected patients with decompensated liver disease.

    Science.gov (United States)

    Lawitz, E; Poordad, F; Gutierrez, J A; Kakuda, T N; Picchio, G; Beets, G; Vandevoorde, A; Van Remoortere, P; Jacquemyn, B; Luo, D; Ouwerkerk-Mahadevan, S; Vijgen, L; Van Eygen, V; Beumont, M

    2016-11-23

    Approximately three million individuals in the United States are chronically infected with hepatitis C virus (HCV). Chronic HCV infection may lead to the development of compensated as well as decompensated liver cirrhosis. The Phase II IMPACT study was conducted in HCV genotype 1- or 4-infected cirrhotic patients with portal hypertension or decompensated liver disease and assessed for the first time the combination of the three direct-acting antivirals simeprevir, daclatasvir and sofosbuvir. Treatment-naïve or treatment-experienced adults with Child-Pugh (CP) score simeprevir 150 mg, daclatasvir 60 mg and sofosbuvir 400 mg, once daily. The primary efficacy endpoint was sustained virologic response 12 weeks after end of treatment (SVR12). Pharmacokinetics and safety were also assessed. Overall, 40 patients were enrolled (CP A: 19; CP B: 21). All 40 patients achieved SVR12. At week 8, the mean pharmacokinetic exposure to simeprevir, sofosbuvir, daclatasvir and GS-331007 (sofosbuvir metabolite) was 2.2-, 1.5-, 1.2- and 1.2-fold higher in patients with CP B than CP A, respectively. Grade 1/2 adverse events (AEs) occurred in 26 of 40 (65%) patients. One CP B patient had a Grade 3 AE (gastrointestinal haemorrhage), which was reported as a serious AE but not considered related to study drugs. Treatment for 12 weeks with simeprevir, daclatasvir and sofosbuvir was generally safe and well tolerated, and resulted in 100% of cirrhotic patients with portal hypertension or decompensated liver disease achieving SVR12.

  8. High Prestroke Physical Activity Is Associated with Reduced Infarct Growth in Acute Ischemic Stroke Patients Treated with Intravenous tPA and Randomized to Remote Ischemic Perconditioning

    DEFF Research Database (Denmark)

    Blauenfeldt, Rolf Ankerlund; Hougaard, Kristina D; Mouridsen, Kim

    2017-01-01

    infarct growth in a cohort of acute ischemic stroke patients treated with intravenous tPA and randomized to remote ischemic perconditioning. METHODS: In this predefined subanalysis, data from a randomized clinical trial investigating the effect of remote ischemic perconditioning (RIPerC) on AIS was used......-on to intravenous thrombolysis, the level of PA the week before the stroke was associated with decreased 24-h infarct growth and final infarct size. These results are highly encouraging and stress the need for further exploration of the potentially protective effects of both PA and remote ischemic conditioning.......BACKGROUND: A high prestroke physical activity (PA) level is associated with reduced stroke rate, stroke mortality, better functional outcome, and possible neuroprotective abilities. The aim of the present study was to examine the possible neuroprotective effect of prestroke PA on 24-h cerebral...

  9. [Diuretic resistance and mechanical ventilation in decompensated cor pulmonale: successful treatment by slow continuous ultrafiltration].

    Science.gov (United States)

    Ries, W; Schenzer, A; Lüken, J; Ries, C; Machraoui, A

    2012-08-01

    We report on a 53-year-old male patient who presented with severe dyspnea at rest and massive volume overload because of decompensated cor pulmonale. Furthermore he suffered from stage 3 chronic kidney disease. As there was diuretics resistance and carbon dioxide narcosis, he had to be intubated and ventilated. The massive volume overload could be successfully treated with slow continuous ultrafiltration (SCUF) with removal of a volume of 27.5 l within 3 days. The SCUF therapy is an effective and gentle method to treat even an excessive volume overload based on diuretics resistance.

  10. Peripartum cardiomyopathy: postpartum decompensation and use of non-invasive cardiac output monitoring.

    Science.gov (United States)

    Lorello, G; Cubillos, J; McDonald, M; Balki, M

    2014-02-01

    The utility of a non-invasive cardiac output monitor (NICOM™) in guiding the peripartum management and identification of postpartum complications in a patient with severe peripartum cardiomyopathy is reported. A 31-year-old nulliparous woman at 35 weeks of gestation presented with a three-week history of worsening dyspnea and progressive functional deterioration. A transthoracic echocardiogram showed severe left ventricular systolic dysfunction with an ejection fraction peripartum cardiomyopathy. We suggest that use of NICOM™ be extended into the postpartum period to detect signs of cardiac decompensation in such patients.

  11. LACTULOSE IN PREOPERATIVE PREPARATION OF CHILDREN WITH DECOMPENSATED TYPE OF CHRONIC COLON STASIS

    Directory of Open Access Journals (Sweden)

    I.V. Kirgizov

    2009-01-01

    Full Text Available This article describes the results of estimation of effectiveness of lactulose (Dupfalac in preoperative preparation of children with decompensated type of chronic colon stasis. Proved, that administration of this medication normalizes such indices of homeostasis as acid-base balance of blood and microbiocenose of colon by 7days. Use of lactulose decreases patient complaints on nausea, vomiting, abdominal pain, weakness in 1.6 times rarely then in group of children using other laxative medications in preoperative preparation.Key words: megacolon syndrome, lactulose, dysbacteriosis, blood acid-base balance.(Voprosy sovremennoi pediatrii — Current Pediatrics. 2009;8(1:68-71

  12. FACTORS EFFECTING THE DECOMPENSATION OF CHRONIC HEART FAILURE IN THE ELDERLY

    Directory of Open Access Journals (Sweden)

    V. N. Larina

    2013-01-01

    Full Text Available Aim. To identify risk factors of decompensation of chronic heart failure (CHF and related hospitalization in elderly outpatients.Material and methods. The total of 248 patients aged 60–85 years with CHF NYHA class II-IV were enrolled into the study. The first group consisted of 87 (35.1% patients who required hospitalization due to CHF decompensation during the follow-up, the second group of 161 patients without need for hospital admission. All the patients had undergone clinical and laboratory examination, estimation of CHF severity by the Scale of clinical state, assessment of quality of life and 6-minute walk test (6MWT, echocardiography.Results. Patients were matched for age, gender, disability occurrence, education level, body mass index, quality of life, hemodynamic parameters, incidence rates of anemia, diabetes mellitus and atrial fibrillation. CHF was more severe in patients who had required hospitalization (p<0.001, they were more often diagnosed with left ventricular aneurysm (p=0.001, chronic kidney disease (p=0.001, left ventricular ejection fraction (LVEF<35% (p<0.001, history of stroke (p<0.001, III-IV degree mitral regurgitation (p=0.007, hyperuricemia (p<0.001, lower exercise tolerance (p=0.007 compared with patients without hospitalization. Higher functional class of CHF (OR=0.29; 95% CI 0.13–0.69; p=0.003, LVEF<35% (OR 0.37; 95% CI 0.18–0.76; p=0.007, chronic kidney disease (OR=0.29; 95% CI 0.13–0.68; p=0.004 and hyperuricemia (OR=0.23; 95%CI 0.10–0.50; p<0.001 were shown to be independent risk factors of CHF decompensation that required hospital admission in elderly patients.Conclusuion. High FC of CHF, low LVEF, hyperuricemia and renal dysfunction play a key role in CHF decompensation and related hospitalization in elderly patients.

  13. Colloid osmotic pressure in decompensated cirrhosis. A 'mirror image' of portal venous hypertension

    DEFF Research Database (Denmark)

    Henriksen, Jens Henrik Sahl

    1985-01-01

    was significantly below that of plasma (average, 25% of IIP; P less than 0.01). Portal pressure (transmural), determined as wedged hepatic venous minus inferior vena caval pressure (WHV--IVCP), was significantly increased (mean, 18 mm Hg, versus normal, 3 mm Hg; P less than 0.01) and inversely correlated to IIA...... 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...

  14. Intermittent versus continuous renal replacement therapy for acute kidney injury patients admitted to the intensive care unit: results of a randomized clinical trial.

    Science.gov (United States)

    Lins, Robert L; Elseviers, Monique M; Van der Niepen, Patricia; Hoste, Eric; Malbrain, Manu L; Damas, Pierre; Devriendt, Jacques

    2009-02-01

    There is uncertainty on the effect of different dialysis modalities for the treatment of patients with acute kidney injury (AKI), admitted to the intensive care unit (ICU). This controlled clinical trial performed in the framework of the multicentre SHARF 4 study (Stuivenberg Hospital Acute Renal Failure) aimed to investigate the outcome in patients with AKI, stratified according to severity of disease and randomized to different treatment options. This was a multicentre prospective randomized controlled trial with stratification according to severity of disease expressed by the SHARF score. ICU patients were eligible for inclusion when serum creatinine was >2 mg/dL, and RRT was initiated. The selected patients were randomized to intermittent (IRRT) or continuous renal replacement therapy (CRRT). A total of 316 AKI patients were randomly assigned to IRRT (n = 144) or CRRT (n = 172). The mean age was 66 (range 18-96); 59% were male. Intention-to-treat analysis revealed a mortality of 62.5% in IRRT compared to 58.1% in CRRT (P = 0.430). No difference between IRRT and CRRT could be observed in the duration of ICU stay or hospital stay. In survivors, renal recovery at hospital discharge was comparable between both groups. Multivariate analysis, including the SHARF score, APACHE II and SOFA scores for correction of disease severity, showed no difference in mortality between both treatment modalities. This result was confirmed in pre-specified subgroup analysis (elderly, patients with sepsis, heart failure, ventilation) and after exclusion of possible confounders (early mortality, delayed ICU admission). Modality of RRT, either CRRT or IRRT, had no impact on the outcome in ICU patients with AKI. Both modalities need to be considered as complementary in the treatment of AKI (Clinical Trial: SHARF 4, NCT00322933, http://ClinicalTrials.gov).

  15. Impact of physical activity on energy balance, food intake and choice in normal weight and obese children in the setting of acute social stress: a randomized controlled trial.

    Science.gov (United States)

    Horsch, Antje; Wobmann, Marion; Kriemler, Susi; Munsch, Simone; Borloz, Sylvie; Balz, Alexandra; Marques-Vidal, Pedro; Borghini, Ayala; Puder, Jardena J

    2015-02-19

    Psychological stress negatively influences food intake and food choices, thereby contributing to the development of childhood obesity. Physical activity can also moderate eating behavior and influence calorie intake. However, it is unknown if acute physical activity influences food intake and overall energy balance after acute stress exposure in children. We therefore investigated the impact of acute physical activity on overall energy balance (food intake minus energy expenditure), food intake, and choice in the setting of acute social stress in normal weight (NW) and overweight/obese (OW/OB) children as well as the impact of psychological risk factors. After receiving written consent from their parents, 26 NW (BMI children were randomly allocated using computer-generated numbers (1:1, after stratification for weight status) to acute moderate physical or to sedentary activity for 30 min. Afterwards, all children were exposed to an acute social stressor. Children and their parents completed self-report questionnaires. At the end of the stressor, children were allowed to eat freely from a range of 12 different foods (6 sweet/6 salty; each of low/high caloric density). Energy balance, food intake/choice and obesity-related psychological risk factors were assessed. Lower overall energy balance (p = 0.019) and a decreased choice of low density salty foods (p children compared with OW/OB children was found after acute moderate physical activity but not sedentary activity. Independent of their allocation, OW/OB children ate more high density salty foods (104 kcal (34 to 173), p = 0.004) following stress. They scored higher on impulsive behavior (p = 0.005), restrained eating (p physical activity can address energy balance in children, a benefit which is especially pronounced in the OW/OB. Positive parenting may act as a protective factor preventing stress-induced eating of comfort food. clinicaltrials.gov NCT01693926 The study was a pilot study of a project funded by the

  16. The effect of acute alcohol intoxication on gut wall integrity in healthy male volunteers; a randomized controlled trial

    NARCIS (Netherlands)

    de Jong, Willem-Jan; Cleveringa, A. M.; Greijdanus, B.; Meyer, P.; Heineman, E.; Hulscher, J. B.

    2015-01-01

    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

  17. Prognostic potential of midregional pro-adrenomedullin following decompensation for systolic heart failure: comparison with cardiac natriuretic peptides.

    Science.gov (United States)

    Morbach, Caroline; Marx, Almuth; Kaspar, Mathias; Güder, Gülmisal; Brenner, Susanne; Feldmann, Carolin; Störk, Stefan; Vollert, Jörn O; Ertl, Georg; Angermann, Christiane E

    2017-05-17

    Whereas guidelines recommend the routine use of natriuretic peptides (NPs) in heart failure (HF) care, the clinical relevance and prognostic potential of midregional pro-adrenomedullin (MR-proADM) is less well established. We aimed to compare the prognostic potential of MR-proADM after acute decompensation for systolic HF with that of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and midregional pro-atrial NP (MR-proANP), to investigate the significance of high/rising MR-proADM, and to evaluate the incremental prognostic yield of repeat measurements. The Interdisciplinary Network Heart Failure (INH) programme enrolled patients hospitalized for acute systolic HF and followed them for 18 months (100% complete). Of 1022 INH participants, 917 (68 ± 12 years, 28% female) who had biomaterials available were enrolled. High MR-proADM was associated with more impaired left ventricular function, higher comorbidity burden, lower doses of HF medications, and lower likelihood of left ventricular reverse remodelling. Compared with NPs, MR-proADM had superior prognostic significance (concordance index 0.72 for all-cause mortality), improved Cox regression models including NPs (P < 0.001), and was the only biomarker also predicting non-cardiac death (hazard ratio 1.8 vs. 1.0). In the setting of low NPs, patients with high MR-proADM experienced non-cardiac death more often. Six month MR-proADM enhanced models including baseline MR-proADM (P < 0.001) for prediction of all-cause death (net reclassification index: 0.48, 95% confidence interval 0.19-0.78). MR-proADM was found to correlate with the global disease burden in HF and proved a potent prognostic indicator, capturing the risk for both cardiac and non-cardiac death. Serial MR-proADM measurements further enhanced risk assessment, thus facilitating substantial reclassification. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

  18. A double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of Cerebrolysin in patients with acute ischaemic stroke in Asia--CASTA.

    Science.gov (United States)

    Hong, Z; Moessler, H; Bornstein, N; Brainin, M; Heiss, W-D

    2009-10-01

    Cerebrolysin has exhibited neuroprotective as well as neurotrophic properties in various animal models of cerebral ischaemia and has shown clinical efficacy and good safety in several small controlled clinical studies in ischaemic stroke. Therefore, a large double-blind placebo-controlled randomized clinical trial was launched in Asia to prove the validity of this treatment strategy. In the more than 50 participating centres patients with acute ischemic hemispheric stroke are randomized within 12 hours of symptoms onset to treatment (30 ml Cerebrolysin diluted in physiologic saline) or placebo (saline) given as intravenous infusion once daily added to standard care for 10 days. The patients are followed with regular visits for 90 days. Efficacy is evaluated on day 90 by three outcome scales - modified Rankin Scale, Barthel Index and NIH Stroke Scale - combined to single global directional test. Additionally, adverse events are documented to prove safety. In this study a total of 1060 patients will be included and analysis of data will be completed in 2010. If positive, this trial will add an effective strategy to the treatment of acute ischaemic stroke.

