WorldWideScience

Sample records for random unit failures

  1. Probability of Failure in Random Vibration

    DEFF Research Database (Denmark)

    Nielsen, Søren R.K.; Sørensen, John Dalsgaard

    1988-01-01

    Close approximations to the first-passage probability of failure in random vibration can be obtained by integral equation methods. A simple relation exists between the first-passage probability density function and the distribution function for the time interval spent below a barrier before out...

  2. Contraceptive failure in the United States

    Science.gov (United States)

    Trussell, James

    2013-01-01

    This review provides an update of previous estimates of first-year probabilities of contraceptive failure for all methods of contraception available in the United States. Estimates are provided of probabilities of failure during typical use (which includes both incorrect and inconsistent use) and during perfect use (correct and consistent use). The difference between these two probabilities reveals the consequences of imperfect use; it depends both on how unforgiving of imperfect use a method is and on how hard it is to use that method perfectly. These revisions reflect new research on contraceptive failure both during perfect use and during typical use. PMID:21477680

  3. Portable suction unit failure in a rural EMS system.

    Science.gov (United States)

    Risavi, Brian L; Sabotchick, K J; Heile, Christopher J

    2013-08-01

    Portable suction units used by EMS personnel are utilized infrequently and often are powered by batteries. Lack of use and inspection often results in failure of the device when it is needed. The purpose of this study was to examine the incidence of portable suction unit failure in a rural EMS system and to identify the reasons for failures. A convenience sample was obtained through both random inspections by the staff of a regional EMS council and data from twice monthly checks reported by respective EMS agencies following a standard protocol for each unit. A standard protocol was used, including checking the vacuum level on each suction unit and inspecting the tubing, canister, and battery. Each inspector assessed whether the unit was capable of achieving 300 mmHg of suction within four seconds. Also, the unit was inspected for any signs of misalignment or dry rot of the gasket, kinking of suction hose, damage to the suction canister, weak/dead battery, or defective pump. Findings were recorded. Over a two-year period, 9,631 suction unit inspections were completed. There were 233 failures (2.4%) noted. The majority (126, 54.1%) were due to battery failure. Seventy-three units failed due to other reasons (not recorded, switch failure, battery not seated). Ten inspections failed due to incorrect assembly. Nineteen inspections failed due to defects with the suction canister. Five inspections failed due to kinked/disconnected suction tubing. Only a relatively small percentage of inspections of suction units revealed failures (4.6% Advanced Life Support, 8.6% Basic Life Support) using the above-stated criteria. However, given the importance of airway management and potential complications associated with airway compromise, including aspiration pneumonia, hypoxia, and hemodynamic instability, this is of concern relative to the morbidity and mortality that could be related to airway failure. Due to the relative infrequency of use and the nature of portable suction units

  4. Insuring unit failures in electricity markets

    Energy Technology Data Exchange (ETDEWEB)

    Pineda, S.; Conejo, A.J.; Carrion, M. [Univ. Castilla-La Mancha (Spain)

    2010-11-15

    An electric energy producer participates in futures markets in the hope of hedging the risk of trading in the pool. However, this producer is required to supply the energy associated with all its signed forward contracts even if some of its units are forced out due to unexpected failures. In this case, the producer must purchase some of the energy needed to meet its futures market commitments in the pool, which may result in high losses if the pool prices happen to be higher than the forward contract prices. To mitigate these losses, the producer can take out insurance against the forced outages of its units. Using a stochastic programming model, this paper analyzes the convenience of signing an insurance against unit failure by an electric energy producer and its impact on forward contracting decisions. Results from a realistic case study are provided and analyzed. (author)

  5. Extubation failure in intensive care unit: Predictors and management

    OpenAIRE

    Kulkarni Atul; Agarwal Vandana

    2008-01-01

    Extubation failure-need for reintubation within 72 h of extubation, is common in intensive care unit (ICU). It can cause increased morbidity, higher costs, higher ICU and hospital length of stay (LOS) and mortality. Patients with advanced age, high severity of illness at ICU admission and extubation, preexisting chronic respiratory and cardiovascular disorders are at increased risk of extubation failure. Unresolved illness, development and progression of organ failure during the time from ext...

  6. Cascading failures in spatially-embedded random networks.

    Science.gov (United States)

    Asztalos, Andrea; Sreenivasan, Sameet; Szymanski, Boleslaw K; Korniss, Gyorgy

    2014-01-01

    Cascading failures constitute an important vulnerability of interconnected systems. Here we focus on the study of such failures on networks in which the connectivity of nodes is constrained by geographical distance. Specifically, we use random geometric graphs as representative examples of such spatial networks, and study the properties of cascading failures on them in the presence of distributed flow. The key finding of this study is that the process of cascading failures is non-self-averaging on spatial networks, and thus, aggregate inferences made from analyzing an ensemble of such networks lead to incorrect conclusions when applied to a single network, no matter how large the network is. We demonstrate that this lack of self-averaging disappears with the introduction of a small fraction of long-range links into the network. We simulate the well studied preemptive node removal strategy for cascade mitigation and show that it is largely ineffective in the case of spatial networks. We introduce an altruistic strategy designed to limit the loss of network nodes in the event of a cascade triggering failure and show that it performs better than the preemptive strategy. Finally, we consider a real-world spatial network viz. a European power transmission network and validate that our findings from the study of random geometric graphs are also borne out by simulations of cascading failures on the empirical network.

  7. Performance of wireless sensor networks under random node failures

    Energy Technology Data Exchange (ETDEWEB)

    Bradonjic, Milan [Los Alamos National Laboratory; Hagberg, Aric [Los Alamos National Laboratory; Feng, Pan [Los Alamos National Laboratory

    2011-01-28

    Networks are essential to the function of a modern society and the consequence of damages to a network can be large. Assessing network performance of a damaged network is an important step in network recovery and network design. Connectivity, distance between nodes, and alternative routes are some of the key indicators to network performance. In this paper, random geometric graph (RGG) is used with two types of node failure, uniform failure and localized failure. Since the network performance are multi-facet and assessment can be time constrained, we introduce four measures, which can be computed in polynomial time, to estimate performance of damaged RGG. Simulation experiments are conducted to investigate the deterioration of networks through a period of time. With the empirical results, the performance measures are analyzed and compared to provide understanding of different failure scenarios in a RGG.

  8. Congestive heart failure detection using random forest classifier.

    Science.gov (United States)

    Masetic, Zerina; Subasi, Abdulhamit

    2016-07-01

    Automatic electrocardiogram (ECG) heartbeat classification is substantial for diagnosing heart failure. The aim of this paper is to evaluate the effect of machine learning methods in creating the model which classifies normal and congestive heart failure (CHF) on the long-term ECG time series. The study was performed in two phases: feature extraction and classification phase. In feature extraction phase, autoregressive (AR) Burg method is applied for extracting features. In classification phase, five different classifiers are examined namely, C4.5 decision tree, k-nearest neighbor, support vector machine, artificial neural networks and random forest classifier. The ECG signals were acquired from BIDMC Congestive Heart Failure and PTB Diagnostic ECG databases and classified by applying various experiments. The experimental results are evaluated in several statistical measures (sensitivity, specificity, accuracy, F-measure and ROC curve) and showed that the random forest method gives 100% classification accuracy. Impressive performance of random forest method proves that it plays significant role in detecting congestive heart failure (CHF) and can be valuable in expressing knowledge useful in medicine. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. Fatigue failure of materials under narrow band random vibrations. I.

    Science.gov (United States)

    Huang, T. C.; Hubbard, R. B.; Lanz, R. W.

    1971-01-01

    A novel approach for the study of fatigue failure of materials under the multifactor influence of narrow band random vibrations is developed. The approach involves the conduction of an experiment in conjunction with various statistical techniques. Three factors including two statistical properties of the excitation or response are considered and varied simultaneously. A minimum of 6 tests for 3 variables is possible for a fractional f actorial design. The four coefficients of the predicting equation can be independently estimated. A look at 3 predicting equations shows the predominant effect of the root mean square stress of the first order equation.

  10. Failure process in heterogeneous materials with randomly oriented fibers

    Science.gov (United States)

    Sbiaai, H.; Hader, A.; Bakir, R.; Achik, I.; Tarras, I.; Boughaleb, Y.

    2017-06-01

    Our aim in this study is to investigate the failure process in heterogeneous materials with randomly oriented fibers. In our proposed system, the fiber bundle model assumes that all the fibers are randomly oriented in all directions relative to the vertical one. Our calculations are performed in the framework of the local load-sharing rule, which states that the applied load of a broken fiber is redistributed only to its neighboring ones. The results show that this system presents a greater resistance than the classical one where the fibers are arranged parallel to the applied load. We found that the density of the broken fibers exhibited a power law and was linearly correlated with the applied load and temperature. However, the results show that the failure process of the considered system is characterized by an avalanche phenomenon with two different regimes. We also studied the crossover behavior of lifetime of the materials versus both applied load and temperature. We compared these results with those obtained from the classical model.

  11. Extubation failure in intensive care unit: predictors and management.

    Science.gov (United States)

    Kulkarni, Atul P; Agarwal, Vandana

    2008-01-01

    Extubation failure-need for reintubation within 72 h of extubation, is common in intensive care unit (ICU). It can cause increased morbidity, higher costs, higher ICU and hospital length of stay (LOS) and mortality. Patients with advanced age, high severity of illness at ICU admission and extubation, preexisting chronic respiratory and cardiovascular disorders are at increased risk of extubation failure. Unresolved illness, development and progression of organ failure during the time from extubation to reintubation and reintubation itself have been proposed as reasons for increased morbidity and mortality. Parameters used to predict extubation failure can be categorized into parameters assessing respiratory mechanics, airway patency and protection and cardiovascular reserve. Adequate cough strength, minimal secretions and alertness are necessary for successful extubation. Evidence suggests that early institution of non-invasive ventilation and prophylactic administration of methylprednisolone may prevent reintubation in some patients. The intensivist needs to identify patients at high risk of extubation failure and be prepared to reinstitute ventilation early to prevent adverse outcomes.

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

    DEFF Research Database (Denmark)

    Bernal, William; Murphy, Nicholas; Brown, Sarah

    2016-01-01

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

  13. Outpatient management of heart failure in the United States, 2006-2008.

    Science.gov (United States)

    Mosalpuria, Kailash; Agarwal, Sunil K; Yaemsiri, Sirin; Pierre-Louis, Bredy; Saba, Samir; Alvarez, Rene; Russell, Stuart D

    2014-06-01

    Better outpatient management of heart failure might improve outcomes and reduce the number of rehospitalizations. This study describes recent outpatient heart-failure management in the United States. We analyzed data from the National Ambulatory Medical Care Survey of 2006-2008, a multistage random sampling of non-Federal physician offices and hospital outpatient departments. Annually, 1.7% of all outpatient visits were for heart failure (51% females and 77% non-Hispanic whites; mean age, 73 ± 0.5 yr). Typical comorbidities were hypertension (62%), hyperlipidemia (36%), diabetes mellitus (35%), and ischemic heart disease (29%). Body weight and blood pressure were recorded in about 80% of visits, and health education was given in about 40%. The percentage of patients taking β-blockers was 38%; the percentage taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEI/ARBs) was 32%. Medication usage did not differ significantly by race or sex. In multivariate-adjusted logistic regression models, a visit to a cardiologist, hypertension, heart failure as a primary reason for the visit, and a visit duration longer than 15 minutes were positively associated with ACEI/ARB use; and a visit to a cardiologist, heart failure as a primary reason for the visit, the presence of ischemic heart disease, and visit duration longer than 15 minutes were positively associated with β-blocker use. Chronic obstructive pulmonary disease was negatively associated with β-blocker use. Approximately 1% of heart-failure visits resulted in hospitalization. In outpatient heart-failure management, gaps that might warrant attention include suboptimal health education and low usage rates of medications, specifically ACEI/ARBs and β-blockers.

  14. Slope failure analysis using the random material point method

    NARCIS (Netherlands)

    Wang, B.; Hicks, M.A.; Vardon, P.J.

    2016-01-01

    The random material point method (RMPM), which combines random field theory and the material point method (MPM), is proposed. It differs from the random finite-element method (RFEM), by assigning random field (cell) values to material points that are free to move relative to the computational grid

  15. Forecasting the Impact of Heart Failure in the United States

    Science.gov (United States)

    Heidenreich, Paul A.; Albert, Nancy M.; Allen, Larry A.; Bluemke, David A.; Butler, Javed; Fonarow, Gregg C.; Ikonomidis, John S.; Khavjou, Olga; Konstam, Marvin A.; Maddox, Thomas M.; Nichol, Graham; Pham, Michael; Piña, Ileana L.; Trogdon, Justin G.

    2013-01-01

    Background Heart failure (HF) is an important contributor to both the burden and cost of national healthcare expenditures, with more older Americans hospitalized for HF than for any other medical condition. With the aging of the population, the impact of HF is expected to increase substantially. Methods and Results We estimated future costs of HF by adapting a methodology developed by the American Heart Association to project the epidemiology and future costs of HF from 2012 to 2030 without double counting the costs attributed to comorbid conditions. The model assumes that HF prevalence will remain constant by age, sex, and race/ethnicity and that rising costs and technological innovation will continue at the same rate. By 2030, >8 million people in the United States (1 in every 33) will have HF. Between 2012 and 2030, real (2010$) total direct medical costs of HF are projected to increase from $21 billion to $53 billion. Total costs, including indirect costs for HF, are estimated to increase from $31 billion in 2012 to $70 billion in 2030. If one assumes all costs of cardiac care for HF patients are attributable to HF (no cost attribution to comorbid conditions), the 2030 projected cost estimates of treating patients with HF will be 3-fold higher ($160 billion in direct costs). Conclusions The estimated prevalence and cost of care for HF will increase markedly because of aging of the population. Strategies to prevent HF and improve the efficiency of care are needed. PMID:23616602

  16. Geographic access to high capability severe acute respiratory failure centers in the United States

    National Research Council Canada - National Science Library

    Wallace, David J; Angus, Derek C; Seymour, Christopher W; Yealy, Donald M; Carr, Brendan G; Kurland, Kristen; Boujoukos, Arthur; Kahn, Jeremy M

    2014-01-01

    .... We sought to measure geographic access to these centers in the United States. Cross-sectional analysis of geographic access to high capability severe acute respiratory failure centers in the United States...

  17. Role of micronutrients in congestive heart failure: A systematic review of randomized controlled trials

    OpenAIRE

    Valiyakizha Kkeveetil, Chandini; Thomas, Grace; Chander, Sam Johnson Udaya

    2016-01-01

    Objectives: To assess the effect of micronutrients on health outcomes in patients with heart failure. Materials and Methods: Only randomized controlled trials testing the effectiveness of different micronutrients either singly or combined versus placebo in heart failure patients were included. We conducted a search in different databases such as Medline from PubMed, Embase and Scopus from Elsevier, and Google Scholar. The keywords used in the search were ?Heart Failure? and its cognates, ?Mic...

  18. Misoprostol versus curettage in women with early pregnancy failure after initial expectant management : a randomized trial

    NARCIS (Netherlands)

    Graziosi, GCM; Mol, BWJ; Reuwer, PJH; Drogtrop, A; Bruinse, HW

    BACKGROUND: Little is known about the effectiveness of misoprostol treatment in women with early pregnancy failure who have been managed expectantly. We therefore performed a randomized trial on this subject. METHODS: Women with early pregnancy failure, who had been managed expectantly for at least

  19. HEART FAILURE OF INTENSIVE CARE UNIT SPECIALIST: DIAGNOSIS, FOLLOW-UP, AND THERAPY

    OpenAIRE

    Yıldız, Mustafa

    2006-01-01

    Heart failure is one of the diseases that require intensive care unit. The complication, repetition rates and cost ratios are high. Careful follow-up, a good treatment and device therapy such as mechanical ventilation may be require. An intensive care unit specialist must have been experience in the pathophysiology and treatment of heart failure.

  20. Development of failure mechanisms for fasteners in the United States

    Science.gov (United States)

    Douglas R. Rammer; Philip Line

    2006-01-01

    In the 2001 National Design Specifications® for Wood Construction (NDS), Appendix E was added to explicitly address wood failure mechanisms that may occur in fasteners. One approach to estimate design capacities for net section, row tear out, and group tear failure mechanisms is presented in Appendix E of the 2001 NDS. Since the 2001 NDS, efforts are being untaken to...

  1. Fatigue failure of materials under broad band random vibrations

    Science.gov (United States)

    Huang, T. C.; Lanz, R. W.

    1971-01-01

    The fatigue life of material under multifactor influence of broad band random excitations has been investigated. Parameters which affect the fatigue life are postulated to be peak stress, variance of stress and the natural frequency of the system. Experimental data were processed by the hybrid computer. Based on the experimental results and regression analysis a best predicting model has been found. All values of the experimental fatigue lives are within the 95% confidence intervals of the predicting equation.

  2. Evaluation of the european heart failure self-care behaviour scale in a united kingdom population

    NARCIS (Netherlands)

    Shuldham, Caroline; Theaker, Chris; Jaarsma, Tiny; Cowie, Martin R.

    2007-01-01

    Title. Evaluation of the European Heart Failure Self-care Behaviour Scale in a United Kingdom population Aim. This paper is a report of a study to test the internal consistency, reliability and validity of the 12-item European Heart Failure Self-care Behaviour Scale in an English-speaking sample in

  3. Classification and Quality Standards of Heart Failure Units: Scientific Consensus of the Spanish Society of Cardiology.

    Science.gov (United States)

    Anguita Sánchez, Manuel; Lambert Rodríguez, José Luis; Bover Freire, Ramón; Comín Colet, Josep; Crespo Leiro, María G; González Vílchez, Francisco; Manito Lorite, Nicolás; Segovia Cubero, Javier; Ruiz Mateas, Francisco; Elola Somoza, Francisco Javier; Íñiguez Romo, Andrés

    2016-10-01

    The prevalence of heart failure remains high and represents the highest disease burden in Spain. Heart failure units have been developed to systematize the diagnosis, treatment, and clinical follow-up of heart failure patients, provide a structure to coordinate the actions of various entities and personnel involved in patient care, and improve prognosis and quality of life. There is ample evidence on the benefits of heart failure units or programs, which have become widespread in Spain. One of the challenges to the analysis of heart failure units is standardization of their classification, by determining which "programs" can be identified as heart failure "units" and by characterizing their complexity level. The aim of this article was to present the standards developed by the Spanish Society of Cardiology to classify and establish the requirements for heart failure units within the SEC-Excellence project. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  4. Care management for low-risk patients with heart failure: a randomized, controlled trial.

    Science.gov (United States)

    DeBusk, Robert Frank; Miller, Nancy Houston; Parker, Kathleen Marie; Bandura, Albert; Kraemer, Helena Chmura; Cher, Daniel Joseph; West, Jeffrey Alan; Fowler, Michael Bruce; Greenwald, George

    2004-10-19

    Nurse care management programs for patients with chronic illness have been shown to be safe and effective. To determine whether a telephone-mediated nurse care management program for heart failure reduced the rate of rehospitalization for heart failure and for all causes over a 1-year period. Randomized, controlled trial of usual care with nurse management versus usual care alone in patients hospitalized for heart failure from May 1998 through October 2001. 5 northern California hospitals in a large health maintenance organization. Of 2786 patients screened, 462 met clinical criteria for heart failure and were randomly assigned (228 to intervention and 234 to usual care). Nurse care management provided structured telephone surveillance and treatment for heart failure and coordination of patients' care with primary care physicians. Time to first rehospitalization for heart failure or for any cause and time to a combined end point of first rehospitalization, emergency department visit, or death. At 1 year, half of the patients had been rehospitalized at least once and 11% had died. Only one third of rehospitalizations were for heart failure. The rate of first rehospitalization for heart failure was similar in both groups (proportional hazard, 0.85 [95% CI, 0.46 to 1.57]). The rate of all-cause rehospitalization was similar (proportional hazard, 0.98 [CI, 0.76 to 1.27]). The findings of this study, conducted in a single health care system, may not be generalizable to other health care systems. The overall effect of the intervention was minor. Among patients with heart failure at low risk on the basis of sociodemographic and medical attributes, nurse care management did not statistically significantly reduce rehospitalizations for heart failure or for any cause. Such programs may be less effective for patients at low risk than those at high risk.

  5. Glove failure in elective thyroid surgery: A prospective randomized study

    Directory of Open Access Journals (Sweden)

    Dariusz Timler

    2015-06-01

    Full Text Available Objectives: To analyze perforation rate in sterile gloves used by surgeons in the operating theatre of the Department of Endocrinological and General Surgery of Medical University of Lodz. Material and Methods: Randomized and controlled trial. This study analyses the incidents of tears in sterile surgical gloves used by surgeons during operations on 3 types of thyroid diseases according to the 10th revision of International Statistical Classification of Diseases and Related Health Problems (ICD-10 codes. Nine hundred seventy-two pairs (sets of gloves were collected from 321 surgical procedures. All gloves were tested immediately following surgery using the water leak test (EN455-1 to detect leakage. Results: Glove perforation was detected in 89 of 972 glove sets (9.2%. Statistically relevant more often glove tears occurred in operator than the 1st assistant (p < 0.001. The sites of perforation were localized mostly on the middle finger of the non-dominant hand (22.5%, and the non-dominant ring finger (17.9%. Conclusions: This study has proved that the role performed by the surgeon during the procedure (operator, 1st assistant has significant influence on the risk of glove perforations. Nearly 90% of glove perforations are unnoticed during surgery.

  6. Failure analysis of storage tank component in LNG regasification unit using fault tree analysis method (FTA)

    Science.gov (United States)

    Mulyana, Cukup; Muhammad, Fajar; Saad, Aswad H.; Mariah, Riveli, Nowo

    2017-03-01

    Storage tank component is the most critical component in LNG regasification terminal. It has the risk of failure and accident which impacts to human health and environment. Risk assessment is conducted to detect and reduce the risk of failure in storage tank. The aim of this research is determining and calculating the probability of failure in regasification unit of LNG. In this case, the failure is caused by Boiling Liquid Expanding Vapor Explosion (BLEVE) and jet fire in LNG storage tank component. The failure probability can be determined by using Fault Tree Analysis (FTA). Besides that, the impact of heat radiation which is generated is calculated. Fault tree for BLEVE and jet fire on storage tank component has been determined and obtained with the value of failure probability for BLEVE of 5.63 × 10-19 and for jet fire of 9.57 × 10-3. The value of failure probability for jet fire is high enough and need to be reduced by customizing PID scheme of regasification LNG unit in pipeline number 1312 and unit 1. The value of failure probability after customization has been obtained of 4.22 × 10-6.

  7. Flight test results of failure detection and isolation algorithms for a redundant strapdown inertial measurement unit

    Science.gov (United States)

    Morrell, F. R.; Motyka, P. R.; Bailey, M. L.

    1990-01-01

    Flight test results for two sensor fault-tolerant algorithms developed for a redundant strapdown inertial measurement unit are presented. The inertial measurement unit (IMU) consists of four two-degrees-of-freedom gyros and accelerometers mounted on the faces of a semi-octahedron. Fault tolerance is provided by edge vector test and generalized likelihood test algorithms, each of which can provide dual fail-operational capability for the IMU. To detect the wide range of failure magnitudes in inertial sensors, which provide flight crucial information for flight control and navigation, failure detection and isolation are developed in terms of a multi level structure. Threshold compensation techniques, developed to enhance the sensitivity of the failure detection process to navigation level failures, are presented. Four flight tests were conducted in a commercial transport-type environment to compare and determine the performance of the failure detection and isolation methods. Dual flight processors enabled concurrent tests for the algorithms. Failure signals such as hard-over, null, or bias shift, were added to the sensor outputs as simple or multiple failures during the flights. Both algorithms provided timely detection and isolation of flight control level failures. The generalized likelihood test algorithm provided more timely detection of low-level sensor failures, but it produced one false isolation. Both algorithms demonstrated the capability to provide dual fail-operational performance for the skewed array of inertial sensors.

  8. Acute Respiratory Failure in Renal Transplant Recipients: A Single Intensive Care Unit Experience.

    Science.gov (United States)

    Ulas, Aydin; Kaplan, Serife; Zeyneloglu, Pinar; Torgay, Adnan; Pirat, Arash; Haberal, Mehmet

    2015-11-01

    Frequency of pulmonary complications after renal transplant has been reported to range from 3% to 17%. The objective of this study was to evaluate renal transplant recipients admitted to an intensive care unit to identify incidence and cause of acute respiratory failure in the postoperative period and compare clinical features and outcomes between those with and without acute respiratory failure. We retrospectively screened the data of 540 consecutive adult renal transplant recipients who received their grafts at a single transplant center and included those patients admitted to an intensive care unit during this period for this study. Acute respiratory failure was defined as severe dyspnea, respiratory distress, decreased oxygen saturation, hypoxemia or hypercapnia on room air, or requirement of noninvasive or invasive mechanical ventilation. Among the 540 adult renal transplant recipients, 55 (10.7%) were admitted to an intensive care unit, including 26 (47.3%) admitted for acute respiratory failure. Median time from transplant to intensive care unit admission was 10 months (range, 0-67 mo). The leading causes of acute respiratory failure were bacterial pneumonia (56%) and cardiogenic pulmonary edema (44%). Mean partial pressure of arterial oxygen to fractional inspired oxygen ratio was 174 ± 59, invasive mechanical ventilation was used in 13 patients (50%), and noninvasive mechanical ventilation was used in 8 patients (31%). The overall mortality was 16.4%. Acute respiratory failure was the reason for intensive care unit admission in almost half of our renal transplant recipients. Main causes of acute respiratory failure were bacterial pneumonia and cardiogenic pulmonary edema. Mortality of patients admitted for acute respiratory failure was similar to those without acute respiratory failure.

  9. Investigation of a Rise in Obstetric Acute Renal Failure in the United States, 1999-2011.

    Science.gov (United States)

    Mehrabadi, Azar; Dahhou, Mourad; Joseph, K S; Kramer, Michael S

    2016-05-01

    To estimate whether the reported increase in obstetric acute renal failure in the United States was attributable to a concurrent rise in postpartum hemorrhage, a change in other risk factors, or changes in the diagnosis of acute renal failure. We conducted a retrospective cohort study to quantify temporal trends in acute renal failure among 10,969,263 hospital deliveries in the United States from 1999 to 2011 using data from the Nationwide Inpatient Sample. Dialysis and maternal death were used as markers of severe acute renal failure. Logistic regression was used to determine whether changes in risk factors explained the temporal rise in acute renal failure. Obstetric acute renal failure rose from 2.4 to 6.3 per 10,000 deliveries between 1999-2001 and 2010-2011, a 10% yearly increase (95% confidence interval [CI] 8-11%) and adjustment for risk factors only partially explained the rise (adjusted yearly increase 6%, 95% CI 5-8%). The overall severity of acute renal failure decreased, although acute renal failure with dialysis rose from 0.27 to 0.36 per 10,000 deliveries (P for trend=.01), and acute renal failure associated with maternal death increased from 0.13 to 0.23 per 10,000 deliveries (P for trend=.01). The temporal increase in acute renal failure with dialysis was abolished by adjustment for chronic kidney disease and chronic hypertension. Changes in diagnosis or ascertainment have led to substantial increases in obstetric acute renal failure, whereas increases in chronic kidney disease and chronic hypertension among pregnant women have resulted in modest but significant increases in acute renal failure with dialysis.

  10. Failure detection and isolation methods for redundant gimballed inertial measurement units.

    Science.gov (United States)

    Solov, E. G.; Thibodeau, J. R., III

    1973-01-01

    Skewed alignment of two redundant conventional inertial measuring units permits nonambiguous detection and isolation of hard and soft failures in real time by an airborne computer. Accelerometer outputs and gimbal readouts are monitored periodically, and attitude rate and velocity error vectors are computed from these data. Magnitudes of these vectors provide failure detection, and projection of these error vectors onto the coordinate axes of the two clusters permits isolation. A detailed Monte Carlo simulation of one version of the mechanization as applied to Space Shuttle boost trajectories demonstrates effectiveness down to very low levels of inertial instrument performance failures. The results indicate that worst case overall navigation performance occurs when accelerometer failures are of the order of 20 sigma and gyro failures are about 100 sigma for conventional state-of-the-art IMU instruments.

  11. Identification of the Parameters of Menétrey -Willam Failure Surface of Calcium Silicate Units

    Science.gov (United States)

    Radosław, Jasiński

    2017-10-01

    The identification of parameters of Menétrey-Willamsurface made of concrete, masonry or autoclaved aerated concrete is not complicated. It is much more difficult to identify failure parameters of masonry units with cavities. This paper describes the concept of identifying the parameters of Menétrey-Willam failure surface (M-W-3) with reference to masonry units with vertical cavities. The M-W-3 surface is defined by uniaxial compressive strength fc, uniaxial tensile strength ft and eccentricity of elliptical function e. A test stand was built to identify surface parameters. It was used to test behaviour of masonry units under triaxial stress and conduct tests on whole masonry units in the uniaxial state. Results from tests on tens of silicate masonry units are presented in the Haigh-Westergaard (H-W) space. Statistical analyses were used to identify the shape of surface meridian, and then to determine eccentricity of the elliptical function.

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

    Science.gov (United States)

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

    2013-06-24

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

  13. Randomized controlled trial of family-based education for patients with heart failure and their carers.

    Science.gov (United States)

    Srisuk, Nittaya; Cameron, Jan; Ski, Chantal F; Thompson, David R

    2017-04-01

    The aim of this study was to evaluate a heart failure education programme developed for patients and carers in Thailand. Heart failure is major health problem. This is the first trial of a family-based education programme for heart failure patients and carers residing in rural Thailand. Randomized controlled trial. One hundred patient-carer dyads attending cardiac clinics in southern Thailand from April 2014 - March 2015 were randomized to usual care (n = 50) or a family-based education programme (n = 50) comprising face-to-face counselling, a heart failure manual and DVD and telephone support. Assessments of heart failure knowledge, health-related quality of life, self-care behaviours and perceived control were conducted at baseline, three and six months. Linear mixed-effects model revealed that patients and carers who received the education programme had higher knowledge scores at three and six months than those who received usual care. Among those who received the education programme, when compared with those who received usual care, patients had better self-care maintenance and confidence, and health-related quality of life scores at three and six months, and better self-care management scores at six months, whereas carers had higher perceived control scores at three months. Addressing a significant service gap in rural Thailand, this family-based heart failure programme improved patient knowledge, self-care behaviours and health-related quality of life and carer knowledge and perceived control. © 2016 John Wiley & Sons Ltd.

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

    OpenAIRE

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

    2013-01-01

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

  15. Effect of a diuretic adjustment algorithm and nonpharmacologic management in patients with heart failure : study protocol for a randomized controlled trial

    OpenAIRE

    Feijó,Maria Karolina Echer Ferreira; Biolo, Andreia; Ruschel,Karen Brasil; Orlandin, Leticia; Aliti,Graziella Badin; Silva, Eneida Rejane Rabelo da

    2015-01-01

    Background One of the challenges in treating patients with heart failure (HF) is achieving clinical stability and reducing the hospital readmission rate. A diuretic dose adjustment algorithm developed in the United States (Diuretic Treatment Algorithm, DTA) and later validated for use in Brazil (as the Algoritmo de Ajuste de Diur?tico, AAD) has proved feasible and readily applicable, but its effect on clinical outcomes has yet to be assessed. This report aims to describe a randomized clinical...

  16. Cascading failures in interdependent modular networks with partial random coupling preference

    Science.gov (United States)

    Tian, Meng; Wang, Xianpei; Dong, Zhengcheng; Zhu, Guowei; Long, Jiachuang; Dai, Dangdang; Zhang, Qilin

    2017-10-01

    Cascading failures have been widely analyzed in interdependent networks with different coupling preferences from microscopic and macroscopic perspectives in recent years. Plenty of real-world interdependent infrastructures, representing as interdependent networks, exhibit community structure, one of the most important mesoscopic structures, and partial coupling preferences, which can affect cascading failures in interdependent networks. In this paper, we propose the partial random coupling in communities, investigating cascading failures in interdependent modular scale-free networks under inner attacks and hub attacks. We mainly analyze the effects of the discoupling probability and the intermodular connection probability on cascading failures in interdependent networks. We find that increasing either the dicoupling probability or the intermodular connection probability can enhance the network robustness under both hub attacks and inner attacks. We also note that the community structure can prevent cascading failures spreading globally in entire interdependent networks. Finally, we obtain the result that if we want to efficiently improve the robustness of interdependent networks and reduce the protection cost, the intermodular connection probability should be protected preferentially, implying that improving the robustness of a single network is the fundamental method to enhance the robustness of the entire interdependent networks.

  17. Palliative care in heart failure : A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhou, K; Mao, Y

    2018-02-21

    Palliative care can play an important role in the management of heart failure. We conducted a systematic review and meta-analysis to compare the efficacy and safety of palliative care in patients with heart failure. PubMed, Embase, Web of Science, EBSCO, and the Cochrane Library databases were systematically searched. Randomized controlled trials (RCTs) on the impact of palliative care on heart failure were included. Two investigators independently searched the articles, extracted data, and assessed the quality of included studies. The primary outcome was mortality. Seven RCTs were included in the meta-analysis. Compared with usual care for heart failure, palliative care was associated with a significantly increased quality of life (standardized mean difference = 1.46; 95% confidence interval [CI] = 0.12 to 2.79; p = 0.03) and reduced depression scores (standardized mean difference = -0.62; 95% CI = -0.99 to -0.25; p = 0.03), but demonstrated no impact on mortality (risk ratio [RR] = 1.28; 95% CI = 0.86 to 1.92; p = 0.22) and rehospitalization (RR = 0.84; 95% CI = 0.66 to 1.07; p = 0.16). Palliative care can improve the quality of life and reduce the occurrence of depression in patients with heart failure.

  18. Does the United States economy affect heart failure readmissions? A single metropolitan center analysis.

    Science.gov (United States)

    Thompson, Keith A; Morrissey, Ryan P; Phan, Anita; Schwarz, Ernst R

    2012-08-01

    To determine the effects of the US economy on heart failure hospitalization rates. The recession was associated with worsening unemployment, loss of private insurance and prescription medication benefits, medication nonadherence, and ultimately increased rates of hospitalization for heart failure. We compared hospitalization rates at a large, single, academic medical center from July 1, 2006 to February 28, 2007, a time of economic stability, and July 1, 2008 to February 28, 2009, a time of economic recession in the United States. Significantly fewer patients had private medical insurance during the economic recession than during the control period (36.5% vs 46%; P = 0.04). Despite this, there were no differences in the heart failure hospitalization or readmission rates, length of hospitalization, need for admission to an intensive care unit, in-hospital mortality, or use of guideline-recommended heart failure medications between the 2 study periods. We conclude that despite significant effects on medical insurance coverage, rates of heart failure hospitalization at our institution were not significantly affected by the recession. Additional large-scale population-based research is needed to better understand the effects of fluctuations in the US economy on heart failure hospitalization rates. © 2012 Wiley Periodicals, Inc.

  19. Estimates of Hospital Based Emergency Department Visits due to Dental Implant Failures in the United States.

    Science.gov (United States)

    Elangovan, Satheesh; Allareddy, Veerasathpurush

    2016-06-01

    Objective of the current study is to provide nationally representative estimates of hospital based emergency department (ED) visits attributed to dental implant failures in the United States. The Nationwide Emergency Department sample for the years 2008-2010 was used. All ED visits with a diagnosis of "dental implant failures" were selected for analysis. Patient demographics were examined. Outcomes of interest included disposition status following the ED visit and ED charges. During the study period, a total of 1200 ED visits were due to dental implant failures. Most ED visits with dental implant failures occurred among those aged dental implant occurred in 31.7% of patients while post-osseointegration mechanical failure of dental implant occurred in 30.4% of patients. Following an ED visit, 82.8% were discharged routinely and 13.3% of patients were admitted as in-patients into the same hospital following the ED visit. The mean ED charge per visit was $1167. Highest proportions of these ED visits were comprised of those aged implant failures. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. The first multicenter, randomized, controlled trial of home telemonitoring for Japanese patients with heart failure: home telemonitoring study for patients with heart failure (HOMES-HF).

    Science.gov (United States)

    Kotooka, Norihiko; Kitakaze, Masafumi; Nagashima, Kengo; Asaka, Machiko; Kinugasa, Yoshiharu; Nochioka, Kotaro; Mizuno, Atsushi; Nagatomo, Daisuke; Mine, Daigo; Yamada, Yoko; Kuratomi, Akiko; Okada, Norihiro; Fujimatsu, Daisuke; Kuwahata, So; Toyoda, Shigeru; Hirotani, Shin-Ichi; Komori, Takahiro; Eguchi, Kazuo; Kario, Kazuomi; Inomata, Takayuki; Sugi, Kaoru; Yamamoto, Kazuhiro; Tsutsui, Hiroyuki; Masuyama, Tohru; Shimokawa, Hiroaki; Momomura, Shin-Ichi; Seino, Yoshihiko; Sato, Yasunori; Inoue, Teruo; Node, Koichi

    2018-02-15

    Home telemonitoring is becoming more important to home medical care for patients with heart failure. Since there are no data on home telemonitoring for Japanese patients with heart failure, we investigated its effect on cardiovascular outcomes. The HOMES-HF study was the first multicenter, open-label, randomized, controlled trial (RCT) to elucidate the effectiveness of home telemonitoring of physiological data, such as body weight, blood pressure, and pulse rate, for Japanese patients with heart failure (UMIN Clinical Trials Registry 000006839). The primary end-point was a composite of all-cause death or rehospitalization due to worsening heart failure. We analyzed 181 recently hospitalized patients with heart failure who were randomly assigned to a telemonitoring group (n = 90) or a usual care group (n = 91). The mean follow-up period was 15 (range 0-31) months. There was no statistically significant difference in the primary end-point between groups [hazard ratio (HR), 0.95; 95% confidence interval (CI), 0.548-1.648; p = 0.572]. Home telemonitoring for Japanese patients with heart failure was feasible; however, beneficial effects in addition to those of usual care were not demonstrated. Further investigation of more patients with severe heart failure, participation of home medical care providers, and use of a more integrated home telemonitoring system emphasizing communication as well as monitoring of symptoms and physiological data are required.

  1. Feasibility of using adaptive logic networks to predict compressor unit failure

    Energy Technology Data Exchange (ETDEWEB)

    Armstrong, W.W.; Chungying Chu; Thomas, M.M. [Dendronic Decisions Limited, Edmonton (Canada)] [and others

    1995-12-31

    In this feasibility study, an adaptive logic network (ALN) was trained to predict failures of turbine-driven compressor units using a large database of measurements. No expert knowledge about compressor systems was involved. The predictions used only the statistical properties of the measurements and the indications of failure types. A fuzzy set was used to model measurements typical of normal operation. It was constrained by a requirement imposed during ALN training, that it should have a shape similar to a Gaussian density, more precisely, that its logarithm should be convex-up. Initial results obtained using this approach to knowledge discovery in the database were encouraging.

  2. Renal Hemodynamic Effects of Serelaxin in Patients With Chronic Heart Failure A Randomized, Placebo-Controlled Study

    NARCIS (Netherlands)

    Voors, Adriaan A.; Dahlke, Marion; Meyer, Sven; Stepinska, Janina; Gottlieb, Stephen S.; Jones, Andrew; Zhang, Yiming; Laurent, Didier; Slart, Riemer H. J. A.; Navis, Gerjan J.

    2014-01-01

    Background-Serelaxin is a promising therapy for acute heart failure. The renal hemodynamic effects of serelaxin in patients with chronic heart failure are unknown. Methods and Results-In this double-blind, randomized, placebo-controlled, multicenter study, patients with New York Heart Association

  3. Pulmonary arterial hypertension treatment with carvedilol for heart failure: a randomized controlled trial

    Science.gov (United States)

    Saygin, Didem; Park, Margaret M.; Cheong, Hoi I.; Asosingh, Kewal; Comhair, Suzy A.A.; Stephens, Olivia R.; Roach, Emir C.; Sharp, Jacqueline; Highland, Kristin B.; DiFilippo, Frank P.; Neumann, Donald R.; Tang, W.H. Wilson; Erzurum, Serpil C.