  19. Risperidone for the treatment of acute mania in children and adolescents with bipolar disorder: a randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Haas, Magali; Delbello, Melissa P; Pandina, Gahan; Kushner, Stuart; Van Hove, Ilse; Augustyns, Ilse; Quiroz, Jorge; Kusumakar, Vivek

    2009-11-01

    To evaluate the efficacy, safety, and tolerability of risperidone monotherapy for the treatment of an acute mixed or manic episode in children and adolescents with bipolar I disorder. This randomized, placebo-controlled, double-blind, 3-arm study (N = 169) included children and adolescents (ages 10-17 years) with a DSM-IV diagnosis of bipolar I disorder, experiencing a manic or mixed episode. Study participants were randomized to placebo (n = 58), risperidone 0.5-2.5 mg/day (n = 50), or risperidone 3-6 mg/day (n = 61) for 3 weeks. The primary efficacy measure was change in Young Mania Rating Scale (YMRS) total score from baseline to end point. Safety assessments included adverse event (AE) monitoring and scores on extrapyramidal symptom rating scales. Improvement in mean YMRS total score was significantly greater in risperidone-treated subjects than in placebo-treated subjects [mean change (SD) -9.1 (11.0) for placebo; -18.5 (9.7) for risperidone 0.5-2.5 mg (p children and adolescents experiencing acute manic or mixed episodes of bipolar I disorder. Results indicate that risperidone 0.5-2.5 mg has a better benefit-risk profile than risperidone 3-6 mg.

  20. Intravenous dipyrone for the acute treatment of episodic tension-type headache: A randomized, placebo-controlled, double-blind study

    Directory of Open Access Journals (Sweden)

    M.E. Bigal

    2002-10-01

    Full Text Available Acute headaches are responsible for a significant percentage of the case load at primary care units and emergency rooms in Brazil. Dipyrone (metamizol is easily available in these settings, being the most frequently used drug. We conducted a randomized, placebo-controlled, double-blind study to assess the effect of dipyrone in the acute treatment of episodic tension-type headache. Sixty patients were randomized to receive placebo (intravenous injection of 10 ml saline or 1 g dipyrone in 10 ml saline. We used seven parameters of analgesic evaluation. The patients receiving dipyrone showed a statistically significant improvement (P<0.05 of pain compared to placebo up to 30 min after drug administration. The therapeutic gain was 30% in 30 min and 40% in 60 min. The number of patients needed to be treated for at least one to have benefit was 3.3 in 30 min and 2.2 in 60 min. There were statistically significant reductions in the recurrence (dipyrone = 25%, placebo = 50% and use of rescue medication (dipyrone = 20%, placebo = 47.6% for the dipyrone group. Intravenous dipyrone is an effective drug for the relief of pain in tension-type headache and its use is justified in the emergency room setting.

  1. Individual, nutritional support prevents undernutrition, increases muscle strength and improves QoL among elderly at nutritional risk hospitalized for acute stroke: a randomized, controlled trial.

    Science.gov (United States)

    Ha, Lisa; Hauge, Truls; Spenning, Anne Bente; Iversen, Per Ole

    2010-10-01

    Undernutrition after an acute stroke increases the risk of poor outcome. We wanted to examine the effect of individualized, nutritional support on weight loss and functional outcomes in stroke patients. Acute stroke patients at nutritional risk were randomized to either individualized, nutritional care or routine care while in hospital. Patients in the intervention group received an individualized treatment plan aiming to prevent weight loss. In accordance with routine care, the controls did not have such a treatment plan. Patients were reviewed at follow-up after three months. Primary outcome measure was the percentage of patients with weight loss ≥5%. Secondary outcomes measures were quality of life (QoL), handgrip strength and length of hospital stay. This trial is registered with ClinicalTrials.gov, number NCT00163007. At follow-up, 20.7% of the intervention group (n = 58) lost ≥5% weight compared with 36.4% in the control group (n = 66) (P = 0.055). The intervention group had a significantly higher increase in QoL score (P = 0.009) and in handgrip strength (P = 0.002). There was no difference in length of hospital stay. Individualized, nutritional treatment strategy can prevent clinically significant weight loss and improve QoL in elderly acute stroke patients at nutritional risk. Copyright © 2010 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  2. Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Kortram, Kirsten; van Ramshorst, Bert; Bollen, Thomas L; Besselink, Marc G H; Gouma, Dirk J; Karsten, Tom; Kruyt, Philip M; Nieuwenhuijzen, Grard A P; Kelder, Johannes C; Tromp, Ellen; Boerma, Djamila

    2012-01-12

    Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients. Netherlands Trial Register (NTR): NTR2666.

  3. Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial: Study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kortram Kirsten

    2012-01-01

    Full Text Available Abstract Background Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice. Methods/Design The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs. Discussion The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients. Trial Registration Netherlands Trial Register (NTR: NTR2666

  4. Comparative efficacy and tolerability of pholcodine and dextromethorphan in the management of patients with acute, non-productive cough : a randomized, double-blind, multicenter study.

    Science.gov (United States)

    Equinozzi, Roberto; Robuschi, Maria

    2006-01-01

    The aim of this study was to compare the efficacy and tolerability of pholcodine with that of dextromethorphan, one of the most used cough sedative products, in patients with acute, non-productive cough. 129 adults with a diagnosis of acute, frequent, non-productive cough participated in a randomized, double-blind, parallel-group, multicenter trial. Medications were in a syrup formulation and were taken orally three times daily for 3 days. The efficacy endpoints were the change from baseline in the daytime and night-time cough frequency on 5-point scales at day 3, and cough intensity. A reduction of 1.4 and 1.3 points in the mean daytime cough frequency at day 3 was seen in the pholcodine and dextromethorphan groups, respectively, in the per-protocol population. The reduction in mean night-time cough was 1.3 for both groups. Cough intensity reduction was 0.7 for pholcodine and 0.8 for dextromethorphan. These findings indicate that the efficacy of a 3-day course of pholcodine is similar to that of dextromethorphan in the treatment of adult patients with acute, non-productive cough. Both medications were well tolerated.

  5. A systematic review and meta-analysis of randomized controlled trials of endovascular thrombectomy compared with best medical treatment for acute ischemic stroke.

    Science.gov (United States)

    Balami, Joyce S; Sutherland, Brad A; Edmunds, Laurel D; Grunwald, Iris Q; Neuhaus, Ain A; Hadley, Gina; Karbalai, Hasneen; Metcalf, Kneale A; DeLuca, Gabriele C; Buchan, Alastair M

    2015-12-01

    Acute ischemic strokes involving occlusion of large vessels usually recanalize poorly following treatment with intravenous thrombolysis. Recent studies have shown higher recanalization and higher good outcome rates with endovascular therapy compared with best medical management alone. A systematic review and meta-analysis investigating the benefits of all randomized controlled trials of endovascular thrombectomy where at least 25% of patients were treated with a thrombectomy device for the treatment of acute ischemic stroke compared with best medical treatment have yet to be performed. To perform a systematic review and a meta-analysis evaluating the effectiveness of endovascular thrombectomy compared with best medical care for treatment of acute ischemic stroke. Our search identified 437 publications, from which eight studies (totaling 2423 patients) matched the inclusion criteria. Overall, endovascular thrombectomy was associated with improved functional outcomes (modified Rankin Scale 0-2) [odds ratio 1·56 (1·32-1·85), P Stroke published by John Wiley & Sons Ltd on behalf of World Stroke Organization.

  6. Bronchodilatory effect of inhaled budesonide/formoterol and budesonide/salbutamol in acute asthma: a double-blind, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Arun Jenish J

    2012-03-01

    Full Text Available Abstract Background There are no published studies that have compared bronchodilatory effect of inhaled budesonide/formoterol combination with budesonide/salbutamol delivered by metered dose inhaler with a spacer in acute exacerbation of asthma in children. We, therefore, compared the bronchodilatory effects of inhaled budesonide/formoterol (dose: 200 μg and 12 μg respectively combination with budesonide (200 μg/salbutamol (200 μg administered by metered dose inhaler and spacer in children of 5-15 years with mild acute exacerbation of asthma [Modified Pulmonary Index Score (MPIS between 6-8] in this double-blind, randomized controlled trial. The primary outcome was FEV1 (% predicted in the two groups at 1, 5, 15, 30, 60 min after administration of the study drug. Results We did not observe any significant differences in the % predicted FEV1 and MPIS between formoterol and salbutamol at various time points from 1 min to 60 min post drug administration. There was significant improvement in FEV1 (% predicted from baseline in both the groups as early as 1 min after drug administration. Conclusions Salbutamol or formoterol delivered along with inhaled corticosteroid by metered dose inhaler with spacer in children between 5-15 years of age with mild acute exacerbation of asthma had similar bronchodilatory effects. Trial Registration ClinicalTrials.gov: NCT00900874

  7. A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia.

    Science.gov (United States)

    Kane, John M; Skuban, Aleksandar; Ouyang, John; Hobart, Mary; Pfister, Stephanie; McQuade, Robert D; Nyilas, Margaretta; Carson, William H; Sanchez, Raymond; Eriksson, Hans

    2015-05-01

    The objective of this study was to evaluate the efficacy, safety and tolerability of brexpiprazole versus placebo in adults with acute schizophrenia. This was a 6-week, multicenter, placebo-controlled double-blind phase 3 study. Patients with acute schizophrenia were randomized to brexpiprazole 1, 2 or 4 mg, or placebo (2:3:3:3) once daily. The primary endpoint was changed from baseline at week 6 in Positive and Negative Syndrome Scale (PANSS) total score; the key secondary endpoint was Clinical Global Impressions-Severity (CGI-S) at week 6. Brexpiprazole 4 mg showed statistically significant improvement versus placebo (treatment difference: -6.47, p=0.0022) for the primary endpoint. Improvement compared with placebo was also seen for the key secondary endpoint (treatment difference: -0.38, p=0.0015), and on multiple secondary efficacy outcomes. Brexpiprazole 1 and 2mg also showed numerical improvements versus placebo, although p>0.05. The most common treatment-emergent adverse events were headache, insomnia and agitation; incidences of akathisia were lower in the brexpiprazole treatment groups (4.2%-6.5%) versus placebo (7.1%). Brexpiprazole treatment was associated with moderate weight gain at week 6 (1.23-1.89 kg versus 0.35 kg for placebo); there were no clinically relevant changes in laboratory parameters and vital signs. In conclusion, brexpiprazole 4 mg is an efficacious and well-tolerated treatment for acute schizophrenia in adults. Clinical Trials.gov NCT01393613; BEACON trial.

  8. Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study

    Directory of Open Access Journals (Sweden)

    Scholten Pieter

    2007-07-01

    Full Text Available Abstract Background Acute left-sided colonic obstruction is most often caused by malignancy and the surgical treatment is associated with a high mortality and morbidity rate. Moreover, these operated patients end up with a temporary or permanent stoma. Initial insertion of an enteral stent to decompress the obstructed colon, allowing for surgery to be performed electively, is gaining popularity. In uncontrolled studies stent placement before elective surgery has been suggested to decrease mortality, morbidity and number of colostomies. However stent perforation can lead to peritoneal tumor spill, changing a potentially curable disease in an incurable one. Therefore it is of paramount importance to compare the outcomes of colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in a randomized multicenter fashion. Methods/design Patients with acute left-sided malignant colonic obstruction eligible for this study will be randomized to either emergency surgery (current standard treatment or colonic stenting as bridge to elective surgery. Outcome measurements are effectiveness and costs of both strategies. Effectiveness will be evaluated in terms of quality of life, morbidity and mortality. Quality of life will be measured with standardized questionnaires (EORTC QLQ-C30, EORTC QLQ-CR38, EQ-5D and EQ-VAS. Morbidity is defined as every event leading to hospital admission or prolonging hospital stay. Mortality will be analyzed as total mortality as well as procedure-related mortality. The total costs of treatment will be evaluated by counting volumes and calculating unit prices. Including 120 patients on a 1:1 basis will have 80% power to detect an effect size of 0.5 on the EORTC QLQ-C30 global health scale, using a two group t-test with a 0.05 two-sided significance level. Differences in quality of life and morbidity will be analyzed using mixed-models repeated measures

  9. Exploring patient satisfaction: a secondary analysis of a randomized clinical trial of spinal manipulation, home exercise, and medication for acute and subacute neck pain.

    Science.gov (United States)

    Leininger, Brent D; Evans, Roni; Bronfort, Gert

    2014-10-01

    The purpose of this study was to assess satisfaction with specific aspects of care for acute neck pain and explore the relationship between satisfaction with care, neck pain, and global satisfaction. This study was a secondary analysis of patient satisfaction from a randomized trial of spinal manipulation therapy (SMT) delivered by doctors of chiropractic, home exercise and advice (HEA) delivered by exercise therapists, and medication (MED) prescribed by a medical doctors for acute/subacute neck pain. Differences in satisfaction with specific aspects of care were analyzed using a linear mixed model. The relationship between specific aspects of care and (1) change in neck pain (primary outcome of the randomized trial) and (2) global satisfaction were assessed using Pearson's correlation and multiple linear regression. Individuals receiving SMT or HEA were more satisfied with the information and general care received than MED group participants. Spinal manipulation therapy and HEA groups reported similar satisfaction with information provided during treatment; however, the SMT group was more satisfied with general care. Satisfaction with general care (r = -0.75 to -0.77; R(2) = 0.55-0.56) had a stronger relationship with global satisfaction compared with satisfaction with information provided (r = -0.65 to 0.67; R(2) = 0.39-0.46). The relationship between satisfaction with care and neck pain was weak (r = 0.17-0.38; R(2) = 0.08-0.21). Individuals with acute/subacute neck pain were more satisfied with specific aspects of care received during spinal manipulation therapy or home exercise interventions compared to receiving medication. The relationship between neck pain and satisfaction with care was weak. Copyright © 2014 National University of Health Sciences. Published by Elsevier Inc. All rights reserved.

  10. Recombinant streptokinase suppositories in the treatment of acute haemorrhoidal disease. Multicentre randomized double-blind placebo-controlled trial (THERESA-2).