    2017-01-01

    BACKGROUND. Right-sided heart failure is the leading cause of death in pulmonary arterial hypertension (PAH). Similar to left heart failure, sympathetic overactivation and β-adrenoreceptor (βAR) abnormalities are found in PAH. Based on successful therapy of left heart failure with β-blockade, the safety and benefits of the nonselective β-blocker/vasodilator carvedilol were evaluated in PAH. METHODS. PAH Treatment with Carvedilol for Heart Failure (PAHTCH) is a single-center, double-blind, randomized, controlled trial. Following 1-week run-in, 30 participants were randomized to 1 of 3 arms for 24 weeks: placebo, low-fixed-dose, or dose-escalating carvedilol. Outcomes included clinical measures and mechanistic biomarkers. RESULTS. Decreases in heart rate and blood pressure with carvedilol were well tolerated; heart rate correlated with carvedilol dose. Carvedilol-treated groups had no decrease in exercise capacity measured by 6-minute walk, but had lower heart rates at peak and after exercise, and faster heart rate recovery. Dose-escalating carvedilol was associated with reduction in right ventricular (RV) glycolytic rate and increase in βAR levels. There was no evidence of RV functional deterioration; rather, cardiac output was maintained. CONCLUSIONS. Carvedilol is likely safe in PAH over 6 months of therapy and has clinical and mechanistic benefits associated with improved outcomes. The data provide support for longer and larger studies to establish guidelines for use of β-blockers in PAH. TRIAL REGISTRATION. ClinicalTrials.gov NCT01586156 FUNDING. This project was supported by NIH R01HL115008 and R01HL60917 and in part by the National Center for Advancing Translational Sciences, UL1TR000439. PMID:28814664

  4. United we stand, divided we conquer: Pilot study of multidisciplinary General Medicine Heart Failure Care Program.

    Science.gov (United States)

    Wahbi Izzettin, Omar; Hopper, Ingrid; Ritchie, Edward; Nagalingam, Vathy; Aung, Ar Kar

    2017-10-11

    Heart failure care and education require a multifaceted approach to ensure appropriate transition from inpatient to outpatient care. To explore the feasibility of a multidisciplinary heart failure care model, General Medicine Heart Failure Care Program (GM-HFCP) within a General Medical Unit (GMU). Prospective non-randomised before-and-after observational quality improvement intervention over a 6-month period. All consecutive patients admitted to GMU at Alfred Hospital with diagnosis of acute decompensated heart failure were included. Main outcome measures included changes in rates of pharmacologic prescription, non-pharmacologic ward-based management, patient education and action plan provision after intervention. 108 patients were included [median age 84(IQR 80-89) years, 47(44%) females]. Significant improvements were noted in non-pharmacologic management for patient education regarding fluid restriction (12% to 30%, p = 0.04), weight monitoring (10% to 28%, p = 0.03), heart failure action plan on discharge (4% to 28%, p = 0.002) and salt restriction (6% to 32%, p = 0.002). The rates of prescription of heart failure medications remained similar between the pre- and post-implementation periods, particularly in patients with reduced ejection fraction by 'appropriateness of prescription' criteria. There were no differences in inpatient mortality or 30-day readmission rates in both groups. This prospective observational study demonstrated that it is possible to share the roles of a heart failure nurse amongst members of the multidisciplinary team, with similar rates of delivery of pharmacologic and non-pharmacologic management aspects. However, further innovative improvements are needed to address certain aspects of heart failure care. This article is protected by copyright. All rights reserved.

  5. Failure mode and effect analysis: improving intensive care unit risk management processes.

    Science.gov (United States)

    Askari, Roohollah; Shafii, Milad; Rafiei, Sima; Abolhassani, Mohammad Sadegh; Salarikhah, Elaheh

    2017-04-18

    Purpose Failure modes and effects analysis (FMEA) is a practical tool to evaluate risks, discover failures in a proactive manner and propose corrective actions to reduce or eliminate potential risks. The purpose of this paper is to apply FMEA technique to examine the hazards associated with the process of service delivery in intensive care unit (ICU) of a tertiary hospital in Yazd, Iran. Design/methodology/approach This was a before-after study conducted between March 2013 and December 2014. By forming a FMEA team, all potential hazards associated with ICU services - their frequency and severity - were identified. Then risk priority number was calculated for each activity as an indicator representing high priority areas that need special attention and resource allocation. Findings Eight failure modes with highest priority scores including endotracheal tube defect, wrong placement of endotracheal tube, EVD interface, aspiration failure during suctioning, chest tube failure, tissue injury and deep vein thrombosis were selected for improvement. Findings affirmed that improvement strategies were generally satisfying and significantly decreased total failures. Practical implications Application of FMEA in ICUs proved to be effective in proactively decreasing the risk of failures and corrected the control measures up to acceptable levels in all eight areas of function. Originality/value Using a prospective risk assessment approach, such as FMEA, could be beneficial in dealing with potential failures through proposing preventive actions in a proactive manner. The method could be used as a tool for healthcare continuous quality improvement so that the method identifies both systemic and human errors, and offers practical advice to deal effectively with them.

  6. Effect of the Mediterranean diet on heart failure biomarkers: a randomized sample from the PREDIMED trial.

    Science.gov (United States)

    Fitó, Montserrat; Estruch, Ramón; Salas-Salvadó, Jordi; Martínez-Gonzalez, Miguel Angel; Arós, Fernando; Vila, Joan; Corella, Dolores; Díaz, Oscar; Sáez, Guillermo; de la Torre, Rafael; Mitjavila, María-Teresa; Muñoz, Miguel Angel; Lamuela-Raventós, Rosa-María; Ruiz-Gutierrez, Valentina; Fiol, Miquel; Gómez-Gracia, Enrique; Lapetra, José; Ros, Emilio; Serra-Majem, Lluis; Covas, María-Isabel

    2014-05-01

    Scarce data are available on the effect of the traditional Mediterranean diet (TMD) on heart failure biomarkers. We assessed the effect of TMD on biomarkers related to heart failure in a high cardiovascular disease risk population. A total of 930 subjects at high cardiovascular risk (420 men and 510 women) were recruited in the framework of a multicentre, randomized, controlled, parallel-group clinical trial directed at testing the efficacy of the TMD on the primary prevention of cardiovascular disease (The PREDIMED Study). Participants were assigned to a low-fat diet (control, n = 310) or one of two TMDs [TMD + virgin olive oil (VOO) or TMD + nuts]. Depending on group assignment, participants received free provision of extra-virgin olive oil, mixed nuts, or small non-food gifts. After 1 year of intervention, both TMDs decreased plasma N-terminal pro-brain natriuretic peptide, with changes reaching significance vs. control group (P cardiovascular disease (CVD) who improved their diet toward a TMD pattern reduced their N-terminal pro-brain natriuretic peptide compared with those assigned to a low-fat diet. The same was found for in vivo oxidized low-density lipoprotein and lipoprotein(a) plasma concentrations after the TMD + VOO diet. From our results TMD could be a useful tool to mitigate against risk factors for heart failure. From our results TMD could modify markers of heart failure towards a more protective mode. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.

  7. Failure factors in non-life insurance companies in United Kingdom

    Science.gov (United States)

    Samsudin, Humaida Banu

    2013-04-01

    Failure in insurance company is a condition of financial distress where a company has difficulty paying off its financial obligations to its creditors. This study continues the research from the study in identifying the determinants for run-off non-life insurance companies in United Kingdom. The analysis continues to identify other variables that could lead companies to financial distress that is macroeconomic factors (GDP rates, inflation rates and interest rates); total companies failed a year before and average size for failed companies'. The result from the analysis indicates that inflation rates, interest rates, total companies failed a year before and average sizes for failed companies are the best predictors. An early detection of failure can prevent companies from bankruptcy and allow management to take action to reduce the failure costs.

  8. Randomized Clinical Trials of Gene Transfer for Heart Failure with Reduced Ejection Fraction.

    Science.gov (United States)

    Penny, William F; Hammond, H Kirk

    2017-05-01

    Despite improvements in drug and device therapy for heart failure, hospitalization rates and mortality have changed little in the past decade. Randomized clinical trials using gene transfer to improve function of the failing heart are the focus of this review. Four randomized clinical trials of gene transfer in heart failure with reduced ejection fraction (HFrEF) have been published. Each enrolled patients with stable symptomatic HFrEF and used either intracoronary delivery of a virus vector or endocardial injection of a plasmid. The initial CUPID trial randomized 14 subjects to placebo and 25 subjects to escalating doses of adeno-associated virus type 1 encoding sarcoplasmic reticulum calcium ATPase (AAV1.SERCA2a). AAV1.SERCA2a was well tolerated, and the high-dose group met a 6 month composite endpoint. In the subsequent CUPID-2 study, 243 subjects received either placebo or the high dose of AAV1.SERCA2a. AAV1.SERCA2a administration, while safe, failed to meet the primary or any secondary endpoints. STOP-HF used plasmid endocardial injection of stromal cell-derived factor-1 to promote stem-cell recruitment. In a 93-subject trial of patients with ischemic etiology heart failure, the primary endpoint (symptoms and 6 min walk distance) failed, but subgroup analyses showed improvements in subjects with the lowest ejection fractions. A fourth trial randomized 14 subjects to placebo and 42 subjects to escalating doses of adenovirus-5 encoding adenylyl cyclase 6 (Ad5.hAC6). There were no safety concerns, and patients in the two highest dose groups (combined) showed improvements in left ventricular function (left ventricular ejection fraction and -dP/dt). The safety data from four randomized clinical trials of gene transfer in patients with symptomatic HFrEF suggest that this approach can be conducted with acceptable risk, despite invasive delivery techniques in a high-risk population. Additional trials are necessary before the approach can be endorsed for clinical

  9. NASA's Evolutionary Xenon Thruster (NEXT) Power Processing Unit (PPU) Capacitor Failure Root Cause Analysis

    Science.gov (United States)

    Soeder, James F.; Pinero, Luis; Schneidegger, Robert; Dunning, John; Birchenough, Art

    2012-01-01

    The NASA's Evolutionary Xenon Thruster (NEXT) project is developing an advanced ion propulsion system for future NASA missions for solar system exploration. A critical element of the propulsion system is the Power Processing Unit (PPU) which supplies regulated power to the key components of the thruster. The PPU contains six different power supplies including the beam, discharge, discharge heater, neutralizer, neutralizer heater, and accelerator supplies. The beam supply is the largest and processes up to 93+% of the power. The NEXT PPU had been operated for approximately 200+ hours and has experienced a series of three capacitor failures in the beam supply. The capacitors are in the same, nominally non-critical location the input filter capacitor to a full wave switching inverter. The three failures occurred after about 20, 30, and 135 hours of operation. This paper provides background on the NEXT PPU and the capacitor failures. It discusses the failure investigation approach, the beam supply power switching topology and its operating modes, capacitor characteristics and circuit testing. Finally, it identifies root cause of the failures to be the unusual confluence of circuit switching frequency, the physical layout of the power circuits, and the characteristics of the capacitor.

  10. High Mortality without ESCAPE: The Registry of Heart Failure Patients Receiving Pulmonary Artery Catheters without Randomization

    Science.gov (United States)

    Allen, Larry A.; Rogers, Joseph G.; Warnica, J. Wayne; DiSalvo, Thomas G.; Tasissa, Gudaye; Binanay, Cynthia; O’Connor, Christopher M.; Califf, Robert M.; Leier, Carl V.; Shah, Monica R.; Stevenson, Lynne W.

    2008-01-01

    Background In ESCAPE, there was no difference in days alive and out of the hospital for patients with decompensated heart failure (HF) randomly assigned to therapy guided by pulmonary artery catheter (PAC) plus clinical assessment versus clinical assessment alone. The external validity of these findings is debated. Methods and Results ESCAPE sites enrolled 439 patients receiving PAC without randomization in a prospective registry. Baseline characteristics, pertinent trial exclusion criteria, reasons for PAC use, hemodynamics, and complications were collected. Survival was determined from the National Death Index and the Alberta Registry. On average, registry patients had lower blood pressure, worse renal function, less neurohormonal antagonist therapy, and higher use of intravenous inotropes as compared with trial patients. Although clinical assessment anticipated less volume overload and greater hypoperfusion among the registry population, measured filling pressures were similarly elevated in the registry and trial, while measured perfusion was slightly higher among registry patients. Registry patients had longer hospitalization (13 vs. 6 days, p <0.001) and higher 6-month mortality (34% vs. 20%, p < 0.001) than trial patients. Conclusions The decision to use PAC without randomization identified a population with higher disease severity and risk of mortality. This prospective registry highlights the complex context of patient selection for randomized trials. PMID:18926438

  11. Efficacy of aliskiren supplementation for heart failure : A meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Luo, Y; Chen, Q

    2018-02-22

    Aliskiren might be beneficial for heart failure. However, the results of various studies are controversial. We conducted a systematic review and meta-analysis to explore the efficacy of aliskiren supplementation for heart failure. PubMed, Embase, Web of Science, EBSCO, and the Cochrane Library databases were systematically searched. Randomized controlled trials (RCTs) assessing the efficacy of aliskiren for heart failure were included. Two investigators independently searched for articles, extracted data, and assessed the quality of included studies. The meta-analysis was performed using the random-effect model. Five RCTs comprising 1973 patients were included in the meta-analysis. Compared with control interventions in heart failure, aliskiren supplementation was found to significantly reduce NT-proBNP levels (standardized mean difference [SMD] = -0.12; 95% CI = -0.21 to -0.03 pg/ml; p = 0.008) and plasma renin activity (SMD = -0.66; 95% CI = -0.89 to -0.44 ng/ml.h; p < 0.00001) while increasing plasma renin concentration (SMD = 0.52; 95% CI = 0.30-0.75 ng/l; p < 0.00001); however, it demonstrated no significant influence on BNP levels (SMD = -0.08; 95% CI = -0.31-0.15 pg/ml; p = 0.49), mortality (RR = 0.97; 95% CI = 0.79-1.20; p = 0.79), aldosterone levels (SMD = -0.09; 95% CI = -0.32-0.14 pmol/l; p = 0.44), adverse events (RR = 3.03; 95% CI = 0.18-49.51; p = 0.44), and serious adverse events (RR = 1.34; 95% CI = 0.54-3.33; p = 0.53). Aliskiren supplementation was found to significantly decrease NT-proBNP levels and plasma renin activity and to improve plasma renin concentration in the setting of heart failure.

  12. Dual chamber pacing with optimal AV delay in congestive heart failure: a randomized study.

    Science.gov (United States)

    Capucci, A; Romano, S; Puglisi, A; Santini, M; Pagani, M; Cazzin, R; Zanuttini, D; Mangiameli, S; Moracchini, P V; Neri, R; De Ciuceis, P; Circo, A; Cavaglià, S; De Seta, F

    1999-07-01

    A prospective randomized trial was set up to evaluate contractile parameters and quality of life in patients with congestive heart failure. We describe the results from 38 patients in sinus rhythm and with chronic heart failure due to congestive cardiomyopathy, prospectively randomized to optimal medical therapy (Group 1, 19 patients) or optimal medical therapy plus dual chamber pacemaker programmed to optimal AV delay (Group 2, 19 patients). At a 6 month follow-up, 7/19 patients in Group 1 had died compared with 5/19 patients in Group 2. During follow-up, there were few significant changes in evaluated parameters except for mitral regurgitation time, which was prolonged in Group 1 and shortened in Group 2. The systolic left ventricular diameter shortened significantly only in Group 2. An energy and activity questionnaire showed that the effect of DDD pacing in the latter patient population was beneficial. From these results we may conclude that at the 6 month follow-up DDD pacing with echo-optimized AV interval programming can improve quality of life without affecting survival.

  13. Prospective randomized study for optimal insulin therapy in type 2 diabetic patients with secondary failure

    Directory of Open Access Journals (Sweden)

    Tojo Katsuyoshi

    2008-05-01

    Full Text Available Abstract Background The large clinical trials proved that Basal-Bolus (BB insulin therapy was effective in the prevention of diabetic complications and their progression. However, BB therapy needs multiple insulin injections per a day. In this regard, a biphasic insulin analogue needs only twice-daily injections, and is able to correct postprandial hyperglycemia. Therefore it may achieve the blood glucose control as same as that of BB therapy and prevent the diabetic complications including macroangiopathy. Methods In PROBE (Prospective, Randomized, Open, Blinded-Endpoint design, forty-two type 2 diabetic patients (male: 73.8%, median(inter quartile range age: 64.5(56.8~71.0years with secondary failure of sulfonylurea (SU were randomly assigned to BB therapy with a thrice-daily insulin aspart and once-daily basal insulin (BB group or to conventional therapy with a twice-daily biphasic insulin analogue (30 Mix group, and were followed up for 6 months to compare changes in HbA1c, daily glycemic profile, intima-media thickness (IMT of carotid artery, adiponectin levels, amounts of insulin used, and QOL between the two groups. Results After 6 months, HbA1c was significantly reduced in both groups compared to baseline (30 Mix; 9.3(8.1~11.3 → 7.4(6.9~8.7%, p Conclusion Both BB and 30 mix group produced comparable reductions in HbA1c in type 2 diabetic patients with secondary failure. There was no significant change in IMT as an indicator of early atherosclerotic changes between the two groups. The basal-bolus insulin therapy may not be necessarily needed if the type 2 diabetic patients have become secondary failure. Trial registration Current Controlled Trials number, NCT00348231

  14. Renal denervation in heart failure with preserved ejection fraction (RDT-PEF): a randomized controlled trial.

    Science.gov (United States)

    Patel, Hitesh C; Rosen, Stuart D; Hayward, Carl; Vassiliou, Vassilios; Smith, Gillian C; Wage, Ricardo R; Bailey, James; Rajani, Ronak; Lindsay, Alistair C; Pennell, Dudley J; Underwood, S Richard; Prasad, Sanjay K; Mohiaddin, Raad; Gibbs, J Simon R; Lyon, Alexander R; Di Mario, Carlo

    2016-06-01

    Heart failure with preserved ejection fraction (HFpEF) is associated with increased sympathetic nervous system (SNS) tone. Attenuating the SNS with renal denervation (RDT) might be helpful and there are no data currently in humans with HFpEF. In this single-centre, randomized, open-controlled study we included 25 patients with HFpEF [preserved left ventricular (LV) ejection fraction, left atrial (LA) dilatation or LV hypertrophy and raised B-type natriuretic peptide (BNP) or echocardiographic assessment of filling pressures]. Patients were randomized (2:1) to RDT with the Symplicity™ catheter or continuing medical therapy. The primary success criterion was not met in that there were no differences between groups at 12 months for Minnesota Living with Heart Failure Questionnaire score, peak oxygen uptake (VO2 ) on exercise, BNP, E/e', LA volume index or LV mass index. A greater proportion of patients improved at 3 months in the RDT group with respect to VO2 peak (56% vs. 13%, P = 0.025) and E/e' (31% vs. 13%, P = 0.04). Change in estimated glomerular filtration rate was comparable between groups. Two patients required plain balloon angioplasty during the RDT procedure to treat renal artery wall oedema. This study was terminated early because of difficulties in recruitment and was underpowered to detect whether RD improved the endpoints of quality of life, exercise function, biomarkers, and left heart remodelling. The procedure was safe in patients with HFpEF, although two patients did require intraprocedure renal artery dilatation. © 2016 The Authors European Journal of Heart Failure © 2016 European Society of Cardiology.

  15. A randomized trial of heart failure disease management in skilled nursing facilities (SNF Connect): Lessons learned.

    Science.gov (United States)

    Daddato, Andrea; Wald, Heidi L; Horney, Carolyn; Fairclough, Diane L; Leister, Erin C; Coors, Marilyn; Capell, Warren H; Boxer, Rebecca S

    2017-06-01

    Conducting clinical trials in skilled nursing facilities is particularly challenging. This manuscript describes facility and patient recruitment challenges and solutions for clinical research in skilled nursing facilities. Lessons learned from the SNF Connect Trial, a randomized trial of a heart failure disease management versus usual care for patients with heart failure receiving post-acute care in skilled nursing facilities, are discussed. Description of the trial design and barriers to facility and patient recruitment along with regulatory issues are presented. The recruitment of Denver-metro skilled nursing facilities was facilitated by key stakeholders of the skilled nursing facilities community. However, there were still a number of barriers to facility recruitment including leadership turnover, varying policies regarding research, fear of litigation and of an increased workload. Engagement of facilities was facilitated by their strong interest in reducing hospital readmissions, marketing potential to hospitals, and heart failure management education for their staff. Recruitment of patients proved difficult and there were few facilitators. Identified patient recruitment challenges included patients being unaware of their heart failure diagnosis, patients overwhelmed with their illness and care, and frequently there was no available proxy for cognitively impaired patients. Flexibility in changing the recruitment approach and targeting skilled nursing facilities with higher rates of admissions helped to overcome some barriers. Recruitment of skilled nursing facilities and patients in skilled nursing facilities for clinical trials is challenging. Strategies to attract both facilities and patients are warranted. These include aligning study goals with facility incentives and flexible recruitment protocols to work with patients in "transition crisis."

  16. Cost -Benefit Analysis of a Single-Unit System with Preventive Maintenance and Weibull Distribution for Failure and Repair Activities

    Directory of Open Access Journals (Sweden)

    Kumar Ashish

    2014-12-01

    Full Text Available This paper deals with a reliability model developed for a single-unit system which goes for preventive maintenance after a pre-specific time ‘t’ up to which no failure occurs. There is a single server who takes some time to arrive at the system for doing repair activities. The unit does not work as new after repair at complete failure and so called the degraded unit. The degraded unit is replaced by new one after its failure with some replacement time. The failure time, preventive maintenance time, replacement time and repair time of the unit are taken as Weibull distributed with common shape parameter and different scale parameters. The switching devices are perfect. The system is observed at suitable regenerative epochs to obtain various measures of system effectiveness of interest to system designers and operation managers.

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

    Science.gov (United States)

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

    2013-08-13

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

  18. Chronic heart failure modifies respiratory mechanics in rats: a randomized controlled trial.

    Science.gov (United States)

    Pacheco, Deise M; Silveira, Viviane D; Thomaz, Alex; Nunes, Ramiro B; Elsner, Viviane R; Dal Lago, Pedro

    2016-01-01

    To analyze respiratory mechanics and hemodynamic alterations in an experimental model of chronic heart failure (CHF) following myocardial infarction. Twenty-seven male adult Wistar rats were randomized to CHF group (n=12) or Sham group (n=15). Ten weeks after coronary ligation or sham surgery, the animals were anesthetized and submitted to respiratory mechanics and hemodynamic measurements. Pulmonary edema as well as cardiac remodeling were measured. The CHF rats showed pulmonary edema 26% higher than the Sham group. The respiratory system compliance (Crs) and the total lung capacity (TLC) were lower (40% and 27%, respectively) in the CHF rats when compared to the Sham group (Prespiratory mechanics, which may be associated with alterations in cardiopulmonary interactions.

  19. Approximations to the Probability of Failure in Random Vibration by Integral Equation Methods

    DEFF Research Database (Denmark)

    Nielsen, Søren R.K.; Sørensen, John Dalsgaard

    Close approximations to the first passage probability of failure in random vibration can be obtained by integral equation methods. A simple relation exists between the first passage probability density function and the distribution function for the time interval spent below a barrier before...... outcrossing. An integral equation for the probability density function of the time interval is formulated, and adequate approximations for the kernel are suggested. The kernel approximation results in approximate solutions for the probability density function of the time interval, and hence for the first...... passage probability density. The results of the theory agree well with simulation results for narrow banded processes dominated by a single frequency, as well as for bimodal processes with 2 dominating frequencies in the structural response....

  20. Palliative Care in Heart Failure: The PAL-HF Randomized, Controlled Clinical Trial.

    Science.gov (United States)

    Rogers, Joseph G; Patel, Chetan B; Mentz, Robert J; Granger, Bradi B; Steinhauser, Karen E; Fiuzat, Mona; Adams, Patricia A; Speck, Adam; Johnson, Kimberly S; Krishnamoorthy, Arun; Yang, Hongqiu; Anstrom, Kevin J; Dodson, Gwen C; Taylor, Donald H; Kirchner, Jerry L; Mark, Daniel B; O'Connor, Christopher M; Tulsky, James A

    2017-07-18

    Advanced heart failure (HF) is characterized by high morbidity and mortality. Conventional therapy may not sufficiently reduce patient suffering and maximize quality of life. The authors investigated whether an interdisciplinary palliative care intervention in addition to evidence-based HF care improves certain outcomes. The authors randomized 150 patients with advanced HF between August 15, 2012, and June 25, 2015, to usual care (UC) (n = 75) or UC plus a palliative care intervention (UC + PAL) (n = 75) at a single center. Primary endpoints were 2 quality-of-life measurements, the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary and the Functional Assessment of Chronic Illness Therapy-Palliative Care scale (FACIT-Pal), assessed at 6 months. Secondary endpoints included assessments of depression and anxiety (measured via the Hospital Anxiety and Depression Scale [HADS]), spiritual well-being (measured via the FACIT-Spiritual Well-Being scale [FACIT-Sp]), hospitalizations, and mortality. Patients randomized to UC + PAL versus UC alone had clinically significant incremental improvement in KCCQ and FACIT-Pal scores from randomization to 6 months (KCCQ difference = 9.49 points, 95% confidence interval [CI]: 0.94 to 18.05, p = 0.030; FACIT-Pal difference = 11.77 points, 95% CI: 0.84 to 22.71, p = 0.035). Depression improved in UC + PAL patients (HADS-depression difference = -1.94 points; p = 0.020) versus UC-alone patients, with similar findings for anxiety (HADS-anxiety difference = -1.83 points; p = 0.048). Spiritual well-being was improved in UC + PAL versus UC-alone patients (FACIT-Sp difference = 3.98 points; p = 0.027). Randomization to UC + PAL did not affect rehospitalization or mortality. An interdisciplinary palliative care intervention in advanced HF patients showed consistently greater benefits in quality of life, anxiety, depression, and spiritual well-being compared with UC alone. (Palliative Care in Heart

  1. TOPICAL MITOMYCIN C IN DACRIOCYSTORHINOSTOMY: ITS EFFECT ON FAILURE RATE OF PROCEDURE - A RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    A ZANDI

    2002-03-01

    Full Text Available Introduction. Epiphoria is one of the most common symptom among patients in ophtalmologic clinics. The most important cause of it, is tear drainage obstrution through the nasolacrimal duct. Dacryocystorhinostomy (DCR is the only critical treatment. The failure is important complication of DCR and in spite of varios methods, failure rate has remained 10 percent. Ingrowgh of fibrous tissue in osteotomy site and flaps has been known as cause of surgical failue. In this study we investigated the efficacy of mitomycin C as antiproliferative agent on DCR failure rate. Methods. In this clinical trial study, 110 patients with primary acquired nasolacrimal duct obstruction have been chosen between who that refer to the Farabi clinic, and were assigned randomly to either mitomycin or control group. Both group were operated with standard method and one surgen. In control group a cotton aid band and in interventional group a cottonoid band soaked with 0.2 mg/cc mitomycin C was applied to the osteotomy site. After 30 minutes was removed transnasaly. Groups have been examined at 1, 3 and 6 months intervals after surgery. Results. All patients in mitomycin group remained symptom free in all examination, and there was five pateints in control group who had recurrent epiphora. In the control group, 3 patients in 1 st month, 1 patient in 3rd months and 1 patient in 6th month were failed. In 3 patients of mitomycin group, severe post operative bleeding was seen. Discussion. The difference between these groups is (P < 0.01. Intraoperative mitomycin C may possibly improve success rates of DCR procedure with no serious complication.

  2. Dynamic critical behavior of failure and plastic deformation in the random fiber bundle model.

    Science.gov (United States)

    Pradhan, S; Bhattacharyya, P; Chakrabarti, B K

    2002-07-01

    The random fiber bundle (RFB) model, with the strength of the fibers distributed uniformly within a finite interval, is studied under the assumption of global load sharing among all unbroken fibers of the bundle. At any fixed value of the applied stress sigma (load per fiber initially present in the bundle), the fraction U(t)(sigma) of fibers that remain unbroken at successive time steps t is shown to follow simple recurrence relations. The model is found to have stable fixed point U*, filled (sigma) for applied stress in the range 0 point sigma = sigma(c), one finds strict power law decay (with time t) of the fraction of unbroken fibers U(t)(sigma(c)) (as t--> infinity). The avalanche size distribution for this mean-field dynamics of failure at sigma < sigma(c) has been studied. The elastic response of the RFB model has also been studied analytically for a specific probability distribution of fiber strengths, where the bundle shows plastic behavior before complete failure, following an initial linear response.

  3. Mediterranean diet and risk of heart failure: results from the PREDIMED randomized controlled trial.

    Science.gov (United States)

    Papadaki, Angeliki; Martínez-González, Miguel Ángel; Alonso-Gómez, Angel; Rekondo, Javier; Salas-Salvadó, Jordi; Corella, Dolores; Ros, Emilio; Fitó, Montse; Estruch, Ramon; Lapetra, José; García-Rodriguez, Antonio; Fiol, Miquel; Serra-Majem, Lluís; Pintó, Xavier; Ruiz-Canela, Miguel; Bulló, Monica; Serra-Mir, Mercè; Sorlí, Jose V; Arós, Fernando

    2017-09-01

    The aim of this study was to evaluate the effect of the Mediterranean diet (MedDiet) on the incidence of heart failure (HF), a pre-specified secondary outcome in the PREDIMED (PREvención con DIeta MEDiterránea) primary nutrition-intervention prevention trial. Participants at high risk of cardiovascular disease were randomly assigned to one of three diets: MedDiet supplemented with extra-virgin olive oil (EVOO), MedDiet supplemented with nuts, or a low-fat control diet. Incident HF was ascertained by a Committee for Adjudication of events blinded to group allocation. Among 7403 participants without prevalent HF followed for a median of 4.8 years, we observed 29 new HF cases in the MedDiet with EVOO group, 33 in the MedDiet with nuts group, and 32 in the control group. No significant association with HF incidence was found for the MedDiet with EVOO and MedDiet with nuts, compared with the control group [hazard ratio (HR) 0.68; 95% confidence interval (CI) 0.41-1.13, and HR 0.92; 95% CI 0.56-1.49, respectively]. In this sample of adults at high cardiovascular risk, the MedDiet did not result in lower HF incidence. However, this pre-specified secondary analysis may have been underpowered to provide valid conclusions. Further randomized controlled trials with HF as a primary outcome are needed to better assess the effect of the MedDiet on HF risk. ISRCTN35739639. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

  4. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial.

    Science.gov (United States)

    Seto, Emily; Leonard, Kevin J; Cafazzo, Joseph A; Barnsley, Jan; Masino, Caterina; Ross, Heather J

    2012-02-16

    Previous trials of telemonitoring for heart failure management have reported inconsistent results, largely due to diverse intervention and study designs. Mobile phones are becoming ubiquitous and economical, but the feasibility and efficacy of a mobile phone-based telemonitoring system have not been determined. The objective of this trial was to investigate the effects of a mobile phone-based telemonitoring system on heart failure management and outcomes. One hundred patients were recruited from a heart function clinic and randomized into telemonitoring and control groups. The telemonitoring group (N = 50) took daily weight and blood pressure readings and weekly single-lead ECGs, and answered daily symptom questions on a mobile phone over 6 months. Readings were automatically transmitted wirelessly to the mobile phone and then to data servers. Instructions were sent to the patients' mobile phones and alerts to a cardiologist's mobile phone as required. Baseline questionnaires were completed and returned by 94 patients, and 84 patients returned post-study questionnaires. About 70% of telemonitoring patients completed at least 80% of their possible daily readings. The change in quality of life from baseline to post-study, as measured with the Minnesota Living with Heart Failure Questionnaire, was significantly greater for the telemonitoring group compared to the control group (P = .05). A between-group analysis also found greater post-study self-care maintenance (measured with the Self-Care of Heart Failure Index) for the telemonitoring group (P = .03). Brain natriuretic peptide (BNP) levels, self-care management, and left ventricular ejection fraction (LVEF) improved significantly for both groups from baseline to post-study, but did not show a between-group difference. However, a subgroup within-group analysis using the data from the 63 patients who had attended the heart function clinic for more than 6 months revealed the telemonitoring group had significant

  5. Standardized Rehabilitation and Hospital Length of Stay Among Patients With Acute Respiratory Failure: A Randomized Clinical Trial.

    Science.gov (United States)

    Morris, Peter E; Berry, Michael J; Files, D Clark; Thompson, J Clifton; Hauser, Jordan; Flores, Lori; Dhar, Sanjay; Chmelo, Elizabeth; Lovato, James; Case, L Douglas; Bakhru, Rita N; Sarwal, Aarti; Parry, Selina M; Campbell, Pamela; Mote, Arthur; Winkelman, Chris; Hite, Robert D; Nicklas, Barbara; Chatterjee, Arjun; Young, Michael P

    2016-06-28

    Physical rehabilitation in the intensive care unit (ICU) may improve the outcomes of patients with acute respiratory failure. To compare standardized rehabilitation therapy (SRT) to usual ICU care in acute respiratory failure. Single-center, randomized clinical trial at Wake Forest Baptist Medical Center, North Carolina. Adult patients (mean age, 58 years; women, 55%) admitted to the ICU with acute respiratory failure requiring mechanical ventilation were randomized to SRT (n=150) or usual care (n=150) from October 2009 through May 2014 with 6-month follow-up. Patients in the SRT group received daily therapy until hospital discharge, consisting of passive range of motion, physical therapy, and progressive resistance exercise. The usual care group received weekday physical therapy when ordered by the clinical team. For the SRT group, the median (interquartile range [IQR]) days of delivery of therapy were 8.0 (5.0-14.0) for passive range of motion, 5.0 (3.0-8.0) for physical therapy, and 3.0 (1.0-5.0) for progressive resistance exercise. The median days of delivery of physical therapy for the usual care group was 1.0 (IQR, 0.0-8.0). Both groups underwent assessor-blinded testing at ICU and hospital discharge and at 2, 4, and 6 months. The primary outcome was hospital length of stay (LOS). Secondary outcomes were ventilator days, ICU days, Short Physical Performance Battery (SPPB) score, 36-item Short-Form Health Surveys (SF-36) for physical and mental health and physical function scale score, Functional Performance Inventory (FPI) score, Mini-Mental State Examination (MMSE) score, and handgrip and handheld dynamometer strength. Among 300 randomized patients, the median hospital LOS was 10 days (IQR, 6 to 17) for the SRT group and 10 days (IQR, 7 to 16) for the usual care group (median difference, 0 [95% CI, -1.5 to 3], P = .41). There was no difference in duration of ventilation or ICU care. There was no effect at 6 months for handgrip (difference, 2.0 kg [95% CI

  6. Cholera gravis associated with acute renal failure in a traveler from Haiti to the United States.

    Science.gov (United States)

    Reyes-Corcho, Andrés; Pinsker, Richard W; Sarkar, Samir; Bagheri, Farshad; Patel, Mahendra C; Lam, Pablo; González, Argentina

    2012-09-01

    Cholera is a gastroenteric disease caused by epidemic or pandemic Vibrio cholerae which still is responsible for over 100,000 annual deaths worldwide. Since October 2010, Haiti experienced a cholera outbreak affecting more than 300,000 persons. Few imported cases related to the Haitian epidemic have been reported so far in the United States and Canada. We presented a patient who developed cholera gravis soon after arrival at New York City from Haiti. The patient needed admission to an Intensive Care Unit, for vigorous intravenous hydration, antibiotic therapy, and hemodialysis due to refractory oliguric renal failure. The patient was discharged the day 6 after admission and V. cholerae O1 was isolated from the stool culture. Cholera can be a life-threatening disease; early recognition based on travel history and clinical features is the corner stone for successful management. Copyright © 2012 Elsevier Ltd. All rights reserved.

  7. Flight test results of a vector-based failure detection and isolation algorithm for a redundant strapdown inertial measurement unit

    Science.gov (United States)

    Morrell, F. R.; Bailey, M. L.; Motyka, P. R.

    1988-01-01

    Flight test results of a vector-based fault-tolerant algorithm for a redundant strapdown inertial measurement unit are presented. Because the inertial sensors provide flight-critical information for flight control and navigation, failure detection and isolation is developed in terms of a multi-level structure. Threshold compensation techniques for gyros and accelerometers, developed to enhance the sensitivity of the failure detection process to low-level failures, are presented. Four flight tests, conducted in a commercial transport type environment, were used to determine the ability of the failure detection and isolation algorithm to detect failure signals, such a hard-over, null, or bias shifts. The algorithm provided timely detection and correct isolation of flight control- and low-level failures. The flight tests of the vector-based algorithm demonstrated its capability to provide false alarm free dual fail-operational performance for the skewed array of inertial sensors.

  8. A randomized trial of heart failure disease management in skilled nursing facilities: design and rationale.

    Science.gov (United States)

    Boxer, Rebecca S; Dolansky, Mary A; Bodnar, Christine A; Singer, Mendel E; Albert, Jeffery M; Gravenstein, Stefan

    2013-09-01

    Heart failure (HF) disease management can improve health outcomes for older community dwelling patients with heart failure. HF disease management has not been studied in skilled nursing facilities, a major site of transitional care for older adults. The objective of this trial is to investigate if a HF- disease management program (HF-DMP) in skilled nursing facilities (SNF)s will decrease all-cause rehospitalizations for the first 60 days post-SNF admission. The trial is a randomized cluster trial to be conducted in 12 for-profit SNF in the greater Cleveland area. The study population is inclusive of patients with HF regardless of ejection fraction but excludes those patients on dialysis and with a life expectancy of 6 months or less. The HF-DMP includes 7 elements considered standard of care for patients with HF documentation of left ventricular function, tracking of weight and symptoms, medication titration, discharge instructions, 7-day follow-up appointment post-SNF discharge, and patient education. The HF-DMP is conducted by a research nurse tasked with adhering to each element of the program and regularly audited to maintain fidelity of the program. Additional outcomes include health status, self-care management, and discharge destination. The SNF-Connect Trial is the first trial of its kind to assess if a HF-DMP will improve outcomes for patients in SNFs. This trial will provide evidence on the effectiveness of HF-DMP to improve outcomes for older frail HF patients undergoing postacute rehabilitation. Copyright © 2013 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2016-09-01

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

  10. Resistance profiles and adherence at primary virological failure in three different highly active antiretroviral therapy regimens: analysis of failure rates in a randomized study

    DEFF Research Database (Denmark)

    Røge, B T; Barfod, T S; Kirk, O

    2004-01-01

    copies/mL) among 293 patients randomized to two nucleoside reverse transcriptase inhibitors (NRTIs)+ritonavir+saquinavir (RS-arm) (n=115), two NRTIs+nevirapine+nelfinavir (NN-arm) (n=118), or abacavir+stavudine+didanosine (ASD-arm) (n=60) followed up for a median of 90 weeks. Data on adherence were...... patients not switched from randomized treatment, we found resistance in two of 12 patients in the RS-arm (M184 V only), four of six patients in the NN-arm [all four had non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations], and seven of 12 patients in the ASD-arm (NRTI mutations only). Two...... adherent patients on randomized treatment failed in the RS-arm, none in the NN-arm, and six in the ASD-arm. CONCLUSIONS: Primary virological failure was caused mainly by treatment interruption. No primary protease inhibitor (PI) mutations were found in patients failing on boosted saquinavir, whereas...

  11. Resistance profiles and adherence at primary virological failure in three different highly active antiretroviral therapy regimens: analysis of failure rates in a randomized study

    DEFF Research Database (Denmark)

    Roge, BT; Barfod, TS; Kirk, O

    2004-01-01

    patients not switched from randomized treatment, we found resistance in two of 12 patients in the RS-arm (M184 V only), four of six patients in the NN-arm [all four had non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations], and seven of 12 patients in the ASD-arm (NRTI mutations only). Two...... adherent patients on randomized treatment failed in the RS-arm, none in the NN-arm, and six in the ASD-arm. CONCLUSIONS: Primary virological failure was caused mainly by treatment interruption. No primary protease inhibitor (PI) mutations were found in patients failing on boosted saquinavir, whereas...... copies/mL) among 293 patients randomized to two nucleoside reverse transcriptase inhibitors (NRTIs)+ritonavir+saquinavir (RS-arm) (n=115), two NRTIs+nevirapine+nelfinavir (NN-arm) (n=118), or abacavir+stavudine+didanosine (ASD-arm) (n=60) followed up for a median of 90 weeks. Data on adherence were...