    Science.gov (United States)

    Hernández-Bernal, F; Valenzuela-Silva, C M; Quintero-Tabío, L; Castellanos-Sierra, G; Monterrey-Cao, D; Aguilera-Barreto, A; López-Saura, P

    2013-11-01

    A four-arm multicentre randomized double-blind placebo-controlled trial was undertaken to assess the effect and safety of suppositories containing recombinant streptokinase (rSK) at two dose levels (100,000 IU and 200,000 IU) with sodium salicylate (SS) compared with placebo and SS for the treatment of acute haemorrhoidal disease. Patients with acute symptoms of haemorrhoids were randomized to four treatment groups: (I) placebo, (II) SS, (III) SS + rSK 100,000 IU and (IV) SS + rSK 200,000 IU per suppository. Inpatient treatment was by four suppositories given every 6 h to discharge at 24 h. Evaluations were made at the time of discharge (24 h) and at 3, 5 and 20 days later. The main end-point was the degree of relief of pain, oedema and reduction in the size of the lesion by 90% on day 5. Adverse events and the occurrence of anti-SK antibodies were also determined. Eighty patients were included. Respective response rates in the four groups were 16%, 30%, 25% and 52%. In the last group there was a significant difference (36.8%) compared with control (95% CI 7.0-58.4%). The time to response was significantly shorter (median 5 days) in the 200,000 IU rSK group with respect to the others. There were no adverse events attributable to the treatment. No increase in anti-SK antibodies was detected 20 days after treatment. Suppositories with 200,000 IU rSK showed a significant improvement in symptoms of acute haemorrhoids, with an adequate safety profile. Colorectal Disease © 2013 The Association of Coloproctology of Great Britain and Ireland.

  11. Effect of nebulized budesonide on respiratory mechanics and oxygenation in acute lung injury/acute respiratory distress syndrome: Randomized controlled study

    Science.gov (United States)

    Mohamed, Hatem Saber; Meguid, Mona Mohamed Abdel

    2017-01-01

    Background: We tested the hypothesis that nebulized budesonide would improve lung mechanics and oxygenation in patients with early acute lung injury (ALI) and/or acute respiratory distress syndrome (ARDS) during protective mechanical ventilation strategy without adversely affecting systemic hemodynamics. Methods: Patients with ALI/ARDS were included and assigned into two groups; budesonide group (30 cases) in whom 1 mg–2 ml budesonide suspension was nebulized through the endotracheal tube and control group (30 cases) in whom 2 ml saline (placebo) were nebulized instead of budesonide. This regimen was repeated every 12 h for three successive days alongside with constant ventilator settings in both groups. Hemodynamics, airway pressures, and PaO2/FiO2 were measured throughout the study period (72 h) with either nebulized budesonide or saline. Furthermore, tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and interleukin-6 (IL-6) were analyzed serologically as markers of inflammation at pre- and post-nebulization sessions. Results: We found a significant difference between the two groups regarding PaO2/FiO2 (P = 0.023), peak (P = 0.021), and plateau (P = 0.032) airway pressures. Furthermore, TNF-α, IL-1β, and IL-6 were significantly reduced after budesonide nebulizations. No significant difference was found between the two groups regarding hemodynamic variables. Conclusion: Nebulized budesonide improved oxygenation, peak, and plateau airway pressures and significantly reduced inflammatory markers (TNF-α, IL-1β and IL-6) without affecting hemodynamics. Trial Registry: Australian New Zealand Clinical Trial Registry (ANZCTR) at the number: ACTRN12615000373572. PMID:28217046

  12. [Cerebral hemodynamic disorders in patients with chronic decompensated respiratory insufficiency. Physiopathogenetic considerations].

    Science.gov (United States)

    Ionescu, M

    1978-01-01

    The present paper reports on 12 patients (8 males, 4 females) suffering from chronic decompensated respiratory failure, who presented concomitant transient haemodynamic disturbances in the carotid and vertebrobasilary systems, manifested by hemisphere or brain stem symptoms. Owing to the adaptive capacity of these patients there exists a certain tolerance threshold to hypercapnic hypoxemia, but following accentuated or rapid aggravation of acid-base hypercapnic hypoxemia, the biological balance is abruptly perturbed leading to cerebral haemodynamic disturbances. The pathophysiological mechanism of production appears to be the accumulation of acid ions caused by pH acidification of the cerebrospinal fluid. Increase in the cerebral arterial output with decrease in the rate of circulation and vascular resistance take place especially in the vessels with atheromatous or hyaline lesions. Under conditions of severe acidosic hypercapnic hypoxemia this, nevertheless, insures a minimum of 10--20% oxygen required by the metabolism of the nerve cell, sufficient for maintaining the structure of the cell (vita minima). These vasculometabolic mechanisms explain why with improvement of haematosis, following remission of the decompensated disease and fall in acidotic hypercapnic hypoxemia values, the cerebral haemodynamic disturbances also show a more or less evident remission because the nerve cells having maintained their structure are able to take up their function again.

  13. [Decompensated right heart failure, intensive care and perioperative management in patients with pulmonary hypertension].

    Science.gov (United States)

    Olsson, K M; Halank, M; Egenlauf, B; Fistera, D; Gall, H; Kaehler, C; Kortmann, K; Kramm, T; Lichtblau, M; Marra, A; Nagel, C; Sablotzki, A; Seyfarth, H-J; Schranz, D; Ulrich, S; Hoeper, M M; Lange, T J

    2016-10-01

    The 2015 European Guidelines on Diagnosis and Treatment of Pulmonary Hypertension are also valid for Germany. The guidelines contain detailed recommendations for the targeted treatment of pulmonary arterial hypertension (PAH). However, the practical implementation of the European Guidelines in Germany requires the consideration of several country-specific issues and already existing novel data. This requires a detailed commentary to the guidelines, and in some aspects an update already appears necessary. In June 2016, a Consensus Conference organized by the PH working groups of the German Society of Cardiology (DGK), the German Society of Respiratory Medicine (DGP) and the German Society of Pediatric Cardiology (DGPK) was held in Cologne, Germany. This conference aimed to solve practical and controversial issues surrounding the implementation of the European Guidelines in Germany. To this end, a number of working groups was initiated, one of which was specifically dedicated to the management of decompensated right heart failure, intensive care management and perioperative management in patients with pulmonary hypertension. This article summarizes the results and recommendations of the working group on decompensated right heart failure, intensive care and perioperative management in patients with pulmonary hypertension. © Georg Thieme Verlag KG Stuttgart · New York.

  14. Decompensated porto-pulmonary hypertension in a cirrhotic patient with thrombosis of portocaval shunt

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    We report a case of decompensated porto-pulmonary hypertension closely associated with the development of intra-portocaval shunt thrombosis. A woman with Laennec's cirrhosis was hospitalized because of severe dyspnea and edema. She underwent surgical portocaval anastomosis ten years ago. Imaging studies showed massive intra-shunt thrombosis, portal hypertension, ascites, pleuro-pericardial effusions and enlargement of right cardiac cavities. Cardiac catheterization allowed to rule out coronary and leftsided heart abnormalities and led to the diagnosis of pre-capillary pulmonary hypertension. Antithrombotic treatment with low molecular weight heparin was instituted. The management also included ACE inhibitors,spironolactone, low-salt diet and lactulose. The patient was discharged and three months later we observed the disappearance of edema, ascites and pleuropericardial effusions, a marked body weight reduction and improved dyspnea and liver function tests. A possible link between the development of intra-shunt thrombosis and clinical decompensation in our patient was hypothesized. In fact, it has been demonstrated that the increased portal pressure, caused by occlusion of portosystemic shunt, reduces renal plasma flow and increases systemic endothelin-1 concentration. In our patient the disappearance of edematous state and improved dyspnea observed after recanalization of the shunt strongly support this hypothesis.

  15. Suboptimal metabolic control and decompensation in children and adolescents with diabetes mellitus type 1

    Directory of Open Access Journals (Sweden)

    N. Ya. Filina

    2016-01-01

    Full Text Available Aim of the study is identifying the causes of decompensation of metabolism in children with different levels of HbA1c by studying daily glycemic profiles using a continuous monitoring system (CGMS, Medtronic MiniMed, USA.Materials and methods. Blood glucose of 207 type 1 diabetes children with different compensation level was researched by continuous glucose monitoring system (СGMS. Statistical processing of the results was carried out using XLSTATS 4.0 program.Results. The causes of diabetes suboptimal control were deficit of bolus insulin doses in 53%, «dawn phenomenon» in 23%, hidden night hypoglycemia in 26%. Patients with HbA1c level higher than 9% have deficit short acting and basal insulin that was the cause of bad metabolic control. The compare of selfcontrol results and CGMS data was preformed and pointed the importance of glucose monitoring system for decompensation causes identification.

  16. Emerging therapies for the management of decompensated heart failure: from bench to bedside.

    Science.gov (United States)

    deGoma, Emil M; Vagelos, Randall H; Fowler, Michael B; Ashley, Euan A

    2006-12-19

    While pharmaceutical innovation has been highly successful in reducing mortality in chronic heart failure, this has not been matched by similar success in decompensated heart failure syndromes. Despite outstanding issues over definitions and end points, we argue in this paper that an unprecedented wealth of pharmacologic innovation may soon transform the management of these challenging patients. Agents that target contractility, such as cardiac myosin activators and novel adenosine triphosphate-dependent transmembrane sodium-potassium pump inhibitors, provide inotropic support without arrhythmogenic increases in cytosolic calcium or side effects of more traditional agents. Adenosine receptor blockade may improve glomerular filtration and diuresis by exerting a direct beneficial effect on glomerular blood flow while vasopressin antagonists promote free water excretion without compromising renal function and may simultaneously inhibit myocardial remodeling. Urodilatin, the renally synthesized isoform of atrial natriuretic peptide, may improve pulmonary congestion via vasodilation and enhanced diuresis. Finally, metabolic modulators such as perhexiline may optimize myocardial energy utilization by shifting adenosine triphosphate production from free fatty acids to glucose, a unique and conceptually appealing approach to the management of heart failure. These advances allow optimism not only for the advancement of our understanding and management of decompensated heart failure syndromes but for the translational research effort in heart failure biology in general.

  17. A single-blind, randomized comparison of olanzapine at a starting dose of 5 mg versus 20 mg in acute schizophrenia.

    Science.gov (United States)

    Mauri, Massimo Carlo; Colasanti, Alessandro; Rossattini, Matteo; Moliterno, Donatella; Baldi, Marialuisa L; Papa, Pietro

    2006-01-01

    Acute psychotic episodes represent critical situations during the course of schizophrenia. Olanzapine (OLZ), a second-generation antipsychotic, is efficacious in acute settings at dosages of 5 to 20 mg/d, and it can be considered a first-line treatment for patients with an acute episode of schizophrenia. The aim of this study was to evaluate the efficacy and tolerability of OLZ at a starting dose of 5 mg versus 20 mg in acute schizophrenic patients and to compare titration versus nontitration.Fifty-one schizophrenic inpatients were randomly assigned to receive OLZ at 5 mg/d (26 patients, group 1) or 20 mg/d (25 patients, group 2) as a starting dosage during an exacerbation phase. In group 1, the OLZ dosage was increased to a mean dosage of 10.55 (+/- 4.00) mg/d. Group 2 received OLZ at a fixed dose of 20 mg throughout the hospitalization period. Olanzapine was significantly and clinically effective on Brief Psychiatric Rating Scale (BPRS), Positive and Negative Syndrome Scale, PANSS positive symptoms, and Hamilton Rating Scale for Depression in both groups. There were no significant differences between groups 1 and 2 in the percent improvement in BPRS, Positive and Negative Syndrome Scale, PANSS positive symptoms, PANSS negative symptoms, or Hamilton Rating Scale for Depression; but group 2 was significantly superior in the mean percent improvement in the BPRS items of anxiety (P < 0.001) and suspiciousness (P < 0.05). In conclusion, the higher doses evidence more efficacy on anxiety and suspiciousness, so it seems to be useful to begin therapy with a full dose of the drug to obtain the maximum effect without any significant side effects.

  18. A randomized, comparative study of dual therapy (doxycycline–rifampin versus triple therapy (doxycycline–rifampin–levofloxacin for treating acute/subacute brucellosis

    Directory of Open Access Journals (Sweden)

    Ahmad Hasanain

    Full Text Available Abstract Aim The aim of this study was to compare both the efficacy and safety profile of the WHO-recommended, dual therapy (doxycycline–rifampin to a quinolone-based, triple therapy (doxycycline–rifampin–levofloxacin for treating acute/subacute brucellosis. Patients and methods We studied 107 consecutive, naïve patients with acute/subacute brucellosis admitted to Assiut University Hospital. Patients were randomly allocated to receive the dual therapy of doxycycline–rifampin (group-A or to receive the triple therapy of doxycycline–rifampin–levofloxacin (group-B. Acute/subacute brucellosis was diagnosed based on the presence of: (1 contact with animals or fresh animal products, (2 suggestive clinical manifestations of less than one-year duration, and (3 positive antibody titer (1:160 by standard tube agglutination test. Results There was no significant difference between the two groups regarding their demographic data. Fever was the most frequent manifestation (96.3%. Epigastric pain was the most frequent adverse effect of treatment (12.1%. Group-A patients had a significantly higher relapse rate compared to group-B patients (22.6% versus 9.3%, p-value = 0.01. The rate of treatment adverse effects was higher among group-B patients, although not reaching statistical significance (20.4% versus 11.3%, p-value = 0.059. Conclusions Adding levofloxacin to the dual therapy for acute/subacute brucellosis (doxycycline–rifampin may increase its efficacy in terms of lowering the relapse rate of the disease. Further, larger scale studies are needed before considering modifying the standard, dual therapy for brucellosis.

  19. Randomized double blind trial of ciprofloxacin prophylaxis during induction treatment in childhood acute lymphoblastic leukemia in the WK-ALL protocol in Indonesia

    Directory of Open Access Journals (Sweden)

    Widjajanto PH

    2013-02-01

    Full Text Available Pudjo H Widjajanto,1 Sumadiono Sumadiono,1 Jacqueline Cloos,2,3 Ignatius Purwanto,1 Sutaryo Sutaryo,1 Anjo JP Veerman1,21Pediatric Hematology and Oncology Division, Department of Pediatrics, Dr Sardjito Hospital, Medical Faculty, Universitas Gadjah Mada, Yogyakarta, Indonesia; 2Pediatric Oncology/Hematology Division, Department of Pediatrics, 3Department of Hematology, VU University Medical Center, Amsterdam, The NetherlandsObjectives: Toxic death is a big problem in the treatment of childhood acute lymphoblastic leukemia (ALL, especially in low-income countries. Studies of ciprofloxacin as single agent prophylaxis vary widely in success rate. We conducted a double-blind, randomized study to test the effects of ciprofloxacin monotherapy as prophylaxis for sepsis and death in induction treatment of the Indonesian childhood ALL protocol.Methods: Patients were randomized to the ciprofloxacin arm (n = 58 and to the placebo arm (n = 52. Oral ciprofloxacin monotherapy or oral placebo was administered twice a day. All events during induction were recorded: toxic death, abandonment, resistant disease, and complete remission rate.Results: Of 110 patients enrolled in this study, 79 (71.8% achieved CR. In comparison to the placebo arm, the ciprofloxacin arm had lower nadir of absolute neutrophil count during induction with median of 62 (range: 5–884 versus 270 (range: 14–25,480 × 109 cells/L (P > 0.01, greater risks for experiencing fever (50.0% versus 32.7%, P = 0.07, clinical sepsis (50.0% versus 38.5%, P = 0.22, and death (18.9% versus 5.8%, P = 0.05.Conclusion: In our setting, a reduced intensity protocol in a low-income situation, the data warn against using ciprofloxacin prophylaxis during induction treatment. A lower nadir of neutrophil count and higher mortality were found in the ciprofloxacin group.Keywords: ciprofloxacin, prophylaxis, childhood acute lymphoblastic leukemia, randomized trial, low-income country

  20. Effect of sample size on multi-parametric prediction of tissue outcome in acute ischemic stroke using a random forest classifier

    Science.gov (United States)

    Forkert, Nils Daniel; Fiehler, Jens

    2015-03-01

    The tissue outcome prediction in acute ischemic stroke patients is highly relevant for clinical and research purposes. It has been shown that the combined analysis of diffusion and perfusion MRI datasets using high-level machine learning techniques leads to an improved prediction of final infarction compared to single perfusion parameter thresholding. However, most high-level classifiers require a previous training and, until now, it is ambiguous how many subjects are required for this, which is the focus of this work. 23 MRI datasets of acute stroke patients with known tissue outcome were used in this work. Relative values of diffusion and perfusion parameters as well as the binary tissue outcome were extracted on a voxel-by- voxel level for all patients and used for training of a random forest classifier. The number of patients used for training set definition was iteratively and randomly reduced from using all 22 other patients to only one other patient. Thus, 22 tissue outcome predictions were generated for each patient using the trained random forest classifiers and compared to the known tissue outcome using the Dice coefficient. Overall, a logarithmic relation between the number of patients used for training set definition and tissue outcome prediction accuracy was found. Quantitatively, a mean Dice coefficient of 0.45 was found for the prediction using the training set consisting of the voxel information from only one other patient, which increases to 0.53 if using all other patients (n=22). Based on extrapolation, 50-100 patients appear to be a reasonable tradeoff between tissue outcome prediction accuracy and effort required for data acquisition and preparation.