  12. Outcomes of a Telehealth Intervention for Homebound Older Adults with Heart or Chronic Respiratory Failure: A Randomized Controlled Trial

    Science.gov (United States)

    Gellis, Zvi D.; Kenaley, Bonnie; McGinty, Jean; Bardelli, Ellen; Davitt, Joan; Ten Have, Thomas

    2012-01-01

    Purpose: Telehealth care is emerging as a viable intervention model to treat complex chronic conditions, such as heart failure (HF) and chronic obstructive pulmonary disease (COPD), and to engage older adults in self-care disease management. Design and Methods: We report on a randomized controlled trial examining the impact of a multifaceted…

  13. OVULATION INDUCTION IN PREMATURE OVARIAN FAILURE - A PLACEBO-CONTROLLED RANDOMIZED TRIAL COMBINING PITUITARY SUPPRESSION WITH GONADOTROPIN STIMULATION

    NARCIS (Netherlands)

    VANKASTEREN, YM; HOEK, A; SCHOEMAKER, J

    Objectives: To determine the effect of pituitary suppression with a GnRH agonist (GnRH-a) on the success of ovulation induction with exogenous gonadotropins in patients with premature ovarian failure (POF). Design: Placebo-controlled, randomized, double-blind study. The data were analyzed with a

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

    Science.gov (United States)

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

    2017-09-01

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

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

    Science.gov (United States)

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

    2016-11-01

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

  16. Telemonitoring Adherence to Medications in Heart Failure Patients (TEAM-HF): A Pilot Randomized Clinical Trial.

    Science.gov (United States)

    Gallagher, Benjamin D; Moise, Nathalie; Haerizadeh, Mytra; Ye, Siqin; Medina, Vivian; Kronish, Ian M

    2017-04-01

    Medication nonadherence contributes to hospitalizations in recently discharged patients with heart failure (HF). We aimed to test the feasibility of telemonitoring medication adherence in patients with HF. We randomized 40 patients (1:1) hospitalized for HF to 30 days of loop diuretic adherence monitoring with telephonic support or to passive adherence monitoring alone. Eighty-three percent of eligible patients agreed to participate. The median age of patients was 64 years, 25% were female, and 45% were Hispanic. Overall, 67% of patients were nonadherent (percentage of days that the correct number of doses were taken patients, respectively, in adherence (median correct dosing adherence 82% vs 73%; P = .41) or in the proportion readmitted within 30 days (30% vs 20%; P = .72). Eighty-eight percent of patients rated the wireless electronic adherence device as somewhat or very easy to use, and 88% agreed to use it again. Adherence telemonitoring was acceptable to most patients with HF. Diuretic nonadherence was common even when patients knew they were being monitored. Future studies should assess whether adherence telemonitoring can improve adherence and reduce readmissions among patients with HF. Copyright © 2016 Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2013-12-01

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

  18. Concept and methodology for evaluating core damage frequency considering failure correlation at multi units and sites and its application

    Energy Technology Data Exchange (ETDEWEB)

    Ebisawa, K.; Teragaki, T.; Nomura, S. [Former Incorporated Administrative Agency, Japan Nuclear Safety Organization (Japan); Abe, H., E-mail: Hiroshi_abe@nsr.go.jp [Former Incorporated Administrative Agency, Japan Nuclear Safety Organization (Japan); Shigemori, M.; Shimomoto, M. [Mizuho Information & Research Institute, 2-3, Kanda-Nishikicho, Chiyoda-ku, Tokyo (Japan)

    2015-07-15

    Highlights: • We develop a method to evaluate CDF considering failure correlation at multi units. • We develop a procedure to evaluate correlation coefficient between multi components. • We evaluate CDF at two different BWR units using correlation coefficients. • We confirm the validity of method and correlation coefficient through the evaluation. - Abstract: The Tohoku earthquake (Mw9.0) occurred on March 11, 2011 and caused a large tsunami. The Fukushima Daiichi Nuclear Power Plant with six units were overwhelmed by the tsunami and core damage occurred. Authors proposed the concept and method for evaluating core damage frequency (CDF) considering failure correlation at the multi units and sites. Based on the above method, one of authors developed the procedure for evaluating the failure correlation coefficient and response correlation coefficient between the multi components under the strong seismic motion. These method and failure correlation coefficients were applied to two different BWR units and their CDF was evaluated by seismic probabilistic risk assessment technology. Through this quantitative evaluation, the validity of the method and failure correlation coefficient was confirmed.

  19. Free-flap failures and complications in an American oral and maxillofacial surgery unit.

    Science.gov (United States)

    Salama, A R; McClure, S A; Ord, R A; Pazoki, A E

    2009-10-01

    Free tissue transfer is a reliable surgical technique that enables primary reconstruction following ablative surgery. Widely practised in many European units, acceptance into mainstream oral and maxillofacial surgery in the USA has been slow. The authors reviewed free flap practice patterns and outcomes in a US oral and maxillofacial surgery training program with specific emphasis on failures and complications to illustrate obstacles encountered during the initial phase of practice implementation. The demographic and clinical data of 71 consecutive patients who underwent microvascular reconstruction over 3 years (2002-2005) were reviewed. The study group included 48 males and 23 females who underwent 72 free tissue transfer procedures. Fourteen patients required operative exploration in the perioperative period. Six patients were explored for clinically compromised flaps. Thrombotic events occurred in 4 patients; 1 flap was successfully salvaged. There were 4 flap failures and 9 complications related to the donor site. Two perioperative deaths occurred from non-flap-related complications. Prolonged hospital stay and ICU utilization was observed in patients with surgical complications. Complications in this study did not affect the overall success rates of free-flaps. Salvage rates from thrombotic events were unaffected despite rigid flap monitoring protocols.

  20. Effect of Educational Program on Quality of Life of Patients with Heart Failure: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Khajegodary

    2013-02-01

    Full Text Available Introduction: Heart failure is one of the most common cardiovascular diseases which decrease the quality of life. Most of the factors influencing the quality of life can be modified with educational interventions. Therefore, this study examined the impact of a continuous training program on quality of life of patients with heart failure. Methods: This randomized clinical trial study was conducted during May to August 2011. Forty four participants with heart failure referred to Shahid Madani's polyclinics of Tabriz were selected through convenient sampling method and were randomly allocated to two groups. The intervention group (n = 22 received ongoing training including one-to-one teaching, counseling sessions and phone calls over 3 months. The control group (n = 22 received routine care program. Data on quality of life was collected using the Minnesota Living with Heart Failure Questionnaire at baseline as well as three months later. Results: The statistical tests showed significant differences in the physical, emotional dimensions and total quality of life in intervention group. But in control group, no significant differences were obtained. There was not any significant association in demographic characteristics and quality of life. Conclusion: Ongoing training programs can be effective in improving quality of life of patients with heart failure. Hence applying ongoing educational program as a non-pharmacological intervention can help to improve the quality of life of these patients.

  1. Low-Intensity Adjusted-Dose Warfarin for the Prevention of Hemodialysis Catheter Failure: A Randomized, Controlled Trial

    Science.gov (United States)

    Wilkieson, Trevor J.; Ingram, Alistair J.; Crowther, Mark A.; Soroka, Steven D.; Nagai, Ryuta; Jindal, Kailash K.

    2011-01-01

    Summary Background and objectives To determine whether warfarin prolongs the time to first mechanical-catheter failure. Design, setting, participants, & measurements This was a multicenter parallel-group randomized controlled trial with blinding of participants, trial staff, clinical staff, outcome assessors, and data analysts. Randomization was in a 1:1 ratio in blocks of four and was concealed by use of fax to a central pharmacy. Hemodialysis patients with newly-placed catheters received low-intensity monitored-dose warfarin, target international normalized ratio (INR) 1.5 to 1.9, or placebo, adjusted according to schedule of sham INR results. The primary outcome was time to first mechanical-catheter failure (inability to establish a circuit or blood flow less than 200 ml/min). Results We randomized 174 patients: 87 to warfarin and 87 to placebo. Warfarin was associated with a hazard ratio (HR) of 0.90 (P = 0.60; 95% confidence interval [CI], 0.57, 1.38) for time to first mechanical-catheter failure. Secondary analyses were: time to first guidewire exchange or catheter removal for mechanical failure (HR 0.78; 95% CI, 0.37, 1.6); time to catheter removal for mechanical failure (HR 0.67; 95% CI, 0.19, 2.37); and time to catheter removal for any cause (HR 0.89; 95% CI, 0.42, 1.81). Major bleeding occurred in 10 participants assigned to warfarin and seven on placebo (relative risk, 1.43; 95% CI, 0.57, 3.58; P = 0.61). Conclusions We found no evidence for efficacy of low-intensity, monitored-dose warfarin in preventing mechanical-catheter failure. PMID:21493739

  2. Liberal versus restricted fluid administration in heart failure patients. A systematic review and meta-analysis of randomized trials.

    Science.gov (United States)

    Li, Yang; Fu, Biao; Qian, Xiaoxian

    2015-01-01

    Restrictive fluid intake is recommended, in addition to standard pharmacologic treatment, in the treatment of patients with chronic heart failure (CHF). However, this recommendation lacks firm scientific evidence. We conducted a systematic review and meta-analysis of published randomized controlled trials to estimate the effect of fluid restriction in patients with heart failure.Randomized controlled trials were identified in the MEDLINE, EMBASE, and Cochrane databases using the search-keywords "fluid" and "heart failure". Outcomes were compared in heart failure patients with liberal and restricted fluid intake. Pooled risk ratios (RR) and weighted mean differences (WMD) were calculated using random effects models. Studies focusing on decompensated heart failure were analyzed separately.Six small randomized trials comparing liberal and restricted fluid intake met the inclusion criteria. Significant heterogeneity was noted in the reported studies for several outcomes. There were no differences in readmission rate (5 studies, pooled RR = 1.32; 95% CI: 0.86 to 2.01; P = 0.2), mortality rate (5 studies, pooled RR = 1.50; 95% CI: 0.87 to 2.57; P = 0.14), perceived thirst (4 studies, WMD = -0.7; 95% CI: -2.58 to 1.17; P = 0.46), duration of intravenous diuretics (2 studies, WMD = 0.17; 95% CI: -1.26 to 1.6; P = 0.81) or serum sodium levels (WMD = -1.61; 95% CI: -3.28 to 0.07; P = 0.06) between the liberal fluid intake group and the restrictive fluid intake group. Mean serum creatinine and BNP levels were significantly higher in the liberal fluid group: WMD 0.20 (95% CI: 0.15 to 0.25; P restrictive fluid intake. Larger studies are needed to confirm our findings.

  3. DUSTMS-D: DISPOSAL UNIT SOURCE TERM - MULTIPLE SPECIES - DISTRIBUTED FAILURE DATA INPUT GUIDE.

    Energy Technology Data Exchange (ETDEWEB)

    SULLIVAN, T.M.

    2006-01-01

    Performance assessment of a low-level waste (LLW) disposal facility begins with an estimation of the rate at which radionuclides migrate out of the facility (i.e., the source term). The focus of this work is to develop a methodology for calculating the source term. In general, the source term is influenced by the radionuclide inventory, the wasteforms and containers used to dispose of the inventory, and the physical processes that lead to release from the facility (fluid flow, container degradation, wasteform leaching, and radionuclide transport). Many of these physical processes are influenced by the design of the disposal facility (e.g., how the engineered barriers control infiltration of water). The complexity of the problem and the absence of appropriate data prevent development of an entirely mechanistic representation of radionuclide release from a disposal facility. Typically, a number of assumptions, based on knowledge of the disposal system, are used to simplify the problem. This has been done and the resulting models have been incorporated into the computer code DUST-MS (Disposal Unit Source Term-Multiple Species). The DUST-MS computer code is designed to model water flow, container degradation, release of contaminants from the wasteform to the contacting solution and transport through the subsurface media. Water flow through the facility over time is modeled using tabular input. Container degradation models include three types of failure rates: (a) instantaneous (all containers in a control volume fail at once), (b) uniformly distributed failures (containers fail at a linear rate between a specified starting and ending time), and (c) gaussian failure rates (containers fail at a rate determined by a mean failure time, standard deviation and gaussian distribution). Wasteform release models include four release mechanisms: (a) rinse with partitioning (inventory is released instantly upon container failure subject to equilibrium partitioning (sorption) with

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

    Science.gov (United States)

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

    2016-05-15

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

  5. Chronic heart failure modifies respiratory mechanics in rats: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Deise M. Pacheco

    2016-01-01

    Full Text Available ABSTRACT Objective To analyze respiratory mechanics and hemodynamic alterations in an experimental model of chronic heart failure (CHF following myocardial infarction. Method Twenty-seven male adult Wistar rats were randomized to CHF group (n=12 or Sham group (n=15. Ten weeks after coronary ligation or sham surgery, the animals were anesthetized and submitted to respiratory mechanics and hemodynamic measurements. Pulmonary edema as well as cardiac remodeling were measured. Results The CHF rats showed pulmonary edema 26% higher than the Sham group. The respiratory system compliance (Crs and the total lung capacity (TLC were lower (40% and 27%, respectively in the CHF rats when compared to the Sham group (P<0.01. There was also an increase in tissue resistance (Gti and elastance (Hti (28% and 45%, respectively in the CHF group. Moreover, left ventricular end-diastolic pressure was higher (32 mmHg vs 4 mmHg, P<0.01, while the left ventricular systolic pressure was lower (118 mmHg vs 130 mmHg, P=0.02 in the CHF group when compared to the control. Pearson’s correlation coefficient showed a negative association between pulmonary edema and Crs (r=–0.70, P=0.0001 and between pulmonary edema and TLC (r=–0.67,P=0.0034. Pulmonary edema correlated positively with Gti (r=0.68, P=0.001 and Hti (r=0.68, P=0.001. Finally, there was a strong positive relationship between pulmonary edema and heart weight (r=0.80, P=0.001. Conclusion Rats with CHF present important changes in hemodynamic and respiratory mechanics, which may be associated with alterations in cardiopulmonary interactions.

  6. [Pediatric non-invasive ventilation for acute respiratory failure in an Intermediate Care Unit].

    Science.gov (United States)

    Prado, Francisco; Godoy, María Adela; Godoy, Marcela; Boza, María Lina

    2005-05-01

    Pediatric noninvasive ventilation (NIV) is infrequently used for acute respiratory failure (ARF), BiPAP/CPAP applied through nasal mask can be attempted if strict selection rules are defined. To evaluate the outcome of NIV in a Pediatric Intermediate Care Unit. The medical records of 14 patients (age range 1 month-13 years, six female), who participated in a prospective protocol of NIV from January to October 2004, were reviewed. Oxygen therapy, delivered through a reservoir bag attached to the ventilation circuit, was used to maintain SaO2 over 90%. The main indication of BiPAP, in 80% of cases, was pulmonary restrictive disease. Indications of NIV were acute exacerbations in patients with chronic domiciliary NIV in three patients, hypoxic ARF in six and hypercapnic ARF in five. The diagnoses were pneumonia/atelectasis in seven patients, bilateral extensive pneumonia in three, RSV bronchiolitis in two, apnea in one, and asthma exacerbation in one. Only one patient required intubation for mechanical ventilation, all others improved. The procedures did not have complications. NIV lasted less than three days in 5 patients, 4 to 7 days in four patients and more than 7 days in five. One third of the patients required fiberoptic bronchoscopy for massive or lobar atelectasis and one third remained on domiciliary NIV program. NIV can be useful and safe in children with ARF admitted to a Pediatric Intermediate Care Unit. If strict inclusion protocols are followed, NIV might avoid mechanical ventilation.

  7. Outcomes of living versus deceased donor liver transplantation for acute liver failure in the United States.

    Science.gov (United States)

    Urrunaga, N H; Rachakonda, V P; Magder, L S; Mindikoglu, A L

    2014-01-01

    Clinical outcomes for living donor liver transplantation (LDLT) for acute liver failure (ALF) in the United States remain to be determined. To address this gap in knowledge, we examined post-liver transplantation outcomes of adults with ALF undergoing LDLT and deceased donor liver transplantation (DDLT) in the United States. We analyzed Organ and Procurement and Transplantation Network data for adults with ALF who were listed for liver transplantation as status 1 or 1A and who underwent LDLT (N = 21) or DDLT (N = 2316) between October 1987 and April 2011. We found no strong evidence that the survival probabilities for adults with ALF who underwent LDLT were inferior to those who underwent DDLT (P = .764). In adults with ALF who underwent LDLT, 1- and 5-year survival probabilities were both 71%; for DDLT these probabilities were 79% and 71%, respectively. In adults with ALF, 1- and 5-year liver graft survival probabilities, respectively, were 62% and 57% for LDLT, and 74% and 66% for DDLT. In these series of adults with ALF who were listed as status 1 or 1A, patient and graft survival rates for LDLT were similar to those for DDLT. Our findings suggest that if deceased donor livers are unavailable, LDLT is an acceptable option in experienced centers for adults with ALF. Copyright © 2014 Elsevier Inc. All rights reserved.

  8. Contraceptive Failure in the United States: Estimates from the 2006-2010 National Survey of Family Growth.

    Science.gov (United States)

    Sundaram, Aparna; Vaughan, Barbara; Kost, Kathryn; Bankole, Akinrinola; Finer, Lawrence; Singh, Susheela; Trussell, James

    2017-03-01

    Contraceptive failure rates measure a woman's probability of becoming pregnant while using a contraceptive. Information about these rates enables couples to make informed contraceptive choices. Failure rates were last estimated for 2002, and social and economic changes that have occurred since then necessitate a reestimation. To estimate failure rates for the most commonly used reversible methods in the United States, data from the 2006-2010 National Survey of Family Growth were used; some 15,728 contraceptive use intervals, contributed by 6,683 women, were analyzed. Data from the Guttmacher Institute's 2008 Abortion Patient Survey were used to adjust for abortion underreporting. Kaplan-Meier methods were used to estimate the associated single-decrement probability of failure by duration of use. Failure rates were compared with those from 1995 and 2002. Long-acting reversible contraceptives (the IUD and the implant) had the lowest failure rates of all methods (1%), while condoms and withdrawal carried the highest probabilities of failure (13% and 20%, respectively). However, the failure rate for the condom had declined significantly since 1995 (from 18%), as had the failure rate for all hormonal methods combined (from 8% to 6%). The failure rate for all reversible methods combined declined from 12% in 2002 to 10% in 2006-2010. These broad-based declines in failure rates reverse a long-term pattern of minimal change. Future research should explore what lies behind these trends, as well as possibilities for further improvements. © 2017 The Authors. Perspectives on Sexual and Reproductive Health published by Wiley Periodicals, Inc., on behalf of the Guttmacher Institute.

  9. Random Learning Units Using WIRIS Quizzes in Moodle

    Science.gov (United States)

    Mora, Angel; Merida, Enrique; Eixarch, Ramon

    2011-01-01

    Moodle is an extended learning management system for developing learning units, including mathematically-based subjects. A wide variety of material can be developed in Moodle which contains facilities for forums, questionnaires, lessons, tasks, wikis, glossaries and chats. Therefore, the Moodle platform provides a meeting point for those working…

  10. Effect of motor subtypes of delirium in the intensive care unit on fast-track failure after cardiac surgery.

    Science.gov (United States)

    Lee, Anna; Mu, Jing Lan; Chiu, Chun Hung; Gin, Tony; Underwood, Malcolm John; Joynt, Gavin Matthew

    2018-01-01

    The purpose of the study was to evaluate the association between motor subtypes of postoperative delirium in the intensive care unit and fast-track failure (a composite outcome of prolonged stay in the intensive care unit >48 hours, intensive care unit readmission, and 30-day mortality) after cardiac surgery. This was a secondary analysis of a prospective cohort study of 600 consecutive adults undergoing cardiac surgery at a university hospital in Hong Kong (July 2013 to July 2015). The motor subtypes of delirium were classified using the Richmond Agitation Sedation Score and Confusion Assessment Method intensive care unit assessments performed by trained bedside nurses. A generalized estimating equation was used to estimate a common relative risk of fast-track failure associated with motor subtypes. The incidences of hypoactive, hyperactive, and mixed motor subtypes were 4.3% (n = 26), 4.0% (n = 24), and 5.5% (n = 33), respectively. Fast-track failure occurred in 88 patients (14.7%). There was an association between delirium (all subtypes) and fast-track failure (P = .048); hyperactive delirium (relative risk, 1.95; 95% confidence interval, 0.96-3.94); hypoactive delirium (relative risk, 2.79; 95% confidence interval, 1.34-5.84); and mixed delirium (relative risk, 2.55; 95% confidence interval, 1.11-5.88). Hypoactive and mixed subtypes were associated with prolonged intensive care unit stay (both P = .001). Patients with pure hypoactive delirium had a similar risk of developing fast-track failure as other motor subtypes. Differentiation of motor subtypes is unlikely to be clinically important for prognostication of fast-track failure. However, because delirium is associated with poor outcomes, potential treatment strategies should address all subtypes equally. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

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

    Science.gov (United States)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2016-04-01

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

  13. Comparing administration of questionnaires via the internet to pen-and-paper in patients with heart failure: randomized controlled trial.

    Science.gov (United States)

    Wu, Robert C; Thorpe, Kevin; Ross, Heather; Micevski, Vaska; Marquez, Christine; Straus, Sharon E

    2009-02-06

    The use of the Internet to administer questionnaires has many potential advantages over the use of pen-and-paper administration. Yet it is important to validate Internet administration, as most questionnaires were initially developed and validated for pen-and-paper delivery. While some have been validated for use over the Internet, these questionnaires have predominately been used amongst the healthy general population. To date, information is lacking on the validity of questionnaires administered over the Internet in patients with chronic diseases such as heart failure. To determine the validity of three heart failure questionnaires administered over the Internet compared to pen-and-paper administration in patients with heart failure. We conducted a prospective randomized study using test-retest design comparing administration via the Internet to pen-and-paper administration for three heart failure questionnaires provided to patients recruited from a heart failure clinic in Toronto, Ontario, Canada: the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Self-Care Heart Failure Index (SCHFI). Of the 58 subjects enrolled, 34 completed all three questionnaires. The mean difference and confidence intervals for the summary scores of the KCCQ, MLHFQ, and SCHFI were 1.2 (CI -1.5 to 4.0, scale from 0 to 100), 4.0 (CI -1.98 to 10.04, scale from 0 to 105), and 10.1 (CI 1.18 to 19.07, scale from 66.7 to 300), respectively. Internet administration of the KCCQ appears to be equivalent to pen-and-paper administration. For the MLHFQ and SCHFI, we were unable to demonstrate equivalence. Further research is necessary to determine if the administration methods are equivalent for these instruments.

  14. Impact of delayed admission to intensive care units on patients with acute respiratory failure.

    Science.gov (United States)

    Hsieh, Chih-Chia; Lee, Ching-Chi; Hsu, Hsiang-Chin; Shih, Hsin-I; Lu, Chien-Hsin; Lin, Chih-Hao

    2017-01-01

    To determine the impact of delayed admission to the intensive care unit (ICU) on the clinical outcomes of patients with acute respiratory failure (ARF) in the emergency department (ED). This retrospective cohort study included non-traumatic adult patients with ARF and mechanical ventilation support in the ED of a tertiary university hospital in Taiwan from January 1, 2013, to August 31, 2013. Clinical data were extracted from chart records. The primary and secondary outcome measures were a prolonged hospital stay (>30 days) and the in-hospital crude mortality within 90 days, respectively. For 267 eligible patients (age range 21.0-98.0 years, mean 70.5±15.1 years; male 184, 68.9%), multivariate analysis was used to determine the significant adverse effects of an ED stay >1.0 hour on in-hospital crude mortality (odds ratio 2.19, PICU admission. In-hospital mortality significantly differed between patients with delayed ICU admission and those without delayed admission, as revealed by the Kaplan-Meier survival curves (PICU waiting time in the ED and the lengths of total hospital stay (r=0.152, PICU stay (r=0.148, PICU admission more than 1.0 hour is a strong determinant of mortality and is associated with a longer ICU stay and a longer need for ventilation. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Efficacy and Safety of Intravenous Urapidil for Older Hypertensive Patients with Acute Heart Failure: A Multicenter Randomized Controlled Trial.

    Science.gov (United States)

    Yang, Wei; Zhou, Yu Jie; Fu, Yan; Qin, Jian; Qin, Shu; Chen, Xiao Min; Guo, Jin Cheng; Wang, De Zhao; Zhan, Hong; Li, Jing; He, Jing Yu; Hua, Qi

    2017-01-01

    Urapidil is putatively effective for patients with hypertension and acute heart failure, although randomized controlled trials thereon are lacking. We investigated the efficacy and safety of intravenous urapidil relative to that of nitroglycerin in older patients with hypertension and heart failure in a randomized controlled trial. Patients (>60 y) with hypertension and heart failure were randomly assigned to receive intravenous urapidil (n=89) or nitroglycerin (n=91) for 7 days. Hemodynamic parameters, cardiac function, and safety outcomes were compared. Patients in the urapidil group had significantly lower mean systolic blood pressure (110.1±6.5 mm Hg) than those given nitroglycerin (126.4±8.1 mm Hg, p=0.022), without changes in heart rate. Urapidil was associated with improved cardiac function as reflected by lower N terminal-pro B type natriuretic peptide after 7 days (3311.4±546.1 ng/mL vs. 4879.1±325.7 ng/mL, p=0.027) and improved left ventricular ejection fraction (62.2±3.4% vs. 51.0±2.4%, p=0.032). Patients given urapidil had fewer associated adverse events, specifically headache (p=0.025) and tachycardia (p=0.004). The one-month rehospitalization and all-cause mortality rates were similar. Intravenous administration of urapidil, compared with nitroglycerin, was associated with better control of blood pressure and preserved cardiac function, as well as fewer adverse events, for elderly patients with hypertension and acute heart failure.

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

    OpenAIRE

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

    2016-01-01

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

  17. Risk factors for noninvasive ventilation failure in cancer patients in the intensive care unit: A retrospective cohort study.

    Science.gov (United States)

    Ferreira, Juliana Carvalho; Medeiros, Pedro; Rego, Francinni Mambrini; Caruso, Pedro

    2015-10-01

    The purpose of the study is to identify risk factors for noninvasive ventilation (NIV) failure in cancer patients with acute respiratory failure (ARF). A retrospective cohort study of adult patients admitted to intensive care unit (ICU), who received NIV for treatment of ARF, was conducted. We conducted a chart review to estimate the NIV failure rate and used logistic regression to identify risk factors. Of 2258 patients admitted to the ICU during the study period, 114 (5%) received NIV for ARF. Noninvasive ventilation was successful in 67 patients (59%) and failed for 47 (41%), of whom 36 were intubated and 11 were sedated for palliation. Factors associated with NIV failure were infection as the primary cause of ARF (odds ratio [OR], 4.90; 95% confidence interval [CI], 1.78-13.45; P = .002), male sex (OR, 2.58; 95% CI, 1.20-5.56; P = .015), and Simplified Acute Physiology Score 3 (OR, 1.04; 95% CI, 1.01-1.07; P = .006). Overall ICU mortality was 40%, and hospital mortality was 56%. Noninvasive ventilation failure was the only independent predictor of ICU mortality (OR, 16.6; 95% CI, 6.5-41.5; P ventilation can avert ARF for most ICU cancer patients with ARF. For patients with pulmonary infections and high severity scores, NIV should be used with caution. Identifying risk factors for NIV failure using a comprehensive diagnostic approach and monitoring of NIV are paramount to improve outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Six-month bracket failure rate with a flowable composite: A split-mouth randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Sindhuja Krishnan

    Full Text Available ABSTRACT INTRODUCTION: The use of flowable composites as an orthodontic bonding adhesive merits great attention because of their adequate bond strength, ease of clinical handling and reduced number of steps in bonding. OBJECTIVE: The aim of this Randomized Controlled Trial was to comparatively evaluate over a 6-month period the bond failure rate of a flowable composite (Heliosit Orthodontic, Ivoclar Vivadent AG, Schaan and a conventional orthodontic bonding adhesive (Transbond XT, 3M Unitek. METHODS: 53 consecutive patients (23 males and 30 females who fulfilled the inclusion and exclusion criteria were included in the study. A total of 891 brackets were analyzed, where 444 brackets were bonded using Heliosit Orthodontic and 447 brackets were bonded using Transbond XT. The survival rates of brackets were estimated with the Kaplan-Meier analysis. Bracket survival distributions for bonding adhesives, tooth location and dental arch were compared with the log-rank test. RESULTS: The failure rates of the Transbond XT and the Heliosit Orthodontic groups were 8.1% and 6% respectively. No significant differences in the survival rates were observed between them (p= 0.242. There was no statistically significant difference in the bond failure rates when the clinical performance of the maxillary versus the mandibular arches and the anterior versus the posterior segments were compared. CONCLUSIONS: Both systems had clinically acceptable bond failure rates and are adequate for orthodontic bonding needs.

  19. High-flow nasal cannula to prevent postextubation respiratory failure in high-risk non-hypercapnic patients: a randomized multicenter trial

    OpenAIRE

    Fernandez, Rafael; Subira, Carles; Frutos-Vivar, Fernando; Rialp, Gemma; Laborda, Cesar; Masclans, Joan Ramon; Lesmes, Amanda; Panadero, Luna; Hernandez, Gonzalo

    2017-01-01

    Background Extubation failure is associated with increased morbidity and mortality, but cannot be safely predicted or avoided. High-flow nasal cannula (HFNC) prevents postextubation respiratory failure in low-risk patients. Objective To demonstrate that HFNC reduces postextubation respiratory failure in high-risk non-hypercapnic patients compared with conventional oxygen. Methods Randomized, controlled multicenter trial in patients who passed a spontaneous breathing trial. We enrolled patient...

  20. The competing risks Cox model with auxiliary case covariates under weaker missing-at-random cause of failure.

    Science.gov (United States)

    Nevo, Daniel; Nishihara, Reiko; Ogino, Shuji; Wang, Molin

    2017-08-04

    In the analysis of time-to-event data with multiple causes using a competing risks Cox model, often the cause of failure is unknown for some of the cases. The probability of a missing cause is typically assumed to be independent of the cause given the time of the event and covariates measured before the event occurred. In practice, however, the underlying missing-at-random assumption does not necessarily hold. Motivated by colorectal cancer molecular pathological epidemiology analysis, we develop a method to conduct valid analysis when additional auxiliary variables are available for cases only. We consider a weaker missing-at-random assumption, with missing pattern depending on the observed quantities, which include the auxiliary covariates. We use an informative likelihood approach that will yield consistent estimates even when the underlying model for missing cause of failure is misspecified. The superiority of our method over naive methods in finite samples is demonstrated by simulation study results. We illustrate the use of our method in an analysis of colorectal cancer data from the Nurses' Health Study cohort, where, apparently, the traditional missing-at-random assumption fails to hold.

  1. Low-dose dopamine or low-dose nesiritide in acute heart failure with renal dysfunction: the ROSE acute heart failure randomized trial.

    Science.gov (United States)

    Chen, Horng H; Anstrom, Kevin J; Givertz, Michael M; Stevenson, Lynne W; Semigran, Marc J; Goldsmith, Steven R; Bart, Bradley A; Bull, David A; Stehlik, Josef; LeWinter, Martin M; Konstam, Marvin A; Huggins, Gordon S; Rouleau, Jean L; O'Meara, Eileen; Tang, W H Wilson; Starling, Randall C; Butler, Javed; Deswal, Anita; Felker, G Michael; O'Connor, Christopher M; Bonita, Raphael E; Margulies, Kenneth B; Cappola, Thomas P; Ofili, Elizabeth O; Mann, Douglas L; Dávila-Román, Víctor G; McNulty, Steven E; Borlaug, Barry A; Velazquez, Eric J; Lee, Kerry L; Shah, Monica R; Hernandez, Adrian F; Braunwald, Eugene; Redfield, Margaret M

    2013-12-18

    Small studies suggest that low-dose dopamine or low-dose nesiritide may enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction; however, neither strategy has been rigorously tested. To test the 2 independent hypotheses that, compared with placebo, addition of low-dose dopamine (2 μg/kg/min) or low-dose nesiritide (0.005 μg/kg/min without bolus) to diuretic therapy will enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction. Multicenter, double-blind, placebo-controlled clinical trial (Renal Optimization Strategies Evaluation [ROSE]) of 360 hospitalized patients with acute heart failure and renal dysfunction (estimated glomerular filtration rate of 15-60 mL/min/1.73 m2), randomized within 24 hours of admission. Enrollment occurred from September 2010 to March 2013 across 26 sites in North America. Participants were randomized in an open, 1:1 allocation ratio to the dopamine or nesiritide strategy. Within each strategy, participants were randomized in a double-blind, 2:1 ratio to active treatment or placebo. The dopamine (n = 122) and nesiritide (n = 119) groups were independently compared with the pooled placebo group (n = 119). Coprimary end points included 72-hour cumulative urine volume (decongestion end point) and the change in serum cystatin C from enrollment to 72 hours (renal function end point). Compared with placebo, low-dose dopamine had no significant effect on 72-hour cumulative urine volume (dopamine, 8524 mL; 95% CI, 7917-9131 vs placebo, 8296 mL; 95% CI, 7762-8830 ; difference, 229 mL; 95% CI, -714 to 1171 mL; P = .59) or on the change in cystatin C level (dopamine, 0.12 mg/L; 95% CI, 0.06-0.18 vs placebo, 0.11 mg/L; 95% CI, 0.06-0.16; difference, 0.01; 95% CI, -0.08 to 0.10; P = .72). Similarly, low-dose nesiritide had no significant effect on 72-hour cumulative urine volume (nesiritide, 8574 mL; 95% CI, 8014-9134 vs placebo

  2. Improving quality in a national intestinal failure unit: greater efficiency, improved access and reduced mortality.

    Science.gov (United States)

    Donaldson, Emma; Taylor, Michael; Abraham, Arun; Carlson, Gordon; Fletcher, Olivia; Varden, Jacqui; Teubner, Antje; Lal, Simon

    2015-07-01

    In 2010, there was a significant waiting list for admission to the intestinal failure unit (IFU) at the Salford Royal National Health Service (NHS) Foundation Trust. There had been a steady increase in the number of new patients referred to the IFU (89 patients 2005; 152 patients 2012) and the number of established patients requiring home parenteral nutrition (HPN) (135 patients 2005; 206 patients 2012) over the last decade. The impact of the resulting long waiting list for these complex patients was that patient deaths occurred in those awaiting admission. Continuous improvement methodology using the model for improvement and sequential plan-do-study-act cycles. Salford Royal NHS Foundation Trust IFU; a large NHS teaching hospital in Northwest England. The primary outcome measures were inpatient length of stay and time spent on waiting list prior to admission. A continuous improvement programme, supported by a project manager. There has been a 21% reduction in average length of stay on the IFU from 55.7 to 44.0 days and a reduction of 72% in the average length of time new patients spent on the waiting list for admission from 65.7 to 18.5 days. These changes were associated with concomitant reduction in 30-day readmission rate from 12.1% to 4.5% and early suggestions of reduced inpatient and waiting list mortality. It is possible to improve the efficiency of a large national service for complex patients using quality improvement methodology, resulting in improved access and reduced waiting list mortality.

  3. Failure of porous tantalum cervical interbody fusion devices: two-year results from a prospective, randomized, multicenter clinical study.

    Science.gov (United States)

    Kasliwal, Manish K; Baskin, David S; Traynelis, Vincent C

    2013-07-01

    The objective of this study was to assess the safety and efficacy of 2 novel cervical interbody fusion devices in the treatment of single-level degenerative cervical disk disease. Both devices were fabricated from a porous tantalum material. The high overall porosity of the devices was intended to facilitate anterior cervical interbody fusion. A prospective, randomized, 3-armed, clinical study was initiated with the following treatment groups: porous tantalum ring device packed with autograft, porous tantalum block device, and iliac crest autograft control. All the patients had single-level symptomatic cervical disk disease that had failed to respond to nonoperative therapy. Clinical and radiographic data were collected preoperatively, during surgery, before hospital discharge, and at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively. Six investigators participated in the clinical study at 6 investigational centers in the United States. Enrollment into the study was terminated after 39 patients had been accrued because of concerns over delayed fusion in the porous tantalum treatment groups. Of the 39 patients enrolled into the clinical study, 11 patients received the control treatment of iliac autograft fusion, 13 patients received the porous tantalum ring device with the center cavity packed with cancellous iliac crest autograft, and 15 patients received the porous tantalum block device. These patients were evaluated for 24 months as per the study protocol. There were no significant differences in any of the patient demographic variables collected. The mean operative times for both the ring and block device groups were slightly lower than the control treatment. Two patients in the block treatment group were determined to be nonunion between the 6- and 12-month time points and underwent additional surgery. Five patients with porous tantalum devices showed radiographic evidence of device fragmentation, and one patient in addition had radiographic

  4. Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit.

    Science.gov (United States)

    Bonfant, Giovanna; Belfanti, Pietro; Paternoster, Giuseppe; Gabrielli, Danila; Gaiter, Alberto M; Manes, Massimo; Molino, Andrea; Pellu, Valentina; Ponzetti, Clemente; Farina, Massimo; Nebiolo, Pier E

    2010-01-01

    The aim of clinical risk management is to improve the quality of care provided by health care organizations and to assure patients' safety. Failure mode and effect analysis (FMEA) is a tool employed for clinical risk reduction. We applied FMEA to chronic hemodialysis outpatients. FMEA steps: (i) process study: we recorded phases and activities. (ii) Hazard analysis: we listed activity-related failure modes and their effects; described control measures; assigned severity, occurrence and detection scores for each failure mode and calculated the risk priority numbers (RPNs) by multiplying the 3 scores. Total RPN is calculated by adding single failure mode RPN. (iii) Planning: we performed a RPNs prioritization on a priority matrix taking into account the 3 scores, and we analyzed failure modes causes, made recommendations and planned new control measures. (iv) Monitoring: after failure mode elimination or reduction, we compared the resulting RPN with the previous one. Our failure modes with the highest RPN came from communication and organization problems. Two tools have been created to ameliorate information flow: "dialysis agenda" software and nursing datasheets. We scheduled nephrological examinations, and we changed both medical and nursing organization. Total RPN value decreased from 892 to 815 (8.6%) after reorganization. Employing FMEA, we worked on a few critical activities, and we reduced patients' clinical risk. A priority matrix also takes into account the weight of the control measures: we believe this evaluation is quick, because of simple priority selection, and that it decreases action times.