  1. Regulation of Lipolysis and Adipose Tissue Signaling during Acute Endotoxin-Induced Inflammation: A Human Randomized Crossover Trial

    DEFF Research Database (Denmark)

    Rittig, Nikolaj; Bach, Ermina; Thomsen, Henrik Holm

    2016-01-01

    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...... = 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......BACKGROUND: 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...

  2. Effectiveness of green tea mouthwash in comparison to chlorhexidine mouthwash in patients with acute pericoronitis: a randomized clinical trial.

    Science.gov (United States)

    Shahakbari, R; Eshghpour, M; Rajaei, A; Rezaei, N M; Golfakhrabadi, P; Nejat, A

    2014-11-01

    The objective of this study was to evaluate the effectiveness of green tea mouthwash in controlling the pain and trismus associated with acute pericoronitis in comparison to chlorhexidine (CHX) mouthwash. Ninety-seven patients with acute pericoronitis underwent debridement and received 5% green tea mouthwash (study group) or 0.12% CHX mouth rinse (control group). Pain (visual analogue scale; VAS), number of analgesics, maximum mouth opening (MMO), and number of patients with trismus were determined. There were no significant differences in demographic variables (P>0.05), or baseline VAS (P>0.006), MMO (P>0.017) or number of patients with trismus (P>0.017) between the two groups. The mean VAS score of the study group was statistically lower than that of the control group between post-treatment days 3 and 5 (P0.017). Fewer of the patients rinsing with green tea had trismus on days 3 and 7, but the difference was non-significant (P>0.017). Hence, green tea mouth rinse could be an appropriate and effective choice for the control of pain and trismus in acute pericoronitis. Copyright © 2014 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  3. Skill execution and sleep deprivation: effects of acute caffeine or creatine supplementation - a randomized placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Kilduff Liam P

    2011-02-01

    Full Text Available Abstract Background We investigated the effects of sleep deprivation with or without acute supplementation of caffeine or creatine on the execution of a repeated rugby passing skill. Method Ten elite rugby players completed 10 trials on a simple rugby passing skill test (20 repeats per trial, following a period of familiarisation. The players had between 7-9 h sleep on 5 of these trials and between 3-5 h sleep (deprivation on the other 5. At a time of 1.5 h before each trial, they undertook administration of either: placebo tablets, 50 or 100 mg/kg creatine, 1 or 5 mg/kg caffeine. Saliva was collected before each trial and assayed for salivary free cortisol and testosterone. Results Sleep deprivation with placebo application resulted in a significant fall in skill performance accuracy on both the dominant and non-dominant passing sides (p Conclusion Acute sleep deprivation affects performance of a simple repeat skill in elite athletes and this was ameliorated by a single dose of either caffeine or creatine. Acute creatine use may help to alleviate decrements in skill performance in situations of sleep deprivation, such as transmeridian travel, and caffeine at low doses appears as efficacious as higher doses, at alleviating sleep deprivation deficits in athletes with a history of low caffeine use. Both options are without the side effects of higher dose caffeine use.

  4. A prospective phase II randomized study of deferasirox to prevent iatrogenic iron overload in patients undertaking induction/consolidation chemotherapy for acute myeloid leukaemia.

    Science.gov (United States)

    Kennedy, Glen A; Morris, Kirk L; Subramonpillai, Elango; Curley, Cameron; Butler, Jason; Durrant, Simon

    2013-06-01

    This prospective randomized phase II study aimed to determine the safety and efficacy of deferasirox in preventing iatrogenic iron overload in patients receiving induction/consolidation chemotherapy for acute myeloid leukaemia (AML) ize. Serum ferritin, transferrin saturation and CRP were measured pre-, mid- and post- each chemotherapy cycle. Patients were randomized to receive either therapy with deferasirox vs. no deferasirox therapy once serum ferritin increased to >500 μg/l. The trial was stopped prematurely due to excess gastrointestinal (GI) and infectious toxicity demonstrable in the deferasirox arm, after 10 patients had been randomized to deferasirox and 6 patients to the control arm. Overall, deferasirox was poorly tolerated, with median maximum tolerated dose only 13·8 mg/kg/d and no patient able to tolerate doses >20 mg/kg/d. Median duration of deferasirox therapy was only 72 d (range 19-130 d), with 9/10 patients requiring unplanned dose interruptions and 4/10 patients unable to continue the drug predominantly due to GI effects. Although all 3 treatment-related deaths occurred in the deferasirox arm (P = 0·25), median overall survival was similar between treatment arms. Use of deferasirox to prevent iatrogenic iron overload in AML patients undertaking induction/consolidation is poorly tolerated and appears to be associated with excess GI and infectious toxicity.

  5. Effects of music therapy on self- and experienced stigma in patients on an acute care psychiatric unit: a randomized three group effectiveness study.

    Science.gov (United States)

    Silverman, Michael J

    2013-10-01

    Stigma is a major social barrier that can restrict access to and willingness to seek psychiatric care. Psychiatric consumers may use secrecy and withdrawal in an attempt to cope with stigma. The purpose of this study was to determine the effects of music therapy on self- and experienced stigma in acute care psychiatric inpatients using a randomized design with wait-list control. Participants (N=83) were randomly assigned by cluster to one of three single-session group-based conditions: music therapy, education, or wait-list control. Participants in the music therapy and education conditions completed only posttests while participants in the wait-list control condition completed only pretests. The music therapy condition was a group songwriting intervention wherein participants composed lyrics for "the stigma blues." Results indicated significant differences in measures of discrimination (experienced stigma), disclosure (self-stigma), and total stigma between participants in the music therapy condition and participants in the wait-list control condition. From the results of this randomized controlled investigation, music therapy may be an engaging and effective psychosocial technique to treat stigma. Limitations, suggestions for future research, and implications for clinical practice and psychiatric music therapy research are provided.

  6. Comparison of the effectiveness and safety of cefpodoxime and ciprofloxacin in acute exacerbation of chronic suppurative otitis media: A randomized, open-labeled, phase IV clinical trial

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    Arijit Ghosh

    2012-01-01

    Full Text Available Objective : To compare the effectiveness and safety of cefpodoxime and ciprofloxacin for the treatment of mild to moderate cases of acute exacerbation of chronic suppurative otitis media (AECSOM. Materials and Methods : Adult patients diagnosed with AECSOM were screened and patients fulfilling the inclusion criteria were randomized to receive either cefpodoxime 200 mg twice daily or ciprofloxacin 500 mg twice daily orally for 7 days. The primary outcome of this randomized, open-labeled, phase IV clinical trial (Registration Number - CTRI/2011/10/002079 was clinical success rate at day 14 visit and the secondary outcome was incidence of adverse events (AEs. Forty-six patients were enrolled: 23 in the cefpodoxime group and 23 in the ciprofloxacin group. Results : The clinical success rates were 95.6% in the cefpodoxime group versus 90.9% in the ciprofloxacin group. These rates are comparable, but no statistically significant difference was observed between the groups. Few mild and self-limiting AEs were observed and the tolerability of both the drugs was also good. Conclusion : The results of this randomized, open-labeled phase IV clinical trial showed that a 7-day course of cefpodoxime is therapeutically comparable to ciprofloxacin in terms of both clinical effectiveness and safety for the treatment of patients with AECSOM.

  7. Double-blind, randomized, double-dummy clinical trial comparing the efficacy of ketorolac trometamol and naproxen for acute low back pain

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    Plapler PG

    2016-06-01

    Full Text Available Pérola Grinberg Plapler,1 Morton Aaron Scheinberg,2 Christina da Cunha Ecclissato,3 Monalisa Fernanda Bocchi de Oliveira,3 Roberto Bleuel Amazonas31Orthopedic and Traumatology Institute of Clinical Hospital, University of São Paulo, 2Clinical Research Center Hospital AACD, São Paulo, 3NC Group Medical Affairs, Hortolândia, São Paulo, Brazil Background: Nonsteroidal anti-inflammatory drugs (NSAIDs are the most common type of medication used in the treatment of acute pain. Ketorolac trometamol (KT is a nonnarcotic, peripherally acting nonsteroidal anti-inflammatory drug with analgesic effects comparable to certain opioids.Objective: The aim of this study was to compare the efficacy of KT and naproxen (NA in the treatment of acute low back pain (LBP of moderate-to-severe intensity.Patients and methods: In this 10-day, Phase III, randomized, double-blind, double-dummy, noninferiority trial, participants with acute LBP of moderate-to-severe intensity as determined through a visual analog scale (VAS were randomly assigned in a 1:1 ratio to receive sublingual KT 10 mg three times daily or oral NA 250 mg three times daily. From the second to the fifth day of treatment, if patient had VAS >40 mm, increased dosage to four times per day was allowed. The primary end point was the reduction in LBP as measured by VAS. We also performed a post hoc superiority analysis.Results: KT was not inferior to NA for the reduction in LBP over 5 days of use as measured by VAS scores (P=0.608 for equality of variance; P=0.321 for equality of means and by the Roland–Morris Disability Questionnaire (P=0.180 for equality of variance test; P=0.446 for equality of means using 95% confidence intervals. The percentage of participants with improved pain relief 60 minutes after receiving the first dose was higher in the KT group (24.2% than in the NA group (6.5%; P=0.049. The most common adverse effects were heartburn, nausea, and vomiting.Conclusion: KT is not inferior

  8. Dexamethasone compared to prednisolone for adults with acute lymphoblastic leukemia or lymphoblastic lymphoma: final results of the ALL-4 randomized, phase III trial of the EORTC Leukemia Group

    Science.gov (United States)

    Labar, Boris; Suciu, Stefan; Willemze, Roel; Muus, Petra; Marie, Jean-Pierre; Fillet, Georges; Berneman, Zwi; Jaksic, Branimir; Feremans, Walter; Bron, Dominique; Sinnige, Harm; Mistrik, Martin; Vreugdenhil, Gerard; De Bock, Robrecht; Nemet, Damir; Gilotay, Caroline; Amadori, Sergio; de Witte, Theo

    2010-01-01

    Background Corticosteroids are a standard component of the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma. Our aim was to determine whether dexamethasone results in a better outcome than prednisolone. Design and Methods Adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma were randomized to receive, as part of their induction therapy on days 1–8 and 15–22, either dexamethasone 8 mg/m2 or prednisolone 60 mg/m2. Those who reached complete remission were given two courses of consolidation therapy with high-dose cytarabine and mitoxantrone and methotrexate and asparaginase. Subsequently patients younger than 50 years, with a suitable donor, were to undergo allogeneic stem cell transplantation, whereas the others were planned to receive either an autologous stem cell transplant or high-dose maintenance chemotherapy with prophylactic central nervous system irradiation. Randomization was done with a minimization technique. The primary endpoint was event-free survival and the analyses was conducted on an intention-to-treat basis. Results Between August 1995 and October 2003, 325 patients between 15 to 72 years of age were randomized to receive either dexamethasone (163 patients) or prednisolone (162 patients). After induction and the course of first consolidation therapy, 131 (80.4%) patients in the dexamethasone group and 124 (76.5%) in the prednisolone group achieved complete remission. No significant difference was observed between the two treatment groups with regards to 6-year event-free survival rates (±SE) which were 25.9% (3.6%) and 28.7% (3.5%) in the dexamethasone and prednisolone groups, respectively (P=0.82, hazard ratio 0.97; 95% confidence interval, 0.75–1.25). Disease-free survival after complete remission was also similar in the dexamethasone and prednisolone groups, the 6-year rates being 32.3% and 37.5%, respectively (hazard ratio 1.03; 95% confidence interval 0.76–1.40). The 6-year cumulative

  9. The efficacy and safety of blonanserin compared with haloperidol in acute-phase schizophrenia: a randomized, double-blind, placebo-controlled, multicentre study.

    Science.gov (United States)

    Garcia, Esther; Robert, Marta; Peris, Francesc; Nakamura, Hiroshi; Sato, Noriko; Terazawa, Yoshikatsu

    2009-01-01

    Blonanserin is a novel atypical antipsychotic agent with potent dopamine D(2) and serotonin 5-HT(2) antagonist properties. It may potentially have a lower incidence of adverse events than other antipsychotic agents. To determine the efficacy and safety of three doses of blonanserin compared with placebo and haloperidol in patients with acute-phase schizophrenia. This was a 6-week, randomized, double-blind, placebo- and haloperidol-controlled, international, multicentre study. Patients with an acute exacerbation of their schizophrenia, with a Positive and Negative Syndrome Scale (PANSS) score >/=70 and a Clinical Global Impression - Severity of Illness (CGI-S) score >/=4 ('moderately ill') [with no decrease >/=20% or >/=1 point, respectively, during the wash-out period] were randomized into one of five treatment groups (blonanserin 2.5, 5 or 10 mg, haloperidol 10 mg or placebo once daily). Patients were assessed weekly for clinical efficacy, adverse events, extrapyramidal symptoms (EPS) and drug compliance, and were assessed biweekly for other safety variables. All 307 randomized patients received at least one dose of study medication and 228 (74.3%) completed the study. The mean reduction in PANSS total score at week 6 was significantly greater with all active treatments compared with placebo (-12.58; p blonanserin 10 mg was significantly superior to blonanserin 2.5 mg (-30.18 vs -20.6; p blonanserin 5 mg (-27.19) and haloperidol 10 mg (-28.16) were not. All active treatments showed greater efficacy against the positive symptoms of schizophrenia, and blonanserin (5 and 10 mg) was more effective against the negative symptoms than haloperidol. Blonanserin was well tolerated at all doses and there was no evidence of clinically important weight gain, orthostatic hypotension, corrected QT interval prolongation or clinically relevant changes in laboratory test results. Haloperidol caused persistent elevation in prolactin levels, but this was not seen with any dose of

  10. CATCH: A randomized trial comparing tinzaparin versus warfarin for treatment of acute venous thromboembolism (VTE) in cancer patients

    NARCIS (Netherlands)

    Lee, Agnes Y.; Bauersachs, Rupert; Janas, Mette S.; Jarner, Mikala F.; Kamphuisen, Pieter W.; Meyer, Guy; Paz-Ares, Luis; Khorana, Alok A.

    2012-01-01

    Background: VTE is a major cause of morbidity and mortality in cancer patients. LMWHs have been shown to be superior to warfarin in one randomized study, but adequately powered confirmatory studies have not been conducted and warfarin continues to be widely used for treatment of cancer-associated VT

  11. Clinical effectiveness and safety of gemifloxacin versus cefpodoxime in acute exacerbation of chronic bronchitis: A randomized, controlled trial

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    S Chatterjee

    2011-01-01

    Conclusion : The results of this randomized, single-blind trial demonstrated that a 7-day course of gemifloxacin is therapeutically comparable to cefpodoxime in terms of both clinical effectiveness and safety for the treatment of type II Anthonisen category AECB patients.

  12. Chronic Hepatitis B with Spontaneous Severe Acute Exacerbation

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    Wei-Lun Tsai

    2015-11-01

    Full Text Available Chronic hepatitis B virus (HBV infection is a major global health problem with an estimated 400 million HBV carriers worldwide. In the natural history of chronic hepatitis B (CHB, spontaneous acute exacerbation (AE is not uncommon, with a cumulative incidence of 10%–30% every year. While exacerbations can be mild, some patients may develop hepatic decompensation and even die. The underlying pathogenesis is possibly related to the activation of cytotoxic T lymphocyte-mediated immune response against HBV. An upsurge of serum HBV DNA usually precedes the rise of alanine aminotransferase (ALT and bilirubin. Whether antiviral treatment can benefit CHB with severe AE remains controversial, but early nucleos(tide analogues treatment seemed to be associated with an improved outcome. There has been no randomized study that compared the effects of different nucleos(tide analogues (NA in the setting of CHB with severe AE. However, potent NAs with good resistance profiles are recommended. In this review, we summarized current knowledge regarding the natural history, pathogenetic mechanisms, and therapeutic options of CHB with severe AE.

  13. Skill execution and sleep deprivation: effects of acute caffeine or creatine supplementation - a randomized placebo-controlled trial

    OpenAIRE

    Kilduff Liam P; Crewther Blair T; Cook Christian J; Drawer Scott; Gaviglio Chris M

    2011-01-01

    Abstract Background We investigated the effects of sleep deprivation with or without acute supplementation of caffeine or creatine on the execution of a repeated rugby passing skill. Method Ten elite rugby players completed 10 trials on a simple rugby passing skill test (20 repeats per trial), following a period of familiarisation. The players had between 7-9 h sleep on 5 of these trials and between 3-5 h sleep (deprivation) on the other 5. At a time of 1.5 h before each trial, they undertook...

  14. Low central venous pressure versus acute normovolemic hemodilution versus conventional fluid management for reducing blood loss in radical retropubic prostatectomy: a randomized controlled trial.

    Science.gov (United States)

    Habib, Ashraf S; Moul, Judd W; Polascik, Thomas J; Robertson, Cary N; Roche, Anthony M; White, William D; Hill, Stephen E; Nosnick, Israel; Gan, Tong J

    2014-05-01

    To compare acute normovolemic hemodilution versus low central venous pressure strategy versus conventional fluid management in reducing intraoperative estimated blood loss, hematocrit drop and need for blood transfusion in patients undergoing radical retropubic prostatectomy under general anesthesia. Patients undergoing radical retropubic prostatectomy under general anesthesia were randomized to conventional fluid management, acute normovolemic hemodilution or low central venous pressure (≤5 mmHg). Treatment effects on estimated blood loss and hematocrit change were tested in multivariable regression models accounting for surgeon, prostate size, and all two-way interactions. Ninety-two patients completed the study. Estimated blood loss (mean ± SD) was significantly lower with low central venous pressure (706 ± 362 ml) compared to acute normovolemic hemodilution (1103 ± 635 ml) and conventional (1051 ± 714 ml) groups (p = 0.0134). There was no difference between the groups in need for blood transfusion, or hematocrit drop from preoperative values. The multivariate model predicting estimated blood loss showed a significant effect of treatment (p = 0.0028) and prostate size (p = 0.0323), accounting for surgeon (p = 0.0013). In the model predicting hematocrit change, accounting for surgeon difference (p = 0.0037), the treatment effect depended on prostate size (p = 0.0007) with the slope of low central venous pressure differing from the other two groups. Hematocrit was predicted to drop more with increased prostate size in acute normovolemic hemodilution and conventional groups but not with low central venous pressure. Limitations include the inability to blind providers to group assignment, possible variability between providers in estimation of blood loss, and the relatively small sample size that was not powered to detect differences between the groups in need for blood transfusion. Maintaining low central venous

  15. The effect of protein intake and resistance training on muscle mass in acutely ill old medical patients - A randomized controlled trial

    DEFF Research Database (Denmark)

    Buhl, Sussi F; Andersen, Aino L; Andersen, Jens Rikardt

    2016-01-01

    admission and a daily protein supplement (18.8 g protein) and resistance training 3 times per week the 12 weeks following discharge. Muscle mass was assessed by Dual-energy X-ray Absorptiometry. Muscle strength was assessed by Hand Grip Strength and Chair Stand Test. Functional ability was assessed......BACKGROUND & AIM: Stress metabolism is associated with accelerated loss of muscle that has large consequences for the old medical patient. The aim of this study was to investigate if an intervention combining protein and resistance training was more effective in counteracting loss of muscle than...... standard care. Secondary outcomes were changes in muscle strength, functional ability and body weight. METHODS: 29 acutely admitted old (>65 years) patients were randomly assigned to the intervention (n = 14) or to standard care (n = 15). The Intervention Group received 1.7 g protein/kg/day during...

  16. Acute effect of topical menthol on chronic pain in slaughterhouse workers with carpal tunnel syndrome: triple-blind, randomized placebo-controlled trial

    DEFF Research Database (Denmark)

    Sundstrup, Emil; Jakobsen, Markus Due; Brandt, Mikkel;

    2014-01-01

    participants with CTS and chronic pain of the arm/hand who were randomly distributed into two groups to receive topical menthol (Biofreeze) or placebo (gel with a menthol scent) during the working day and 48 hours later the other treatment (crossover design). Participants rated arm/hand pain intensity during...... the last hour of work (scale 0-10) immediately before 1, 2, and 3 hours after application. Furthermore, global rating of change (GROC) in arm/hand pain was assessed 3 hours after application. Compared with placebo, pain intensity and GROC improved more following application of topical menthol (P = 0.......026 and P = 0.044, resp.). Pain intensity of the arm/hand decreased by -1.2 (CI 95%: -1.7 to -0.6) following topical menthol compared with placebo, corresponding to a moderate effect size of 0.63. In conclusion, topical menthol acutely reduces pain intensity during the working day in slaughterhouse workers...

  17. A randomized, controlled, dose-ranging study investigating single doses of GW406381, naproxen sodium, or placebo in patients with acute pain after third molar tooth extraction.

    Science.gov (United States)

    Varner, Julie; Lomax, Mark; Blum, David; Quessy, Steve

    2009-09-01

    To evaluate the efficacy and tolerability of 4 doses of GW406381, a cyclooxygenase-2 inhibitor, compared with placebo in a standard model of acute inflammatory pain. This randomized, double-blind, placebo-controlled, single-center study compared single doses of GW406381 (10 to 70 mg) or naproxen sodium 550 mg with placebo in patients after extraction of 2 or more partially bony impacted third molar teeth. A total of 300 patients were randomized (50 per group). The primary efficacy variable was the pain relief intensity difference score at each time point, which was calculated as the sum of the pain intensity difference and pain relief categorical scores at each time point. Each treatment was compared with placebo at each time point using an ordered hierarchical approach with closed testing procedures and last observation carried forward imputation methods. Pain relief intensity differences from placebo were statistically significant beginning at 1.5 hours postdosing for GW406381 70 and 50 mg and at 2-hour postdosing for GW406381 25 and 10 mg. The median time to onset of analgesia was 71 minutes for GW406381 50 mg, 72 minutes for GW406381 70 mg, and 36 minutes for naproxen. The median duration of analgesia was 5.9 hours for GW406381 50 mg, 7.9 hours for GW406391 70 mg, and 11.3 hours for naproxen. All treatments were well tolerated. GW406381 50 and 70 mg demonstrated clinically meaningful analgesia in this acute pain setting, although the onset of analgesia was greater than 1 hour.

  18. Effect of a brief outreach educational intervention on the translation of acute poisoning treatment guidelines to practice in rural Sri Lankan hospitals: a cluster randomized controlled trial.

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    Lalith Senarathna

    Full Text Available BACKGROUND: In developing countries, including Sri Lanka, a high proportion of acute poisoning and other medical emergencies are initially treated in rural peripheral hospitals. Patients are then usually transferred to referral hospitals for further treatment. Guidelines are often used to promote better patient care in these emergencies. We conducted a cluster randomized controlled trial (ISRCTN73983810 which aimed to assess the effect of a brief educational outreach ('academic detailing' intervention to promote the utilization of treatment guidelines for acute poisoning. METHODS AND FINDINGS: This cluster RCT was conducted in the North Central Province of Sri Lanka. All peripheral hospitals in the province were randomized to either intervention or control. All hospitals received a copy of the guidelines. The intervention hospitals received a brief out-reach academic detailing workshop which explained poisoning treatment guidelines and guideline promotional items designed to be used in daily care. Data were collected on all patients admitted due to poisoning for 12 months post-intervention in all study hospitals. Information collected included type of poison exposure, initial investigations, treatments and hospital outcome. Patients transferred from peripheral hospitals to referral hospitals had their clinical outcomes recorded. There were 23 intervention and 23 control hospitals. There were no significant differences in the patient characteristics, such as age, gender and the poisons ingested. The intervention hospitals showed a significant improvement in administration of activated charcoal [OR 2.95 (95% CI 1.28-6.80]. There was no difference between hospitals in use of other decontamination methods. CONCLUSION: This study shows that an educational intervention consisting of brief out-reach academic detailing was effective in changing treatment behavior in rural Sri Lankan hospitals. The intervention was only effective for treatments with

  19. Efficacy of a children’s procedural preparation and distraction device on healing in acute burn wound care procedures: study protocol for a randomized controlled trial

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    Brown Nadia J

    2012-12-01

    Full Text Available Abstract Background The intense pain and anxiety triggered by burns and their associated wound care procedures are well established in the literature. Non-pharmacological intervention is a critical component of total pain management protocols and is used as an adjunct to pharmacological analgesia. An example is virtual reality, which has been used effectively to dampen pain intensity and unpleasantness. Possible links or causal relationships between pain/anxiety/stress and burn wound healing have previously not been investigated. The purpose of this study is to investigate these relationships, specifically by determining if a newly developed multi-modal procedural preparation and distraction device (Ditto™ used during acute burn wound care procedures will reduce the pain and anxiety of a child and increase the rate of re-epithelialization. Methods/design Children (4 to 12 years with acute burn injuries presenting for their first dressing change will be randomly assigned to either the (1 Control group (standard distraction or (2 Ditto™ intervention group (receiving Ditto™, procedural preparation and Ditto™ distraction. It is intended that a minimum of 29 participants will be recruited for each treatment group. Repeated measures of pain intensity, anxiety, stress and healing will be taken at every dressing change until complete wound re-epithelialization. Further data collection will aid in determining patient satisfaction and cost effectiveness of the Ditto™ intervention, as well as its effect on speed of wound re-epithelialization. Discussion Results of this study will provide data on whether the disease process can be altered by reducing stress, pain and anxiety in the context of acute burn wounds. Trial registration ACTRN12611000913976

  20. Effects on muscle performance of NSAID treatment with Piroxicam versus placebo in geriatric patients with acute infection-induced inflammation. a double blind randomized controlled trial

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    Beyer Ingo

    2011-12-01

    Full Text Available Abstract Background Inflammation is the main cause of disease-associated muscle wasting. In a previous single blind study we have demonstrated improved recovery of muscle endurance following celecoxib treatment in hospitalized geriatric patients with acute infection. Here we further evaluate NSAID treatment with piroxicam in a double blind RCT and investigate the role of cytokines and heat shock proteins (Hsp with respect to muscle performance. We hypothesized that NSAID treatment would preserve muscle performance better than antibiotic treatment alone, by reducing infection-associated inflammation and by increasing expression of cytoprotective Hsp. Methods Consecutive admissions to the geriatric ward were screened. 30 Caucasian patients, median age 84.5 years, with acute infection-induced inflammation and serum levels of CRP > 10 mg/L were included and randomized to active treatment with 10 mg piroxicam daily or placebo. Assessment comprised general clinical and biochemical parameters, 25 cytokines in serum, intra-and extracellular Hsp27 and Hsp70, Elderly Mobility Scale (EMS scores, grip strength (GS, fatigue resistance (FR and lean body mass (LBM. Patients were evaluated until discharge with a maximum of 3 weeks after treatment allocation. Results EMS scores, FR and grip work (GW, a measure taking into account GS and FR, significantly improved with piroxicam, but not with placebo. Early decreases in IL-6 serum levels with piroxicam correlated with better muscle performance at week 2. Basal expression of Hsp27 in monocytes without heat challenge (WHC was positively correlated with FR at baseline and significantly increased by treatment with piroxicam compared to placebo. Profound modifications in the relationships between cytokines or Hsp and changes in muscle parameters were observed in the piroxicam group. Conclusions Piroxicam improves clinically relevant measures of muscle performance and mobility in geriatric patients hospitalized with

  1. Study design for the fostering eating after stroke with transcranial direct current stimulation trial: a randomized controlled intervention for improving Dysphagia after acute ischemic stroke.