  5. Stress ulcers and organ failure in intubated patients in surgical intensive care units.

    Science.gov (United States)

    Martin, L F; Booth, F V; Reines, H D; Deysach, L G; Kochman, R L; Erhardt, L J; Geis, G S

    1992-01-01

    This study compared prophylactic administration of either intragastric misoprostol (200 micrograms four times a day), a prostaglandin E1 analog, or bolus intravenous cimetidine (300 mg every 6 hours) in preventing stress lesions and stress bleeding in 127 adult postoperative patients who required mechanical ventilation and also had developed hypotension or sepsis. Both drug treatments were equally effective in preventing the development of diffuse gastritis (greater than 10 gastric hemorrhagic lesions) and in preventing upper gastrointestinal hemorrhage (UGIH). The combined data from both groups showed that for the 44 (35%) patients who died, death was significantly associated with the presence at study entry of renal failure (64% of 25 patients with renal failure died), hepatic failure (57% of 23 patients) or coagulopathy (62% of 29 patients) (p less than 0.02 for each), and with the number of organ system failures at study entry (48% of 69 patients with multiple organ system failures died, p less than 0.001). Death was also significantly associated with the presence of adult respiratory distress syndrome (ARDS) at study entry or the development of ARDS (63% of 24 patients with ARDS died, p less than 0.001), and the development of UGIH (5% of 93 patients with known bleeding outcome died, p less than 0.05). The number of stress lesions that developed was significantly associated with subsequent UGIH (p less than 0.001). Additional organ system failure developed during the study in 31% of the 127 patients, as did diffuse gastritis in 20% of 111 patients who had a follow-up endoscopy. These results demonstrate that postoperative patients who require mechanical ventilation and have hypotension or sepsis are at significant risk for the development of stress gastric lesions and multiple organ system failure even when prophylaxis for stress ulcers is provided. Furthermore, the presence of ARDS, renal failure, hepatic failure, coagulopathy, and UGIH are significantly

  6. Updated Results and Patterns of Failure in a Randomized Hypofractionation Trial for High-risk Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Arcangeli, Stefano [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Strigari, Lidia [Laboratory of Medical Physics and Expert Systems, Regina Elena National Cancer Institute, Rome (Italy); Gomellini, Sara; Saracino, Biancamaria; Petrongari, Maria Grazia; Pinnaro, Paola; Pinzi, Valentina [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Arcangeli, Giorgio, E-mail: arcangeli.gio@tiscali.it [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy)

    2012-12-01

    Purpose: To report long-term results and patterns of failure after conventional and hypofractionated radiation therapy in high-risk prostate cancer. Methods and Materials: This randomized phase III trial compared conventional fractionation (80 Gy at 2 Gy per fraction in 8 weeks) vs hypofractionation (62 Gy at 3.1 Gy per fraction in 5 weeks) in combination with 9-month androgen deprivation therapy in 168 patients with high-risk prostate cancer. Freedom from biochemical failure (FFBF), freedom from local failure (FFLF), and freedom from distant failure (FFDF) were analyzed. Results: In a median follow-up of 70 months, biochemical failure (BF) occurred in 35 of the 168 patients (21%) in the study. Among these 35 patients, local failure (LF) only was detected in 11 (31%), distant failure (DF) only in 16 (46%), and both LF and DF in 6 (17%). In 2 patients (6%) BF has not yet been clinically detected. The risk reduction by hypofractionation was significant in BF (10.3%) but not in LF and DF. We found that hypofractionation, with respect to conventional fractionation, determined only an insignificant increase in the actuarial FFBF but no difference in FFLF and FFDF, when considering the entire group of patients. However, an increase in the 5-year rates in all 3 endpoints-FFBF, FFLF, and FFDF-was observed in the subgroup of patients with a pretreatment prostate-specific antigen (iPSA) level of 20 ng/mL or less. On multivariate analysis, the type of fractionation, iPSA level, Gleason score of 4+3 or higher, and T stage of 2c or higher have been confirmed as independent prognostic factors for BF. High iPSA levels and Gleason score of 4+3 or higher were also significantly associated with an increased risk of DF, whereas T stage of 2c or higher was the only independent variable for LF. Conclusion: Our results confirm the isoeffectiveness of the 2 fractionation schedules used in this study, although a benefit in favor of hypofractionation cannot be excluded in the subgroup of

  7. Characteristics and in-hospital outcomes of patients with acute coronary syndromes and heart failure in the United Arab Emirates

    OpenAIRE

    Shehab, Abdulla; Al-Dabbagh, Bayan; Almahmeed, Wael; Bustani, Nazar; Nagelkerke, Nicolaas; Yusufali, Afzal; Wassef, Adel; Ibrahim, Mohamed; Brek, Azan Bin

    2012-01-01

    Abstract Background Heart failure (HF) is a serious complication of acute coronary syndromes (ACS), and is associated with high in-hospital mortality and poor long-term survival. The aims of this study were to describe the clinical characteristics, management and in-hospital outcomes of coronary syndrome (ACS) patients with HF in the United Arab Emirates. Findings The study was selected from the Gulf Registry of Acute Coronary Events (Gulf RACE), a prospective multi-national, multicenter regi...

  8. Laparoscopic ovarian diathermy after clomiphene failure in polycystic ovary syndrome: is it worthwhile? A randomized controlled trial.

    Science.gov (United States)

    Abu Hashim, Hatem; Foda, Osama; Ghayaty, Essam; Elawa, Ahmed

    2011-11-01

    Laparoscopic ovarian diathermy (LOD) represents a successful treatment option for women with clomiphene citrate (CC)-resistant polycystic ovary syndrome (PCOS). However, in case of CC failure PCOS, LOD offers several theoretical advantages. This study was conducted to compare the efficacy of LOD versus continuation of CC up to six further cycles in PCOS patients who failed to achieve pregnancy despite the previous successful CC induced ovulation. One hundred and seventy six infertile women with CC failure PCOS were selected in this randomized controlled trial. Patients (n = 87) underwent LOD with 6 months follow-up or received CC (n = 89) up to six cycles. Outcome measures were; clinical pregnancy rate, midcycle endometrial thickness, cycle length, miscarriage and live birth rates. The clinical pregnancy rate per patient and the cumulative pregnancy rate after six cycles were comparable in both groups (39 vs. 33.7% and 47 vs. 39.2%, respectively). Four twin pregnancies occurred in CC group and none in LOD group and the difference was statistically significant (p < 0.05). No significant difference in midcycle endometrial thickness was observed (8.8 ± 1.2 mm vs. 7.7 ± 1.1 mm). Improvement in cycle length, miscarriage and live birth rates were comparable in both groups. No cases of ovarian hyperstimulation syndrome occurred in either group. LOD during the 6 months follow-up period and CC for up to six further cycles are equally effective for achieving pregnancy in CC failure PCOS patients.

  9. The nutritional and metabolic support of heart failure in the intensive care unit.

    Science.gov (United States)

    Meltzer, Joseph S; Moitra, Vivek K

    2008-03-01

    Heart failure and cardiovascular disease are common causes of morbidity and mortality, contributing to many ICU admissions. Nutritional deficiencies have been associated with the development and worsening of chronic heart failure. Nutritional and metabolic support may improve outcomes in critically ill patients with heart failure. This review analyzes the role of this support in the acute care setting of the ICU. Cardiac cachexia is a complex pathophysiologic process. It is characterized by inflammation and anabolic-catabolic imbalance. Nutritional supplements containing selenium, vitamins and antioxidants may provide needed support to the failing myocardium. Evidence shows that there is utility in intensive insulin therapy in the critically ill. Finally, there is an emerging metabolic role for HMG-CoA reductase inhibition, or statin therapy, in the treatment of heart failure. Shifting the metabolic milieu from catabolic to anabolic, reducing free radicals, and quieting inflammation in addition to caloric supplementation may be the key to nutritional support in the heart failure patient. Tight glycemic control with intensive insulin therapy plays an expanding role in the care of the critically ill. Glucose-insulin-potassium therapy probably does not improve the condition of the patient with heart failure or acute myocardial infarction.

  10. Safety and efficacy of a fully closed-loop control ventilation (IntelliVent-ASV®) in sedated ICU patients with acute respiratory failure: a prospective randomized crossover study.

    Science.gov (United States)

    Arnal, Jean-Michel; Wysocki, Marc; Novotni, Dominik; Demory, Didier; Lopez, Ricardo; Donati, Stéphane; Granier, Isabelle; Corno, Gaëlle; Durand-Gasselin, Jacques

    2012-05-01

    IntelliVent-ASV(®) is a development of adaptive support ventilation (ASV) that automatically adjusts ventilation and oxygenation parameters. This study assessed the safety and efficacy of IntelliVent-ASV(®) in sedated intensive care unit (ICU) patients with acute respiratory failure. This prospective randomized crossover comparative study was conducted in a 12-bed ICU in a general hospital. Two periods of 2 h of ventilation in randomly applied ASV or IntelliVent-ASV(®) were compared in 50 sedated, passively ventilated patients. Tidal volume (V(T)), respiratory rate (RR), inspiratory pressure (P(INSP)), SpO(2) and E(T)CO(2) were continuously monitored and recorded breath by breath. Mean values over the 2-h period were calculated. Respiratory mechanics, plateau pressure (P(PLAT)) and blood gas exchanges were measured at the end of each period. There was no safety issue requiring premature interruption of IntelliVent-ASV(®). Minute ventilation (MV) and V(T) decreased from 7.6 (6.5-9.5) to 6.8 (6.0-8.0) L/min (p mechanics, pH, PaO(2) and PaO(2)/FiO(2) ratio were not different but PaCO(2) was slightly higher during IntelliVent-ASV(®) as compared to ASV. In passive patients with acute respiratory failure, IntelliVent-ASV(®) was safe and able to ventilate patients with less pressure, volume and FiO(2) while producing the same results in terms of oxygenation.

  11. The effects of a low-carbohydrate diet on oxygen saturation in heart failure patients: a randomized controlled clinical trial.

    Science.gov (United States)

    González-Islas, Dulce; Orea-Tejeda, Arturo; Castillo-Martínez, Lilia; Olvera-Mayorga, Gabriela; Rodríguez-García, Wendy Daniella; Santillán-Díaz, Cira; Keirnes-Davis, Candace; Vaquero-Barbosa, Nayeli

    2017-07-28

    Nutritional therapy in heart failure (HF) patients has been focused on fluid and sodium restriction with the aim of decreasing volume overload. However, these recommendations are not well established and sometimes controversial. To evaluate the effect of the consumption of a low-carbohydrate diet on oxygen saturation, body composition and clinical variables during two months of follow-up in chronic, stable heart failure patients. In a parallel group randomized controlled clinical trial, 88 ambulatory patients were randomly assigned to a low-carbohydrate diet group (40% carbohydrates, 20% protein and 40% fats [12% saturated, 18% monounsaturated and 10% polyunsaturated]) or a standard diet group (50% carbohydrates, 20% protein and 30% fats [10% saturated, 10% monounsaturated and 10% polyunsaturated]) for two months. Diets were normocaloric in both groups. At baseline and at two months of follow-up, the variables evaluated were: oxygen saturation, dietary intake, body composition and handgrip strength. After two months of follow-up, the low-carbohydrate diet group decreased the carbohydrate consumption and had improved oxygen saturation (93.0 ±4.4 to 94.6 ± 3.2, p = 0.02), while the standard diet group had decreased (94.90 ± 2.4 to 94.0 ± 2.9, p = 0.03). There were also differences between the groups at the end of the study (p = 0.04). No significant differences showed in handgrip strength in both groups, low-carbohydrate diet group (26.4 ± 8.3 to 27.2 ± 8.3 kg, p = 0.07) and standard diet group (25.4 ± 8.9 to 26.1 ± 9.5 kg, p = 0.14). Low-carbohydrate diet may improve the oxygen saturation in patients with chronic stable heart failure.

  12. Importance of RIFLE (Risk, Injury, Failure, Loss, and End-Stage Renal Failure) and AKIN (Acute Kidney Injury Network) in Hemodialysis Initiation and Intensive Care Unit Mortality.

    Science.gov (United States)

    Kara, Iskender; Yildirim, Fatma; Kayacan, Esra; Bilaloğlu, Burcu; Turkoglu, Melda; Aygencel, Gülbin

    2017-07-01

    Our study evaluated the differences between early and late hemodialysis (HD) initiation in the intensive care unit (ICU) according to the RIFLE (Risk, Injury, Failure, Loss, and End-stage renal failure) and AKIN (Acute Kidney Injury Network) classifications. On the assumption that early initiation of HD in critical patients according to the RIFLE and AKIN criteria decreases mortality, we retrospectively evaluated the medical records of 68 patients in our medical ICU and divided the patients into 2 groups: Those undergoing HD in no risk, risk, or injury stage according to RIFLE and in stage 0, I, or II according to AKIN were defined as early HD and those in failure stage according to RIFLE and in stage III according to AKIN were defined as late HD. The median age of the patients was 66.5 years, and 56.5% were male. HD was started in 25% and 39.7% of the patients in the early stage in the RIFLE and AKIN classification, respectively. According to RIFLE, HD was started in 61.5% of the surviving patients in the early stage; this rate was 16.4% in the deceased patients (P=0.001). HD was commenced in 69.2% of the surviving patients in AKIN stages 0, I, and II and in 32.7% of the deceased patients (P=0.026). Sepsis (61.5% vs. 94.5%; P=0.001) and mechanical ventilation (30.8% vs. 87.3%; P<0.001) during HD increased ICU mortality, whereas HD initiation in the early stages according to RIFLE decreased ICU mortality (61.5% vs. 16.4%; P=0.001). In conclusion, in critically ill patients, HD initiation in the early stages according to the RIFLE classification decreased our ICU mortality.

  13. Rescue Sedation With Intranasal Dexmedetomidine for Pediatric Ophthalmic Examination After Chloral Hydrate Failure: A Randomized, Controlled Trial.

    Science.gov (United States)

    Gan, Xiaoliang; Lin, Haotian; Chen, Jingjing; Lin, Zhuoling; Lin, Yiquan; Chen, Weirong

    2016-06-01

    It is a challenge to rescue ophthalmology examinations performed in children in the sedation room after initial chloral hydrate failure. Intranasal dexmedetomidine can be used in rescue sedation in children undergoing computed tomography. The present study aimed to assess the efficacy and tolerability of intranasal dexmedetomidine use in children undergoing ophthalmic examination after chloral hydrate failure. Sixty uncooperative pediatric patients with cataract (aged 5-36 months; weight, 7-15 kg) presented for follow-up ophthalmic examination. Patients who experienced chloral hydrate failure were randomized to 1 of 2 groups to receive intranasal dexmedetomidine 1 or 2 μg/kg for rescue sedation. Each group contained 30 patients. The primary outcome was the rate of a successful ophthalmic examination. Secondary outcomes included sedation onset time, recovery time, duration of examination, discharge time, and adverse events, including percentage of heart rate reduction, respiratory depression, vomiting, and postsedative agitation. A successful ophthalmic examination was achieved in 93.3% (28/30) of patients in the 2-μg/kg dose group and in 66.7% (20/30) of patients in the 1-μg/kg dose group (P = 0.021). The onset time, recovery time, and discharge time did not significantly differ between the 2 groups. None of the patients required clinical intervention due to heart rate reduction, and none of the patients in either group experienced vomiting, respiratory depression, or agitation after the administration of dexmedetomidine. In children undergoing ophthalmic examination, intranasal dexmedetomidine can be administered in the sedation room for rescue sedation after chloral hydrate failure, with the 2-μg/kg dose being more efficacious than the 1-μg/kg dose, as measured by success rate. ClinicalTrials.gov identifier: NCT02077712. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

  14. Acute Right Ventricle Failure in the Intensive Care Unit: Assessment and Management.

    Science.gov (United States)

    Hrymak, Carmen; Strumpher, Johann; Jacobsohn, Eric

    2017-01-01

    Caring for the critically ill patient with acute right ventricle (RV) failure is a diagnostic and management challenge. A thorough understanding of normal RV anatomy and physiology is essential to manage RV failure. Despite the fact that the RV is essentially a volume chamber that ejects into a low-pressure system, the left ventricle contributes significantly to RV function through maintenance of the transseptal gradient (TSG). Preserving systemic mean arterial pressure maintains the TSG and RV perfusion. Various pathological states cause acute RV failure by decreasing the TSG and RV perfusion and/or increasing pulmonary vascular resistance. Early diagnosis prevents rapid progression of RV failure due to the "double hit phenomenon," which is acute intra-abdominal multiple organ system failure as a result of a reduced blood pressure and elevated central venous pressure. Management includes hemodynamic support and reversal of the precipitating cause through optimizing RV rate and rhythm, determining ideal RV filling pressure, reducing RV afterload through nonpharmacologic and pharmacological means, and selecting the appropriate RV inotrope or mechanical support. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  15. Dealing with Design Failures in Randomized Field Experiments: Analytic Issues Regarding the Evaluation of Treatment Effects.

    Science.gov (United States)

    Gartin, Patrick R.

    1995-01-01

    Asserts that several analytical issues in randomized field experiments conducted by criminal justice scholars must be addressed more systematically. Notes that issues related to statistical power and desired sample size remain unresolved. Reviews related literature from the field of medicine to provide insights regarding the dilemmas created by…

  16. Effect of enalapril on the progression of chronic renal failure. A randomized controlled trial

    DEFF Research Database (Denmark)

    Kamper, A L; Strandgaard, S; Leyssac, P P

    1992-01-01

    In order to study the influence of angiotensin converting enzyme (ACE) inhibition on the progression of chronic nephropathy, 70 patients with a median glomerular filtration rate (GFR) of 15 (range, 6 to 54) mL/min/1.73 m2 were randomized in an open study to basic treatment with enalapril or conve...

  17. Numerical modelling of failure of cement concrete using a unit cell ...

    Indian Academy of Sciences (India)

    In this paper, a unit cell based approach is followed, where a unit cell consisting of one aggregate surrounded by mortar matrix is used for numerical simulation of mechanical response of cement concrete. Unit cell approach is a simple mathematical approximation that helps us to simplify the simulation of mechanical ...

  18. Numerical modelling of failure of cement concrete using a unit cell ...

    Indian Academy of Sciences (India)

    MS received 8 March 2010; revised 5 October 2010; accepted 26 October 2010. Abstract. In this paper, a unit cell based approach is followed, where a unit cell con- sisting of one aggregate surrounded by mortar matrix is used for numerical simulation of mechanical response of cement concrete. Unit cell approach is a ...

  19. Receiving early mobility during an intensive care unit admission is a predictor of improved outcomes in acute respiratory failure.

    Science.gov (United States)

    Morris, Peter E; Griffin, Leah; Berry, Michael; Thompson, Clif; Hite, R Duncan; Winkelman, Chris; Hopkins, Ramona O; Ross, Amelia; Dixon, Luz; Leach, Susan; Haponik, Edward

    2011-05-01

    Hospitals are under pressure to provide care that not only shortens hospital length of stay but also reduces subsequent hospital admissions. Hospital readmissions have received increased attention in outcome reporting. The authors identified survivors of acute respiratory failure who then required subsequent hospitalization. A cohort of acute respiratory failure survivors, who participated in an early intensive care unit (ICU) mobility program, was assessed to determine if variables from the index hospitalization predict hospital readmission or death, within 12 months of hospital discharge. Hospital database and responses to letters mailed to 280 acute respiratory failure survivors. Univariate predictor variables shown to be associated with hospital readmission or death (P early ICU mobility therapy [OR, 1.77 (95%CI, 1.04-3.01)] predicted readmission or death in the first year postindex hospitalization. Tracheostomy, female gender, higher Charlson Comorbidity Index and lack of early ICU mobility were associated with readmissions or death during the first year. Although the mechanisms of increased hospital readmission are unclear, these findings may provide further support for early ICU mobility for patients with acute respiratory failure.

  20. Cardiac contractility modulation in heart failure patients: Randomized comparison of signal delivery through one vs. two ventricular leads.

    Science.gov (United States)

    Röger, Susanne; Said, Samir; Kloppe, Axel; Lawo, Thomas; Emig, Ulf; Rousso, Benny; Gutterman, David; Borggrefe, Martin; Kuschyk, Jürgen

    2017-01-01

    Cardiac contractility modulation (CCM) is an electrical stimulation treatment for symptomatic heart failure (HF) patients. The procedure involves implantation of two ventricular leads for delivery of CCM impulses. The purpose of this study is to compare the efficacy and safety of CCM when the signal is delivered through one vs. two ventricular leads. This prospective blinded randomized trial enrolled 48 patients. Eligible subjects had symptoms despite optimal HF medications, left ventricular ejection fraction leads, and were randomized to CCM active through both or just one ventricular lead; 25 patients were randomized to receive signal delivery through two leads (Group A) and 23 patients to signal delivery through one lead (Group B). The study compared the mean changes from baseline to 6 months follow-up in peakVO2, New York Heart Association (NYHA) classification, and quality of life (by MLWHFQ). Following 6 months, similar and significant (pleads. These results support the potential use of a single ventricular lead for delivery of CCM. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  1. Earplugs and eye masks vs routine care prevent sleep impairment in post-anaesthesia care unit: a randomized study.

    Science.gov (United States)

    Le Guen, M; Nicolas-Robin, A; Lebard, C; Arnulf, I; Langeron, O

    2014-01-01

    Post-anaesthesia care units (PACUs) with 24/7 activity and consequently artificial light and noise may disturb the sleep of patients who require prolonged medical supervision. After one postoperative night, we compared sleep quality in patients with and without noise (earplug) and light (eye mask) protection. After ethical board approval, 46 patients without any neurological or respiratory failure undergoing major non-cardiac surgery were prospectively included. They were randomized to sleep with or without protective devices during the first postoperative night in the PACU. Sleep quality was simultaneously measured by sleep-quality scales (Spiegel score and Medical Outcomes Study Sleep), nurses' assessment, and through a wrist actigraph (Actiwatch). Secondary outcomes such as pain control and nocturnal activity were recorded. Comparisons between groups were made by Student's t-test or non-parametric test for repeated measures as appropriate (SPSS 10.0). A P-value Earplugs and eye masks applied in the PACU during the first postoperative night significantly preserve sleep quality. Such non-invasive and cheap devices may be generalized in the PACU or in intensive care units.

  2. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition–Heart Failure (BEAT-HF) Randomized Clinical Trial

    Science.gov (United States)

    Ong, Michael K.; Romano, Patrick S.; Edgington, Sarah; Aronow, Harriet U.; Auerbach, Andrew D.; Black, Jeanne T.; De Marco, Teresa; Escarce, Jose J.; Evangelista, Lorraine S.; Hanna, Barbara; Ganiats, Theodore G.; Greenberg, Barry H.; Greenfield, Sheldon; Kaplan, Sherrie H.; Kimchi, Asher; Liu, Honghu; Lombardo, Dawn; Mangione, Carol M.; Sadeghi, Bahman; Sadeghi, Banafsheh; Sarrafzadeh, Majid; Tong, Kathleen; Fonarow, Gregg C.

    2016-01-01

    Importance It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure (HF) after hospitalization. Objective To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF. Design, Setting, and Participants We randomized 1437 patients hospitalized for HF between October 12, 2011, and September 30, 2013, to the intervention arm (715 patients) or to the usual care arm (722 patients) of the Better Effectiveness After Transition–Heart Failure (BEAT-HF) study and observed them for 180 days. The dates of our study analysis were March 30, 2014, to October 1, 2015. The setting was 6 academic medical centers in California. Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF. Interventions The intervention combined health coaching telephone calls and telemonitoring. Telemonitoring used electronic equipment that collected daily information about blood pressure, heart rate, symptoms, and weight. Centralized registered nurses conducted telemonitoring reviews, protocolized actions, and telephone calls. Main outcomes and measures The primary outcome was readmission for any cause within 180 days after discharge. Secondary outcomes were all-cause readmission within 30 days, all-cause mortality at 30 and 180 days, and quality of life at 30 and 180 days. Results Among 1437 participants, the median age was 73 years. Overall, 46.2% (664 of 1437) were female, and 22.0% (316 of 1437) were African American. The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge, which occurred in 50.8% (363 of 715) and 49.2% (355 of 722) of patients, respectively (adjusted hazard ratio, 1.03; 95% CI, 0.88-1.20; P = .74). In secondary analyses, there were no significant differences in 30-day

  3. Application of failure mode and effect analysis in managing catheter-related blood stream infection in intensive care unit.

    Science.gov (United States)

    Li, Xixi; He, Mei; Wang, Haiyan

    2017-12-01

    In this study, failure mode and effect analysis (FMEA), a proactive tool, was applied to reduce errors associated with the process which begins with assessment of patient and ends with treatment of complications. The aim of this study is to assess whether FMEA implementation will significantly reduce the incidence of catheter-related bloodstream infections (CRBSIs) in intensive care unit.The FMEA team was constructed. A team of 15 medical staff from different departments were recruited and trained. Their main responsibility was to analyze and score all possible processes of central venous catheterization failures. Failure modes with risk priority number (RPN) ≥100 (top 10 RPN scores) were deemed as high-priority-risks, meaning that they needed immediate corrective action. After modifications were put, the resulting RPN was compared with the previous one. A centralized nursing care system was designed.A total of 25 failure modes were identified. High-priority risks were "Unqualified medical device sterilization" (RPN, 337), "leukopenia, very low immunity" (RPN, 222), and "Poor hand hygiene Basic diseases" (RPN, 160). The corrective measures that we took allowed a decrease in the RPNs, especially for the high-priority risks. The maximum reduction was approximately 80%, as observed for the failure mode "Not creating the maximal barrier for patient." The averaged incidence of CRBSIs was reduced from 5.19% to 1.45%, with 3 months of 0 infection rate.The FMEA can effectively reduce incidence of CRBSIs, improve the security of central venous catheterization technology, decrease overall medical expenses, and improve nursing quality. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

  4. Hemodialysis membrane with a high-molecular-weight cutoff and cytokine levels in sepsis complicated by acute renal failure: a phase 1 randomized trial.

    Science.gov (United States)

    Haase, Michael; Bellomo, Rinaldo; Baldwin, Ian; Haase-Fielitz, Anja; Fealy, Nigel; Davenport, Piers; Morgera, Stanislao; Goehl, Hermann; Storr, Markus; Boyce, Neil; Neumayer, Hans-Hellmut

    2007-08-01

    Sepsis is the leading cause of acute renal failure. Intermittent hemodialysis (IHD) is a common treatment for patients with acute renal failure. However, standard hemodialysis membranes achieve only little diffusive removal of circulating cytokines. Modified membranes may enable both successful IHD treatment and simultaneous diffusive cytokine removal. Double-blind, crossover, randomized, controlled, phase 1 trial. Tertiary intensive care unit. 10 septic patients with acute renal failure according to RIFLE class F. Each patient was treated with 4 hours of high-cutoff (HCO)-IHD and 4 hours of high-flux (HF)-IHD. We chose relative change in plasma interleukin 6 (IL-6) concentrations from baseline to 4 hours as the primary outcome for effective cytokine removal. We measured plasma and effluent concentrations of cytokines (IL-6, IL-8, IL-10, and IL-18) and albumin. Median age was 53 years (25(th) to 75(th) percentiles, 43 to 71 years). Both treatments achieved equal control of uremia. Four hours of HCO-IHD accomplished a greater decrease in plasma IL-6 levels (-30.3%) than 4 hours of HF-IHD (1.1%; P = 0.05). HCO-IHD, but not HF-IHD, achieved substantial diffusive clearance of several cytokines (IL-6, 14.1 mL/min; IL-8, 75.2 mL/min; and IL-10, 25.5 mL/min). Such clearance also was associated with greater relative decreases in plasma IL-8 and IL-10 levels in favor of HCO-IHD (P = 0.02, P = 0.04). We found significantly greater relative changes from prefilter to postfilter plasma IL-6, IL-8, and IL-10 values in favor of HCO-IHD (P = 0.02, P = 0.01, P effluent was 7.7 g (25(th) to 75(th) percentiles, 4.8 to 19.6) versus less than 1.0 g for HF-IHD (P septic patients with acute renal failure, HCO-IHD achieved simultaneous uremic control and diffusive cytokine clearances and a greater relative decrease in plasma cytokine concentrations than standard HF-IHD.

  5. Treatment of localized gingival recessions using gingival unit grafts: a randomized controlled clinical trial.

    Science.gov (United States)

    Kuru, Bahar; Yıldırım, Selin

    2013-01-01

    One of the success factors in periodontal plastic surgery is the synergistic relationship between involved tissues and vascular supply. Gingiva as a functional unit is unique with a specific vascular configuration and contains the supracrestal portion naturally created to survive over avascular root surfaces. The aim of this randomized controlled trial is to clinically evaluate the treatment of localized gingival recessions by using gingival unit grafts (palatal tissue involving marginal gingiva and papillae) compared with conventional palatal grafts. Seventeen patients with Class I to II recession defects on mandibular anterior teeth were included and randomly divided into two groups. Recessions were treated with gingival unit grafts in group 1 (n = 8) and with palatal grafts in group 2 (n = 9). Clinical parameters including vertical recession (VR), probing depth, keratinized tissue (KT), and attachment level were recorded at baseline and 8 months after surgery. Both treatments produced significant clinical improvements within the groups. Intergroup comparison revealed significantly higher VR reduction, attachment, and KT gain in group 1 than in group 2; mean percentages of the defect coverage were 91.62% ± 9.74% and 68.97% ± 13.67%, respectively (P <0.05). Healing of the gingival unit donor site was uneventful. Within its limits, this study demonstrates the possibility of treating buccal recessions with gingival unit grafts as an alternative technique using gingival donor graft of site-specific vascular configuration, with better defect coverage, clinical, and esthetic improvements compared with palatal grafts.

  6. Results of the Randomized Aldosterone Antagonism in Heart Failure with Preserved Ejection Fraction trial (RAAM-PEF).

    Science.gov (United States)

    Deswal, Anita; Richardson, Peter; Bozkurt, Biykem; Mann, Douglas L

    2011-08-01

    Cardiac fibrosis is a major determinant of myocardial stiffness, diastolic dysfunction, and heart failure (HF). By reducing cardiac fibrosis, aldosterone antagonists have the potential to be beneficial in heart failure with preserved ejection fraction (HFpEF). In a randomized, double-blind, placebo-controlled trial of 44 patients with HFpEF, we examined the effects of eplerenone, an aldosterone antagonist, on changes in 6-minute walk distance (primary end point), diastolic function, and biomarkers of collagen turnover (secondary end points). All patients had a history of hypertension, 61% were diabetic, and 52% had prior HF hospitalization. After 6 months of treatment, similar improvements in 6 minute walk distance were noted in the eplerenone and placebo groups (P = .91). However, compared with placebo, eplerenone was associated with a significant reduction in serum markers of collagen turnover (procollagen type I aminoterminal peptide, P = .009 and carboxy-terminal telopeptide of collagen type I, P = .026) and improvement in echocardiographic measures of diastolic function (E/E', P = .01). Although eplerenone was not associated with an improvement in exercise capacity compared to placebo, it was associated with significant reduction in markers of collagen turnover and improvement in diastolic function. Whether these favorable effects will translate into morbidity and mortality benefit in HFpEF remains to be determined. Published by Elsevier Inc.

  7. Positive predictive value and impact of misdiagnosis of a heart failure diagnosis in administrative registers among patients admitted to a University Hospital cardiac care unit

    DEFF Research Database (Denmark)

    Mard, Shan; Nielsen, Finn Erland

    2010-01-01

    To evaluate the positive predictive value (PPV) of a diagnosis of heart failure (HF) in the Danish National Registry of Patients (NRP) among patients admitted to a University Hospital cardiac care unit, and to evaluate the impact of misdiagnosing HF.......To evaluate the positive predictive value (PPV) of a diagnosis of heart failure (HF) in the Danish National Registry of Patients (NRP) among patients admitted to a University Hospital cardiac care unit, and to evaluate the impact of misdiagnosing HF....

  8. Failure detection and isolation analysis of a redundant strapdown inertial measurement unit

    Science.gov (United States)

    Motyka, P.; Landey, M.; Mckern, R.

    1981-01-01

    The objective of this study was to define and develop techniques for failure detection and isolation (FDI) algorithms for a dual fail/operational redundant strapdown inertial navigation system are defined and developed. The FDI techniques chosen include provisions for hard and soft failure detection in the context of flight control and navigation. Analyses were done to determine error detection and switching levels for the inertial navigation system, which is intended for a conventional takeoff or landing (CTOL) operating environment. In addition, investigations of false alarms and missed alarms were included for the FDI techniques developed, along with the analyses of filters to be used in conjunction with FDI processing. Two specific FDI algorithms were compared: the generalized likelihood test and the edge vector test. A deterministic digital computer simulation was used to compare and evaluate the algorithms and FDI systems.

  9. Failure or mutation: A random course after a loss of goals

    Directory of Open Access Journals (Sweden)

    Lucas Ruvira Palau

    2016-11-01

    Full Text Available It is known that the term "culture" is very polysemic. The concept to which it alludes, even with scarce centuries of existence, is very broad and encompasses a myriad of definitions and connotations, which have been treated by ethologists, anthropologists and educators in their different fields. But almost all of them underlie a vision of knowledge transmission, as well as progressivity and growth. Cultural development can be considered as an imperative of behavior for personal and social development. However, in recent times this imperative seems to be blurred in a looser sense of its meaning, where other spurious meanings fit, giving way to the articulation of discourses that are far from their original goal. Is culture a means to produce development? Or is development a means to produce culture? Should they be the cultural agents or social educators on whom responsibility for righting this drift influenced by the consumer markets? Should these, however, merely redistribute demands and offers? Within the framework of our economic system, perhaps the key to this mutation or failure of culture can be found in a growing practice of cultic activity as a ritual and idle phenomenon, which places greater emphasis on the economic benefit of its practice, leaving Aside their important role in the development and knowledge on different subjects. As an attitude, culture, rather than a laissez faire, should be a dialogue and not an acceptance and submission to a single thought imposed by the system.

  10. Predicting the velocity and azimuth of fragments generated by the range destruction or random failure of rocket casings and tankage

    Science.gov (United States)

    Eck, M.; Mukunda, M.

    The proliferation of space vehicle launch sites and the projected utilization of these facilities portends an increase in the number of on-pad, ascent, and on-orbit solid-rocket motor (SRM) casings and liquid-rocket tanks which will randomly fail or will fail from range destruct actions. Beyond the obvious safety implications, these failures may have serious resource implications for mission system and facility planners. SRM-casing failures and liquid-rocket tankage failures result in the generation of large, high velocity fragments which may be serious threats to the safety of launch support personnel if proper bunkers and exclusion areas are not provided. In addition, these fragments may be indirect threats to the general public's safety if they encounter hazardous spacecraft payloads which have not been designed to withstand shrapnel of this caliber. They may also become threats to other spacecraft if, by failing on-orbit, they add to the ever increasing space-junk collision cross-section. Most prior attempts to assess the velocity of fragments from failed SRM casings have simply assigned the available chamber impulse to available casing and fuel mass and solved the resulting momentum balance for velocity. This method may predict a fragment velocity which is high or low by a factor of two depending on the ratio of fuel to casing mass extant at the time of failure. Recognizing the limitations of existing methods, the authors devised an analytical approach which properly partitions the available impulse to each major system-mass component. This approach uses the Physics International developed PISCES code to couple the forces generated by an Eulerian modeled gas flow field to a Lagrangian modeled fuel and casing system. The details of a predictive analytical modeling process as well as the development of normalized relations for momentum partition as a function of SRM burn time and initial geometry are discussed in this paper. Methods for applying similar modeling

  11. Determinants of immediate failure of noninvasive mechanical ventilation outside the intensive care unit.

    Science.gov (United States)

    Briones Claudett, Killen H; Briones Claudett, Monica H; Esquinas, Antonio M; Grunauer Andrade, Michelle

    2017-01-01

    This study aimed to characterize which are the early determinants of immediate failure of the use of noninvasive mechanical ventilation (NIMV) outside the ICU. This prospective study included patients who were admitted to the Military Hospital in Guayaquil, Ecuador. Each variable was analyzed independently by using a multiple logistic regression model toward establishing an association with the event. A total of 249 cases of NIMV over a 10 year period of its application outside the ICU was included in the study. Fifty-five (22.10%) patients were transferred to the ICU, A multivariate analysis showed that the determinants of immediate NIMV failure outside the ICU were the following: age (OR: 1.12; P = 0.03); SBP (OR: 1.04; P = 0.001); HR (OR: 1.66; P < 0.0001); pCO₂ (OR: 1.16; P = 0.007); pO2 (OR: 1.35; P = 0.003); levels of IPAP (OR: 1.35; P < 0.0001); and the number of quadrants affected, as shown in a chest X-ray (OR: 1.40; P < 0.0001). The number of affected quadrants in a chest X-ray, tachyarrhythmia and hypoxemia may be useful in the initial decision in the use of NIMV outside the ICU. High values of IPAP, the persistence of elevated pCO₂, arterial hypotension, and age could be useful as a second screening associated with immediate NIMV failure outside the ICU.

  12. Use of home telemonitoring to support multidisciplinary care of heart failure patients in Finland: randomized controlled trial.

    Science.gov (United States)

    Vuorinen, Anna-Leena; Leppänen, Juha; Kaijanranta, Hannu; Kulju, Minna; Heliö, Tiina; van Gils, Mark; Lähteenmäki, Jaakko

    2014-12-11

    Heart failure (HF) patients suffer from frequent and repeated hospitalizations, causing a substantial economic burden on society. Hospitalizations can be reduced considerably by better compliance with self-care. Home telemonitoring has the potential to boost patients' compliance with self-care, although the results are still contradictory. A randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization. HF patients were eligible whose left ventricular ejection fraction was lower than 35%, NYHA functional class ≥2, and who needed regular follow-up. Patients in the telemonitoring group (n=47) measured their body weight, blood pressure, and pulse and answered symptom-related questions on a weekly basis, reporting their values to the heart failure nurse using a mobile phone app. The heart failure nurse followed the status of patients weekly and if necessary contacted the patient. The primary outcome was the number of HF-related hospital days. Control patients (n=47) received multidisciplinary treatment according to standard practices. Patients' clinical status, use of health care resources, adherence, and user experience from the patients' and the health care professionals' perspective were studied. Adherence, calculated as a proportion of weekly submitted self-measurements, was close to 90%. No difference was found in the number of HF-related hospital days (incidence rate ratio [IRR]=0.812, P=.351), which was the primary outcome. The intervention group used more health care resources: they paid an increased number of visits to the nurse (IRR=1.73, Ppatients (IRR=3.82, Ppatient-induced contacts). There were no statistically significant differences in patients' clinical health status or in their self-care behavior. The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the

  13. Meteorological Satellites (METSAT) and Earth Observing System (EOS) Advanced Microwave Sounding Unit-A (AMSU-A) Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL)

    Science.gov (United States)

    1996-01-01

    This Failure Modes and Effects Analysis (FMEA) is for the Advanced Microwave Sounding Unit-A (AMSU-A) instruments that are being designed and manufactured for the Meteorological Satellites Project (METSAT) and the Earth Observing System (EOS) integrated programs. The FMEA analyzes the design of the METSAT and EOS instruments as they currently exist. This FMEA is intended to identify METSAT and EOS failure modes and their effect on spacecraft-instrument and instrument-component interfaces. The prime objective of this FMEA is to identify potential catastrophic and critical failures so that susceptibility to the failures and their effects can be eliminated from the METSAT/EOS instruments.

  14. Cognitive Behavior Therapy for Depression and Self-Care in Heart Failure Patients: A Randomized Clinical Trial.

    Science.gov (United States)

    Freedland, Kenneth E; Carney, Robert M; Rich, Michael W; Steinmeyer, Brian C; Rubin, Eugene H

    2015-11-01

    Depression and inadequate self-care are common and interrelated problems that increase the risks of hospitalization and mortality in patients with heart failure (HF). To determine the efficacy of an integrative cognitive behavior therapy (CBT) intervention for depression and HF self-care. Randomized clinical trial with single-blind outcome assessments. Eligible patients were enrolled at Washington University Medical Center in St Louis between January 4, 2010, and June 28, 2013. The primary data analyses were conducted in February 2015. The participants were 158 outpatients in New York Heart Association Class I, II, and III heart failure with comorbid major depression. Cognitive behavior therapy delivered by experienced therapists plus usual care (UC), or UC alone. Usual care was enhanced in both groups with a structured HF education program delivered by a cardiac nurse. The primary outcome was severity of depression at 6 months as measured by the Beck Depression Inventory. The Self-Care of Heart Failure Index Confidence and Maintenance subscales were coprimary outcomes. Secondary outcomes included measures of anxiety, depression, physical functioning, fatigue, social roles and activities, and quality of life. Hospitalizations and deaths were exploratory outcomes. One hundred fifty-eight patients were randomized to UC (n = 79) or CBT (n = 79). Within each arm, 26 (33%) of the patients were taking an antidepressant at baseline. One hundred thirty-two (84%) of the participants completed the 6-month posttreatment assessments; 60 (76%) of the UC and 58 (73%) of the CBT participants completed every follow-up assessment (P = .88). Six-month depression scores were lower in the CBT than the UC arm on the Beck Depression Inventory (BDI-II) (12.8 [10.6] vs 17.3 [10.7]; P = .008). Remission rates differed on the BDI-II (46% vs 19%; number needed to treat [NNT] = 3.76; 95% CI, 3.62-3.90; P Beck Depression Inventory scores 6 months after randomization were lower in the CBT

  15. Failure Analysis Results and Corrective Actions Implemented for the Extravehicular Mobility Unit 3011 Water in the Helmet Mishap

    Science.gov (United States)

    Steele, John; Metselaar, Carol; Peyton, Barbara; Rector, Tony; Rossato, Robert; Macias, Brian; Weigel, Dana; Holder, Don

    2015-01-01

    Water entered the Extravehicular Mobility Unit (EMU) helmet during extravehicular activity (EVA) no. 23 aboard the International Space Station on July 16, 2013, resulting in the termination of the EVA approximately 1 hour after it began. It was estimated that 1.5 liters of water had migrated up the ventilation loop into the helmet, adversely impacting the astronaut's hearing, vision, and verbal communication. Subsequent on-board testing and ground-based test, tear-down, and evaluation of the affected EMU hardware components determined that the proximate cause of the mishap was blockage of all water separator drum holes with a mixture of silica and silicates. The blockages caused a failure of the water separator degassing function, which resulted in EMU cooling water spilling into the ventilation loop, migrating around the circulating fan, and ultimately pushing into the helmet. The root cause of the failure was determined to be ground-processing shortcomings of the Airlock Cooling Loop Recovery (ALCLR) Ion Filter Beds, which led to various levels of contaminants being introduced into the filters before they left the ground. Those contaminants were thereafter introduced into the EMU hardware on-orbit during ALCLR scrubbing operations. This paper summarizes the failure analysis results along with identified process, hardware, and operational corrective actions that were implemented as a result of findings from this investigation.