    Science.gov (United States)

    Marchina, Sarah; Schlaug, Gottfried; Kumar, Sandeep

    2015-03-01

    Dysphagia is a major stroke complication but lacks effective therapy that can promote recovery. Noninvasive brain stimulation with and without peripheral sensorimotor activities may be an attractive treatment option for swallowing recovery but has not been systematically investigated in the stroke population. This article describes the study design of the first prospective, single-center, double-blinded trial of anodal versus sham transcranial direct current stimulation (tDCS) used in combination with swallowing exercises in patients with dysphagia from an acute ischemic stroke. The aim of this study is to gather safety data on cumulative sessions of tDCS in acute-subacute phases of stroke, obtain information about effects of this intervention on important physiologic and clinically relevant swallowing parameters, and examine possible dose effects. Ninety-nine consecutive patients with dysphagia from an acute unilateral hemispheric infarction with a Penetration and Aspiration Scale (PAS) score of 4 or more and without other confounding reasons for dysphagia will be enrolled at a single tertiary care center. Subjects will be randomized to either a high or low dose tDCS or a sham group and will undergo 10 sessions over 5 consecutive days concomitantly with effortful swallowing maneuvers. The main efficacy measures are a change in the PAS score before and after treatment; the main safety measures are mortality, seizures, neurologic, motor, and swallowing deterioration. The knowledge gained from this study will help plan a larger confirmatory trial for treating stroke-related dysphagia and advance our understanding of important covariates influencing swallowing recovery and response to the proposed intervention. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  2. GLP-1-Based Therapies Have No Microvascular Effects in Type 2 Diabetes Mellitus: An Acute and 12-Week Randomized, Double-Blind, Placebo-Controlled Trial.

    Science.gov (United States)

    Smits, Mark M; Tonneijck, Lennart; Muskiet, Marcel H A; Hoekstra, Trynke; Kramer, Mark H H; Diamant, Michaela; Serné, Erik H; van Raalte, Daniël H

    2016-10-01

    To assess the effects of glucagon-like peptide (GLP)-1-based therapies (ie, GLP-1 receptor agonists and dipeptidyl peptidase-4 inhibitors) on microvascular function in patients with type 2 diabetes mellitus. We studied 57 patients with type 2 diabetes mellitus (mean±SD age: 62.8±6.9 years; body mass index: 31.8±4.1 kg/m(2); HbA1c [glycated hemoglobin] 7.3±0.6%) in an acute and 12-week randomized, placebo-controlled, double-blind trial conducted at the Diabetes Center of the VU University Medical Center. In the acute study, the GLP-1 receptor agonist exenatide (therapeutic concentrations) or placebo (saline 0.9%) was administered intravenously. During the 12-week study, patients received the GLP-1 receptor agonist liraglutide (1.8 mg daily), the dipeptidyl peptidase-4 inhibitor sitagliptin (100 mg daily), or matching placebos. Capillary perfusion was assessed by nailfold skin capillary videomicroscopy and vasomotion by laser Doppler fluxmetry, in the fasting state and after a high-fat mixed meal. In neither study, treatment affected fasting or postprandial capillary perfusion compared with placebo (P>0.05). In the fasting state, acute exenatide infusion increased neurogenic vasomotion domain power, while reducing myogenic domain power (both Pdiabetes mellitus. Twelve-week treatment with liraglutide or sitagliptin has no effect on capillary perfusion or vasomotion in these patients. Our data suggest that the effects of GLP-1-based therapies on glucose are not mediated through microvascular responses. © 2016 American Heart Association, Inc.

  3. Association between desloratadine and prednisolone in the treatment of children with acute symptoms of allergic rhinitis: a double-blind, randomized and controlled clinical trial.

    Science.gov (United States)

    Wandalsen, Gustavo F; Miranda, Carolina; Ensina, Luis Felipe; Sano, Flavio; Amazonas, Roberto Bleul; Silva, Joyce Macedo da; Solé, Dirceu

    2016-09-13

    A combination of antihistamines and oral corticosteroids is often used to treat acute symptoms of allergic rhinitis. To evaluate safety and efficacy of desloratadine plus prednisolone in the treatment of acute symptoms of children (2-12 years) with allergic rhinitis, and to compare it to dexchlorpheniramine plus betamethasone. Children with moderate/severe persistent allergic rhinitis and symptomatic (nasal symptoms score [0-12]≥6) were allocated in a double-blind, randomized fashion to receive dexchlorpheniramine plus betamethasone (n=105; three daily doses) or desloratadine plus prednisolone (n=105; single dose followed by two of placebo) for 7 days. At the beginning and end of the evaluation, the following were obtained: nasal symptoms score, extra nasal symptoms score, peak nasal inspiratory flow, blood biochemistry, and electrocardiogram. Ninety-six children of the dexchlorpheniramine plus betamethasone group and 98 of the desloratadine plus prednisolone group completed the protocol. The two groups were similar regarding initial and final nasal symptoms scores, extra nasal symptoms scores and peak nasal inspiratory flow. A drop of 76.4% and 79.1% for nasal symptoms score, 86.0% and 79.2% for extra nasal symptoms score, as well as an increase of 25.2% and 24.3% for peak nasal inspiratory flow occurred for those treated with desloratadine plus prednisolone and dexchlorpheniramine plus betamethasone, respectively. There were no significant changes in blood chemistry. Sinus tachycardia was the most frequent electrocardiogram change, but with no clinical significance. Drowsiness was reported significantly more often among those of dexchlorpheniramine plus betamethasone group (17.14%×8.57%, respectively). The desloratadine plus prednisolone combination was able to effectively control acute symptoms of rhinitis in children, improving symptoms and nasal function. Compared to the dexchlorpheniramine plus betamethasone combination, it showed similar clinical action

  4. Acute and Chronic Effect of Acoustic and Visual Cues on Gait Training in Parkinson’s Disease: A Randomized, Controlled Study

    Directory of Open Access Journals (Sweden)

    Roberto De Icco

    2015-01-01

    Full Text Available In this randomized controlled study we analyse and compare the acute and chronic effects of visual and acoustic cues on gait performance in Parkinson’s Disease (PD. We enrolled 46 patients with idiopathic PD who were assigned to 3 different modalities of gait training: (1 use of acoustic cues, (2 use of visual cues, or (3 overground training without cues. All patients were tested with kinematic analysis of gait at baseline (T0, at the end of the 4-week rehabilitation programme (T1, and 3 months later (T2. Regarding the acute effect, acoustic cues increased stride length and stride duration, while visual cues reduced the number of strides and normalized the stride/stance distribution but also reduced gait speed. As regards the chronic effect of cues, we recorded an improvement in some gait parameters in all 3 groups of patients: all 3 types of training improved gait speed; visual cues also normalized the stance/swing ratio, acoustic cues reduced the number of strides and increased stride length, and overground training improved stride length. The changes were not retained at T2 in any of the experimental groups. Our findings support and characterize the usefulness of cueing strategies in the rehabilitation of gait in PD.

  5. Effects of Educational Music Therapy on State Hope for Recovery in Acute Care Mental Health Inpatients: A Cluster-Randomized Effectiveness Study

    Directory of Open Access Journals (Sweden)

    Michael J. Silverman

    2016-10-01

    Full Text Available Background: There has been an increasing emphasis on recovery as the expectation for people with mental health disorders. Purpose: The purpose of this effectiveness study is to determine if group-based educational music therapy can immediately impact state hope for recovery in acute care mental health patients. Research questions included: Will acute care mental health inpatients who participate in a single music therapy session have higher agency and pathway aspects of state hope for recovery than patients in a control condition? Will there be differences in state hope for recovery as a result of hope-oriented songwriting or lyric analysis interventions?Method: Participants (N = 169 were cluster randomized to one of three single-session conditions: lyric analysis, songwriting, or wait-list control. Results: There was no significant between-group difference. However, both music therapy conditions tended to have slightly higher mean pathway, agency, and total state hope scores than the control condition even within the temporal parameters of a single music therapy session. There was no between-group difference in the songwriting and lyric analysis interventions. Conclusions: Although not significant, results support that educational music therapy may impact state hope for recovery within the temporal parameters of a single session. The specific type of educational music therapy intervention did not affect results. Implications for practice, limitations, and suggestions for future research are provided.

  6. Effects of Educational Music Therapy on State Hope for Recovery in Acute Care Mental Health Inpatients: A Cluster-Randomized Effectiveness Study.

    Science.gov (United States)

    Silverman, Michael J

    2016-01-01

    Background: There has been an increasing emphasis on recovery as the expectation for people with mental health disorders. Purpose: The purpose of this effectiveness study is to determine if group-based educational music therapy can immediately impact state hope for recovery in acute care mental health patients. Research questions included: will acute care mental health inpatients who participate in a single music therapy session have higher agency and pathway aspects of state hope for recovery than patients in a control condition? Will there be differences in state hope for recovery as a result of hope-oriented songwriting or lyric analysis interventions? Method: Participants (N = 169) were cluster randomized to one of three single-session conditions: lyric analysis, songwriting, or wait-list control. Results: There was no significant between-group difference. However, both music therapy conditions tended to have slightly higher mean pathway, agency, and total state hope scores than the control condition even within the temporal parameters of a single music therapy session. There was no between-group difference in the songwriting and lyric analysis interventions. Conclusion: Although not significant, results support that educational music therapy may impact state hope for recovery within the temporal parameters of a single session. The specific type of educational music therapy intervention did not affect results. Implications for practice, limitations, and suggestions for future research are provided.

  7. The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: A randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Laura Amy Massee

    2015-05-01

    Full Text Available Cocoa supplementation has been associated with benefits to cardiovascular health. However, cocoa’s effects on cognition are less clear. A randomized, placebo-controlled, double-blind clinical trial (n=40, age M= 24.13 years, SD = 4.47 years was conducted to investigate the effects of both acute (same-day and sub-chronic (daily for four-weeks 250mg cocoa supplementation on mood and mental fatigue, cognitive performance and cardiovascular functioning in young, healthy adults. Assessment involved repeated 10-minute cycles of the Cognitive Demand Battery (CDB encompassing two serial subtraction tasks (Serial Threes and Sevens, a Rapid Visual Information Processing task, and a mental fatigue scale over the course of half an hour. The Swinburne University Computerised Cognitive Assessment Battery (SUCCAB was also completed to evaluate cognition. Cardiovascular function included measuring both peripheral and central blood pressure and cerebral blood flow. At the acute time point, consumption of cocoa significantly improved self-reported mental fatigue and performance on the Serial Sevens task in cycle one of the CDB. No other significant effects were found. This trial was registered with the Australian and New Zealand Clinical Trial Registry (Trial ID: ACTRN12613000626763. Accessible via http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN126130006 26763&ddlSearch=Registered

  8. A double blind placebo controlled randomized trial of the effect of acute uric acid changes on inflammatory markers in humans: A pilot study.

    Science.gov (United States)

    Tanaka, Toshiko; Milaneschi, Yuri; Zhang, Yongqing; Becker, Kevin G; Zukley, Linda; Ferrucci, Luigi

    2017-01-01

    Uric acid has been linked with increased risk of chronic disease such as cardiovascular disease and this association has been attributed to a pro-inflammatory effect. Indeed, observational studies have shown that high uric acid is associated with high level of pro-inflammatory cytokines in the blood. However, whether high uric acid directly affects inflammation or rather represents a parallel defensive antioxidant mechanism in response to pathology that causes inflammation is unknown. To determine whether acute increase or decrease uric acid levels affects inflammation in healthy individuals, a randomized, placebo-controlled, double blind clinical study of uric acid or rasburicase with 20 healthy volunteers in each treatment-placebo group was conducted at the National Institute on Aging (NIA) Clinical Research Unit (CRU) at Harbor Hospital in Baltimore, MD. Change in inflammatory response was assessed by administering an oral lipid tolerance before and after the treatment of uric acid, rasburicase and placebo. Following uric acid administration, there was an accentuated increase in IL-6 during the oral lipid tolerance test (Puric acid with rasburicase. No side effects were reported throughout the trial. In health individuals, acute increase in uric acid results in an increased IL-6 response when challenged with lipid load. Such effect of amplification of inflammatory response may explain the higher risk of chronic diseases observed in subclinical hyperuricemia in observational studies. ClinicalTrials.gov NCT01323335.

  9. Clinical efficacy comparison of Saccharomyces boulardii and yogurt fluid in acute non-bloody diarrhea in children: a randomized, controlled, open label study.

    Science.gov (United States)

    Eren, Makbule; Dinleyici, Ener C; Vandenplas, Yvan

    2010-03-01

    The purpose of this trial is to evaluate the clinical efficacy and cost/effectiveness of Saccharomyces boulardii compared with yogurt fluid (YF) in acute non-bloody diarrhea in children. This randomized, prospective open-label clinical trial includes 55 children (36 boys, 19 girls; mean age 21.2 +/- 28.2 months). Group A (N = 28) received lyophilized S. boulardii and group B (N = 27) received YF. The duration of diarrhea was shorter with S. boulardii but the hospital stay was reduced with YF, although these differences were not significant. However, diarrhea had resolved in significantly more children on day 3 in the S. boulardii group (48.5% versus 25.5%; P yogurt treatment was cheaper than S. boulardii whereas in hospitalized patients, treatment cost was similar. In conclusion, the effect of daily freshly prepared YF was comparable to S. boulardii in the treatment of acute non-bloody diarrhea in children. The duration of diarrhea was shorter in the S. boulardii group, expressed as a significantly higher number of patients with normal stools on day 3.

  10. The acute and sub-chronic effects of cocoa flavanols on mood, cognitive and cardiovascular health in young healthy adults: a randomized, controlled trial.

    Science.gov (United States)

    Massee, Laura A; Ried, Karin; Pase, Matthew; Travica, Nikolaj; Yoganathan, Jaesshanth; Scholey, Andrew; Macpherson, Helen; Kennedy, Greg; Sali, Avni; Pipingas, Andrew

    2015-01-01

    Cocoa supplementation has been associated with benefits to cardiovascular health. However, cocoa's effects on cognition are less clear. A randomized, placebo-controlled, double-blind clinical trial (n = 40, age M = 24.13 years, SD = 4.47 years) was conducted to investigate the effects of both acute (same-day) and sub-chronic (daily for four-weeks) 250 mg cocoa supplementation on mood and mental fatigue, cognitive performance and cardiovascular functioning in young, healthy adults. Assessment involved repeated 10-min cycles of the Cognitive Demand Battery (CDB) encompassing two serial subtraction tasks (Serial Threes and Sevens), a Rapid Visual Information Processing task, and a mental fatigue scale over the course of half an hour. The Swinburne University Computerized Cognitive Assessment Battery (SUCCAB) was also completed to evaluate cognition. Cardiovascular function included measuring both peripheral and central blood pressure and cerebral blood flow. At the acute time point, consumption of cocoa significantly improved self-reported mental fatigue and performance on the Serial Sevens task in cycle one of the CDB. No other significant effects were found. This trial was registered with the Australian and New Zealand Clinical Trial Registry (Trial ID: ACTRN12613000626763). Accessible via http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12613000626763&ddlSearch=Registered.

  11. Effects of Educational Music Therapy on State Hope for Recovery in Acute Care Mental Health Inpatients: A Cluster-Randomized Effectiveness Study

    Science.gov (United States)

    Silverman, Michael J.