  16. Success/Failure Prediction of Noninvasive Mechanical Ventilation in Intensive Care Units. Using Multiclassifiers and Feature Selection Methods.

    Science.gov (United States)

    Martín-González, Félix; González-Robledo, Javier; Sánchez-Hernández, Fernando; Moreno-García, María N

    2016-05-17

    This paper addresses the problem of decision-making in relation to the administration of noninvasive mechanical ventilation (NIMV) in intensive care units. Data mining methods were employed to find out the factors influencing the success/failure of NIMV and to predict its results in future patients. These artificial intelligence-based methods have not been applied in this field in spite of the good results obtained in other medical areas. Feature selection methods provided the most influential variables in the success/failure of NIMV, such as NIMV hours, PaCO2 at the start, PaO2 / FiO2 ratio at the start, hematocrit at the start or PaO2 / FiO2 ratio after two hours. These methods were also used in the preprocessing step with the aim of improving the results of the classifiers. The algorithms provided the best results when the dataset used as input was the one containing the attributes selected with the CFS method. Data mining methods can be successfully applied to determine the most influential factors in the success/failure of NIMV and also to predict NIMV results in future patients. The results provided by classifiers can be improved by preprocessing the data with feature selection techniques.

  17. Failure analysis and performance evaluation of NASA inertial reference unit (DRIRU 2) after 50 months of orbital operation

    Science.gov (United States)

    Green, K. N.; Ritter, J. W.; Skinner, D.; Vanalstine, R. L.

    1985-01-01

    The first production DRIRU 2 (NASA standard high performance inertial reference unit) system was launched as a subsystem of the Modular Attitude Control System for the Solar Maximum Mission (SMM) spacecraft in February 1980. This hardware was retrieved during the repair of the SMM during Shuttle Flight 41-C in April 1984 and returned to Teledyne Systems Company (manufacturer) for investigation and performance measurements as directed by Goddard Space Flight Center. A failure of one of the three gyro channels occurred approximately 6.5 months after launch. The built in redundancy functioned properly, the DRIRU 2 continued to provide the required attitude control function without performance degradation. Subsequent failure of other attitude control subsystems made the SMM a candidate for the first demonstration of the shuttle in-orbit repair capabilty. The in-orbit DRIRU 2 II failure scenario and the results of the analyses/tests conducted after retrieval are discussed. Comparison of this data with similar data prior to launch demonstates the excellent stability of performance parameters achieveable with DRIRU 2.

  18. Collective consciousness and its pathologies: Understanding the failure of AIDS control and treatment in the United States

    Directory of Open Access Journals (Sweden)

    Fullilove Robert E

    2007-02-01

    Full Text Available Abstract We address themes of distributed cognition by extending recent formal developments in the theory of individual consciousness. While single minds appear biologically limited to one dynamic structure of linked cognitive submodules instantiating consciousness, organizations, by contrast, can support several, sometimes many, such constructs simultaneously, although these usually operate relatively slowly. System behavior remains, however, constrained not only by culture, but by a developmental path dependence generated by organizational history, in the context of market selection pressures. Such highly parallel multitasking – essentially an institutional collective consciousness – while capable of reducing inattentional blindness and the consequences of failures within individual workspaces, does not eliminate them, and introduces new characteristic malfunctions involving the distortion of information sent between workspaces and the possibility of pathological resilience – dysfunctional institutional lock-in. Consequently, organizations remain subject to canonical and idiosyncratic failures analogous to, but more complicated than, those afflicting individuals. Remediation is made difficult by the manner in which pathological externalities can write images of themselves onto both institutional function and corrective intervention. The perspective is applied to the failure of AIDS control and treatment in the United States.

  19. Failure mode and effects analysis of skin electronic brachytherapy using Esteya® unit

    Directory of Open Access Journals (Sweden)

    Blanca Ibanez-Rosello

    2016-12-01

    Full Text Available Purpose: Esteya® (Nucletron, an Elekta company, Elekta AB, Stockholm, Sweden is an electronic brachytherapy device used for skin cancer lesion treatment. In order to establish an adequate level of quality of treatment, a risk analysis of the Esteya treatment process has been done, following the methodology proposed by the TG-100 guidelines of the American Association of Physicists in Medicine (AAPM. Material and methods: A multidisciplinary team familiar with the treatment process was formed. This team developed a process map (PM outlining the stages, through which a patient passed when subjected to the Esteya treatment. They identified potential failure modes (FM and each individual FM was assessed for the severity (S, frequency of occurrence (O, and lack of detection (D. A list of existing quality management tools was developed and the FMs were consensually reevaluated. Finally, the FMs were ranked according to their risk priority number (RPN and their S. Results : 146 FMs were identified, 106 of which had RPN ≥ 50 and 30 had S ≥ 7. After introducing the quality management tools, only 21 FMs had RPN ≥ 50. The importance of ensuring contact between the applicator and the surface of the patient’s skin was emphasized, so the setup was reviewed by a second individual before each treatment session with periodic quality control to ensure stability of the applicator pressure. Some of the essential quality management tools are already being implemented in the installation are the simple templates for reproducible positioning of skin applicators, that help marking the treatment area and positioning of X-ray tube. Conclusions : New quality management tools have been established as a result of the application of the failure modes and effects analysis (FMEA treatment. However, periodic update of the FMEA process is necessary, since clinical experience has suggested occurring of further new possible potential failure modes.

  20. Instantaneous responses to high-frequency chest wall oscillation in patients with acute pneumonic respiratory failure receiving mechanical ventilation: A randomized controlled study.

    Science.gov (United States)

    Chuang, Ming-Lung; Chou, Yi-Ling; Lee, Chai-Yuan; Huang, Shih-Feng

    2017-03-01

    Endotracheal intubation and prolonged immobilization of patients receiving mechanical ventilation may reduce expectoration function. High-frequency chest wall oscillation (HFCWO) may ameliorate airway secretion movement; however, the instantaneous changes in patients' cardiopulmonary responses are unknown. Moreover, HFCWO may influence ventilator settings by the vigorous oscillation. The aim of this study was to investigate these issues. Seventy-three patients (52 men) aged 71.5 ± 13.4 years who were intubated with mechanical ventilation for pneumonic respiratory failure were recruited and randomly classified into 2 groups (HFCWO group, n = 36; and control group who received conventional chest physical therapy (CCPT, n = 37). HFCWO was applied with a fixed protocol, whereas CCPT was conducted using standard protocols. Both groups received sputum suction after the procedure. Changes in ventilator settings and the subjects' responses were measured at preset intervals and compared within groups and between groups. Oscillation did not affect the ventilator settings (all P > 0.05). The mean airway pressure, breathing frequency, and rapid shallow breathing index increased, and the tidal volume and SpO2 decreased (all P ventilation decreased (all P ventilator settings, whereas CCPT maintains a steadier condition. After sputum suction, HFCWO slightly improved Ppeak compared to CCPT, suggesting that the study extends the indications of HFCWO for these patients in intensive care unit. (ClinicalTrials.gov number NCT02758106, retrospectively registered.).

  1. Exercise training combined with electromyostimulation in the rehabilitation of patients with chronic heart failure: A randomized trial.

    Science.gov (United States)

    Soska, Vladimir; Dobsak, Petr; Pohanka, Michal; Spinarova, Lenka; Vitovec, Jiri; Krejci, Jan; Hude, Petr; Homolka, Pavel; Novakova, Marie; Eicher, Jean-Christophe; Wolf, Jean-Eric; Dusek, Ladislav; Siegelova, Jarmila

    2014-01-01

    Both aerobic training (AT) and electromyostimulation (EMS) of leg muscles improve exercise tolerance in patients suffering from chronic heart failure (CHF). It was speculated that combination of both methods might have an additive effect. This study was performed to evaluate the effects of a combination of AT and EMS in rehabilitation (RHB) of CHF patients. Patients (n=71; age 59 ± 10.2 yrs, NYHA II/III, EF 32 ± 7.1%) were randomized into 3 groups: a) group AT, b) group EMS, and c) group AT+EMS. AT protocol included standard activity on bicycle 3x a week at the level of individual anaerobic threshold. EMS (10 Hz, mode 20s "on"/20s "off") was applied to leg extensors for 2 h/day. Total time of given type of RHB was 12 weeks. Data analysis revealed statistically significant improvements of patients in all experimental groups (averaged difference after 12 weeks of exercise as related to initial value: ∆VO2peak: +12.9%, ∆VO2AT: +9.3%, ∆Wpeak: +22.7%). No statistically significant difference among experimental groups was found. Quality of life (Minnesota Living with Heart Failure - MLHF) global score was significantly improved in all 3 groups: AT (∆MLHF: -27.9%; P=0.001), AT+EMS (∆MLHF: -29.1%; P=0.002), and EMS (∆MLHF: -16.6%; P=0.008). MLHF score in EMS group showed the smallest time-related improvement compared to AT and AT+EMS groups, and this difference in improvement between the groups was statistically significant (P=0.021). No significant difference was found between the two types of exercise training.and nor did, their combination have any significant additional improvement.

  2. A randomized controlled trial to assess effectiveness of a nurse-led home-based heart failure management program

    Directory of Open Access Journals (Sweden)

    Mamata Rai

    2017-01-01

    Full Text Available Introduction: The burden of cardiovascular disease is increasing in India. It is a chronic condition, and poor management can increase the risk and frequency of acute episodes resulting in poor quality of life (QOL, frequent hospital admissions, and mortality. Disease management programs can improve medication adherence and patient's QOL. Objective: The aim of this study is to assess the effectiveness of nurse-led home-based heart failure management program (HOME-N. Materials and Methods: This randomized controlled trial was conducted among fifty outpatient heart failure (HF patients visiting a tertiary care hospital. The control group received usual routine care, whereas the experimental group received HOME-N, which included formal health teaching, a HF checklist (Hriday card, telemonitoring of vital parameters (blood pressure, heart rate, and weight weekly through a mobile application named as “Dhadkan” and telephonic follow-up for 3 months. Kansas City Cardiomyopathy Questionnaire (KCCQ and adherence to refills and medications scale were used to assess QOL and drug adherence, respectively, in the study patients. The outcome measures were the QOL, drug compliance, hospitalization, and mortality rate. Results: At baseline, the demographic and morbidity profile, and QOL and drug compliance scores of both groups were comparable. After intervention, the QOL domain score of KCCQ as well as drug compliance improved significantly both within the experimental group (P = 0.001, P = 0.001 and as compared to control group (P = 0.001, P = 0.004, respectively. Conclusion: The HOME-N was significantly effective in improving QOL and drug compliance in HF patients.

  3. A randomized trial of noninvasive positive end expiratory pressure in patients with acquired immune deficiency syndrome and hypoxemic respiratory failure.

    Science.gov (United States)

    Anjos, Carlos Frederico Dantas; Schettino, Guilherme Paula Pinto; Park, Marcelo; Souza, Vladimir Silva; Scalabrini Neto, Augusto

    2012-02-01

    Acquired immunodeficiency syndrome (AIDS) is a pandemic disease commonly associated with respiratory infections, hypoxemia, and death. Noninvasive PEEP has been shown to improve hypoxemia. In this study, we evaluated the physiologic effects of different levels of noninvasive PEEP in hypoxemic AIDS patients. Thirty AIDS patients with acute hypoxemic respiratory failure received a randomized sequence of noninvasive PEEP (5, 10, or 15 cm H(2)O) for 20 min. PEEP was provided through a facial mask with pressure-support ventilation (PSV) of 5 cm H(2)O and an F(IO(2)) of 1. Patients were allowed to breathe spontaneously for a 20-min washout period in between each PEEP trial. Arterial blood gases and clinical variables were recorded after each PEEP treatment. The results indicate that oxygenation improves linearly with increasing levels of PEEP. However, oxygenation levels were similar regardless of the first PEEP level administered (5, 10, or 15 cm H(2)O), and only the subgroup that received an initial treatment of the lowest level of PEEP (ie, 5 cm H(2)O) showed further improvements in oxygenation when higher PEEP levels were subsequently applied. The P(aCO(2)) also increased in response to PEEP elevation, especially with the highest level of PEEP (ie, 15 cm H(2)O). PSV of 5 cm H(2)O use was associated with significant and consistent improvements in the subjective sensations of dyspnea and respiratory rate reported by patients treated with any level of PEEP (from 0 to 15 cm H(2)O). AIDS patients with hypoxemic respiratory failure improve oxygenation in response to a progressive sequential elevation of PEEP (up to 15 cm H(2)O). However, corresponding elevations in P(aCO(2)) limit the recommended level of PEEP to 10 cm H(2)O. At a level of 5 cm H(2)O, PSV promotes an improvement in the subjective sensation of dyspnea regardless of the PEEP level employed.

  4. Hemoglobin, exercise training, and health status in patients with chronic heart failure (from the HF-ACTION randomized controlled trial).

    Science.gov (United States)

    Piña, Ileana L; Lin, Li; Weinfurt, Kevin P; Isitt, John J; Whellan, David J; Schulman, Kevin A; Flynn, Kathryn E

    2013-10-01

    Anemia is common in patients with chronic heart failure (HF), with a prevalence ranging from 10% to 56%, and may be a risk factor for poor outcomes. Anemia in HF remains poorly understood, with significant gaps in its impact on health-related quality of life (HRQoL), with most studies in HF being retrospective or from registries. The purpose of this study was to explore the relation of hemoglobin (Hgb) with HRQoL and training-induced changes in HRQoL in a cohort of patients in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION). Using data from HF-ACTION, a randomized controlled trial of exercise training in patients with HF and low left ventricular ejection fractions, HRQoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 3 and 12 months, and annually up to 4 years. Treatment group effects on HRQoL were estimated using linear mixed models according to the intention-to-treat principle. It was hypothesized that baseline Hgb would be correlated with baseline KCCQ scales and that Hgb would moderate the beneficial effect of exercise training on HRQoL. Hgb level was not significantly correlated with baseline HRQoL. Baseline Hgb did not moderate the beneficial effect of exercise training on KCCQ overall or subscales relative to usual care. In conclusion, in the HF-ACTION cohort, there was no correlation with baseline Hgb and baseline HRQoL as measured by the KCCQ. In addition, the beneficial effects of HRQoL from exercise training were not modulated by baseline Hgb. Copyright © 2013 Elsevier Inc. All rights reserved.

  5. Continuous renal replacement therapy for acute renal failure on the intensive care unit

    NARCIS (Netherlands)

    E.F.H. van Bommel (Eric)

    1995-01-01

    textabstractDuring the last decade, impressive advances have been made in the techniques available for the treatment of ARF in critically ill patients. This has led to the increased use of continuous hemofiltration and its derived modifications on the intensive care unit (lCU) as opposed to the use

  6. Procedure to establish inspection intervals of regularity maintained in-service units subject to failure

    Science.gov (United States)

    1996-05-01

    Procedures have been developed for determining the period between regular inspections that is required to ensure, with a : specified level of confidence, that no more than a certain percentage of the units of a population that is in service is : fail...

  7. Randomized, double-blind, placebo-controlled study to evaluate the effect of two dosing regimens of darbepoetin alfa in patients with heart failure and anaemia

    NARCIS (Netherlands)

    van Veldhuisen, Dirk J.; Dickstein, Kenneth; Cohen-Solal, Alain; Lok, Dirk J. A.; Wasserman, Scott M.; Baker, Nigel; Rosser, Dylan; Cleland, John G. F.; Ponikowski, Piotr

    Aims Anaemia is common in chronic heart failure (CHF) and associated with worse outcome. This randomized, double-blind, placebo -controlled study evaluated the effect of two darbepoetin alfa dosing regimens on haemoglobin (Hb) rate of rise and clinical effects in patients with CHF and anaemia.

  8. Misoprostol versus curettage in women with early pregnancy failure: impact on women's health-related quality of life. A randomized controlled trial

    NARCIS (Netherlands)

    Graziosi, G. C. M.; Bruinse, H. W.; Reuwer, P. J. H.; van Kessel, P. H.; Westerweel, P. E.; Mol, B. W.

    2005-01-01

    BACKGROUND: We aimed to compare patients' health-related quality of life after a misoprostol strategy to a curettage in women with early pregnancy failure after failed expectant management. METHODS: A multicentre randomized clinical trial was performed in The Netherlands. In all, 154 women with

  9. The Effects of Coach Training on Fear of Failure in Youth Swimmers: A Latent Growth Curve Analysis from a Randomized, Controlled Trial

    Science.gov (United States)

    Conroy, David E.; Coatsworth, Douglas J.

    2004-01-01

    The present study was a randomized trial of the efficacy of psychosocial and injury prevention-based coach training programs for reducing fear of failure (FF) among youth swimmers aged 7 to 18 years. Results revealed that (a) psychosocial training increased coaches' use of reward/reinforcement, (b) the FF measure demonstrated strong factorial…

  10. Taurolidine-citrate-heparin lock reduces catheter-related bloodstream infections in intestinal failure patients dependent on home parenteral support: a randomized, placebo-controlled trial.

    Science.gov (United States)

    Tribler, Siri; Brandt, Christopher F; Petersen, Anne H; Petersen, Jørgen H; Fuglsang, Kristian A; Staun, Michael; Broebech, Per; Moser, Claus E; Jeppesen, Palle B

    2017-09-01

    Background: In patients with intestinal failure who are receiving home parenteral support (HPS), catheter-related bloodstream infections (CRBSIs) inflict health impairment and high costs.Objective: This study investigates the efficacy and safety of the antimicrobial catheter lock solution, taurolidine-citrate-heparin, compared with heparin 100 IE/mL on CRBSI occurrence.Design: Forty-one high-risk patients receiving HPS followed in a tertiary HPS unit were randomly assigned in a double-blinded, placebo-controlled trial. External, stratified randomization was performed according to age, sex, and prior CRBSI incidence. The prior CRBSI incidence in the study population was 2.4 episodes/1000 central venous catheter (CVC) days [95% Poisson confidence limits (CLs): 2.12, 2.71 episodes/1000 CVC days]. The maximum treatment period was 2 y or until occurrence of a CRBSI or right-censoring because of CVC removal. The exact permutation tests were used to calculate P values for the log-rank tests.Results: Twenty patients received the taurolidine-citrate-heparin lock and 21 received the heparin lock, with 9622 and 6956 treatment days, respectively. In the taurolidine-citrate-heparin arm, no CRBSIs occurred, whereas 7 CRBSIs occurred in the heparin arm, with an incidence of 1.0/1000 CVC days (95% Poisson CLs: 0.4, 2.07/1000 CVC days; P = 0.005). The CVC removal rates were 0.52/1000 CVC days (95% Poisson CLs: 0.17, 1.21/1000 CVC days) and 1.72/1000 CVC days (95% Poisson CLs: 0.89, 3.0/1000 CVC days) in the taurolidine-citrate-heparin and heparin arm, respectively, tending to prolong CVC survival in the taurolidine arm (P = 0.06). Costs per treatment year were lower in the taurolidine arm (€2348) than in the heparin arm (€6744) owing to fewer admission days related to treating CVC-related complications (P = 0.02).Conclusions: In patients with intestinal failure who are life dependent on HPS, the taurolidine-citrate-heparin catheter lock demonstrates a clinically substantial and

  11. Teaching Emotional Intelligence to Intensive Care Unit Nurses and their General Health: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    F Sharif

    2013-07-01

    Full Text Available Background: Emotion and how people manage it is an important part of personality that would immensely affect their health. Investigations showed that emotional intelligence is significantly related to and can predict psychological health. Objective: To determine the effect of teaching emotional intelligence to intensive care unit nurses on their general health. Methods: This randomized clinical trial (registered as IRCT201208022812N9 was conducted on 52 of 200 in intensive care unit nurses affiliated to Shiraz University of Medical Sciences. They were recruited through purposeful convenience sampling and then randomly categorized into two groups. The intervention group members were trained in emotional intelligence. Bar-on emotional intelligence and Goldberg's general health questionnaires were administered to each participant before, immediately after, and one month after the intervention. Results: While the mean score of general health for the intervention group decreased from 25.4 before the intervention, to 18.1 immediately after the intervention and to 14.6 one month later, for the control group, it increased from 22.0, to 24.2 and to 26.5, respectively (p<0.001. Conclusion: Teaching emotional intelligence improved the general health of intensive care unit nurses.

  12. Outcome of liver transplantation for drug-induced acute liver failure in the United States: analysis of the United Network for Organ Sharing database.

    Science.gov (United States)

    Mindikoglu, Ayse L; Magder, Laurence S; Regev, Arie

    2009-07-01

    Acute liver failure (ALF) is an uncommon but potentially lethal drug-related adverse effect that often leads to liver transplantation (LT) or death. A retrospective cohort study was performed with the United Network for Organ Sharing Standard Transplant Analysis and Research files. Recipients who underwent LT for drug-induced acute liver failure (DIALF) from 1987 through 2006 were analyzed. A total of 661 patients transplanted for DIALF were included in the analysis. The 4 leading implicated drug groups were acetaminophen (n = 265; 40%), antituberculosis drugs (n = 50; 8%), antiepileptics (n = 46; 7%), and antibiotics (n = 39; 6%). One-year estimated survival probabilities were 76%, 82%, 52%, 82%, and 79% for acetaminophen, antituberculosis drugs, antiepileptics, antibiotics, and others, respectively. The lower rate of survival among those exposed to antiepileptics was observed mainly in children. Of the 22 patients less than 18 years old who had ALF due to antiepileptics, 73% died within the first year. The difference in overall survival between acetaminophen-related and non-acetaminophen-related ALF was not statistically significant. Patients with acetaminophen-related ALF required dialysis prior to LT at a significantly higher rate than all other drug groups (27% versus 3%-10%, P < 0.0001). According to Cox proportional hazards regression analysis, the independent pretransplant predictors of death after LT were being on life support, DIALF due to antiepileptic drugs at age less than 18, and elevated serum creatinine. In conclusion, the leading drug groups causing LT due to DIALF in the United States were acetaminophen, antituberculosis drugs, antiepileptics, and antibiotics. Children who had ALF due to antiepileptics had a substantially higher risk of death after LT in comparison with other drugs. Patients transplanted for acetaminophen-related ALF required dialysis at a significantly higher rate. Being on life support, DIALF due to antiepileptics (at age less

  13. A cost-effectiveness study of person-centered integrated heart failure and palliative home care: Based on a randomized controlled trial.

    Science.gov (United States)

    Sahlen, Klas-Göran; Boman, Kurt; Brännström, Margareta

    2016-03-01

    Previous economic studies of person-centered palliative home care have been conducted mainly among patients with cancer. Studies on cost-effectiveness of advanced home care for patients with severe heart failure are lacking when a diagnosis of heart failure is the only main disease as the inclusion criterion. To assess the cost-effectiveness of a new concept of care called person-centered integrated heart failure and palliative home care. A randomized controlled trial was conducted from January 2011 to 2013 at a center in Sweden. Data collection included cost estimates for health care and the patients' responses to the EQ-5D quality of life instrument. Patients with chronic and severe heart failure were randomly assigned to an intervention (n = 36) or control (n = 36) group. The intervention group received the Palliative Advanced Home Care and Heart Failure Care intervention over 6 months. The control group received the same care that is usually provided by a primary health care center or heart failure clinic at the hospital. EQ-5D data indicated that the intervention resulted in a gain of 0.25 quality-adjusted life years, and cost analysis showed a significant cost reduction with the Palliative Advanced Home Care and Heart Failure Care intervention. Even if costs for staffing are higher than usual care, this is more than made up for by the reduced need for hospital-based care. This intervention made it possible for the county council to use €50,000 for other needs. The Palliative Advanced Home Care and Heart Failure Care working mode saves financial resources and should be regarded as very cost-effective. © The Author(s) 2015.

  14. Monte Carlo Simulations of Random Frustrated Systems on Graphics Processing Units

    Science.gov (United States)

    Feng, Sheng; Fang, Ye; Hall, Sean; Papke, Ariane; Thomasson, Cade; Tam, Ka-Ming; Moreno, Juana; Jarrell, Mark

    2012-02-01

    We study the implementation of the classical Monte Carlo simulation for random frustrated models using the multithreaded computing environment provided by the the Compute Unified Device Architecture (CUDA) on modern Graphics Processing Units (GPU) with hundreds of cores and high memory bandwidth. The key for optimizing the performance of the GPU computing is in the proper handling of the data structure. Utilizing the multi-spin coding, we obtain an efficient GPU implementation of the parallel tempering Monte Carlo simulation for the Edwards-Anderson spin glass model. In the typical simulations, we find over two thousand times of speed-up over the single threaded CPU implementation.

  15. [APACHE II and ATN-ISS in acute renal failure (ARF) in intensive care unit (ICU) and non-ICU].

    Science.gov (United States)

    Fernandes, Natáia Maria da Silva; Pinto, Patrícia dos Santos; Lacet, Thiago Bento de Paiva; Rodrigues, Dominique Fonseca; Bastos, Marcus Gomes; Stella, Sérgio Reinaldo; Cendoroglo Neto, Miguel

    2009-01-01

    Acute renal failure (ARF) remains highly prevalent with a high rate of morbidity and mortality. of this study was to compare use of the APACHE II scoring prognosis with that of the ATN-ISS to determine whether the APACHE II could be used for patients with ARF outside the ICU. For this purpose, 205 patients with ARF were accompanied in a prospective cohort. Demographic data, preexisting conditions, organ failure and characteristics of ARF were analyzed. The prognostic scores were performed with the assessment of a nephrologist. The mean age was 52 +/- 18 years, 50% were male, 69% were white, 45% were treated in ICU and 55% in other units. Mortality in the ICU group was 85% and in the non-ICU group 18%. Factors that correlated with higher mortality were more prevalent in the ICU group: age, male, hospitalization with ARF, organ failure, sepsis, septic IRA, oliguria and need of dialysis. Overall, the prognostic markers were the same for both the ICU and non-ICU groups. The discrimination with the APACHE II was similar in both, ICU and non-ICU groups and calibration was better in the non-ICU group. The ATN-ISS achieved good discrimination in both the ICU and non-ICU groups, but, regarding calibration, there was a discreet over estimating of mortality in the non-ICU group. The ATN-ISS showed a greater capacity for discrimination than the APACHE II in both the ICU and non-ICU groups. It was concluded that the APACHE II and ATN-ISS scores could be used for stratification of risk in patients with ARF treated outside of the ICU in Brazil.

  16. Randomized Crossover Study of the Natural Restorative Environment Intervention to Improve Attention and Mood in Heart Failure.

    Science.gov (United States)

    Jung, Miyeon; Jonides, John; Northouse, Laurel; Berman, Marc G; Koelling, Todd M; Pressler, Susan J

    In heart failure (HF), attention may be decreased because of lowered cerebral blood flow and increased attentional demands needed for self-care. Guided by the Attention Restoration Theory, the objective was to test the efficacy of the natural restorative environment (NRE) intervention on improving attention and mood among HF patients and healthy adults. A randomized crossover pilot study was conducted among 20 HF patients and an age- and education-matched comparison group of 20 healthy adults to test the efficacy of the NRE intervention compared with an active control intervention. Neuropsychological tests were administered to examine attention, particularly attention span, sustained attention, directed attention, and attention switching, at before and after the intervention. Mood was measured with the Positive and Negative Affect Schedule. No significant differences were found in attention and mood after the NRE intervention compared with the control intervention among the HF patients and the healthy adults. In analyses with HF patients and healthy adults combined (n = 40), significant differences were found. Compared with the control intervention, sustained attention improved after the NRE intervention (P = .001) regardless of the presence of HF. Compared with the healthy adults, HF patients performed significantly worse on attention switching after the control intervention (P = .045). The NRE intervention may be efficacious in improving sustained attention in HF patients. Future studies are needed to enhance the NRE intervention to be more efficacious and tailored for HF patients and test the efficacy in a larger sample of HF patients.

  17. Changes in self-reported sleep and cognitive failures: a randomized controlled trial of a stress management intervention.

    Science.gov (United States)

    Dalgaard, Ligaya; Eskildsen, Anita; Carstensen, Ole; Willert, Morten Vejs; Andersen, Johan Hviid; Glasscock, David J

    2014-11-01

    This study evaluated the effectiveness of a stress management intervention combining individual cognitive behavioral therapy (CBT) with a brief workplace intervention on self-reported measures of sleep and cognitive functioning among patients on sick leave due to work-related stress complaints. Participants were patients referred to the regional Department of Occupational Medicine. Inclusion criteria were (i) sick leave due to work-related stress complaints and (ii) a diagnosis of adjustment disorder/reactions to stress or mild depression. Participants (N=137) were randomized to either an intervention (N=57) or control (N=80) group. The intervention comprised six sessions with a psychologist and the offer of a small workplace intervention. Questionnaires were answered at baseline and after 4, and 10 months. Symptoms were significantly reduced over time in both groups but there was no significant treatment effect on sleep or cognitive outcomes at any time point. From 0-4 months, there was a tendency for larger improvements in the intervention group with regards to sleep and cognitive failures in distraction. Although neither was significant, the results came close to significance depicting a small effect size (Cohen's d) on sleep complaints and distractions (but not memory). The specific intervention was not superior to the control condition in reducing symptoms of sleep problems and cognitive difficulties at any time point during the 10-month follow-up period. Substantial improvements in symptoms over time were seen in both groups.

  18. Transformer failure and common-mode loss of instrument power at Nine Mile Point Unit 2 on August 13, 1991

    Energy Technology Data Exchange (ETDEWEB)

    1991-10-01

    On August 13, 1991, at Nine Mile Point Unit 2 nuclear power plant, located near Scriba, New York, on Lake Ontario, the main transformer experienced an internal failure that resulted in degraded voltage which caused the simultaneous loss of five uninterruptible power supplies, which in turn caused the loss of several nonsafety systems, including reactor control rod position indication, some reactor power and water indication, control room annunciators, the plant communications system, the plant process computer, and lighting at some locations. The reactor was subsequently brought to a safe shutdown. Following this event, the US Nuclear Regulatory Commission dispatched an Incident Investigation Team to the site to determine what happened, to identify the probable causes, and to make appropriate findings and conclusions. This report describes the incident, the methodology used by the team in its investigation, and presents and the team's findings and conclusions. 59 figs., 14 tabs.

  19. Positive predictive value and impact of misdiagnosis of a heart failure diagnosis in administrative registers among patients admitted to a University Hospital cardiac care unit

    DEFF Research Database (Denmark)

    Mard, Shan; Nielsen, Finn Erland

    2010-01-01

    OBJECTIVE: To evaluate the positive predictive value (PPV) of a diagnosis of heart failure (HF) in the Danish National Registry of Patients (NRP) among patients admitted to a University Hospital cardiac care unit, and to evaluate the impact of misdiagnosing HF. DESIGN: The NRP was used to identify...... patients with heart failure from July 1, 2005 to June 30, 2007. Heart failure was defined in accordance with European Society of Cardiology (ESC) guidelines. The recorded diagnoses from the NRP were compared with clinical data from the medical records. RESULTS: We identified 758 patients with a diagnosis...... of heart failure in the NRP. The PPV of a heart failure discharge diagnosis was 84.0% (95% confidence interval: 81.2-86.6). Patients with a discharge diagnosis of HF in the NRP without fulfilling the ESC criteria for HF had a better survival rate, a lower rate of rehospitalization, none were followed...

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

    Science.gov (United States)

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

    2017-07-11

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

  1. Effect of a diuretic adjustment algorithm and nonpharmacologic management in patients with heart failure: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Feijó, Maria Karolina Echer Ferreira; Biolo, Andreia; Ruschel, Karen Brasil; Orlandin, Letícia; Aliti, Graziella Badin; Rabelo-Silva, Eneida Rejane

    2015-02-08

    One of the challenges in treating patients with heart failure (HF) is achieving clinical stability and reducing the hospital readmission rate. A diuretic dose adjustment algorithm developed in the United States (Diuretic Treatment Algorithm, DTA) and later validated for use in Brazil (as the Algoritmo de Ajuste de Diurético, AAD) has proved feasible and readily applicable, but its effect on clinical outcomes has yet to be assessed. This report aims to describe a randomized clinical trial protocol designed to assess the effectiveness of the AAD and of nonpharmacologic management in improving clinical stability and reducing the readmission rate at 90 days in patients with HF. A PROBE (prospective randomized open blinded endpoint) parallel-group design will be used. Adult patients with a diagnosis of reduced ejection fraction HF, who are being treated at a specialized HF clinic are being recruited. Those with indications for loop diuretic dose adjustment during routine clinic visits will be randomized to take part in the trial. Participants in the intervention group (IG) shall have their diuretic doses adjusted in accordance with the AAD and receive four telephone calls (one per week) over 30 days to reinforce guidance on nonpharmacological management (fluid and sodium restriction). Participants in the control group (CG) shall have their diuretic doses adjusted by a physician during the first trial visit and shall not receive any telephone calls. Patients in both groups shall return at 1 month for face-to-face reassessment. The study endpoints shall comprise readmission and/or emergency department visits due to HF decompensation within 90 days and clinical instability. All participants shall be required to have a scale at home (or easy access to one), a telephone number, agree to telephone-based follow-up, and be available to return for a 1-month trial visit. Overall, 135 patients are expected to be enrolled in each group. This trial shall assess the effectiveness of

  2. Balanced Crystalloids versus Saline in the Intensive Care Unit. The SALT Randomized Trial.

    Science.gov (United States)

    Semler, Matthew W; Wanderer, Jonathan P; Ehrenfeld, Jesse M; Stollings, Joanna L; Self, Wesley H; Siew, Edward D; Wang, Li; Byrne, Daniel W; Shaw, Andrew D; Bernard, Gordon R; Rice, Todd W

    2017-05-15

    Saline is the intravenous fluid most commonly administered to critically ill adults, but it may be associated with acute kidney injury and death. Whether use of balanced crystalloids rather than saline affects patient outcomes remains unknown. To pilot a cluster-randomized, multiple-crossover trial using software tools within the electronic health record to compare saline to balanced crystalloids. This was a cluster-randomized, multiple-crossover trial among 974 adults admitted to a tertiary medical intensive care unit from February 3, 2015 to May 31, 2015. The intravenous crystalloid used in the unit alternated monthly between saline (0.9% sodium chloride) and balanced crystalloids (lactated Ringer's solution or Plasma-Lyte A). Enrollment, fluid delivery, and data collection were performed using software tools within the electronic health record. The primary outcome was the difference between study groups in the proportion of isotonic crystalloid administered that was saline. The secondary outcome was major adverse kidney events within 30 days (MAKE30), a composite of death, dialysis, or persistent renal dysfunction. Patients assigned to saline (n = 454) and balanced crystalloids (n = 520) were similar at baseline and received similar volumes of crystalloid by 30 days (median [interquartile range]: 1,424 ml [500-3,377] vs. 1,617 ml [500-3,628]; P = 0.40). Saline made up a larger proportion of the isotonic crystalloid given in the saline group than in the balanced crystalloid group (91% vs. 21%; P < 0.001). MAKE30 did not differ between groups (24.7% vs. 24.6%; P = 0.98). An electronic health record-embedded, cluster-randomized, multiple-crossover trial comparing saline with balanced crystalloids can produce well-balanced study groups and separation in crystalloid receipt. Clinical trial registered with www.clinicaltrials.gov (NCT 02345486).

  3. The early history of dialysis for chronic renal failure in the United States: a view from Seattle.

    Science.gov (United States)

    Blagg, Christopher R

    2007-03-01

    Forty-seven years have passed since the first patient started treatment for chronic renal failure by repeated hemodialysis (HD) at the University of Washington Hospital in Seattle in March 1960, and some 34 years have elapsed since the United States Congress passed legislation creating the Medicare End-Stage Renal Disease Program. Many nephrologists practicing today are unfamiliar with the history of the clinical and political developments that occurred during the 13 years between these 2 dates and that led to dialysis as we know it today in this country. This review briefly describes these events. Clinical developments following introduction of the Teflon shunt by Belding Scribner and Wayne Quinton included empirical observations leading to better understanding of HD and patient management, out-of-hospital dialysis by nurses, bioethical discussions of the problems of patient selection, home HD, improved dialysis technology, intermittent peritoneal dialysis, including automated equipment for home use and an effective peritoneal access catheter, the arteriovenous fistula for more reliable blood access, dialyzer reuse, the first for-profit dialysis units, understanding of many of the complications of treatment, the first considerations of dialysis adequacy, early development of other technologies, and more frequent HD. Political developments began less than 3 years after the first Seattle patient began dialysis, but it took another 10 years of intermittent activities before Congress acted on legislation to provide almost universal Medicare entitlement to patients with chronic kidney disease requiring dialysis or kidney transplantation.

  4. A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial.

    Science.gov (United States)

    Piette, John D; Striplin, Dana; Marinec, Nicolle; Chen, Jenny; Trivedi, Ranak B; Aron, David C; Fisher, Lawrence; Aikens, James E

    2015-06-10

    Mobile health (mHealth) interventions may improve heart failure (HF) self-care, but standard models do not address informal caregivers' needs for information about the patient's status or how the caregiver can help. We evaluated mHealth support for caregivers of HF patients over and above the impact of a standard mHealth approach. We identified 331 HF patients from Department of Veterans Affairs outpatient clinics. All patients identified a "CarePartner" outside their household. Patients randomized to "standard mHealth" (n=165) received 12 months of weekly interactive voice response (IVR) calls including questions about their health and self-management. Based on patients' responses, they received tailored self-management advice, and their clinical team received structured fax alerts regarding serious health concerns. Patients randomized to "mHealth+CP" (n=166) received an identical intervention, but with automated emails sent to their CarePartner after each IVR call, including feedback about the patient's status and suggestions for how the CarePartner could support disease care. Self-care and symptoms were measured via 6- and 12-month telephone surveys with a research associate. Self-care and symptom data also were collected through the weekly IVR assessments. Participants were on average 67.8 years of age, 99% were male (329/331), 77% where white (255/331), and 59% were married (195/331). During 15,709 call-weeks of attempted IVR assessments, patients completed 90% of their calls with no difference in completion rates between arms. At both endpoints, composite quality of life scores were similar across arms. However, more mHealth+CP patients reported taking medications as prescribed at 6 months (8.8% more, 95% CI 1.2-16.5, P=.02) and 12 months (13.8% more, CI 3.7-23.8, Phealth during weekly IVR calls. Compared to a relatively intensive model of IVR monitoring, self-management assistance, and clinician alerts, a model including automated feedback to an informal

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

    Science.gov (United States)

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

    2017-12-14

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

  6. A pilot randomized study of a gratitude journaling intervention on HRV and inflammatory biomarkers in Stage B heart failure patients

    Science.gov (United States)

    Redwine, Laura; Henry, Brook L.; Pung, Meredith A.; Wilson, Kathleen; Chinh, Kelly; Knight, Brian; Jain, Shamini; Rutledge, Thomas; Greenberg, Barry; Maisel, Alan; Mills, Paul J

    2016-01-01

    Objective Stage B, asymptomatic heart failure (HF) presents a therapeutic window for attenuating disease progression and development of HF symptoms, and improving quality of life. Gratitude, the practice of appreciating positive life features, is highly related to quality of life, leading to development of promising clinical interventions. However, few gratitude studies have investigated objective measures of physical health; most relied on self-report measures. We conducted a pilot study in Stage B HF patients to examine whether gratitude journaling improved biomarkers related to HF prognosis. Methods Patients (N = 70; mean age = 66.2 years, SD = 7.6) were randomized to an 8-week gratitude journaling intervention or treatment as usual (TAU). Baseline (T1) assessments included 6-item Gratitude Questionnaire (GQ-6), resting heart rate variability (HRV), and an inflammatory biomarker index. At T2 (mid-intervention) GQ6 was measured. At T3 (post-intervention), T1 measures were repeated but also included a gratitude journaling task. Results The gratitude intervention was associated with improved trait gratitude scores (F = 6.0, p = .017, η2 = .10), reduced inflammatory biomarker index score over time (F = 9.7, p = .004, η2 = .21) and increased parasympathetic HRV responses during the gratitude journaling task (F = 4.2, p = .036, η2 = .15), compared with TAU. However, there were no resting pre- to post-intervention group differences in HRV (p's > .10). Conclusions Gratitude journaling may improve biomarkers related to HF morbidity, such as reduced inflammation; large-scale studies with active control conditions are needed to confirm these findings. PMID:27187845

  7. Hydrotherapy added to endurance training versus endurance training alone in elderly patients with chronic heart failure: a randomized pilot study.

    Science.gov (United States)

    Caminiti, Giuseppe; Volterrani, Maurizio; Marazzi, Giuseppe; Cerrito, Anna; Massaro, Rosalba; Sposato, Barbara; Arisi, Arianna; Rosano, Giuseppe

    2011-04-14

    To assess if Hydrotherapy (HT) added to endurance training (ET) is more effective than ET alone in order to improve exercise tolerance of elderly male patients with chronic heart failure (CHF). Twenty-one male CHF patients, age 68+/-7 (mean+/-DS) years; ejection fraction 32+/-9. NYHA II-III were enrolled. Eleven pts were randomized to combined training (CT) group performing HT+ET and 10 patients to ET group (ET only). At baseline and after 24 weeks all patients underwent: 6-minute walking test (6MWT), assessment of quadriceps maximal voluntary contraction (MVC) and peak torque (PT), blood pressure and heart rate (HR), echocardiography and non-invasive hemodynamic evaluation. HT was performed 3 times/week in upright position at up to the xyphoid process at a temperature of 31°C. ET was performed 3 times/week. Exercise was well tolerated. No patients had adverse events. Distance at 6MWT improved in both groups (CT group: 150+/-32 m; ET group:105+/-28 m) with significant intergroup differences (p 0.001). On land diastolic BP and HR significantly decreased in the CT group while remained unchanged in the ET group (-11 mmHg+/-2, p 0.04; e - 12 bpm, p 0.03; respectively) CO and SV had a relative despite no significant increase in CT group TPR on land significantly decreased in CT group (-23+/-3 mmHg/l/m; p 0.01) while remained unchanged in ET group. Patients of CT group had no significant higher increase of both MVC and PT than ET group. CT training, significantly improves exercise tolerance and hemodynamic profile of patients with CHF. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

  8. A randomized controlled pilot study of outcomes of strict allowance of fluid therapy in hyponatremic heart failure (SALT-HF).

    Science.gov (United States)

    Albert, Nancy M; Nutter, Benjamin; Forney, Jennifer; Slifcak, Ellen; Tang, W H Wilson

    2013-01-01

    Currently, fluid restriction recommendations in heart failure (HF) are based on expert opinion. After implementing a 1,000-mL/d fluid restriction for 60 days after discharge, outcomes were examined. In a randomized controlled design, hyponatremic patients (serum sodium ≤137 mg/dL) received usual care (UC; n = 26) or 1,000 mL/d fluid restriction (n = 20) at discharge. Quality of life (QoL), thirst, difficulty following fluid recommendations, adherence to fluid restriction, HF emergency care, HF rehospitalization, and all-cause death were examined. Mean age was 62.8 ± 12.8 years; 46% were white. There were no differences by group in baseline demographics, comorbidities, and QoL, except that more UC patients had New York Heart Association (NYHA) functional class III/IV status (P = .019). Median [interquartile range] QoL scores were better in the 1,000 mL/d group for symptom burden (83.3 [68.8-91.7] vs 50 [29.2-79.2]; P = .018), total symptoms (77.1 [58.1-91.7] vs 54.2 [30.2-73.9]; P = .022), overall QoL summary (72.6 [52.2-86.3] vs 51.0 [37.7-68.5]; P = .038), and clinical QoL summary (75.5 [57.8-92.9] vs 59.1 [35.7-77.3]; P = .039). There were no group differences in thirst, difficulty adhering to fluid recommendations, adherence to fluid restriction, or health care consumption. The 1,000 mL/d fluid restriction led to improved QoL at 60 days after discharge. Future research in a larger more heterogeneous sample is needed. Copyright © 2013 Elsevier Inc. All rights reserved.

  9. Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF: protocol for a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Grandinetti Giuseppe

    2011-02-01

    Full Text Available Abstract Background Heart failure(HF and atrial fibrillation(AF frequently coexist in the same patient and are associated with increased mortality and frequent hospitalizations. As the concomitance of AF and HF is often associated with a poor prognosis, the prompt treatment of AF in HF patients may significantly improve outcome. Methods/design Recent implantable cardiac resynchronization (CRT devices allow electrical therapies to treat AF automatically. TRADE-HF (trial registration: NCT00345592; http://www.clinicaltrials.gov is a prospective, randomized, double arm study aimed at demonstrating the efficacy of an automatic, device-based therapy for treatment of atrial tachycardia and fibrillation(AT/AF in patients indicated for CRT. The study compares automatic electrical therapy to a traditional more usual treatment of AT/AF: the goal is to demonstrate a reduction in a combined endpoint of unplanned hospitalizations for cardiac reasons, death from cardiovascular causes or permanent AF when using automatic atrial therapy as compared to the traditional approach involving hospitalization for symptoms and in-hospital treatment of AT/AF. Discussion CRT pacemaker with the additional ability to convert AF as well as ventricular arrhythmias may play a simultaneous role in rhythm control and HF treatment. The value of the systematic implantation of CRT ICDs with the capacity to deliver atrial therapy in HF patients at risk of AF has not yet been explored. The TRADE-HF study will assess in CRT patients whether a strategy based on automatic management of atrial arrhythmias might be a valuable option to reduce the number of hospital admission and to reduce the progression the arrhythmia to a permanent form. Trial registration NCT00345592

  10. Random Deterioration Process of Conveyor Belt Evaluated by Statistical Analysis of Core Failures Detected Along Belt Axis and Elapsed Time

    Science.gov (United States)

    Blazej, Ryszard; Jurdziak, Leszek; Kirjanów, Agata; Kozlowski, Tomasz

    2017-12-01

    Magnetic diagnostic methods are used for steel cord belt condition evaluation since the beginning of 1970s. Initially they generated an analogue signal for several tens of centimetres of conveyor belts scanned sequentially with one measuring head in several cycles or the whole width of the belt at one time thanks to the installation of many measuring heads across the entire cross section. This did not allow identification of single centimetre failures, but rather an aggregate assessment of the state of quite wide waist. Modern diagnostic devices, thanks to miniaturization, allow up to 200 heads per belt width to identify damage of individual cords. Instead of analogue signals, they generate a zero-one digital signal corresponding to a change in the magnetic field sign, which can illustrate damage on 2D images. This makes it easier to identify the location and size of the damage in the belt image. Statistical analysis of digital signals summed up for consecutive sections along the belt axis allows to present both the source signal and its aggregation for band of a given width to form aggregate measures of belt damage such as the damage density per 1 meter of belt. Observation of changes in these measurements at different times allows on evaluation of its rate of change over time, which can be used to forecast future belt condition and to select the proper moment of preventive belt replacement to another one to avoid emergency downtimes (egg in underground mines) or to recondition of belts (egg. in lignite surface mines). The paper presents the results of investigations of the damage condition of a core of a single belt segment working in one of the copper ore underground mines. Scanning of the belt condition was performed few times at intervals of several months. The paper presents the results of the analysis of the changes in core condition, showing the random character of the damage process along the axis and its change over time.

  11. Development and Pilot of a Checklist for Management of Acute Liver Failure in the Intensive Care Unit.

    Directory of Open Access Journals (Sweden)

    Oren K Fix

    Full Text Available Acute liver failure (ALF is an ideal condition for use of a checklist. Our aims were to develop a checklist for the management of ALF in the intensive care unit (ICU and assess the usability of the checklist among multiple providers.The initial checklist was developed from published guidelines and expert opinion. The checklist underwent pilot testing at 11 academic liver transplant centers in the US and Canada. An anonymous, written survey was used to assess the usability and quality of the checklist. Written comments were used to improve the checklist following the pilot testing period.We received 81 surveys involving the management of 116 patients during the pilot testing period. The overall quality of the checklist was judged to be above average to excellent by 94% of users. On a 5-point Likert scale, the majority of survey respondents agreed or agreed strongly with the following checklist characteristics: the checklist was easy to read (99% agreed/agreed strongly, easy to use (97%, items are categorized logically (98%, time to complete the checklist did not interfere with delivery of appropriate and safe patient care (94% and was not excessively burdensome (92%, the checklist allowed the user the freedom to use his or her clinical judgment (80%, it is a useful tool in the management of acute liver failure (98%. Web-based and mobile apps were developed for use of the checklist at the point of care.The checklist for the management of ALF in the ICU was shown in this pilot study to be easy to use, helpful and accepted by a wide variety of practitioners at multiple sites in the US and Canada.

  12. [Characteristics of the population hospitalized for advanced and terminal heart failure and experiences in palliative caring in the Intensive Care Unit of cardiology].

    Science.gov (United States)

    Bedet, A; Garçon, P; Boulogne, M; Richard, J F; Opatowski, L; Moubarak, G; Rejasse, G; Cador, R

    2015-09-01

    Advanced heart failure incidence is in progression. Palliative care access remains difficult due to its unpredictable course. The aim of this study was to describe the characteristics of patients admitted in Cardiology Intensive Care Unit for advanced heart failure who received palliative care and compare them to the whole population of acute heart failure hospitalized in the same period. The patients hospitalized for acute heart failure were retrospectively included from 2009 to 2013. We identified among them those who received palliative care. Specific caring was decided in pluridisciplinary meeting. On 940 patients included, 42 patients (4.5%) receive palliative care. Ischemic heart disease was the main etiology (n=19; 45.2%). Right ventricular dysfunction (n=34; 80.9%) was associated with supra-ventricular arrhythmia (n=28; 66.7%). Twenty-eight patients (57.1%) have died in hospital, 9 (21.4%) were referred to a palliative care unit and 8 (19.1%) was discharged or referred to a rehabilitation center. Time between inclusion and death was 6 days on average. Intra-hospital mortality in control group was 6.8%. Palliative care in cardiology is uncommon and has often been too late because of its poor adaptability to advanced heart failure. It is, as consequence, necessary to identify the prognostic factors of these patients in order to propose a personalized care and to adjust the intensity of care ahead of the terminal evolution of heart failure. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  13. The antioxidant acetylcysteine reduces cardiovascular events in patients with end-stage renal failure: a randomized, controlled trial

    DEFF Research Database (Denmark)

    Tepel, Martin; van der Giet, Markus; Statz, Mario

    2003-01-01

    Patients with end-stage renal failure have increased oxidative stress and show elevated cardiovascular mortality. Whether increased cardiovascular events can be prevented by the administration of antioxidants is unknown.......Patients with end-stage renal failure have increased oxidative stress and show elevated cardiovascular mortality. Whether increased cardiovascular events can be prevented by the administration of antioxidants is unknown....

  14. [Ten-year evolution of mechanical ventilation in acute respiratory failure in the hematogical patient admitted to the intensive care unit].

    Science.gov (United States)

    Belenguer-Muncharaz, A; Albert-Rodrigo, L; Ferrandiz-Sellés, A; Cebrián-Graullera, G

    2013-10-01

    A comparison was made between invasive mechanical ventilation (IMV) and noninvasive positive pressure ventilation (NPPV) in haematological patients with acute respiratory failure. A retrospective observational study was made from 2001 to December 2011. A clinical-surgical intensive care unit (ICU) in a tertiary hospital. Patients with hematological malignancies suffering acute respiratory failure (ARF) and requiring mechanical ventilation in the form of either IMV or NPPV. Analysis of infection and organ failure rates, duration of mechanical ventilation and ICU and hospital stays, as well as ICU, hospital and mortality after 90 days. The same variables were analyzed in the comparison between NPPV success and failure. Forty-one patients were included, of which 35 required IMV and 6 NPPV. ICU mortality was higher in the IMV group (100% vs 37% in NPPV, P=.006). The intubation rate in NPPV was 40%. Compared with successful NPPV, failure in the NPPV group involved more complications, a longer duration of mechanical ventilation and ICU stay, and greater ICU and hospital mortality. Multivariate analysis of mortality in the NPPV group identified NPPV failure (OR 13 [95%CI 1.33-77.96], P=.008) and progression to acute respiratory distress syndrome (OR 10 [95%CI 1.95-89.22], P=.03) as prognostic factors. The use of NPPV reduced mortality compared with IMV. NPPV failure was associated with more complications. Copyright © 2012 Elsevier España, S.L. and SEMICYUC. All rights reserved.

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

    Science.gov (United States)

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

    2016-03-01

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

  16. Characteristics and in-hospital outcomes of patients with acute coronary syndromes and heart failure in the United Arab Emirates

    Directory of Open Access Journals (Sweden)

    Shehab Abdulla

    2012-09-01

    Full Text Available Abstract Background Heart failure (HF is a serious complication of acute coronary syndromes (ACS, and is associated with high in-hospital mortality and poor long-term survival. The aims of this study were to describe the clinical characteristics, management and in-hospital outcomes of coronary syndrome (ACS patients with HF in the United Arab Emirates. Findings The study was selected from the Gulf Registry of Acute Coronary Events (Gulf RACE, a prospective multi-national, multicenter registry of patients hospitalized with ACS in six Middle East countries. The present analysis was focused on participants admitted to various hospitals in the UAE with a diagnosis of ACS in 2007 and were analyzed in terms of HF (Killip class II/III and IV on admission. Of 1691 patients (mean age: 52.6 ± 11.7 years; 210 Females, 1481 Males with ACS, 356 (21% had an admission diagnosis of HF (Killip class II/III and IV. HF patients were less frequently males (19.2% vs. 34.3%; P  0.001. HF was more frequently associated with hypertension (64.3% vs. 43.9%; P  Conclusions HF is observed in about 1 in 5 patients with ACS in the UAE and is associated with a significant increase in in-hospital mortality and other adverse outcomes.

  17. Evaluation of the liver injury unit scoring system to predict survival in a multinational study of pediatric acute liver failure.

    Science.gov (United States)

    Lu, Brandy R; Zhang, Song; Narkewicz, Michael R; Belle, Steven H; Squires, Robert H; Sokol, Ronald J

    2013-05-01

    To examine the predictive value of the Liver Injury Units (LIU) and admission values (aLIU) of bilirubin and prothrombin time and international normalized ratio scores in a large cohort from the Pediatric Acute Liver Failure (PALF) Study Group, a multinational prospective study. LIU and aLIU scores were calculated for 461 and 579 individuals, respectively, enrolled in the PALF study from 1999 to 2008. Receiver operator characteristic curves were used to evaluate the scores with respect to survival without liver transplantation (LT), death, or LT by 21 days after enrollment. At 21 days, 50.3% of participants were alive without LT, 36.2% underwent LT, and 13.4% died. The c-indices for transplant-free survival were 0.81 based on the LIU score with the international normalized ratio (95% CI, 0.78-0.85) and 0.76 based on the aLIU score (95% CI, 0.72-0.79). The LIU score predicted LT better than it predicted death (c-index for LT 0.84, c-index for death 0.76). Based on data from a large, multicenter cohort of patients with PALF, the LIU score was a better predictor of transplant-free survival than was the aLIU score. The LIU score might be a helpful, dynamic tool to predict clinical outcomes in patients with PALF. Copyright © 2013 Mosby, Inc. All rights reserved.

  18. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association.

    Science.gov (United States)

    Heidenreich, Paul A; Albert, Nancy M; Allen, Larry A; Bluemke, David A; Butler, Javed; Fonarow, Gregg C; Ikonomidis, John S; Khavjou, Olga; Konstam, Marvin A; Maddox, Thomas M; Nichol, Graham; Pham, Michael; Piña, Ileana L; Trogdon, Justin G

    2013-05-01

    Heart failure (HF) is an important contributor to both the burden and cost of national healthcare expenditures, with more older Americans hospitalized for HF than for any other medical condition. With the aging of the population, the impact of HF is expected to increase substantially. We estimated future costs of HF by adapting a methodology developed by the American Heart Association to project the epidemiology and future costs of HF from 2012 to 2030 without double counting the costs attributed to comorbid conditions. The model assumes that HF prevalence will remain constant by age, sex, and race/ethnicity and that rising costs and technological innovation will continue at the same rate. By 2030, >8 million people in the United States (1 in every 33) will have HF. Between 2012 and 2030, real (2010$) total direct medical costs of HF are projected to increase from $21 billion to $53 billion. Total costs, including indirect costs for HF, are estimated to increase from $31 billion in 2012 to $70 billion in 2030. If one assumes all costs of cardiac care for HF patients are attributable to HF (no cost attribution to comorbid conditions), the 2030 projected cost estimates of treating patients with HF will be 3-fold higher ($160 billion in direct costs). The estimated prevalence and cost of care for HF will increase markedly because of aging of the population. Strategies to prevent HF and improve the efficiency of care are needed.

  19. The real world mental health needs of heart failure patients are not reflected by the depression randomized controlled trial evidence.

    Directory of Open Access Journals (Sweden)

    Phillip J Tully

    Full Text Available INTRODUCTION: International depression screening guidelines in heart failure (HF are partly based on depression treatment efficacy from randomized controlled trials (RCTs. Our aim was to test the external validity of depression RCT criteria in a sample of real-world HF patients. METHODS: HF patients admitted to 3 hospitals in South Australia were referred to a HF psychologist if not already receiving current psychiatric management by psychologist or psychiatrist elsewhere. Screening and referral protocol consisted of the following; (a. Patient Health Questionnaire ≥ 10; (b. Generalized Anxiety Disorder Questionnaire ≥ 7; (c. positive response to 1 item panic attack screener; (d. evidence of suicidality. Patients were evaluated against the most common RCT exclusion criteria personality disorder, high suicide risk, cognitive impairment, psychosis, alcohol or substance abuse or dependency, bi-polar depression. RESULTS: Total 81 HF patients were referred from 404 HF admissions, and 73 were assessed (age 60.6 ± 13.4, 47.9% female. Nearly half (47% met at least 1 RCT exclusion criterion, most commonly personality disorder (28.5%, alcohol/substance abuse (17.8% and high suicide risk (11.0%. RCT ineligibility criteria was more frequent among patients with major depression (76.5% vs. 46.2%, p<.01 and dysthymia (26.5% vs. 7.7%, p = .03 but not significantly associated with anxiety disorders. RCT ineligible patients reported greater severity of depression (M = 16.6 ± 5.0 vs. M = 12.9 ± 7.2, p = .02 and were higher consumers of HF psychotherapy services (M = 11.5 ± 4.7 vs. M = 8.5 ± 4.8, p = .01. CONCLUSION: In this real-world sample comparable in size to recent RCT intervention arms, patients with depression disorders presented with complex psychiatric needs including comorbid personality disorders, alcohol/substance use and suicide risk. These findings suggest external validity of depression screening and RCTs could serve as a basis for

  20. A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study.

    Science.gov (United States)

    Hale, Timothy M; Jethwani, Kamal; Kandola, Manjinder Singh; Saldana, Fidencio; Kvedar, Joseph C

    2016-04-17

    Heart failure (HF) is a chronic condition affecting nearly 5.7 million Americans and is a leading cause of morbidity and mortality. With an aging population, the cost associated with managing HF is expected to more than double from US $31 billion in 2012 to US $70 billion by 2030. Readmission rates for HF patients are high-25% are readmitted at 30 days and nearly 50% at 6 months. Low medication adherence contributes to poor HF management and higher readmission rates. Remote telehealth monitoring programs aimed at improved medication management and adherence may improve HF management and reduce readmissions. The primary goal of this randomized controlled pilot study is to compare the MedSentry remote medication monitoring system versus usual care in older HF adult patients who recently completed a HF telemonitoring program. We hypothesized that remote medication monitoring would be associated with fewer unplanned hospitalizations and emergency department (ED) visits, increased medication adherence, and improved health-related quality of life (HRQoL) compared to usual care. Participants were randomized to usual care or use of the remote medication monitoring system for 90 days. Twenty-nine participants were enrolled and the final analytic sample consisted of 25 participants. Participants completed questionnaires at enrollment and closeout to gather data on medication adherence, health status, and HRQoL. Electronic medical records were reviewed for data on baseline classification of heart function and the number of unplanned hospitalizations and ED visits during the study period. Use of the medication monitoring system was associated with an 80% reduction in the risk of all-cause hospitalization and a significant decrease in the number of all-cause hospitalization length of stay in the intervention arm compared to usual care. Objective device data indicated high adherence rates (95%-99%) among intervention group participants despite finding no significant difference

  1. Cognitive impairment in heart failure: results from the Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure (TIME-CHF) randomized trial.

    Science.gov (United States)

    Huijts, Marjolein; van Oostenbrugge, Robert J; Duits, Annelien; Burkard, Thilo; Muzzarelli, Stefano; Maeder, Micha T; Schindler, Ruth; Pfisterer, Matthias E; Brunner-La Rocca, Hans-Peter

    2013-06-01

    Up to 50% of patients with heart failure (HF) may suffer from severe cognitive impairment (SCI), but longitudinal studies are sparse, and effects of changes in HF severity on cognitive function are unknown. Therefore, we assessed the prevalence of SCI in HF patients, its relationship with HF severity, its effects on morbidity and mortality, and the relationship between changes in HF severity and cognitive function. We included 611 patients from the Trial of Intensified versus standard Medical therapy in Elderly patients with Congestive Heart Failure (TIME-CHF) and assessed cognitive function [Hodkinson Abbreviated Mental Test (AMT)] in relation to severity of HF (NYHA class, NT-proBNP) at baseline and 18 months (n = 382) and effects on hospitalization-free survival and mortality. SCI (i.e. AMT score ≤ 7) was present in 9.2% of patients at baseline, but only 20% of them had a diagnosis of dementia. Prevalence of SCI remained stable during follow-up. SCI was present at baseline more often in NYHA IV patients compared with NYHA II [odds ratio 2.94; 95% confidence interval (CI) 1.15-7.51, P = 0.025], but it was not related to NT-proBNP levels. SCI was related to higher mortality (hazard ratio 1.53, 95% CI 1.02-2.30, P = 0.04), but not hospitalization-free survival. Changes in HF severity were not significantly related to changes in cognitive function. SCI is a frequent, but often unrecognized finding in HF patients, but the influence of HF severity and its changes on cognitive function were less than hypothesized. Trial registration ISRCTN43596477.

  2. Lycopene Supplementation in the Complementary Management of PSA Failure: A Randomized Placebo-Controlled Trial for Prostate Cancer Survivors

    National Research Council Canada - National Science Library

    Ukoli, Flora A; Kucuk, Omer; Fowke, Jay H

    2007-01-01

    ...) or whole-food supplement (Lyc-O-Mato(Registered)) in control of biochemical (PSA) failure in 78 African-American prostate cancer survivors treated initially by radical prostatectomy or radiation...

  3. Indirect vs direct bonding of mandibular fixed retainers in orthodontic patients: a single-center randomized controlled trial comparing placement time and failure over a 6-month period.

    Science.gov (United States)

    Bovali, Efstathia; Kiliaridis, Stavros; Cornelis, Marie A

    2014-12-01

    The objective of this 2-arm parallel single-center trial was to compare placement time and numbers of failures of mandibular lingual retainers bonded with an indirect procedure vs a direct bonding procedure. Sixty-four consecutive patients at the postgraduate orthodontic clinic of the University of Geneva in Switzerland scheduled for debonding and mandibular fixed retainer placement were randomly allocated to either an indirect bonding procedure or a traditional direct bonding procedure. Eligibility criteria were the presence of the 4 mandibular incisors and the 2 mandibular canines, and no active caries, restorations, fractures, or periodontal disease of these teeth. The patients were randomized in blocks of 4; the randomization sequence was generated using an online randomization service (www.randomization.com). Allocation concealment was secured by contacting the sequence generator for treatment assignment; blinding was possible for outcome assessment only. Bonding time was measured for each procedure. Unpaired t tests were used to assess differences in time. Patients were recalled at 1, 2, 4, and 6 months after bonding. Mandibular fixed retainers having at least 1 composite pad debonded were considered as failures. The log-rank test was used to compare the Kaplan-Meier survival curves of both procedures. A test of proportion was applied to compare the failures at 6 months between the treatment groups. Sixty-four patients were randomized in a 1:1 ratio. One patient dropped out at baseline after the bonding procedure, and 3 patients did not attend the recalls at 4 and 6 months. Bonding time was significantly shorter for the indirect procedure (321 ± 31 seconds, mean ± SD) than for the direct procedure (401 ± 40 seconds) (per protocol analysis of 63 patients: mean difference = 80 seconds; 95% CI = 62.4-98.1; P technique and 7 of 29 (24%) with the direct technique (log rank: P = 0.35; test of proportions: risk difference = 0.08; 95% CI = -0.15 to

  4. Positive predictive value and impact of misdiagnosis of a heart failure diagnosis in administrative registers among patients admitted to a University Hospital cardiac care unit

    Directory of Open Access Journals (Sweden)

    Shan Mard

    2010-10-01

    Full Text Available Shan Mard, Finn Erland NielsenDepartment of Cardiology, Herlev University Hospital, DenmarkObjective: To evaluate the positive predictive value (PPV of a diagnosis of heart failure (HF in the Danish National Registry of Patients (NRP among patients admitted to a University Hospital cardiac care unit, and to evaluate the impact of misdiagnosing HF.Design: The NRP was used to identify patients with heart failure from July 1, 2005 to June 30, 2007. Heart failure was defined in accordance with European Society of Cardiology (ESC guidelines. The recorded diagnoses from the NRP were compared with clinical data from the medical records.Results: We identified 758 patients with a diagnosis of heart failure in the NRP. The PPV of a heart failure discharge diagnosis was 84.0% (95% confidence interval: 81.2–86.6. Patients with a discharge diagnosis of HF in the NRP without fulfilling the ESC criteria for HF had a better survival rate, a lower rate of rehospitalization, none were followed in the outpatient clinic, and they had a lower consumption of anticongestive medicine after discharge.Conclusion: We found a relatively high PPV of the HF diagnosis in the NRP, and the NRP can therefore be a valuable tool for identification of patients with HF. However, using the NRP alone will not give a true picture of the cost and total burden of the disease.Keywords: heart failure, diagnosis, positive predictive value, National Registry of Patients

  5. In-vitro bond strengths and clinical failure rates of metal brackets bonded with different light-emitting diode units and curing times.

    Science.gov (United States)

    Oz, Abdullah Alper; Oz, Aslıhan Zeynep; Arici, Selim

    2016-02-01

    The purpose of this study was to compare the clinical failure rates and the in-vitro bond strengths of metal brackets bonded with different light-emitting diode (LED) devices and curing times. Forty patients were included in the clinical part of this study. A split-mouth design was used, with the adhesive in group 1 cured for 10 seconds with an LED unit (Elipar S10; 3M Unitek, Monrovia, Calif), and the adhesive in group 2 cured for 3 seconds with another LED unit (VALO Ortho; Ultradent Products, South Jordan, Utah). Bond failures during 12 months of orthodontic treatment were recorded. In-vitro performance of the brackets was also compared by bonding brackets to extracted premolars and using the same light units and curing times (n = 20 for each group). The adhesive remnant index was used to determine the bond failure interface. Clinical bond failure rates were 2.90% for the Elipar and 3.16% for the VALO curing units. The difference in bracket failure rates between the 2 LED devices was not statistically significant. No statistically significant difference was found between the in-vitro bond strengths of the groups. Our findings regarding long-term clinical survival rates and in-vitro bond strengths indicate that bracket bonding can be safely accomplished in 10 seconds of light-curing with an Elipar LED and 3 seconds of light-curing with a VALO LED. Copyright © 2016 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

  6. Time to failure and neuromuscular response to intermittent isometric exercise at different levels of vascular occlusion: a randomized crossover study

    Directory of Open Access Journals (Sweden)

    Mikhail Santos Cerqueira

    2017-04-01

    Full Text Available Objectives: The purpose this study was investigate the effects of different vascular occlusion levels (total occlusion (TO, partial occlusion (PO or free flow (FF during intermittent isometric handgrip exercise (IIHE on the time to failure (TF and the recovery of the maximum voluntary isometric force (MVIF, median frequency (EMGFmed and peak of EMG signal (EMGpeak after failure.  Methods: Thirteen healthy men (21 ± 1.71 year carried out an IIHE until the failure at 45% of MVIF with TO, PO or FF. Occlusion pressure was determined previously to the exercise. The MVIF, EMGFmed and EMGpeak were measured before and after exercise. Results: TF (in seconds was significantly different (p < 0.05 among all investigated conditions: TO (150 ± 68, PO (390 ± 210 and FF (510 ± 240. The MVIF was lower immediately after IIHE, remaining lower eleven minutes after failure in all cases (p <0.05, when compared to pre exercise. There was a greater force reduction (p <0.05 one minute after the failure in the PO (-45.8% and FF (-39.9% conditions, when compared to TO (-28.1%. Only the PO condition caused lower MVIF (p <0.05 than in the OT, eleven minutes after the task failure. PO caused a greater reduction in EMGFmed compared TO and greater increase in EMGpeak, when compared to TO and FF (p <0.05. Conclusions: TO during IIHE lead to a lower time to failure, but a faster MVIF recovery, while the PO seems to be associated to a slower neuromuscular recovery, when compared to other conditions.

  7. Endogenous markers of two separate hypoxia response pathways (hypoxia inducible factor 2 alpha and carbonic anhydrase 9) are associated with radiotherapy failure in head and neck cancer patients recruited in the CHART randomized trial.

    Science.gov (United States)

    Koukourakis, Michael I; Bentzen, Søren M; Giatromanolaki, Alexandra; Wilson, George D; Daley, Frances M; Saunders, Michele I; Dische, Stanley; Sivridis, Efthimios; Harris, Adrian L

    2006-02-10

    Randomized controlled trials have generally shown a benefit from accelerated radiotherapy in head and neck squamous cell carcinoma (HNSCC). However, the large randomized United Kingdom trial CHART (Continuous Hyperfractionated Accelerated Radiotherapy) failed to show a benefit of strongly accelerated over standard radiotherapy (RT) in 918 patients with HNSCC. In this study, we investigated the impact of tumor hypoxia on the outcome of HNSCC patients in the CHART trial. There are two distinct hypoxia inducible factors (HIFs) that control different gene response pathways and we assessed them both with endogenous markers of hypoxia, hypoxia inducible factor HIF-2 alpha (HIF-2) and carbonic anhydrase CA9, an indicator of HIF-1 alpha (HIF-1) function. Tissue from pre-RT biopsies performed in 198 of 918 patients recruited was analyzed for the immunohistochemical expression of HIF-2 and CA9. A significant association of high HIF2 and of high CA9 reactivity with poor locoregional control (P uni-directional hypothesis, that a benefit from randomization to CHART should be seen in the nonhypoxic tumors, was supported by the data (one-tailed P = .04). Expression of endogenous markers of hypoxia for the HIF-1 and HIF-2 pathway is strongly associated with radiotherapy failure. Using immunohistochemical methods it is possible to identify subgroups of HNSCC patients who are highly curable with radiotherapy, or who are excellent candidates for clinical trials on hypoxia-targeting drugs in two distinct pathways.

  8. The CONFINE (Comorbidities and Outcome iN patients with chronic heart Failure: a study in INternal mEdicine units study: a new epidemiologic observational study on heart failure in the internal medicine departments in Italy

    Directory of Open Access Journals (Sweden)

    P. Biagi

    2013-05-01

    Full Text Available BACKGROUND The burden of heart failure (HF is enormous and its prevalence increases sharply with age. It has been estimated that heart failure affects up to 3% of the general population and 10% of the elderly. It contributes to hospital admission for most of them, mainly elder adults (admitted in internal medicine units with more than one comorbidity, cognitive disorders, impairment and so on. Despite the increasing prevalence of heart failure, its exact incidence and prevalence remain largely unknown and probably underestimated due to a lack of accurate epidemiological data and difficulties associated with comorbidities and correct diagnosis: over 40% of recurrent hospitalization causes, either cardiac or extracardiac, cannot be determined due to the lack of data. AIM OF THE STUDY The objective of this study estimated the prevalence and the primary care burden associated with comorbidities in internal medicine units. METHOD The design: a longitudinal multicentric observational study using spot analysis three data sheets were filled in during the hospital stay according to three crucial moments: enrolment (“the index day”, admission and discharge. Will be analyzed the following primary outcomes: total and cardiovascular mortality, intensive unit care admission, recurrent cardiovascular disorders, length of stay, hospital readmission, changes in activities of daily living, need for care. Second outcomes: clinical, therapeutic, instrumental and laboratory changes during the admission process. Deep analysis of the following comorbidities will be also taken into account: acute and chronic kidney failure, anaemia, chronic obstructive pulmonary disease, muscle loss, nutritional status, cirrhosis of the liver, neoplasms, blood cell disorders, chronic inflammatory diseases. Further evalutation items: cognitive impairment, self-sufficiency and perception of quality life.

  9. [Survey on the management of acute renal failure and renal replacement techniques in Spanish intensive care units].

    Science.gov (United States)

    Úbeda-Iglesias, A; Herrera-Rojas, D; Gómez-González, C

    2015-03-01

    To analyze knowledge and experience in the diagnosis and management of acute renal failure (ARF) and the use of renal replacement therapy (RRT) in different Spanish Intensive Care Units (ICUs). A case series with a survey conducted by the Nephro-Intensive Care Working Group of the SEMICYUC was compiled between January and November 2011. Spanish national ICUs. A survey of 28 questions with multiple and open responses. The survey was sent to 99 ICUs. Volunteers consisting of the medical staff belonging to the 51 ICUs that responded. Main variables of interest General characteristics of hospitals and ICUs, definitions of ARF and RRT (indications and management). RIFLE/AKIN scales to define ARF (47%). ARF diagnosis: plasma creatinine (80.4%), creatinine clearance (52.9%). Protocols for RRT: 72.5%. RRT in non-renal indications: 70.6%. Indications for initiation of RRT: oliguria, increased creatinine and urea. End of RRT: increased diuresis. RRT dose: 21-35 ml/kg/h (41.2%), 36-45ml/kg/h (33.3%). There is great variability in the ARF detection methods, and adequate incorporation of the RIFLE/AKIN systems to daily clinical practice in the ICU is still lacking. Written protocols aimed at establishing an early diagnosis of ARF are needed, based on these systems. On the other hand, there is growing interest in RRT, despite the fact that there are no definitive indications or guidelines on the use and handling of such techniques. Copyright © 2013 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

  10. Long-term intermittent dobutamine infusion, combined with oral amiodarone for end-stage heart failure: a randomized double-blind study.

    Science.gov (United States)

    Nanas, John N; Tsagalou, Eleftheria P; Kanakakis, John; Nanas, Serafim N; Terrovitis, John V; Moon, Thomas; Anastasiou-Nana, Maria I

    2004-04-01

    To examine the effects of long-term intermittent dobutamine infusion, combined with oral amiodarone in patients with congestive heart failure (CHF) refractory to standard medical treatment. Prospective, randomized, double-blind, placebo-controlled clinical trial. Inpatient and outpatient heart failure clinic in a university teaching hospital. Thirty patients with end-stage CHF refractory to standard medical treatment who could be weaned from dobutamine therapy after a first 72-h infusion were randomized in a double-blind manner to receive IV infusions of placebo (group 1; 14 patients) vs dobutamine in a dose of 10 micro g/kg/min (group 2; 16 patients) for 8 h every 14 days. All patients received standard medical therapy and also were treated with oral amiodarone, 400 mg/d, which was started at least 2 weeks before randomization. Kaplan-Meier survival analysis showed a 60% reduction in the risk of death from any cause in the group treated with the combination of dobutamine and amiodarone, compared with the group treated with placebo and amiodarone (hazard ratio, 0.403; 95% confidence interval, 0.164 to 0.992; p = 0.048). The 1-year and 2-year survival rates were 69% and 44%, respectively, in the dobutamine-treated group, vs 28% and 21%, respectively, in the placebo-treated group (p amiodarone added to the conventional drugs improved the survival of patients with advanced CHF that was refractory to conventional treatment.

  11. The hot (invisible? hand: can time sequence patterns of success/failure in sports be modeled as repeated random independent trials?

    Directory of Open Access Journals (Sweden)

    Gur Yaari

    Full Text Available The long lasting debate initiated by Gilovich, Vallone and Tversky in [Formula: see text] is revisited: does a "hot hand" phenomenon exist in sports? Hereby we come back to one of the cases analyzed by the original study, but with a much larger data set: all free throws taken during five regular seasons ([Formula: see text] of the National Basketball Association (NBA. Evidence supporting the existence of the "hot hand" phenomenon is provided. However, while statistical traces of this phenomenon are observed in the data, an open question still remains: are these non random patterns a result of "success breeds success" and "failure breeds failure" mechanisms or simply "better" and "worse" periods? Although free throws data is not adequate to answer this question in a definite way, we speculate based on it, that the latter is the dominant cause behind the appearance of the "hot hand" phenomenon in the data.

  12. Introducing random safety audits (RSA) in a neonatal intensive care unit (NICU).

    LENUS (Irish Health Repository)

    Szymanska, M

    2012-01-31

    Random safety audits (RSA) have been shown to be effective in improving standards of clinical practice. 19 data collection audits were performed relating to hygiene, safe prescribing, oxygen pulse oximetry monitoring and documentation in keeping with the requirements of the new Medical Practitioners Act (MPA) 2007. Hygiene audits (range from 20\\/25 to 21\\/21 80%-100%) and safe prescribing audits (range from 23\\/25 to 25\\/25 86%-100%) achieved n=25 100% compliance with unit guidelines over a 3 month period. Compliance with oxygen pulse oximetry monitoring guideline limits improved from 4\\/27 (15%) to 9\\/16 (56%). Compliance with requirement and use of Physician IMC registration number in documentation was only 10\\/18 (56%). RSA\\'s led to improvements in hygiene and prescribing. Compliance with oxygen monitoring guideline limits highlighted the need for greater education. Awareness of legal requirements relating to documentation improved but this has not translated into a change in practice. RSA\\'s can facilitate real time quality improvement in daily clinical practice.

  13. Addition of non-invasive ventilatory support to combined aerobic and resistance training improves dyspnea and quality of life in heart failure patients: a randomized controlled trial.

    Science.gov (United States)

    Bittencourt, Hugo Souza; Cruz, Cristiano Gonçalves; David, Bruno Costa; Rodrigues-Jr, Erenaldo; Abade, Camille Magalhães; Junior, Roque Aras; Carvalho, Vitor Oliveira; Dos Reis, Francisco Borges Faria; Gomes Neto, Mansueto

    2017-11-01

    To test the hypothesis that combined aerobic and resistance training and non-invasive ventilatory support result in additional benefits compared with combined aerobic and resistance training alone in heart failure patients. A randomized, single-blind, controlled study. Cardiac rehabilitation center. A total of 46 patients with New York Heart Association class II/III heart failure were randomly assigned to a 10-week program of combined aerobic and resistance training, plus non-invasive ventilatory support ( n = 23) or combined aerobic and resistance training alone ( n = 23). Before and after intervention, results for the following were obtained: 6-minute walk test, forced vital capacity, forced expiratory volume at one second, maximal inspiratory muscle pressure, and maximal expiratory muscle pressure, with evaluation of dyspnea by the London Chest Activity of Daily Living scale, and quality of life with the Minnesota Living With Heart Failure questionnaire. Of the 46 included patients, 40 completed the protocol. The combined aerobic and resistance training plus non-invasive ventilatory support, as compared with combined aerobic and resistance training alone, resulted in significantly greater benefit for dyspnea (mean change: 4.8 vs. 1.3, p = 0.004), and quality of life (mean change: 19.3 vs. 6.8, p = 0.017 ). In both groups, the 6-minute walk test improved significantly (mean change: 45.7 vs. 44.1, p = 0.924), but without a statistically significant difference. Non-invasive ventilatory support combined with combined aerobic and resistance training provides additional benefits for dyspnea and quality of life in moderate heart failure patients. ClinicalTrials.gov identifier: NCT02384798. Registered 03 April 2015.