    2016-01-01

    Background: There has been an increasing emphasis on recovery as the expectation for people with mental health disorders. Purpose: The purpose of this effectiveness study is to determine if group-based educational music therapy can immediately impact state hope for recovery in acute care mental health patients. Research questions included: will acute care mental health inpatients who participate in a single music therapy session have higher agency and pathway aspects of state hope for recovery than patients in a control condition? Will there be differences in state hope for recovery as a result of hope-oriented songwriting or lyric analysis interventions? Method: Participants (N = 169) were cluster randomized to one of three single-session conditions: lyric analysis, songwriting, or wait-list control. Results: There was no significant between-group difference. However, both music therapy conditions tended to have slightly higher mean pathway, agency, and total state hope scores than the control condition even within the temporal parameters of a single music therapy session. There was no between-group difference in the songwriting and lyric analysis interventions. Conclusion: Although not significant, results support that educational music therapy may impact state hope for recovery within the temporal parameters of a single session. The specific type of educational music therapy intervention did not affect results. Implications for practice, limitations, and suggestions for future research are provided. PMID:27774084

  12. Acute Effect of Topical Menthol on Chronic Pain in Slaughterhouse Workers with Carpal Tunnel Syndrome: Triple-Blind, Randomized Placebo-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Emil Sundstrup

    2014-01-01

    Full Text Available Topical menthol gels are classified “topical analgesics” and are claimed to relieve minor aches and pains of the musculoskeletal system. In this study we investigate the acute effect of topical menthol on carpal tunnel syndrome (CTS. We screened 645 slaughterhouse workers and recruited 10 participants with CTS and chronic pain of the arm/hand who were randomly distributed into two groups to receive topical menthol (Biofreeze or placebo (gel with a menthol scent during the working day and 48 hours later the other treatment (crossover design. Participants rated arm/hand pain intensity during the last hour of work (scale 0–10 immediately before 1, 2, and 3 hours after application. Furthermore, global rating of change (GROC in arm/hand pain was assessed 3 hours after application. Compared with placebo, pain intensity and GROC improved more following application of topical menthol (P=0.026 and P=0.044, resp.. Pain intensity of the arm/hand decreased by −1.2 (CI 95%: −1.7 to −0.6 following topical menthol compared with placebo, corresponding to a moderate effect size of 0.63. In conclusion, topical menthol acutely reduces pain intensity during the working day in slaughterhouse workers with CTS and should be considered as an effective nonsystemic alternative to regular analgesics in the workplace management of chronic and neuropathic pain.

  13. A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen®) in the Clinical Management of Acute Viral Diarrhea in Children

    Science.gov (United States)

    García-Menor, Emilia; García-Marín, Fátima; Vecino-López, Raquel; Horcajo-Martínez, Gloria; de Ibarrondo Guerrica-Echevarría, María-José; Gómez-González, Pedro; Velasco-Ortega, Syra; Suárez-Almarza, Javier; Nieto-Magro, Concepción

    2016-01-01

    This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p diarrhea (median and interquartile range) was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377). The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children. PMID:28229091

  14. Efficacy of a respiratory rehabilitation exercise training package in hospitalized elderly patients with acute exacerbation of COPD: a randomized control trial.

    Science.gov (United States)

    Liao, Lin-Yu; Chen, Kuei-Min; Chung, Wei-Sheng; Chien, Jung-Yien

    2015-01-01

    NCT02329873. Acute exacerbation (AE) of COPD is characterized by a sudden worsening of COPD symptoms. Previous studies have explored the effectiveness of respiratory rehabilitation for patients with COPD; however, no training program specific to acute exacerbation in elderly patients or unstable periods during hospitalization has been developed. To evaluate the effects of a respiratory rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum expectoration among hospitalized elderly patients with AECOPD. A randomized control trial was conducted. Pretest and posttest evaluations of 61 elderly inpatients with AECOPD (experimental group n=30; control group n=31) were performed. The experimental group received respiratory rehabilitation exercise training twice a day, 10-30 minutes per session for 4 days. The clinical parameters (dyspnea, cough, exercise tolerance, and sputum expectoration) were assessed at the baseline and at the end of the fourth day. All participants (median age =70 years, male =60.70%, and peak expiratory flow 140 L) completed the study. In the patients of the experimental group, dyspnea and cough decreased and exercise tolerance and sputum expectoration increased significantly compared with those of the patients in the control group (all Pexercise tolerance significantly improved in the experimental group by the end of the fourth day (all Pexercise training package reduced symptoms and enhanced the effectiveness of the care of elderly inpatients with AECOPD.

  15. A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen® in the Clinical Management of Acute Viral Diarrhea in Children

    Directory of Open Access Journals (Sweden)

    Emilia García-Menor MD

    2016-11-01

    Full Text Available This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p < 0.001. The duration of diarrhea (median and interquartile range was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377. The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children.

  16. Simultaneous bilensectomy and endothelial keratoplasty for angle-supported phakic intraocular lens-induced corneal decompensation

    Directory of Open Access Journals (Sweden)

    Vikas Mittal

    2011-01-01

    Full Text Available A 40-year-old lady presented with severe endothelial cell loss in both eyes 14 years after angle-supported phakic intraocular lens (AS PIOL implantation. The left eye had severe corneal edema with bullous keratopathy. The right eye had markedly reduced endothelial cell count (655 cells/mm 2 although the cornea was clear. She underwent simultaneous bilensectomy (AS PIOL explantation and phacoemulsification and Descemet′s stripping and endothelial keratoplasty (DSEK in the left eye. Explanted AS PIOL was identified as ZSAL-4 (Morcher, Stuttgart, Germany model. Corneal edema cleared completely in 2 months with a best corrected visual acuity (-2.25 D sph of 20/60. No intervention was done in the right eye. The present case illustrates that AS PIOL-induced endothelial decompensation can be effectively managed by simultaneous bilensectomy and endothelial keratoplasty.

  17. Pathophysiology of the Cardiorenal Syndromes : Executive Summary from the Eleventh Consensus Conference of the Acute Dialysis Quality Initiative (ADQI)

    NARCIS (Netherlands)

    McCullough, Peter A.; Kellum, John A.; Haase, Michael; Mueller, Christian; Damman, Kevin; Murray, Patrick T.; Cruz, Dinna; House, Andrew A.; Schmidt-Ott, Kai M.; Vescovo, Giorgio; Bagshaw, Sean M.; Hoste, Eric A.; Briguori, Carlos; Braam, Branko; Chawla, Lakhmir S.; Costanzo, Maria R.; Tumlin, James A.; Herzog, Charles A.; Mehta, Ravindra L.; Rabb, Hamid; Shaw, Andrew D.; Singbartl, Kai; Ronco, Claudio

    2014-01-01

    Cardiorenal syndromes (CRS) have been recently classified into five distinct entities, each with different major pathophysiologic mechanisms. CRS type 1 most commonly occurs in the setting of acutely decompensated heart failure where approximately 25% of patients develop a rise in serum creatinine a

  18. Antiviral therapy in hepatitis C virus cirrhotic patients in compensated and decompensated condition

    Institute of Scientific and Technical Information of China (English)

    Angelo Iacobellis; Antonio Ippolito; Angelo Andriulli

    2008-01-01

    The main goals of treating cirrhotic patients with antiviral therapy are to attain sustained viral clearance (SVR), halt disease progression, and prevent re-infection of the liver graft. However, while the medical need is great, the use of interferon and ribavirin might expose these patients to severe treated-related side effects as a large proportion of them have pre-existing hematological cytopenias. We have reviewed potential benefits and risks associated with antiviral drugs in patients with liver cirrhosis, due to hepatitis C virus (HCV) infection. In cases presenting with bridging fibrosis or cirrhosis, current regimens of antiviral therapy have attained a 44%-48% rate of SVR. In cirrhotic patients with portal hypertension, the SVR rate was 22% overall, 12.5% in patients with genotype 1, and 66.7% in those with genotypes 2 and 3 following therapy with low doses of either Peg-IFN alpha-2b and of ribavirin. In patients with decompensated cirrhosis, full dosages of Peg-IFN alpha-2b and of ribavirin produced a SVR rate of 35% overall, 16% in patients with genotype 1 and 4, and 59% in those with genotype 2 and 3. Use of hematological cytokines will either ensure full course of treatment to be accomplished with and prevent development of treatment-associated side effects. Major benefits after HCV eradication were partial recovery of liver metabolic activity, prevention of hepatitis C recurrence after transplantation, and removal of some patients from the waiting list for liver transplant. Several observations highlighted that therapy is inadvisable for individuals with poor hepatic reserve (ChUd-Pugh-Turcotte score ≥ 10). Although SVR rates are low in decompensated cirrhotics due to hepatitis C, these patients have the most to gain as successful antiviral therapy is potentially lifesaving. C 2008 The W.1G Press. All dghts reserved.

  19. Clinical Effect of 58 Cases Entecavir Treatment of Liver Cirrhosis Decompensated%恩替卡韦治疗58例乙肝后肝硬化失代偿期临床效果观察

    Institute of Scientific and Technical Information of China (English)

    曾伟华

    2013-01-01

    Objective:to study the entecavir in patients with decompensated cirrhosis after hepatitis b period of treatment ef ect. Methods:58 patients with decompensated cirrhosis after hepatitis b period were randomly divided into two groups, control group of 29 patients with routine comprehensive treatment, the team in 29 cases in the control group treatment with oral entecavir, based on comparing two groups before and after the treatment of hepatic function index, after treatment, TBil, ALT, propagated and case fatality rate, HBVDNA turn rate. Results:the two groups before treatment there was no statistical y significant dif erence liver result index, (P> 0.05); The team TBil and ALT significantly lower than the control group after treatment, propagated is significantly higher than the control group, (P0.05);治疗后研究组TBil和ALT明显低于对照组,ALB明显高于对照组,(P<0.01)。研究组病死率明显低于对照组, HBVDNA转阴率明显高于对照组,(P<0.01)。结论恩替卡韦治疗乙肝后肝硬化失代偿期具有较好的临床效果,可加强抗病毒效果,迅速控制病情发展,延长患者生命。

  20. A multifaceted intervention to narrow the evidence-based gap in the treatment of acute coronary syndromes: rationale and design of the Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE-ACS) cluster-randomized trial.

    Science.gov (United States)

    Berwanger, Otávio; Guimarães, Hélio P; Laranjeira, Ligia N; Cavalcanti, Alexandre B; Kodama, Alessandra; Zazula, Ana Denise; Santucci, Eliana; Victor, Elivane; Flato, Uri A; Tenuta, Marcos; Carvalho, Vitor; Mira, Vera Lucia; Pieper, Karen S; Mota, Luiz Henrique; Peterson, Eric D; Lopes, Renato D

    2012-03-01

    Translating evidence into clinical practice in the management of acute coronary syndromes (ACS) is challenging. Few ACS quality improvement interventions have been rigorously evaluated to determine their impact on patient care and clinical outcomes. We designed a pragmatic, 2-arm, cluster-randomized trial involving 34 clusters (Brazilian public hospitals). Clusters were randomized to receive a multifaceted quality improvement intervention (experimental group) or routine practice (control group). The 6-month educational intervention included reminders, care algorithms, a case manager, and distribution of educational materials to health care providers. The primary end point was a composite of evidence-based post-ACS therapies within 24 hours of admission, with the secondary measure of major cardiovascular clinical events (death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke). Prescription of evidence-based therapies at hospital discharge were also evaluated as part of the secondary outcomes. All analyses were performed by the intention-to-treat principle and took the cluster design into account using individual-level regression modeling (generalized estimating equations). If proven effective, this multifaceted intervention would have wide use as a means of promoting optimal use of evidence-based interventions for the management of ACS. Copyright © 2012 Mosby, Inc. All rights reserved.

  1. The Effect of Bee Venom Acupuncture(BVA on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study

    Directory of Open Access Journals (Sweden)

    Song, Ho-Seub

    2005-06-01

    Full Text Available Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC participated in the study, who were divided into two groups (A and B randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41 of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo or BVA was done and then acupuncture at 坵墟(GB40, 中封(LR4, 商丘(SP5, 解谿(ST41, 足三里(ST36, 陽陵泉(G34 of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS and Visual Analogue Scale(VAS were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective

  2. A randomized controlled trial of vitamin D dosing strategies after acute hip fracture: No advantage of loading doses over daily supplementation

    Directory of Open Access Journals (Sweden)

    Farrauto Leonardo

    2011-06-01

    Full Text Available Abstract Background There remains uncertainty regarding the appropriate therapeutic management of hip fracture patients. The primary aim of our study was to examine whether large loading doses in addition to daily vitamin D offered any advantage over a simple daily low-dose vitamin D regimen for increasing vitamin D levels. Methods In this randomized controlled study, patients over age 50 with an acute fragility hip fracture were enrolled from two hospital sites in Ontario, Canada. Participants were randomized to one of three loading dose groups: placebo; 50,000 IU vitamin D2; or 100,000 IU D2. Following a placebo/loading dose, all patients received a daily tablet of 1,000 IU vitamin D3 for 90 days. Serum 25-hydroxy vitamin D (25-OHD was measured at baseline, discharge from acute care (approximately 4-weeks, and 3-months. Results Sixty-five patients were enrolled in the study (44% male. An immediate rise in 25-OHD occurred in the 100,000 group, however there were no significant differences in 25-OHD between the placebo, 50,000 and 100,000 loading dose groups after 4-weeks (69.3, 84.5, 75.6 nmol/L, p = 0.15 and 3-months (86.7, 84.2, 73.3 nmol/L, p = 0.09, respectively. At the end of the study, approximately 75% of the placebo and 50,000 groups had reached the target therapeutic range (75 nmol/L, and 44% of the 100,000 group. Conclusions In correcting vitamin D insufficiency/deficiency in elderly patients with hip fracture, our findings suggest that starting with a lower daily dose of Vitamin D3 achieved similar results as providing an additional large loading dose of Vitamin D2. At the end of the study, all three groups were equally effective in attaining improvement in 25-OHD levels. Given that a daily dose of 1,000 IU vitamin D3 (with or without a loading dose resulted in at least 25% of patients having suboptimal vitamin D status, patients with acute hip fracture may benefit from a higher daily dose of vitamin D. Trial registration Clinical

  3. Ready-to-use therapeutic food with elevated n-3 polyunsaturated fatty acid content, with or without fish oil, to treat severe acute malnutrition: a randomized controlled trial.