  14. 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

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

    Science.gov (United States)

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

    2015-01-01

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

  16. Effects of Coping Skills Training on Quality of Life, Disease Biomarkers, and Clinical Outcomes in Patients With Heart Failure: A Randomized Clinical Trial.

    Science.gov (United States)

    Sherwood, Andrew; Blumenthal, James A; Koch, Gary G; Hoffman, Benson M; Watkins, Lana L; Smith, Patrick J; O'Connor, Christopher M; Adams, Kirkwood F; Rogers, Joseph G; Sueta, Carla; Chang, Patricia P; Johnson, Kristy S; Schwartz, Jeanne; Hinderliter, Alan L

    2017-01-01

    Heart failure (HF) is a chronic disease that compromises patients' quality of life (QoL). Interventions designed to reduce distress and improve disease self-management are needed. We evaluated the efficacy of a telephone-based coping skills training (CST) intervention. This randomized clinical trial involved 180 HF outpatients with reduced ejection fraction. Participants ranged in age from 29 to 87 years (mean=58 years); 27% were women, and 47% were nonwhite. Participants were randomized to either a CST intervention or heart failure education, both delivered over 16 weeks. The primary outcomes were (1) postintervention effects on QoL and HF disease biomarkers (both with α=0.01), and (2) a composite measure of time to death or first hospitalization (with α=0.03) over a median follow-up period of 3 years. CST resulted in greater improvements in QoL compared with heart failure education (P<0.01), including the Kansas City Cardiomyopathy Questionnaire (P=0.009), depressive symptoms (P=0.027), and the 6-minute walk test (P=0.012). However, it did not differentially improve HF disease biomarkers or reduce risk of all-cause hospitalizations or death (hazard ratio=0.84 [95% confidence interval, 0.59-1.12]). Interestingly, exploratory analyses showed that participants randomized to CST experienced a reduction in the composite end point of worsening HF hospitalization or death during the 3-year follow-up period (hazard ratio=0.65 [95% confidence interval, 0.44-0.98]; P=0.040). CST improved QoL in patients with HF. Monitoring and improving QoL is emerging as an important aspect of the clinical management of HF that can reduce disease burden and may help improve clinical outcomes in this vulnerable patient population. URL: https://www.clinicaltrials.gov. Unique identifier: NCT00873418. © 2017 American Heart Association, Inc.

  17. A prospective randomized trial of open surgery versus endourological stone removal in patients of staghorn stones with chronic renal failure

    Directory of Open Access Journals (Sweden)

    Anant Kumar

    2001-01-01

    Conclusion: In view of the better clearance rate and lesser cost of treatment, open surgery still has a place in the management of staghorn stones with chronic renal failure even in a tertiary urological center. However postoperative pain and a larger scar cannot be ignored.

  18. The burden of nosocomial infection in the intensive care unit: Effects on organ failure, mortality and costs. A nested case-control study.

    Science.gov (United States)

    Sánchez-Velázquez, Luis D; Ponce de León Rosales, Samuel; Rangel Frausto, M Sigfrido

    2006-04-01

    Nosocomial infections increase mortality and costs in the intensive care units; however, few studies have addressed organ failure that developed in infected patients and their overall costs. The goal of this study was to measure the frequency of organ failure in nosocomial infection and the mortality and costs of these in critical care areas. This was a nested 1:2 case-control study in a cohort of all consecutively hospitalized patients comparing those with and without nosocomial infections over a year in an institutional intensive care unit (ICU). Those patients who acquired an infection during hospitalization were considered cases. Controls were matched by hospital stay at least as long as the cases' time acquisition of nosocomial infection, age +/-5 years and APACHE II +/-5 points. Forty-three patients developed at least one nosocomial infection event (cases). The matching success was about 94%. Higher frequency and duration of organ failures was observed in the cases, as well as the number of devices and procedures (p nosocomial infection acquired in the ICU was 12,155 dollars. Nosocomial infection acquired in the ICU increases length of stay, frequency and duration of organ failures, mortality, and costs.

  19. Serum 1H-NMR metabolomic fingerprints of acute-on-chronic liver failure in intensive care unit patients with alcoholic cirrhosis.

    Directory of Open Access Journals (Sweden)

    Roland Amathieu

    Full Text Available INTRODUCTION: Acute-on-chronic liver failure is characterized by acute deterioration of liver function in patients with compensated or decompensated, but stable, cirrhosis. However, there is no accurate definition of acute-on-chronic liver failure and physicians often use this term to describe different clinical entities. Metabolomics investigates metabolic changes in biological systems and identifies the biomarkers or metabolic profiles. Our study assessed the metabolomic profile of serum using proton nuclear magnetic resonance ((1H-NMR spectroscopy to identify metabolic changes related to acute-on-chronic liver failure. PATIENTS: Ninety-three patients with compensated or decompensated cirrhosis (CLF group but stable liver function and 30 patients with cirrhosis and hospitalized for the management of an acute event who may be responsible of acute-on-chronic liver failure (ACLF group, were fully analyzed. Blood samples were drawn at admission, and sera were separated and stored at -80°C until (1H-NMR spectral analysis. Using orthogonal projection to latent-structure discriminant analyses, various metabolites contribute to the complete separation between these both groups. RESULTS: The predictability of the model was 0.73 (Q(2 Y and the explained variance was 0.63 (R(2 Y. The main metabolites that had increased signals related to acute-on-chronic liver failure were lactate, pyruvate, ketone bodies, glutamine, phenylalanine, tyrosine, and creatinine. High-density lipids were lower in the ALCF group than in CLF group. CONCLUSION: A serum metabolite fingerprint for acute-on-chronic liver failure, obtained with (1H-NMR, was identified. Metabolomic profiling may aid clinical evaluation of patients with cirrhosis admitted into intensive care units with acute-on-chronic liver failure, and provide new insights into the metabolic processes involved in acute impairment of hepatic function.

  20. Management of diabetes by a healthcare team in a cardiology unit: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Maria Antonieta P. de Moraes

    2013-11-01

    Full Text Available OBJECTIVE: To assess the effectiveness of healthcare team guidance in the implementation of a glycemic control protocol in the non-intensive care unit of a cardiology hospital. METHODS: This was a randomized clinical trial comparing 9 months of intensive guidance by a healthcare team on a protocol for diabetes care (Intervention Group, n = 95 with 9 months of standard care (Control Group, n = 87. Clinicaltrials.gov: NCT01154413. RESULTS: The mean age of the patients was 61.7±10 years, and the mean glycated hemoglobin level was 71±23 mmol/mol (8.7±2.1%. The mean capillary glycemia during hospitalization was similar between the groups (9.8±2.9 and 9.1±2.4 mmol/l for the Intervention Group and Control Group, respectively, p = 0.078. The number of hypoglycemic episodes (p = 0.77, hyperglycemic episodes (47 vs. 50 in the Intervention Group and Control Group, p = 0.35, respectively, and the length of stay in the hospital were similar between the groups (p = 0.64. The amount of regular insulin administered was 0 (0-10 IU in the Intervention Group and 28 (7-56 IU in the Control Group (p<0.001, and the amount of NPH insulin administered was similar between the groups (p = 0.16. CONCLUSIONS: While guidance on a glycemic control protocol given by a healthcare team resulted in a modification of the therapeutic strategy, no changes in glycemic control, frequency of episodes of hypoglycemia and hyperglycemia, or hospitalization duration were observed.

  1. Intensive Early Rehabilitation in the Intensive Care Unit for Liver Transplant Recipients: A Randomized Controlled Trial.

    Science.gov (United States)

    Maffei, Pierre; Wiramus, Sandrine; Bensoussan, Laurent; Bienvenu, Laurence; Haddad, Eric; Morange, Sophie; Fathallah, Mohamed; Hardwigsen, Jean; Viton, Jean-Michel; Le Treut, Y Patrice; Albanese, Jacques; Gregoire, Emilie

    2017-08-01

    To validate the feasibility and tolerance of an intensive rehabilitation protocol initiated during the postoperative period in an intensive care unit (ICU) in liver transplant recipients. Prospective randomized study. ICU. Liver transplant recipients over a period of 1 year (N=40). The "usual treatment group" (n=20), which benefited from the usual treatment applied in the ICU (based on physician prescription for the physiotherapist, with one session a day), and the experimental group (n=20), which followed a protocol of early and intensive rehabilitation (based on a written protocol validated by physicians and an evaluation by physiotherapist, with 2 sessions a day), were compared. Our primary aims were tolerance, assessed from the number of adverse events during rehabilitation sessions, and feasibility, assessed from the number of sessions discontinued. The results revealed a small percentage of adverse events (1.5% in the usual treatment group vs 1.06% in the experimental group) that were considered to be of low intensity. Patients in the experimental group sat on the edge of their beds sooner (2.6 vs 9.7d; P=.048) and their intestinal transit resumed earlier (5.6 vs 3.7d; P=.015) than patients in the usual treatment group. There was no significant difference between the 2 arms regarding length of stay (LOS), despite a decrease in duration in the experimental group. The introduction of an intensive early rehabilitation program for liver transplant recipients was well tolerated and feasible in the ICU. We noted that the different activities proposed were introduced sooner in the experimental group. Moreover, there is a tendency to decreased LOS in the ICU for the experimental group. These results now need to be confirmed by studies on a larger scale. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  2. Hydrochlorothiazide in intensive care unit-acquired hypernatremia: A randomized controlled trial.

    Science.gov (United States)

    van IJzendoorn, Marjolein M C O; Buter, Hanneke; Kingma, W Peter; Koopmans, Matty; Navis, Gerjan; Boerma, E Christiaan

    2017-04-01

    Thiazides are suggested as a treatment for intensive care unit (ICU)-acquired hypernatremia (IAH). The primary aim of the study was reducing serum sodium concentration (sNa) in patients with IAH with hydrochlorothiazide (HCT) in comparison to placebo. Secondary end points were a difference in urine sodium concentration (uNa) and duration of severe IAH. A monocentric, double-blind, placebo-controlled trial was conducted in 50 patients with IAH and urine potassium + uNa less than sNa in a spot urine sample. Patients were randomized to HCT 25 mg or placebo 1 qd for maximal 7 days. Patients on renal replacement therapy, on medication inducing diabetes insipidus, or with recent use of diuretics were excluded. IAH was defined as sNa of at least 143 mmol/L. At baseline, sNa and uNa were comparable between groups. During the study period, sNa decreased significantly with median 4 mmol/L in both groups, with no significant difference between groups (P=.32). Median uNa increased significantly in both groups (46 [16-86] mmol/L in the HCT-group; 20 [10-66]mmol/L in the placebo group), with no difference between groups (P=.34). Median duration of sNa of at least 145 mmol/L was 3 days in both groups (P=.91). HCT 25 mg 1 qd did not significantly affect sNa or uNa in patients with IAH. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  3. A vector-based failure detection and isolation algorithm for a dual fail-operational redundant strapdown inertial measurement unit

    Science.gov (United States)

    Morrell, Frederick R.; Bailey, Melvin L.

    1987-01-01

    A vector-based failure detection and isolation technique for a skewed array of two degree-of-freedom inertial sensors is developed. Failure detection is based on comparison of parity equations with a threshold, and isolation is based on comparison of logic variables which are keyed to pass/fail results of the parity test. A multi-level approach to failure detection is used to ensure adequate coverage for the flight control, display, and navigation avionics functions. Sensor error models are introduced to expose the susceptibility of the parity equations to sensor errors and physical separation effects. The algorithm is evaluated in a simulation of a commercial transport operating in a range of light to severe turbulence environments. A bias-jump failure level of 0.2 deg/hr was detected and isolated properly in the light and moderate turbulence environments, but not detected in the extreme turbulence environment. An accelerometer bias-jump failure level of 1.5 milli-g was detected over all turbulence environments. For both types of inertial sensor, hard-over, and null type failures were detected in all environments without incident. The algorithm functioned without false alarm or isolation over all turbulence environments for the runs tested.

  4. Weaning injured patients with prolonged pulmonary failure from mechanical ventilation in a non-intensive care unit setting.

    Science.gov (United States)

    deBoisblanc, M W; Goldman, R K; Mayberry, J C; Brand, D M; Pangburn, P D; Soifer, B E; Mullins, R J

    2000-08-01

    Injured patients with pulmonary failure often require prolonged length of stay in an intensive care unit (ICU), which includes weaning from ventilatory support. In the last decade, noninvasive ventilation modes have been established as safe and effective. One method for accomplishing this mode of ventilation uses a simple bilevel ventilator. Because this ventilator has been successfully used in hospital wards, we postulated that bilevel ventilators could provide sufficient support during weaning from mechanical ventilation of injured patients in a non-ICU setting. A retrospective review of trauma patients (August 1996-January 1999) undergoing bilevel positive pressure ventilation as the final phase of weaning was conducted. Before ward transfer with bilevel ventilation, conventionally ventilated ICU patients were changed to bilevel ventilation and were required to tolerate this mode for at least 24 hours. All patients had a tracheostomy as a secure airway. Outcomes analyzed included ICU length of stay, hospital length of stay, duration of mechanical ventilation, weaning success, complications, and survival. Fifty-one patients (39 men, 12 women) with a mean age of 53 received more than 24 hours of bilevel positive pressure ventilation. Mean Injury Severity Score was 29, with blunt mechanisms of injury occurring in 90%. Chest or spinal cord injuries that affected pulmonary mechanics were present in 75% of patients. Ventilator-associated pneumonia was treated in 43% of patients. Mean ICU length of stay and hospital length of stay were 21 and 34 days, respectively. Weaning was successful in 89% of patients, whereas 11% were discharged to skilled nursing facilities still receiving bilevel positive pressure ventilation. Two patients died, neither from a pulmonary nor airway complication. Of the remaining 49 patients, 12 were weaned in the ICU and 37 were transferred to the ward with bilevel ventilatory support. The average length of ward ventilation was 6.5 +/- 5.4 days

  5. Use of simulation-based education to improve resident learning and patient care in the medical intensive care unit: a randomized trial.

    Science.gov (United States)

    Schroedl, Clara J; Corbridge, Thomas C; Cohen, Elaine R; Fakhran, Sherene S; Schimmel, Daniel; McGaghie, William C; Wayne, Diane B

    2012-04-01

    The purpose of this study is to determine the effect of simulation-based education on the knowledge and skills of internal medicine residents in the medical intensive care unit (MICU). From January 2009 to January 2010, 60 first-year residents at a tertiary care teaching hospital were randomized by month of rotation to an intervention group (simulator-trained, n = 26) and a control group (traditionally trained, n = 34). Simulator-trained residents completed 4 hours of simulation-based education before their medical intensive care unit (MICU) rotation. Topics included circulatory shock, respiratory failure, and mechanical ventilation. After their rotation, residents completed a standardized bedside skills assessment using a 14-item checklist regarding respiratory mechanics, ventilator settings, and circulatory parameters. Performance of simulator-trained and traditionally trained residents was compared using a 2-tailed independent-samples t test. Simulator-trained residents scored significantly higher on the bedside skills assessment compared with traditionally trained residents (82.5% ± 10.6% vs 74.8% ± 14.1%, P = .027). Simulator-trained residents were highly satisfied with the simulation curriculum. Simulation-based education significantly improved resident knowledge and skill in the MICU. Knowledge acquired in the simulated environment was transferred to improved bedside skills caring for MICU patients. Simulation-based education is a valuable adjunct to standard clinical training for residents in the MICU. Copyright © 2012 Elsevier Inc. All rights reserved.

  6. Targeted anticytokine therapy in patients with chronic heart failure: results of the Randomized Etanercept Worldwide Evaluation (RENEWAL)

    DEFF Research Database (Denmark)

    Mann, Douglas L; McMurray, John J V; Packer, Milton

    2004-01-01

    BACKGROUND: Studies in experimental models and preliminary clinical experience suggested a possible therapeutic role for the soluble tumor necrosis factor antagonist etanercept in heart failure. METHODS AND RESULTS: Patients with New York Heart Association class II to IV chronic heart failure...... and a left ventricular ejection fraction etanercept used. In RECOVER, patients received placebo (n=373) or subcutaneous etanercept in doses of 25 mg every week (n=375) or 25 mg twice per week (n=375). In RENAISSANCE, patients...... received placebo (n=309), etanercept 25 mg twice per week (n=308), or etanercept 25 mg 3 times per week (n=308). The primary end point of each individual trial was clinical status at 24 weeks. Analysis of the effect of the 2 higher doses of etanercept on the combined outcome of death or hospitalization due...

  7. Predicting the Velocity and Azimuth of Fragments Generated by the Range Destruction or Random Failure of Rocket Casings and Tankage

    Energy Technology Data Exchange (ETDEWEB)

    Eck, Marshall B.; Mukunda, Meera

    1988-10-01

    The details of a predictive analytical modeling process as well as the development of normalized relations for momentum partition as a function of SRM burn time and initial geometry are discussed in this paper. Methods for applying similar modeling techniques to liquid-tankage-over-pressure failures are also discussed. These methods have been calibrated against observed SRM ascent failures and on-orbit tankage failures. Casing-quadrant sized fragments with velocities exceeding 100 m/s resulted from Titan 34D-SRM range destruct actions at 10 sec mission elapsed time (MET). Casing-quadrant sized fragments with velocities of approximately 200 m/s resulted from STS-SRM range destruct actions at 110 sec MET. Similar sized fragments for Ariane third stage and Delta second stage tankage were predicted to have maximum velocities of 260 m/s and 480 m/s respectively. Good agreement was found between the predictions and observations for five specific events and it was concluded that the methods developed have good potential for use in predicting the fragmentation process of a number of generically similar casing and tankage systems. There are three copies in the file, one of these is loose.

  8. N-acetylcysteine for prevention of acute renal failure in patients with chronic renal insufficiency undergoing cardiac surgery: a prospective, randomized, clinical trial.

    Science.gov (United States)

    Sisillo, Erminio; Ceriani, Roberto; Bortone, Franco; Juliano, Glauco; Salvi, Luca; Veglia, Fabrizio; Fiorentini, Cesare; Marenzi, Giancarlo

    2008-01-01

    To assess the preventive effect of the antioxidant N-acetylcysteine on postoperative acute renal failure in patients with renal insufficiency undergoing cardiac surgery. Randomized, placebo-controlled, prospective study. University cardiology center. Two hundred fifty-four consecutive patients with chronic renal insufficiency (estimated creatinine clearance 25% increase in serum creatinine from baseline) and the in-hospital clinical course were evaluated. Acute renal failure occurred in 46% of patients and was associated with increased in-hospital mortality (7% vs. 0.7%; p = .024). It occurred in 52% of control patients and 40% of N-acetylcysteine-treated patients (p = .06). In-hospital mortality and need for renal replacement therapy were not affected by N-acetylcysteine, but a lower percentage of N-acetylcysteine-treated patients required mechanical ventilation prolonged for > 48 hrs (3% vs. 18%; p 4 days (13% vs. 33%; p < .001). Intravenous administration of N-acetylcysteine does not clearly prevent postoperative acute renal failure in patients with renal insufficiency undergoing cardiac surgery.

  9. Effects of intravenous iron therapy in iron-deficient patients with systolic heart failure: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Jankowska, Ewa A; Tkaczyszyn, Michał; Suchocki, Tomasz; Drozd, Marcin; von Haehling, Stephan; Doehner, Wolfram; Banasiak, Waldemar; Filippatos, Gerasimos; Anker, Stefan D; Ponikowski, Piotr

    2016-07-01

    The aim of this study was to assess the net clinical and prognostic effects of intravenous (i.v.) iron therapy in patients with systolic heart failure (HF) and iron deficiency (ID). We performed an aggregate data meta-analysis (random effects model) of randomized controlled trials that evaluated the effects of i.v. iron therapy in iron-deficient patients with systolic HF. We searched electronic databases up to September 2014. We identified five trials which fulfilled the inclusion criteria (509 patients received i.v. iron therapy in comparison with 342 controls). Intravenous iron therapy has been shown to reduce the risk of the combined endpoint of all-cause death or cardiovascular hospitalization [odds ratio (OR) 0.44, 95% confidence interval (CI) 0.30-0.64, P Intravenous iron therapy resulted in a reduction in NYHA class (data are reported as a mean net effect with 95% CIs for all continuous variables) (-0.54 class, 95% CI -0.87 to -0.21, P = 0.001); an increase in 6-min walking test distance (+31 m, 95% CI 18-43, P therapy in iron-deficient patients with systolic HF improves outcomes, exercise capacity, and quality of life, and alleviates HF symptoms. © 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.

  10. A Randomized Trial to Evaluate the Effect of Local Endometrial Injury on the Clinical Pregnancy Rate of Frozen Embryo Transfer Cycles in Patients With Repeated Implantation Failure

    Directory of Open Access Journals (Sweden)

    Ensieh Shahrokh-Tehraninejad

    2016-12-01

    Full Text Available Objective: Repeated implantation failure (RIF is a condition in which the embryos implantation decreases in the endometrium. So, our aim was to evaluate the effect of local endometrial injury on embryo transfer results.Materials and methods: In this simple randomized clinical trial (RCT, a total of 120 patients were selected. The participants were less than 40 years old, and they are in their minimum two cycles of vitro fertilization (IVF. Patients were divided randomly into two groups of LEI (Local endometrial injury and a control group (n = 60 in each group. The first group had four small endometrial injuries from anterior, posterior, and lateral uterus walls which were obtained from people who were in 21th day of their previous IVF cycle. The second group was the patients who have not received any intervention.Results: The experimental and control patients were matched in the following factors. Regarding the clinical pregnancy rate, there was no significant difference noted between the experimental and the control group.Conclusion: Local endometrial injury in a preceding cycle does not increase the clinical pregnancy rate in the subsequent FET cycle of patients with repeated implantation failure.

  11. Functional and psychosocial effects of either a traditional dancing or a formal exercising training program in patients with chronic heart failure: a comparative randomized controlled study.

    Science.gov (United States)

    Kaltsatou, Antonia C H; Kouidi, Evangelia I; Anifanti, Maria A; Douka, Stella I; Deligiannis, Asterios P

    2014-02-01

    To compare the effects of traditional dancing with formal exercise training in terms of functional and cardiovascular benefits and motivation in patients with chronic heart failure. Randomized controlled trial. Sports Medicine Laboratory. Fifty-one Greek male patients aged 67.1±5.5 years with chronic heart failure of New York Heart Association (NYHA) class II-III, participated in an eight-month study. They were randomly assigned to either training with Greek traditional dances (group A, n=18), formal exercise training (group B, n=16) or a sedentary control group (group C, n=17). At entry and the end of the study all patients underwent cardiopulmonary exercise testing, functional ability assessment and quality of life evaluations. The Intrinsic Motivation Inventory was also used to assess participants' subjective experience. After training group A showed increased peak oxygen consumption by 33.8% (19.5 vs. 26.1 ml/kg/min, pdances led to functional and cardiovascular benefits similar to formal exercise training and to a higher level of motivation.

  12. Long Term Follow-Up after a Randomized Integrated Educational and Psychosocial Intervention in Patient-Partner Dyads Affected by Heart Failure.

    Directory of Open Access Journals (Sweden)

    Maria Liljeroos

    Full Text Available To date, contemporary heart failure care remains patient-focused, but awareness of the partners' and families' situation is increasing. Randomized studies have mainly evaluated the short-term effects of dyadic interventions. Therefore, the aim of this study was to determine the 24-month effects of an intervention with psych-educational support in dyads of heart failure patients and their partners.This study used a randomized study design and 155 patient-partner dyads were enrolled. The intervention included a nurse-led program of three sessions addressing psychoeducational support.The intervention did not have any effect on health, depressive symptoms or perceived control among the patient-partner dyads after 24 months. Furthermore, time to first event did not differ significantly between the intervention group and the control patients.This study may be regarded as a first step in trying to understand dyads' need for supportive care. Individualized and more targeted interventions seem necessary to achieve a higher impact on dyad outcomes.ClinicalTrials.gov NCT02398799.

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

    Science.gov (United States)

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

    2015-01-01

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

  14. Effects of yoga versus hydrotherapy training on health-related quality of life and exercise capacity in patients with heart failure: A randomized controlled study.

    Science.gov (United States)

    Hägglund, Ewa; Hagerman, Inger; Dencker, Kerstin; Strömberg, Anna

    2017-06-01

    The aims of this study were to determine whether yoga and hydrotherapy training had an equal effect on the health-related quality of life in patients with heart failure and to compare the effects on exercise capacity, clinical outcomes, and symptoms of anxiety and depression between and within the two groups. The design was a randomized controlled non-inferiority study. A total of 40 patients, 30% women (mean±SD age 64.9±8.9 years) with heart failure were randomized to an intervention of 12 weeks, either performing yoga or training with hydrotherapy for 45-60 minutes twice a week. Evaluation at baseline and after 12 weeks included self-reported health-related quality of life, a six-minute walk test, a sit-to-stand test, clinical variables, and symptoms of anxiety and depression. Yoga and hydrotherapy had an equal impact on quality of life, exercise capacity, clinical outcomes, and symptoms of anxiety and depression. Within both groups, exercise capacity significantly improved (hydrotherapy p=0.02; yoga p=0.008) and symptoms of anxiety decreased (hydrotherapy p=0.03; yoga p=0.01). Patients in the yoga group significantly improved their health as rated by EQ-VAS ( p=0.004) and disease-specific quality of life in the domains symptom frequency ( p=0.03), self-efficacy ( p=0.01), clinical summary as a combined measure of symptoms and social factors ( p=0.05), and overall summary score ( p=0.04). Symptoms of depression were decreased in this group ( p=0.005). In the hydrotherapy group, lower limb muscle strength improved significantly ( p=0.01). Yoga may be an alternative or complementary option to established forms of exercise training such as hydrotherapy for improvement in health-related quality of life and may decrease depressive symptoms in patients with heart failure.

  15. Effect of a multidisciplinary supportive program for family caregivers of patients with heart failure on caregiver burden, quality of life, and depression: A randomized controlled study.

    Science.gov (United States)

    Hu, Xiaolin; Dolansky, Mary A; Su, Yonglin; Hu, Xiuying; Qu, Moying; Zhou, Lingjuan

    2016-10-01

    Caregivers of patients with heart failure experience burden and negative health outcomes. Adequate support for family caregivers improves their well-being and the quality of care provided to the patients. However, little is known about the benefits of interventions for caregivers of patients with heart failure in China. To test the effects of a multidisciplinary supportive program for family caregivers on caregiver burden, quality of life, and depression. A randomized controlled design with repeated measures was used in this study. A total of 118 participants were randomized into experimental (n=59) and control groups (n=59) from May to December 2014 in one hospital in Chengdu, People's Republic of China. Participants in the experimental group received a 3-month multidisciplinary supportive program, consisting of three 60-min sessions of group classes, three 30-min peer support groups, and regular telephone follow-ups and consultations, while participants in the control group received usual care only. Outcomes were caregiver burden, quality of life, and depression. Data were collected at baseline, post-test (3 months after discharge), and 3 months after post-test (6 months after discharge). The repeated measures analysis of variance was used to examine the effects of groups, changes over time, and time-group interaction on outcome variables. There were significant improvements in caregiver burden, mental health, and depression after post-test and 3 months after post-test in the experimental group. However, there was no significant improvement in caregivers' physical health at either 3 or 6 months following discharge. A multidisciplinary supportive program for caregivers of heart failure patients had positive effects and provides a unique perspective of an intervention considering Chinese culture and customs. Copyright © 2016 Elsevier Ltd. All rights reserved.

  16. Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure With Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce Elevated Left Atrial Pressure in Patients With Heart Failure]): A Phase 2, Randomized, Sham-Controlled Trial.

    Science.gov (United States)

    Feldman, Ted; Mauri, Laura; Kahwash, Rami; Litwin, Sheldon; Ricciardi, Mark J; van der Harst, Pim; Penicka, Martin; Fail, Peter S; Kaye, David M; Petrie, Mark C; Basuray, Anupam; Hummel, Scott L; Forde-McLean, Rhondalyn; Nielsen, Christopher D; Lilly, Scott; Massaro, Joseph M; Burkhoff, Daniel; Shah, Sanjiv J

    2018-01-23

    In nonrandomized, open-label studies, a transcatheter interatrial shunt device (IASD, Corvia Medical) was associated with lower pulmonary capillary wedge pressure (PCWP), fewer symptoms, and greater quality of life and exercise capacity in patients with heart failure (HF) and midrange or preserved ejection fraction (EF ≥40%). We conducted the first randomized sham-controlled trial to evaluate the IASD in HF with EF ≥40%. REDUCE LAP-HF I (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure) was a phase 2, randomized, parallel-group, blinded multicenter trial in patients with New York Heart Association class III or ambulatory class IV HF, EF ≥40%, exercise PCWP ≥25 mm Hg, and PCWP-right atrial pressure gradient ≥5 mm Hg. Participants were randomized (1:1) to the IASD versus a sham procedure (femoral venous access with intracardiac echocardiography but no IASD placement). The participants and investigators assessing the participants during follow-up were blinded to treatment assignment. The primary effectiveness end point was exercise PCWP at 1 month. The primary safety end point was major adverse cardiac, cerebrovascular, and renal events at 1 month. PCWP during exercise was compared between treatment groups using a mixed-effects repeated measures model analysis of covariance that included data from all available stages of exercise. A total of 94 patients were enrolled, of whom 44 met inclusion/exclusion criteria and were randomized to the IASD (n=22) and control (n=22) groups. Mean age was 70±9 years, and 50% were female. At 1 month, the IASD resulted in a greater reduction in PCWP compared with sham control (P=0.028 accounting for all stages of exercise). Peak PCWP decreased by 3.5±6.4 mm Hg in the treatment group versus 0.5±5.0 mm Hg in the control group (P=0.14). There were no peri-procedural or 1-month major adverse cardiac, cerebrovascular, and renal events in the IASD group and 1 event (worsening renal function) in the

  17. Managing Successful Pregnancies in Patients with Chronic Intestinal Failure on Home Parenteral Nutrition: Experience from a UK National Intestinal Failure Unit.

    Science.gov (United States)

    Bond, Ashley; Vasant, Dipesh H; Gashau, Wadiamu; Abraham, Arun; Teubner, Antje; Farrer, Kristine; Leahy, Gavin; Lal, Simon

    2017-12-01

    There are minimal reports of pregnancy in the chronic intestinal failure (CIF)/ home parenteral nutrition (HPN) population, with some concern relating to the risk associated with such pregnancies. The aim of this retrospective observational study was to evaluate pregnancy experience and outcomes in patients with CIF requiring HPN in a national UK CIF referral centre. All known pregnancies in patients treated with HPN for CIF between 1982 and 2016 were identified retrospectively from a prospectively maintained database. Maternal and foetal outcomes were collated, along with PN requirements before and during pregnancy. There were 5 pregnancies in 5 mothers in our cohort consisting of over 700 patients, males and females. The median age at conception was 28 years (range 24-33 years). The median duration on HPN prior to pregnancy was 26 months (range 4-85 months). One patient had Crohn's disease, another had pan-enteric dysmotility and the other three patients had ischaemic complications leading to short bowel syndrome (SBS). All mothers were intensively monitored in an obstetric clinic and a dedicated CIF multi-disciplinary clinic throughout pregnancy. There were 2/5 preterm deliveries. One of the preterm deliveries was associated with spontaneous labour and the other had a planned induction as a result of maternal clinical need. Neonatal complications were seen in both prenates. There were no recorded maternal catheter related line infections during the 5 pregnancies. Successful pregnancy whilst receiving HPN is feasible but requires close, intensive monitoring and dedicated optimisation of PN in order to minimise maternal and foetal complications. All women of child-bearing age on HPN should be counselled about pregnancy.

  18. Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial.

    Science.gov (United States)

    Kalter-Leibovici, Ofra; Freimark, Dov; Freedman, Laurence S; Kaufman, Galit; Ziv, Arnona; Murad, Havi; Benderly, Michal; Silverman, Barbara G; Friedman, Nurit; Cukierman-Yaffe, Tali; Asher, Elad; Grupper, Avishay; Goldman, Dorit; Amitai, Miriam; Matetzky, Shlomi; Shani, Mordechai; Silber, Haim

    2017-05-01

    The efficacy of disease management programs in improving the outcome of heart failure patients remains uncertain and may vary across health systems. This study explores whether a countrywide disease management program is superior to usual care in reducing adverse health outcomes and improving well-being among community-dwelling adult patients with moderate-to-severe chronic heart failure who have universal access to advanced health-care services and technologies. In this multicenter open-label trial, 1,360 patients recruited after hospitalization for heart failure exacerbation (38%) or from the community (62%) were randomly assigned to either disease management or usual care. Disease management, delivered by multi-disciplinary teams, included coordination of care, patient education, monitoring disease symptoms and patient adherence to medication regimen, titration of drug therapy, and home tele-monitoring of body weight, blood pressure and heart rate. Patients assigned to usual care were treated by primary care practitioners and consultant cardiologists. The primary composite endpoint was the time elapsed till first hospital admission for heart failure exacerbation or death from any cause. Secondary endpoints included the number of all hospital admissions, health-related quality of life and depression during follow-up. Intention-to-treat comparisons between treatments were adjusted for baseline patient data and study center. During the follow-up, 388 (56.9%) patients assigned to disease management and 387 (57.1%) assigned to usual care had a primary endpoint event. The median (range) time elapsed until the primary endpoint event or end of study was 2.0 (0-5.0) years among patients assigned to disease management, and 1.8 (0-5.0) years among patients assigned to usual care (adjusted hazard ratio, 0.908; 95% confidence interval, 0.788 to 1.047). Hospital admissions were mostly (70%) unrelated to heart failure. Patients assigned to disease management had a better

  19. Cascaded failures in weighted networks

    Science.gov (United States)

    Mirzasoleiman, Baharan; Babaei, Mahmoudreza; Jalili, Mahdi; Safari, Mohammadali

    2011-10-01

    Many technological networks can experience random and/or systematic failures in their components. More destructive situations can happen if the components have limited capacity, where the failure in one of them might lead to a cascade of failures in other components, and consequently break down the structure of the network. In this paper, the tolerance of cascaded failures was investigated in weighted networks. Three weighting strategies were considered including the betweenness centrality of the edges, the product of the degrees of the end nodes, and the product of their betweenness centralities. Then, the effect of the cascaded attack was investigated by considering the local weighted flow redistribution rule. The capacity of the edges was considered to be proportional to their initial weight distribution. The size of the survived part of the attacked network was determined in model networks as well as in a number of real-world networks including the power grid, the internet in the level of autonomous system, the railway network of Europe, and the United States airports network. We found that the networks in which the weight of each edge is the multiplication of the betweenness centrality of the end nodes had the best robustness against cascaded failures. In other words, the case where the load of the links is considered to be the product of the betweenness centrality of the end nodes is favored for the robustness of the network against cascaded failures.

  20. Etiology and Outcome of Patients with HIV Infection and Respiratory Failure Admitted to the Intensive Care Unit.

    Science.gov (United States)

    Orsini, Jose; Ahmad, Noeen; Butala, Ashvin; Flores, Rosemarie; Tran, Truc; Llosa, Alfonso; Fishkin, Edward

    2013-01-01

    Background. Although access to HAART has prolonged survival and improved quality of life, HIV-infected patients with severe immunosuppression or comorbidities may develop complications that require critical care support. Our objective is to evaluate the etiology of respiratory failure in patients with HIV infection admitted to the ICU, its relationship with the T-lymphocytes cell count as well as the use of HAART, and its impact on outcome. Methods. A single-center, prospective, and observational study among all patients with HIV-infection and respiratory failure admitted to the ICU from December 1, 2011, to February 28, 2013, was conducted. Results. A total of 42 patients were admitted during the study period. Their median CD4 cell count was 123 cells/ μ L (mean 205.7, range 2.0-694.0), with a median HIV viral load of 203.5 copies/mL (mean 58,676, range <20-367,649). At the time of admission, 23 patients (54.8%) were receiving HAART. Use of antiretroviral therapy at ICU admission was not associated with survival, but it was associated with higher CD4 cell counts and lower HIV viral loads. Twenty-five patients (59.5%) had respiratory failure secondary to non-HIV-related diseases. Mechanical ventilation was required in 36 patients (85.1%). Thirteen patients (31.0%) died. Conclusions. Noninfectious etiologies of respiratory failure account for majority of HIV-infected patients admitted to ICU. Increased mortality was observed among patients with sepsis as etiology of respiratory failure (HIV related and non-AIDS related), in those receiving mechanical ventilation, and in patients with decreased CD4 cell count. Survival was not associated with the use of HAART. Complementary studies are warranted to address the impact of HAART on outcomes of HIV-infected patients with respiratory failure admitted to ICU.

  1. Etiology and Outcome of Patients with HIV Infection and Respiratory Failure Admitted to the Intensive Care Unit

    Directory of Open Access Journals (Sweden)

    Jose Orsini

    2013-01-01

    Full Text Available Background. Although access to HAART has prolonged survival and improved quality of life, HIV-infected patients with severe immunosuppression or comorbidities may develop complications that require critical care support. Our objective is to evaluate the etiology of respiratory failure in patients with HIV infection admitted to the ICU, its relationship with the T-lymphocytes cell count as well as the use of HAART, and its impact on outcome. Methods. A single-center, prospective, and observational study among all patients with HIV-infection and respiratory failure admitted to the ICU from December 1, 2011, to February 28, 2013, was conducted. Results. A total of 42 patients were admitted during the study period. Their median CD4 cell count was 123 cells/μL (mean 205.7, range 2.0–694.0, with a median HIV viral load of 203.5 copies/mL (mean 58,676, range <20–367,649. At the time of admission, 23 patients (54.8% were receiving HAART. Use of antiretroviral therapy at ICU admission was not associated with survival, but it was associated with higher CD4 cell counts and lower HIV viral loads. Twenty-five patients (59.5% had respiratory failure secondary to non-HIV-related diseases. Mechanical ventilation was required in 36 patients (85.1%. Thirteen patients (31.0% died. Conclusions. Noninfectious etiologies of respiratory failure account for majority of HIV-infected patients admitted to ICU. Increased mortality was observed among patients with sepsis as etiology of respiratory failure (HIV related and non-AIDS related, in those receiving mechanical ventilation, and in patients with decreased CD4 cell count. Survival was not associated with the use of HAART. Complementary studies are warranted to address the impact of HAART on outcomes of HIV-infected patients with respiratory failure admitted to ICU.

  2. Pediatric Acute-on-Chronic Liver Failure in a Specialized Liver Unit: Prevalence, Profile, Outcome, and Predictive Factors.

    Science.gov (United States)

    Alam, Seema; Lal, Bikrant B; Sood, Vikrant; Rawat, Dinesh

    2016-10-01

    The aim of the study was to assess the prevalence, profile, outcome, and predictive factors of pediatric acute-on-chronic liver failure (ACLF). All children 3 months to 18 years satisfying the Asia Pacific Association for the Study of Liver Diseases definition of ACLF were included. Data were both extracted from records (January 2011 to December 2014) and prospectively collected (January to October 2015). Successful outcome was defined as survival with native liver at 90 days, whereas poor outcome included those who died or received liver transplantation. Of the 499 children with chronic liver disease (CLD), 56 (11.2%) presented as ACLF, with a mean age of 9.35 (±4.39) years. Wilson disease and autoimmune hepatitis were the commonest underlying CLDs accounting for 24 (42.8%) and 18 (32.1%) cases, respectively. The most frequent events precipitating ACLF were a flare up of the underlying disease in 27 (48.2%) and acute viral hepatitis in 17 (30%). Poor outcome occurred in 22 (39.3%) children: 17 (30.4%) died and 5 (8.9%) received liver transplantation. Poor outcome was associated with grades 3 to 4 hepatic encephalopathy, bilirubin ≥17.5, international normalized ratio ≥3.5, and presence of 2 or more organ failures. On multivariate analysis, a Chronic Liver Failure-Sequential Organ Failure Assessment score ≥10 best predicted mortality (odds ratio 20.45, 95% confidence interval 3.9-106.7). ACLF is present in 11.2% of childhood CLD, with a 90-day native liver survival of 61%. A Chronic Liver Failure-Sequential Organ Failure Assessment score of ≥10 best predicts mortality at day 90.