    Science.gov (United States)

    Jones, Kelsey D J; Ali, Rehema; Khasira, Maureen A; Odera, Dennis; West, Annette L; Koster, Grielof; Akomo, Peter; Talbert, Alison W A; Goss, Victoria M; Ngari, Moses; Thitiri, Johnstone; Ndoro, Said; Knight, Miguel A Garcia; Omollo, Kenneth; Ndungu, Anne; Mulongo, Musa M; Bahwere, Paluku; Fegan, Greg; Warner, John O; Postle, Anthony D; Collins, Steve; Calder, Philip C; Berkley, James A

    2015-04-23

    Ready-to-use therapeutic foods (RUTF) are lipid-based pastes widely used in the treatment of acute malnutrition. Current specifications for RUTF permit a high n-6 polyunsaturated fatty acid (PUFA) content and low n-3 PUFA, with no stipulated requirements for preformed long-chain n-3 PUFA. The objective of this study was to develop an RUTF with elevated short-chain n-3 PUFA and measure its impact, with and without fish oil supplementation, on children's PUFA status during treatment of severe acute malnutrition. This randomized controlled trial in children with severe acute malnutrition in rural Kenya included 60 children aged 6 to 50 months who were randomized to receive i) RUTF with standard composition; ii) RUTF with elevated short chain n-3 PUFA; or iii) RUTF with elevated short chain n-3 PUFA plus fish oil capsules. Participants were followed-up for 3 months. The primary outcome was erythrocyte PUFA composition. Erythrocyte docosahexaenoic acid (DHA) content declined from baseline in the two arms not receiving fish oil. Erythrocyte long-chain n-3 PUFA content following treatment was significantly higher for participants in the arm receiving fish oil than for those in the arms receiving RUTF with elevated short chain n-3 PUFA or standard RUTF alone: 3 months after enrollment, DHA content was 6.3% (interquartile range 6.0-7.3), 4.5% (3.9-4.9), and 3.9% (2.4-5.7) of total erythrocyte fatty acids (P RUTF with elevated short chain n-3 PUFA and fish oil capsules were acceptable to participants and carers, and there were no significant differences in safety outcomes. PUFA requirements of children with SAM are not met by current formulations of RUTF, or by an RUTF with elevated short-chain n-3 PUFA without additional preformed long-chain n-3 PUFA. Clinical and growth implications of revised formulations need to be addressed in large clinical trials. Clinicaltrials.gov NCT01593969. Registered 4 May 2012.

  4. Inclusion of thoracic spine thrust manipulation into an electro-therapy/thermal program for the management of patients with acute mechanical neck pain: a randomized clinical trial.

    Science.gov (United States)

    González-Iglesias, Javier; Fernández-de-las-Peñas, Cesar; Cleland, Joshua A; Alburquerque-Sendín, Francisco; Palomeque-del-Cerro, Luis; Méndez-Sánchez, Roberto

    2009-06-01

    Our aim was to examine the effects of a seated thoracic spine distraction thrust manipulation included in an electrotherapy/thermal program on pain, disability, and cervical range of motion in patients with acute neck pain. This randomized controlled trial included 45 patients (20 males, 25 females) between 23 and 44 years of age presenting with acute neck pain. Patients were randomly divided into 2 groups: an experimental group which received a thoracic manipulation, and a control group which did not receive the manipulative procedure. Both groups received an electrotherapy program consisting of 6 sessions of TENS (frequency 100Hz; 20min), superficial thermo-therapy (15min) and soft tissue massage. The experimental group also received a thoracic manipulation once a week for 3 consecutive weeks. Outcome measures included neck pain (numerical pain rate scale; NPRS), level of disability (Northwick Park Neck Pain Questionnaire; NPQ) and neck mobility. These outcomes were assessed at baseline and 1 week after discharge. A 2-way repeated-measures ANOVA with group as between-subject variable and time as within-subject variable was used. Patients receiving thoracic manipulation experienced greater reductions in both neck pain, with between-group difference of 2.3 (95% CI 2-2.7) points on a 11-NPRS, and perceived disability with between-group differences 8.5 (95% CI 7.2-9.8) points. Further, patients receiving thoracic manipulation experienced greater increases in all cervical motions with between-group differences of 10.6 degrees (95% CI 8.8-12.5 degrees) for flexion; 9.9 degrees (95% CI 8.1-11.7 degrees) for extension; 9.5 degrees (95% CI 7.6-11.4 degrees) for right lateral-flexion; 8 degrees (95% CI 6.2-9.8 degrees) for left lateral-flexion; 9.6 degrees (95% CI 7.7-11.6 degrees) for right rotation; and 8.4 degrees (95% CI 6.5-10.3 degrees) for left rotation. We found that the inclusion of a thoracic manipulation into an electrotherapy/thermal program was effective in

  5. A randomized controlled trial testing an adherence-optimized Vitamin D regimen to mitigate bone change in adolescents being treated for acute lymphoblastic leukemia.

    Science.gov (United States)

    Orgel, Etan; Mueske, Nicole M; Sposto, Richard; Gilsanz, Vicente; Wren, Tishya A L; Freyer, David R; Butturini, Anna M; Mittelman, Steven D

    2017-10-01

    Adolescents with acute lymphoblastic leukemia (ALL) develop osteopenia early in therapy, potentially exacerbated by high rates of concurrent Vitamin D deficiency. We conducted a randomized clinical trial testing a Vitamin D-based intervention to improve Vitamin D status and reduce bone density decline. Poor adherence to home supplementation necessitated a change to directly observed therapy (DOT) with intermittent, high-dose Vitamin D3 randomized versus standard of care (SOC). Compared to SOC, DOT Vitamin D3 successfully increased trough Vitamin 25(OH)D levels (p = .026) with no residual Vitamin D deficiency, 100% adherence to DOT Vitamin D3, and without associated toxicity. However, neither Vitamin D status nor supplementation impacted bone density. Thus, this adherence-optimized intervention is feasible and effective to correct Vitamin D deficiency in adolescents during ALL therapy. Repletion of Vitamin D and calcium alone did not mitigate osteopenia, however, and new, comprehensive approaches are needed to address treatment-associated osteopenia during ALL therapy.

  6. A randomized controlled trial of surface neuromuscular electrical stimulation applied early after acute stroke: effects on wrist pain, spasticity and contractures.

    Science.gov (United States)

    Malhotra, Shweta; Rosewilliam, Sheeba; Hermens, Hermie; Roffe, Christine; Jones, Peter; Pandyan, Anand David

    2013-07-01

    To investigate effects of surface neuromuscular electrical stimulation applied early after stroke to the wrist and finger extensor muscles on upper limb pain, spasticity and contractures in patients with no functional arm movement. Secondary analysis from a Phase II, randomized, controlled, single-blind study. An acute hospital stroke unit. Patients with no useful arm function within six weeks of a first stroke. Patients were randomized to treatment (30-minute sessions of surface neuromuscular stimulation to wrist and finger extensors and 45 minutes of physiotherapy) or control (45 minutes of physiotherapy) groups. All patients had access to routine care. Treatment was given for six weeks from recruitment. Ninety patients (49% male, median age 74 years (range 32-98), median time since stroke onset three weeks (range one to six weeks)) were included. Treatment compliance was variable (mean 28%). The treatment prevented the development of pain (mean difference in rate of change 0.4 units/week, 95% confidence interval (CI) 0.09 to 0.6). Treatment may have prevented a deterioration in contractures (quantified by measuring passive range of movement) in severely disabled patients (mean rate of deterioration -0.5 deg/week; 95% CI -0.9 to -0.06). There were no significant changes in stiffness and spasticity. Surface neuromuscular electrical stimulation reduces pain in stroke patients with a non-functional arm. There was some evidence that treatment with electrical stimulation was beneficial in reducing contractures. Treatment had no effect on spasticity.

  7. [Physical therapy intervention during hospitalization in patients with acute exacerbation of chronic obstructive pulmonary disease and pneumonia: A randomized clinical trial].

    Science.gov (United States)

    Martín-Salvador, Adelina; Colodro-Amores, Gloria; Torres-Sánchez, Irene; Moreno-Ramírez, M Paz; Cabrera-Martos, Irene; Valenza, Marie Carmen

    2016-04-01

    Respiratory infections involve not only hospitalization due to pneumonia, but also acute exacerbations of COPD (AECOPD). The objective of the present study was to evaluate the effectiveness of a physical therapy intervention during hospitalization in patients admitted due to community-acquired pneumonia (CAP) and AECOPD. Randomized clinical trial, 44 patients were randomized into 2 groups: a control group which received standard medical therapy (oxygen therapy and pharmacotherapy) and an experimental group that received standard treatment and a physical therapy intervention (breathing exercises, electrostimulation, exercises with elastic bands and relaxation). Between-groups analysis showed that after the intervention (experimental vs. control) significant differences were found in perceived dyspnoea (P=.041), and right and left quadriceps muscle strength (P=.008 and P=.010, respectively). In addition, the subscale of "domestic activities" of the functional ability related to respiratory symptoms questionnaire showed significant differences (P=.036). A physical therapy intervention during hospitalization in patients with AECOPD and CAP can generate skeletal muscle level gains that exceed the deterioration caused by immobilization during hospitalization. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  8. A comparison of neurocognitive functioning in children previously randomized to dexamethasone or prednisone in the treatment of childhood acute lymphoblastic leukemia.

    Science.gov (United States)

    Kadan-Lottick, Nina S; Brouwers, Pim; Breiger, David; Kaleita, Thomas; Dziura, James; Liu, Haibei; Chen, Lu; Nicoletti, Megan; Stork, Linda; Bostrom, Bruce; Neglia, Joseph P

    2009-08-27

    In previous clinical trials of childhood acute lymphoblastic leukemia (ALL), dexamethasone resulted in higher event-free survival rates than prednisone, presumably due to greater central nervous system penetration. Dexamethasone's association with long-term neurocognitive toxicity is unknown. In this multisite study, we measured neurocognitive functioning in 92 children with standard-risk ALL, 1 to 9.99 years at diagnosis, at a mean of 9.8 years after randomization to prednisone (n = 41) or dexamethasone (n = 51) on Children's Cancer Group (CCG) 1922. No significant overall differences in mean neurocognitive and academic performance scores were found between the prednisone and dexamethasone groups after adjusting for age, sex, and time since diagnosis. The exception was that patients receiving dexamethasone scored one-third of a standard deviation worse on word reading (98.8 +/- 1.7 vs 104.9 +/- 1.8; P = .02). There were no group differences in the distribution of test scores or the parents' report of neurologic complications, psychotropic drug use, and special education. Further analyses suggested for the dexamethasone group, older age of diagnosis was associated with worse neurocognitive functioning; for the prednisone group, younger age at diagnosis was associated with worse functioning. In conclusion, our study did not demonstrate any meaningful differences in long-term cognitive functioning of childhood ALL patients based on corticosteroid randomization. This study is registered with http://www.clinicaltrials.gov under NCT00085176.

  9. Use of the PiCCO system in critically ill patients with septic shock and acute respiratory distress syndrome: a study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Zhang Zhongheng

    2013-02-01

    Full Text Available Abstract Background Hemodynamic monitoring is very important in critically ill patients with shock or acute respiratory distress syndrome(ARDS. The PiCCO (Pulse index Contour Continuous Cardiac Output, Pulsion Medical Systems, Germany system has been developed and used in critical care settings for several years. However, its impact on clinical outcomes remains unknown. Methods/design The study is a randomized controlled multi-center trial. A total of 708 patients with ARDS, septic shock or both will be included from January 2012 to January 2014. Subjects will be randomized to receive PiCCO monitoring or not. Our primary end point is 30-day mortality, and secondary outcome measures include ICU length of stay, days on mechanical ventilation, days of vasoactive agent support, ICU-free survival days during a 30-day period, mechanical-ventilation-free survival days during a 30-day period, and maximum SOFA score during the first 7 days. Discussion We investigate whether the use of PiCCO monitoring will improve patient outcomes in critically ill patients with ARDS or septic shock. This will provide additional data on hemodynamic monitoring and help clinicians to make decisions on the use of PiCCO. Trial registration http://www.clinicaltrials.gov NCT01526382

  10. THE USE OF RHEUM PALMATUM L. IN THE TREATMENT OF ACUTE RESPIRATORY DISTRESS SYNDROME: A META-ANALYSIS OF RANDOMIZED, CONTROLLED TRIALS.

    Science.gov (United States)

    Yang, Tie-Zhu; Liu, Yan; Liu, Yue-Yun; Ding, Xiu-Fang; Chen, Jia-Xu; Kou, Mei-Jing; Zou, Xiao-Juan

    2017-01-01

    Chinese medicine theory shows that "lung being connected with large intestine", and the modern western medicine also shows that the lung and intestinal tract affect each other in physiological and pathological conditions. If the lung ventilation dysfunction is caused by inflammatory exudate or secretions obstruction of the small airway ventilation, blood gas partial pressure is increased and intestinal gas absorption difficulty may lead to intestinal inflation and dysfunction (Wang N et al., 2011). Rheum palmatum L. can play the roles of anti-coagulation and anti-thrombosis, and improve microcirculation through lowering the endotoxin-induced permeability of microvascular tissue, reducing tissue oedema, decreasing inflammatory exudation and necrosis, and enhancing cyto-protection mechanism (Yang TZ et al., 2014). Therefore, systemic evaluation of the evidence pertaining to the usage of Rheum palmatum L. in treating acute lung injury and acute respiratory distress syndrome (ARDS) has significant clinical significance. Various Electronic Databases CBM, CNKI, VIP, Wanfang, PubMed and Cochrane Library were searched until December 2015. Numerous randomized-controlled trials (RCTs) evaluating the efficacy of Rheum palmatum L. for the treatment of acute lung injury and acute respiratory distress syndrome were collected. The quality of the included studies was evaluated and a meta-analysis was performed using the RevMan5.0 software. Eight RCTs involving 489 patients were selected for this review. The results of the Meta-analysis revealed that Rheum palmatum L. therapy, combined with routine comprehensive treatment, was significantly superior to that of routine comprehensive treatment alone, in the areas of decreasing mortality, the mechanical ventilation time, the level of interleukin-6,8 and the untoward effect, and also in improving arterial blood gas (PaO2/FiO2, PaO2) (P<0.05). Compared with treatment with routine comprehensive alone, Rheum palmatum L. treatment combined

  11. Acute beetroot juice supplementation on sympathetic nerve activity: a randomized, double-blind, placebo-controlled proof-of-concept study.

    Science.gov (United States)

    Notay, Karambir; Incognito, Anthony V; Millar, Philip J

    2017-07-01

    Acute dietary nitrate ([Formula: see text]) supplementation reduces resting blood pressure in healthy normotensives. This response has been attributed to increased nitric oxide bioavailability and peripheral vasodilation, although nitric oxide also tonically inhibits central sympathetic outflow. We hypothesized that acute dietary [Formula: see text] supplementation using beetroot (BR) juice would reduce blood pressure and muscle sympathetic nerve activity (MSNA) at rest and during exercise. Fourteen participants (7 men and 7 women, age: 25 ± 10 yr) underwent blood pressure and MSNA measurements before and after (165-180 min) ingestion of 70ml high-[Formula: see text] (~6.4 mmol [Formula: see text]) BR or [Formula: see text]-depleted BR placebo (PL; ~0.0055 mmol [Formula: see text]) in a double-blind, randomized, crossover design. Blood pressure and MSNA were also collected during 2 min of static handgrip (30% maximal voluntary contraction). The changes in resting MSNA burst frequency (-3 ± 5 vs. 3 ± 4 bursts/min, P = 0.001) and burst incidence (-4 ± 7 vs. 4 ± 5 bursts/100 heart beats, P = 0.002) were lower after BR versus PL, whereas systolic blood pressure (-1 ± 5 vs. 2 ± 5 mmHg, P = 0.30) and diastolic blood pressure (4 ± 5 vs. 5 ± 7 mmHg, P = 0.68) as well as spontaneous arterial sympathetic baroreflex s