  3. A Multisite Randomized Trial of Social Norms Marketing Campaigns to Reduce College Student Drinking: A Replication Failure

    Science.gov (United States)

    DeJong, William; Schneider, Shari Kessel; Towvim, Laura Gomberg; Murphy, Melissa J.; Doerr, Emily E.; Simonsen, Neal R.; Mason, Karen E.; Scribner, Richard A.

    2009-01-01

    A 14-site randomized trial tested the effectiveness of social norms marketing (SNM) campaigns, which present accurate student survey data in order to correct misperceptions of subjective drinking norms and thereby drive down alcohol use. Cross-sectional student surveys were conducted by mail at baseline and at posttest 3 years later. Hierarchical…

  4. New-onset heart failure due to heart muscle disease in childhood: a prospective study in the United kingdom and Ireland.

    Science.gov (United States)

    Andrews, Rachel E; Fenton, Matthew J; Ridout, Deborah A; Burch, Michael

    2008-01-01

    We undertook the first prospective, national, multicenter study to describe the incidence and outcome of heart muscle disease-induced heart failure in children. Data were collected on patients admitted to a hospital through 2003 with a first episode of heart failure in the absence of congenital heart disease. All 17 pediatric cardiac centers in the United Kingdom and Ireland participated. Follow-up data were obtained to a minimum of 1 year. The incidence was 0.87/100,000 population Heart Association class III to IV. Causes of heart failure included dilated cardiomyopathy (50 idiopathic, 8 familial), probable myocarditis (23), occult arrhythmia (7), anthracycline toxicity (5), metabolic disease (4), left ventricular noncompaction (3), and other (4). Overall 1-year survival was 82%, and event (death or transplantation)-free survival was 66%. Regression analysis showed older age and reduced systolic function on admission echocardiogram increased the event risk. Only 8% of event-free survivors (n=69) remained in New York Heart Association class III to IV, but 35 required readmission during the study period, and all but 8 remained on medication. This first national prospective study of new-onset heart failure in children has shown an incidence of 0.87/100,000. Multivariable analysis of survival data indicates a better outcome for younger children and for those with better systolic function at presentation, but overall, one third of children die or require transplantation within 1 year of presentation.

  5. Rationale and design of a randomized, double-blind, event-driven, multicentre study comparing the efficacy and safety of oral rivaroxaban with placebo for reducing the risk of death, myocardial infarction or stroke in subjects with heart failure and significant coronary artery disease following an exacerbation of heart failure: the COMMANDER HF trial.

    Science.gov (United States)

    Zannad, Faiez; Greenberg, Barry; Cleland, John G F; Gheorghiade, Mihai; van Veldhuisen, Dirk J; Mehra, Mandeep R; Anker, Stefan D; Byra, William M; Fu, Min; Mills, Roger M

    2015-07-01

    Thrombin is a critical element of crosstalk between pathways contributing to worsening of established heart failure (HF). The aim of this study is to explore the efficacy and safety of rivaroxaban 2.5 mg bid compared with placebo (with standard care) after an exacerbation of HF in patients with reduced ejection fraction (HF-rEF) and documented coronary artery disease. This is an international prospective, multicentre, randomized, double-blind, placebo-controlled, event-driven study of approximately 5000 patients for a targeted 984 events. Patients must have a recent symptomatic exacerbation of HF, increased plasma concentrations of natriuretic peptides (B-type natriuretic peptide ≥200 pg/mL or N-terminal pro-B-type natriuretic peptide ≥800 pg/mL), with left ventricular ejection fraction ≤40% and coronary artery disease. Patients requiring anticoagulation for atrial fibrillation or other conditions will be excluded. After an index event (overnight hospitalization, emergency department or observation unit admission, or unscheduled outpatient parenteral treatment for worsening HF), patients will be randomized 1:1 to rivaroxaban or placebo (with standard of care). The primary efficacy outcome event is a composite of all-cause mortality, myocardial infarction or stroke. The principal safety outcome events are the composite of fatal bleeding or bleeding into a critical space with potential permanent disability, bleeding events requiring hospitalization and major bleeding events according to International Society on Thrombosis and Haemostasis bleeding criteria. COMMANDER HF is the first prospective study of a target-specific oral antithrombotic agent in HF. It will provide important information regarding rivaroxaban use following an HF event in an HF-rEF patient population with coronary artery disease. © 2015 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

  6. Patterns of scheduled follow-up appointments following hospitalization for heart failure: insights from an urban medical center in the United States

    Directory of Open Access Journals (Sweden)

    Goyal P

    2016-09-01

    Full Text Available Parag Goyal,1 Madeline R Sterling,2 Ashley N Beecy,2 John T Ruffino,2 Sonal S Mehta,3 Erica C Jones,1 Mark S Lachs,3 Evelyn M Horn1 1Division of Cardiology, Department of Medicine, 2Department of Medicine, 3Division of Geriatrics, Department of Medicine, Weill Cornell Medicine, New York, NY, USA Objectives: Although postdischarge outpatient follow-up appointments after a hospitalization for heart failure represent a potentially effective strategy to prevent heart failure readmissions, patterns of scheduled follow-up appointments upon discharge are poorly described. We aimed to characterize real-world patterns of scheduled follow-up appointments among adult patients with heart failure upon hospital discharge.Patients and methods: This was a retrospective cohort study performed at a large urban academic center in the United States among adults hospitalized with a principal diagnosis of congestive heart failure between January 1, 2013, and December 31, 2014. Patient demographics, administrative data, clinical parameters, echocardiographic indices, and scheduled postdischarge outpatient follow-up appointments were collected.Results: Of the 796 patients hospitalized for heart failure, just over half of the cohort had a scheduled follow-up appointment upon discharge. Follow-up appointments were less likely among patients who were white and had heart failure with preserved ejection fraction and more likely among patients with Medicaid and chronic obstructive pulmonary disease. In an adjusted multivariable regression model, age ≥65 years was inversely associated with a scheduled follow-up appointment upon hospital discharge, despite higher rates of several cardiovascular and noncardiovascular comorbidities.Conclusion: Just half of the patients discharged home following a hospitalization for heart failure had a follow-up appointment scheduled, representing a missed opportunity to provide a recommended care transition intervention. Despite a greater

  7. Gastrointestinal failure in intensive care: a retrospective clinical study in three different intensive care units in Germany and Estonia

    Directory of Open Access Journals (Sweden)

    Starkopf Joel

    2006-06-01

    Full Text Available Abstract Background While gastrointestinal problems are common in ICU patients with multiple organ failure, gastrointestinal failure has not been given the consideration other organ systems receive. The aim of this study was to evaluate the incidence of gastrointestinal failure (GIF, to identify its risk factors, and to determine its association with ICU mortality. Methods A retrospective analysis of adult patients (n = 2588 admitted to three different ICUs (two ICUs at the university hospital Charité-Universitätsmedizin Berlin, Germany and one at Tartu University Clinics, Estonia during the year 2002 was performed. Data recorded in a computerized database were used in Berlin. In Tartu, the data documented in the patients' charts was retrospectively transferred into a similar database. GIF was defined as documented gastrointestinal problems (food intolerance, gastrointestinal haemorrhage, and/or ileus in the patient data at any period of their ICU stay. ICU mortality, length of stay, and duration of mechanical ventilation were assessed as outcome parameters. Results GIF was identified in 252 patients (9.7% of all patients. Only 20% of GIF patients were identifiable at admission. GIF was related to significantly higher mortality (43.7% vs. 5.3% in patients without GIF, as well as prolonged length of ICU stay (10 vs. 2 days and mechanical ventilation (8 vs. 1 day, p Conclusion Gastrointestinal failure represents a relevant clinical problem accompanied by an increased mortality, longer ICU stay and mechanical ventilation.

  8. Relevance of chest sonography in the diagnosis of acute respiratory failure: Comparison with current diagnostic tools in intensive care units

    Directory of Open Access Journals (Sweden)

    Rasha Daabis

    2014-10-01

    Conclusions: Lung ultrasound provided an immediate diagnosis of the underlying etiology of acute respiratory failure in most cases; it can therefore be added to the armamentarium of ICU where urgent decisions are needed for rapid diagnosis and management of patients with ARF.

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

    Science.gov (United States)

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

    2015-03-01

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

  10. Cost-utility analysis of the EVOLVO study on remote monitoring for heart failure patients with implantable defibrillators: randomized controlled trial.

    Science.gov (United States)

    Zanaboni, Paolo; Landolina, Maurizio; Marzegalli, Maurizio; Lunati, Maurizio; Perego, Giovanni B; Guenzati, Giuseppe; Curnis, Antonio; Valsecchi, Sergio; Borghetti, Francesca; Borghi, Gabriella; Masella, Cristina

    2013-05-30

    Heart failure patients with implantable defibrillators place a significant burden on health care systems. Remote monitoring allows assessment of device function and heart failure parameters, and may represent a safe, effective, and cost-saving method compared to conventional in-office follow-up. We hypothesized that remote device monitoring represents a cost-effective approach. This paper summarizes the economic evaluation of the Evolution of Management Strategies of Heart Failure Patients With Implantable Defibrillators (EVOLVO) study, a multicenter clinical trial aimed at measuring the benefits of remote monitoring for heart failure patients with implantable defibrillators. Two hundred patients implanted with a wireless transmission-enabled implantable defibrillator were randomized to receive either remote monitoring or the conventional method of in-person evaluations. Patients were followed for 16 months with a protocol of scheduled in-office and remote follow-ups. The economic evaluation of the intervention was conducted from the perspectives of the health care system and the patient. A cost-utility analysis was performed to measure whether the intervention was cost-effective in terms of cost per quality-adjusted life year (QALY) gained. Overall, remote monitoring did not show significant annual cost savings for the health care system (€1962.78 versus €2130.01; P=.80). There was a significant reduction of the annual cost for the patients in the remote arm in comparison to the standard arm (€291.36 versus €381.34; P=.01). Cost-utility analysis was performed for 180 patients for whom QALYs were available. The patients in the remote arm gained 0.065 QALYs more than those in the standard arm over 16 months, with a cost savings of €888.10 per patient. Results from the cost-utility analysis of the EVOLVO study show that remote monitoring is a cost-effective and dominant solution. Remote management of heart failure patients with implantable defibrillators

  11. Association Between Deep Sedation from Continuous Intravenous Sedatives and Extubation Failures in Mechanically Ventilated Patients in the Pediatric Intensive Care Unit.

    Science.gov (United States)

    Schultheis, Jennifer M; Heath, Travis S; Turner, David A

    2017-01-01

    The primary objective of this study was to determine whether an association exists between deep sedation from continuous infusion sedatives and extubation failures in mechanically ventilated children. Secondary outcomes evaluated risk factors associated with deep sedation. This was a retrospective cohort study conducted between January 1, 2009, and October 31, 2012, in the pediatric intensive care unit (PICU) at Duke Children's Hospital. Patients were included in the study if they had been admitted to the PICU, had been mechanically ventilated for ≥48 hours, and had received at least one continuous infusion benzodiazepine and/or opioid infusion for ≥24 hours. Patients were separated into 2 groups: those deeply sedated and those not deeply sedated. Deep sedation was defined as having at least one documented State Behavioral Scale (SBS) of -3 or -2 within 72 hours prior to planned extubation. A total of 108 patients were included in the analysis. Both groups were well matched with regard to baseline characteristics. For the primary outcome, there was no difference in extubation failures in those who were deeply sedated compared to those not deeply sedated (14 patients [22.6%] versus 7 patients [15.2%], respectively; p = 0.33). After adjusting for potential risk factors, patients with a higher weight percentile for age (odds ratio [OR] 1.02; 95% confidence interval [CI] 1.00-1.03), lower Glasgow Coma Score (GCS) score prior to intubation (OR 0.85; 95% CI 0.74-0.97), and larger maximum benzodiazepine dose (OR 1.93; 95% CI 1.01-3.71) were associated with greater odds of deep sedation. A higher GCS prior to intubation was significantly associated with increased odds of extubation failure (OR 1.19; 95% CI 1.02-1.39). While there was no statistically significant difference in extubation failures between the 2 groups included in this study, considering the severe consequences of extubation failure, the numerical difference reported may be clinically important.

  12. Comparison of patient-ventilator asynchrony during pressure support ventilation and proportional assist ventilation modes in surgical Intensive Care Unit: A randomized crossover study.

    Science.gov (United States)

    Gautam, Parshotam Lal; Kaur, Gaganjot; Katyal, Sunil; Gupta, Ruchi; Sandhu, Preetveen; Gautam, Nikhil

    2016-12-01

    The patient-ventilator asynchrony is almost observed in all modes of ventilation, and this asynchrony affects lung mechanics adversely resulting in deleterious outcome. Innovations and advances in ventilator technology have been trying to overcome this problem by designing newer modes of ventilation. Pressure support ventilation (PSV) is a commonly used flow-cycled mode where a constant pressure is delivered by ventilator. Proportional assist ventilation (PAV) is a new dynamic inspiratory pressure assistance and is supposed to be better than PSV for synchrony and tolerance, but reports are still controversial. Moreover, most of these studies are conducted in chronic obstructive pulmonary disease patients with respiratory failure; the results of these studies may not be applicable to surgical patients. Thus, we proposed to do compare these two modes in surgical Intensive Care Unit (ICU) patients as a randomized crossover study. Comparison of patient-ventilator asynchrony between PSV and PAV plus (PAV+) in surgical patients while weaning. After approval by the Hospital Ethics Committee, we enrolled twenty patients from surgical ICU of tertiary care institute. The patients were ventilated with pressure support mode (PSV) and PAV+ for 12 h as a crossover from one mode to another after 6 h while weaning. Average age and weight of patients were 41.80 ± 15.20 years (mean ± standard deviation [SD]) and 66.50 ± 12.47 (mean ± SD) kg, respectively. Comparing the asynchronies between the two modes, the mean number of total asynchronous recorded breaths in PSV was 7.05 ± 0.83 and 4.35 ± 5.62, respectively, during sleep and awake state, while the same were 6.75 ± 112.24 and 10.85 ± 11.33 in PAV+. Both PSV and PAV+ modes of ventilation performed similarly for patient-ventilator synchrony in surgical patients. In surgical patients with acute respiratory failure, dynamic inspiratory pressure assistance modalities are not superior to PSV with respect to cardiorespiratory

  13. Supporting Heart Failure Patient Transitions From Acute to Community Care With Home Telemonitoring Technology: A Protocol for a Provincial Randomized Controlled Trial (TEC4Home).

    Science.gov (United States)

    2016-12-18

    Seniors with chronic diseases such as heart failure have complex care needs. They are vulnerable to their condition deteriorating and, without timely intervention, may require multiple emergency department visits and/or repeated hospitalizations. Upon discharge, the transition from the emergency department to home can be a vulnerable time for recovering patients with disruptions in the continuity of care. Remote monitoring of heart failure patients using home telemonitoring, coupled with clear communication protocols between health care professionals, can be effective in increasing the safety and quality of care for seniors with heart failure discharged from the emergency department. The aim of the Telehealth for Emergency-Community Continuity of Care Connectivity via Home Telemonitoring (TEC4Home) study is to generate evidence through a programmatic evaluation and a clinical trial to determine how home telemonitoring may improve care and increase patient safety during the transition of care and determine how it is best implemented to support patients with heart failure within this context. This 4-year project consists of 3 studies to comprehensively evaluate the outcomes and effectiveness of TEC4Home. Study 1 is a feasibility study with 90 patients recruited from 2 emergency department sites to test implementation and evaluation procedures. Findings from the feasibility study will be used to refine protocols for the larger trial. Study 2 is a cluster randomized controlled trial that will include 30 emergency department sites and 900 patients across British Columbia. The primary outcome of the randomized controlled trial will be emergency department revisits and hospital readmission rates. Secondary outcomes include health care resource utilization/costs, communication between members of the care team, and patient quality of life. Study 3 will run concurrently to study 2 and test the effectiveness of predictive analytic software to detect patient deterioration

  14. Impact of peer support on virologic failure in HIV-infected patients on antiretroviral therapy - a cluster randomized controlled trial in Vietnam.

    Science.gov (United States)

    Cuong, Do Duy; Sönnerborg, Anders; Van Tam, Vu; El-Khatib, Ziad; Santacatterina, Michele; Marrone, Gaetano; Chuc, Nguyen Thi Kim; Diwan, Vinod; Thorson, Anna; Le, Nicole K; An, Pham Nhat; Larsson, Mattias

    2016-12-16

    The effect of peer support on virologic and immunologic treatment outcomes among HIVinfected patients receiving antiretroviral therapy (ART) was assessed in a cluster randomized controlled trial in Vietnam. Seventy-one clusters (communes) were randomized in intervention or control, and a total of 640 patients initiating ART were enrolled. The intervention group received peer support with weekly home-visits. Both groups received first-line ART regimens according to the National Treatment Guidelines. Viral load (VL) (ExaVir™ Load) and CD4 counts were analyzed every 6 months. The primary endpoint was virologic failure (VL >1000 copies/ml). Patients were followed up for 24 months. Intention-to-treat analysis was used. Cluster longitudinal and survival analyses were used to study time to virologic failure and CD4 trends. Of 640 patients, 71% were males, mean age 32 years, 83% started with stavudine/lamivudine/nevirapine regimen. After a mean of 20.8 months, 78% completed the study, and the median CD4 increase was 286 cells/μl. Cumulative virologic failure risk was 7.2%. There was no significant difference between intervention and control groups in risk for and time to virologic failure and in CD4 trends. Risk factors for virologic failure were ART-non-naïve status [aHR 6.9;(95% CI 3.2-14.6); p < 0.01]; baseline VL ≥100,000 copies/ml [aHR 2.3;(95% CI 1.2-4.3); p < 0.05] and incomplete adherence (self-reported missing more than one dose during 24 months) [aHR 3.1;(95% CI 1.1-8.9); p < 0.05]. Risk factors associated with slower increase of CD4 counts were: baseline VL ≥100,000 copies/ml [adj.sq.Coeff (95% CI): -0.9 (-1.5;-0.3); p < 0.01] and baseline CD4 count <100 cells/μl [adj.sq.Coeff (95% CI): -5.7 (-6.3;-5.4); p < 0.01]. Having an HIV-infected family member was also significantly associated with gain in CD4 counts [adj.sq.Coeff (95% CI): 1.3 (0.8;1.9); p < 0.01]. There was a low virologic failure risk during the first 2 years of

  15. Effects of a 14-month low-cost maintenance training program in patients with chronic systolic heart failure: a randomized study

    DEFF Research Database (Denmark)

    Prescott, Eva; Hjardem-Hansen, Rasmus; Dela, Flemming

    2009-01-01

    BACKGROUND: Exercise training is known to be beneficial in chronic heart failure (CHF) patients but there is a lack of studies following patient groups for longer duration with maintenance training programs to defer deconditioning. METHODS: Study base consisted of all patients diagnosed with CHF...... in a 3-year period. Sixty-six patients with systolic CHF (ejection fraction Heart Association II-III) were randomized to 12 months of either usual care orhome-based maintenance exercise with group training sessions every 2 weeks after an initial 8-week training program. The primary endpoint...... was maximum workload; secondary endpoints were 6-min walk test, incremental shuttle walk test, sit-to-stand test, quality of life, and serological markers. RESULTS: Six patients died and 43 completed the study. The initial 8-week training was associated with small but significant improvement in all...

  16. Effect of everolimus on survival in advanced hepatocellular carcinoma after failure of sorafenib: the EVOLVE-1 randomized clinical trial.

    Science.gov (United States)

    Zhu, Andrew X; Kudo, Masatoshi; Assenat, Eric; Cattan, Stéphane; Kang, Yoon-Koo; Lim, Ho Yeong; Poon, Ronnie T P; Blanc, Jean-Frederic; Vogel, Arndt; Chen, Chao-Long; Dorval, Etienne; Peck-Radosavljevic, Markus; Santoro, Armando; Daniele, Bruno; Furuse, Junji; Jappe, Annette; Perraud, Kevin; Anak, Oezlem; Sellami, Dalila B; Chen, Li-Tzong

    2014-07-02

    Aside from the multikinase inhibitor sorafenib, there are no effective systemic therapies for the treatment of advanced hepatocellular carcinoma. To assess the efficacy of everolimus in patients with advanced hepatocellular carcinoma for whom sorafenib treatment failed. EVOLVE-1 was a randomized, double-blind, phase 3 study conducted among 546 adults with Barcelona Clinic Liver Cancer stage B or C hepatocellular carcinoma and Child-Pugh A liver function whose disease progressed during or after sorafenib or who were intolerant of sorafenib. Patients were enrolled from 17 countries between May 2010 and March 2012. Randomization was stratified by region (Asia vs rest of world) and macrovascular invasion (present vs absent). Everolimus, 7.5 mg/d, or matching placebo, both given in combination with best supportive care and continued until disease progression or intolerable toxicity. Per the 2:1 randomization scheme, 362 patients were randomized to the everolimus group and 184 patients to the placebo group. The primary end point was overall survival. Secondary end points included time to progression and the disease control rate (the percentage of patients with a best overall response of complete or partial response or stable disease). No significant difference in overall survival was seen between treatment groups, with 303 deaths (83.7%) in the everolimus group and 151 deaths (82.1%) in the placebo group (hazard ratio [HR], 1.05; 95% CI, 0.86-1.27; P = .68; median overall survival, 7.6 months with everolimus, 7.3 months with placebo). Median time to progression with everolimus and placebo was 3.0 months and 2.6 months, respectively (HR, 0.93; 95% CI, 0.75-1.15), and disease control rate was 56.1% and 45.1%, respectively (P = .01). The most common grade 3/4 adverse events for everolimus vs placebo were anemia (7.8% vs 3.3%, respectively), asthenia (7.8% vs 5.5%, respectively), and decreased appetite (6.1% vs 0.5%, respectively). No patients experienced hepatitis C

  17. Effects of short-term continuous positive airway pressure on myocardial sympathetic nerve function and energetics in patients with heart failure and obstructive sleep apnea: a randomized study.

    Science.gov (United States)

    Hall, Allison B; Ziadi, Maria C; Leech, Judith A; Chen, Shin-Yee; Burwash, Ian G; Renaud, Jennifer; deKemp, Robert A; Haddad, Haissam; Mielniczuk, Lisa M; Yoshinaga, Keiichiro; Guo, Ann; Chen, Li; Walter, Olga; Garrard, Linda; DaSilva, Jean N; Floras, John S; Beanlands, Rob S B

    2014-09-09

    Heart failure with reduced ejection fraction and obstructive sleep apnea (OSA), 2 states of increased metabolic demand and sympathetic nervous system activation, often coexist. Continuous positive airway pressure (CPAP), which alleviates OSA, can improve ventricular function. It is unknown whether this is due to altered oxidative metabolism or presynaptic sympathetic nerve function. We hypothesized that short-term (6-8 weeks) CPAP in patients with OSA and heart failure with reduced ejection fraction would improve myocardial sympathetic nerve function and energetics. Forty-five patients with OSA and heart failure with reduced ejection fraction (left ventricular ejection fraction 35.8±9.7% [mean±SD]) were evaluated with the use of echocardiography and 11C-acetate and 11C-hydroxyephedrine positron emission tomography before and ≈6 to 8 weeks after randomization to receive short-term CPAP (n=22) or no CPAP (n=23). Work metabolic index, an estimate of myocardial efficiency, was calculated as follows: (stroke volume index×heart rate×systolic blood pressure÷Kmono), where Kmono is the monoexponential function fit to the myocardial 11C-acetate time-activity data, reflecting oxidative metabolism. Presynaptic sympathetic nerve function was measured with the use of the 11C-hydroxyephedrine retention index. CPAP significantly increased hydroxyephedrine retention versus no CPAP (Δretention: +0.012 [0.002, 0.021] versus -0.006 [-0.013, 0.005] min(-1); P=0.003). There was no significant change in work metabolic index between groups. However, in those with more severe OSA (apnea-hypopnea index>20 events per hour), CPAP significantly increased both work metabolic index and systolic blood pressure (Penergetics. In those with more severe OSA, CPAP may improve cardiac efficiency. Further outcome-based investigation of the consequences of CPAP is warranted. http://www.clinicaltrials.gov. Unique identifier: NCT00756366. © 2014 American Heart Association, Inc.

  18. Management of kyphoscoliosis patients with respiratory failure in the intensive care unit and during long term follow up

    Directory of Open Access Journals (Sweden)

    Adıgüzel Nalan

    2012-09-01

    Full Text Available Abstract Background We aimed to evaluate the ICU management and long-term outcomes of kyphoscoliosis patients with respiratory failure. Methods A retrospective observational cohort study was performed in a respiratory ICU and outpatient clinic from 2002–2011. We enrolled all kyphoscoliosis patients admitted to the ICU and followed-up at regular intervals after discharge. Reasons for acute respiratory failure (ARF, ICU data, mortality, length of ICU stay and outpatient clinic data, non-invasive ventilation (NIV device settings, and compliance were recorded. NIV failure in the ICU and the long term effect of NIV on pulmonary performance were analyzed. Results Sixty-two consecutive ICU kyphoscoliosis patients with ARF were enrolled in the study. NIV was initially applied to 55 patients, 11 (20% patients were intubated, and the majority had sepsis and septic shock (p  Conclusions We strongly discourage the use of NIV in the case of septic shock in ICU kyphoscoliosis patients with ARF. Pulmonary performance improved with NIV during long term follow up.

  19. Effectiveness of transcendental meditation on functional capacity and quality of life of African Americans with congestive heart failure: a randomized control study.

    Science.gov (United States)

    Jayadevappa, Ravishankar; Johnson, Jerry C; Bloom, Bernard S; Nidich, Sanford; Desai, Shashank; Chhatre, Sumedha; Raziano, Donna B; Schneider, Robert

    2007-01-01

    To evaluate the effectiveness of a Transcendental Meditation (TM) stress reduction program for African Americans with congestive heart failure (CHF). Randomized, controlled study We recruited 23 African American patients > or = 55 years of age who were recently hospitalized with New York Heart Association class II or III CHF and with an ejection fraction of Depression Scale (CES-D), rehospitalizations, brain natriuretic peptide, and cortisol. Changes in outcomes from baseline to three and six months after treatment were analyzed by using repeated measures analysis of variance, covarying for baseline score. For the primary outcome of functional capacity, the TM group significantly improved on the six-minute walk test from baseline to six months after treatment compared to the HE group (P = .034). On the secondary outcome measures, the TM group showed improvements in SF-36 subscales and total score on the Minnesota Living with Heart Failure scale. On the CES-D, the TM group showed significant decrease from baseline to six months compared to the HE group (P = .03). Also, the TM group had fewer rehospitalizations during the six months of followup. Results indicate that TM can be effective in improving the quality of life and functional capacity of African American CHF patients. Further validation of outcomes is planned via a large, multicenter trial with long-term follow-up.

  20. Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Eplerenone in Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF).

    Science.gov (United States)

    Tsutsui, Hiroyuki; Ito, Hiroshi; Kitakaze, Masafumi; Komuro, Issei; Murohara, Toyoaki; Izumi, Tohru; Sunagawa, Kenji; Yasumura, Yoshio; Yano, Masafumi; Yamamoto, Kazuhiro; Yoshikawa, Tsutomu; Tsutamoto, Takayoshi; Zhang, Junwei; Okayama, Akifumi; Ichikawa, Yoshihiko; Kanmuri, Kazuhiro; Matsuzaki, Masunori

    2017-12-25

    The mineralocorticoid receptor antagonist eplerenone improved clinical outcomes among patients with heart failure with reduced ejection faction (HFrEF) in the EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure) study. However, similar efficacy and safety have not been established in Japanese patients. We evaluated the efficacy and safety of eplerenone in patients with HFrEF in a multicenter, randomized, double-blind placebo-controlled outcome study (ClinicalTrials.gov Identifier: NCT01115855). The aim of the study was to evaluate efficacy predefined as consistency of the primary endpoint with that of EMPHASIS-HF at a point estimate of HF. The primary endpoint occurred in 29.7% of patients in the eplerenone group vs. 32.7% in the placebo group [hazard ratio=0.85 (95% CI: 0.53-1.36)]. Hospitalization for any cause and changes in plasma BNP and LVEF were favorable with eplerenone. A total of 17 patients (15.3%) in the eplerenone group and 10 patients (9.1%) in the placebo group died. Adverse events, including hyperkalemia, were similar between the groups. Eplerenone was well-tolerated in Japanese patients with HFrEF and showed results consistent with those reported in the EMPHASIS-HF study.

  1. Effects of carvedilol in heart failure due to dilated cardiomyopathy. Results of a double-blind randomized placebo-controlled study (CARIBE study

    Directory of Open Access Journals (Sweden)

    Paulo Roberto Chizzola

    2000-03-01

    Full Text Available OBJECTIVE: To assess the effects of carvedilol in patients with idiopathic dilated cardiomyopathy. METHODS: In a double-blind randomized placebo-controlled study, 30 patients (7 women with functional class II and III heart failure were assessed. Their ages ranged from 28 to 66 years (mean of 43±9 years, and their left ventricular ejection fraction varied from 8% to 35%. Carvedilol was added to the usual therapy of 20 patients; placebo was added to the usual therapy of 10 patients. The initial dose of carvedilol was 12.5 mg, which was increased weekly until it reached 75 mg/day, according to the patient's tolerance. Clinical assessment, electrocardiogram, echocardiogram, and radionuclide ventriculography were performed in the pretreatment phase, being repeated after 2 and 6 months of medication use. RESULTS: A reduction in heart rate (p=0.016 as well as an increase in left ventricular shortening fraction (p=0.02 and in left ventricular ejection fraction (p=0.017 occurred in the group using carvedilol as compared with that using placebo. CONCLUSION: Carvedilol added to the usual therapy for heart failure resulted in better heart function.

  2. Influence of crossover on mortality in a randomized study of revascularization in patients with systolic heart failure and coronary artery disease.

    Science.gov (United States)

    Doenst, Torsten; Cleland, John G F; Rouleau, Jean L; She, Lilin; Wos, Stanislaw; Ohman, E Magnus; Krzeminska-Pakula, Maria; Airan, Balram; Jones, Robert H; Siepe, Matthias; Sopko, George; Velazquez, Eric J; Racine, Normand; Gullestad, Lars; Filgueira, Jose Luis; Lee, Kerry L

    2013-05-01

    To assess the influence of therapy crossovers on treatment comparisons and mortality at 5 years in patients with ischemic heart disease and heart failure randomly assigned to medical therapy alone (MED) or to MED and coronary artery bypass graft (CABG) surgery in the Surgical Treatment for Ischemic Heart Failure (STICH) trial. The influence of early crossover (within the first year after randomization) on 5-year mortality was assessed using time-dependent multivariable Cox models. CABG was performed in 65/602 patients (10.8%) assigned to MED, and 55/610 patients (9.0%) assigned to CABG received MED only. Common reasons for crossover from MED to CABG were progressive symptoms or acute decompensation. MED-assigned patients who underwent CABG had lower 5-year mortality than those who received MED only (25% vs 42%; hazard ratio, 0.50; 95% confidence interval, 0.30-0.85; P=0.008).The main reason for crossover from CABG to MED was patient/family decision. Five patients did not undergo their assigned CABG within a year but died before receiving surgery without status change. They were deemed crossover to MED. The CABG-to-MED crossover population had higher 5-year mortality compared with those treated with CABG per-protocol (59% vs 33%; hazard ratio, 2.01; 95% confidence interval, 1.36-2.96; P<0.001). CABG was associated with lower mortality compared with MED in per-protocol and several time-dependent analyses (all P<0.05). CABG reduced mortality in both the per-protocol and crossover STICH patient populations. Crossover from assigned therapy, therefore, diminished the impact of CABG on survival in STICH when analyzed by intention to treat. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00023595.

  3. Efficient Statistical Extraction of the Per-Unit-Length Capacitance and Inductance Matrices of Cables with Random Parameters

    Directory of Open Access Journals (Sweden)

    P. Manfredi

    2015-05-01

    Full Text Available Cable bundles often exhibit random parameter variations due to uncertain or uncontrollable physical properties and wire positioning. Efficient tools, based on the so-called polynomial chaos, exist to rapidly assess the impact of such variations on the per-unit-length capacitance and inductance matrices, and on the pertinent cable response. Nevertheless, the state-of-the-art method for the statistical extraction of the per-unit-length capacitance and inductance matrices of cables suffers from several inefficiencies that hinder its applicability to large problems, in terms of number of random parameters and/or conductors. This paper presents an improved methodology that overcomes the aforementioned limitations by exploiting a recently-published, alternative approach to generate the pertinent polynomial chaos system of equations. A sparse and decoupled system is obtained that provides remarkable benefits in terms of speed, memory consumption and problem size that can be dealt with. The technique is thoroughly validated through the statistical analysis of two canonical structures, i.e. a ribbon cable and a shielded cable with random geometry and position.

  4. Importance of RIFLE (Risk, Injury, Failure, Loss, and End-Stage Renal Failure and AKIN (Acute Kidney Injury Network in Hemodialysis Initiation and Intensive Care Unit Mortality

    Directory of Open Access Journals (Sweden)

    Iskender Kara

    2017-07-01

    Full Text Available Our study evaluated the differences between early and late hemodialysis (HD initiation in the intensive care unit (ICU according to the RIFLE (Risk, Injury, Failure, Loss, and End-stage renal failure and AKIN (Acute Kidney Injury Network classifications. On the assumption that early initiation of HD in critical patients according to the RIFLE and AKIN criteria decreases mortality, we retrospectively evaluated the medical records of 68 patients in our medical ICU and divided the patients into 2 groups: those undergoing HD in no risk, risk, or injury stage according to RIFLE and in stage 0, I, or II according to AKIN were defined as early HD and those in failure stage according to RIFLE and in stage III according to AKIN were defined as late HD. The median age of the patients was 66.5 years, and 56.5% were male. HD was started in 25% and 39.7% of the patients in the early stage in the RIFLE and AKIN classification, respectively. According to RIFLE, HD was started in 61.5% of the surviving patients in the early stage; this rate was 16.4% in the deceased patients (P=0.001. HD was commenced in 69.2% of the surviving patients in AKIN stages 0, I, and II and in 32.7% of the deceased patients (P=0.026. Sepsis (61.5% vs. 94.5%; P=0.001 and mechanical ventilation (30.8% vs. 87.3%; P<0.001 during HD increased ICU mortality, whereas HD initiation in the early stages according to RIFLE decreased ICU mortality (61.5% vs. 16.4%; P=0.001. In conclusion, in critically ill patients, HD initiation in the early stages according to the RIFLE classification decreased our ICU mortality.

  5. Randomized trial of automated, electronic monitoring to facilitate early detection of sepsis in the intensive care unit*.

    Science.gov (United States)

    Hooper, Michael H; Weavind, Lisa; Wheeler, Arthur P; Martin, Jason B; Gowda, Supriya Srinivasa; Semler, Matthew W; Hayes, Rachel M; Albert, Daniel W; Deane, Norment B; Nian, Hui; Mathe, Janos L; Nadas, Andras; Sztipanovits, Janos; Miller, Anne; Bernard, Gordon R; Rice, Todd W

    2012-07-01

    To determine whether automated identification with physician notification of the systemic inflammatory response syndrome in medical intensive care unit patients expedites early administration of new antibiotics or improvement of other patient outcomes in patients with sepsis. : A prospective randomized, controlled, single center study. Medical intensive care unit of an academic, tertiary care medical center. Four hundred forty-two consecutive patients admitted over a 4-month period who met modified systemic inflammatory response syndrome criteria in a medical intensive care unit. Patients were randomized to monitoring by an electronic "Listening Application" to detect modified (systemic inflammatory response syndrome) criteria vs. usual care. The listening application notified physicians in real time when modified systemic inflammatory response syndrome criteria were detected, but did not provide management recommendations. The median time to new antibiotics was similar between the intervention and usual care groups when comparing among all patients (6.0 hr vs. 6.1 hr, p = .95), patients with sepsis (5.3 hr vs. 5.1 hr; p = .90), patients on antibiotics at enrollment (5.2 hr vs. 7.0 hr, p = .27), or patients not on antibiotics at enrollment (5.2 hr vs. 5.1 hr, p = .85). The amount of fluid administered following detection of modified systemic inflammatory response syndrome criteria was similar between groups whether comparing all patients or only patients who were hypotensive at enrollment. Other clinical outcomes including intensive care unit length of stay, hospital length of stay, and mortality were not shown to be different between patients in the intervention and control groups. Realtime alerts of modified systemic inflammatory response syndrome criteria to physicians in one tertiary care medical intensive care unit were feasible and safe but did not influence measured therapeutic interventions for sepsis or significantly alter clinical outcomes.

  6. Safety Management of a Clinical Process Using Failure Mode and Effect Analysis: Continuous Renal Replacement Therapies in Intensive Care Unit Patients.

    Science.gov (United States)

    Sanchez-Izquierdo-Riera, Jose Angel; Molano-Alvarez, Esteban; Saez-de la Fuente, Ignacio; Maynar-Moliner, Javier; Marín-Mateos, Helena; Chacón-Alves, Silvia

    2016-01-01

    The failure mode and effect analysis (FMEA) may improve the safety of the continuous renal replacement therapies (CRRT) in the intensive care unit. We use this tool in three phases: 1) Retrospective observational study. 2) A process FMEA, with implementation of the improvement measures identified. 3) Cohort study after FMEA. We included 54 patients in the pre-FMEA group and 72 patients in the post-FMEA group. Comparing the risks frequencies per patient in both groups, we got less cases of under 24 hours of filter survival time in the post-FMEA group (31 patients 57.4% vs. 21 patients 29.6%; p process FMEA, there were several improvements in the management of intensive care unit patients receiving CRRT, and we consider it a useful tool for improving the safety of critically ill patients.

  7. Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial.

    Science.gov (United States)

    Castro, Mario; King, Tonya S; Kunselman, Susan J; Cabana, Michael D; Denlinger, Loren; Holguin, Fernando; Kazani, Shamsah D; Moore, Wendy C; Moy, James; Sorkness, Christine A; Avila, Pedro; Bacharier, Leonard B; Bleecker, Eugene; Boushey, Homer A; Chmiel, James; Fitzpatrick, Anne M; Gentile, Deborah; Hundal, Mandeep; Israel, Elliot; Kraft, Monica; Krishnan, Jerry A; LaForce, Craig; Lazarus, Stephen C; Lemanske, Robert; Lugogo, Njira; Martin, Richard J; Mauger, David T; Naureckas, Edward; Peters, Stephen P; Phipatanakul, Wanda; Que, Loretta G; Sheshadri, Ajay; Smith, Lewis; Solway, Julian; Sullivan-Vedder, Lisa; Sumino, Kaharu; Wechsler, Michael E; Wenzel, Sally; White, Steven R; Sutherland, E Rand

    2014-05-01

    In asthma and other diseases, vitamin D insufficiency is associated with adverse outcomes. It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency. To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels. The VIDA (Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma) randomized, double-blind, parallel, placebo-controlled trial studying adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by January 2014. After a run-in period that included treatment with an inhaled corticosteroid, 408 patients were randomized. Oral vitamin D3 (100,000 IU once, then 4000 IU/d for 28 weeks; n = 201) or placebo (n = 207) was added to inhaled ciclesonide (320 µg/d). If asthma control was achieved after 12 weeks, ciclesonide was tapered to 160 µg/d for 8 weeks, then to 80 µg/d for 8 weeks if asthma control was maintained. The primary outcome was time to first asthma treatment failure (a composite outcome of decline in lung function and increases in use of β-agonists, systemic corticosteroids, and health care). Treatment with vitamin D3 did not alter the rate of first treatment failure during 28 weeks (28% [95% CI, 21%-34%] with vitamin D3 vs 29% [95% CI, 23%-35%] with placebo; adjusted hazard ratio, 0.9 [95% CI, 0.6-1.3]). Of 14 prespecified secondary outcomes, 9 were analyzed, including asthma exacerbation; of those 9, the only statistically significant outcome was a small difference in the overall dose of ciclesonide required to maintain asthma control (111.3 µg/d [95% CI, 102.2-120.4 µg/d] in the vitamin D3 group vs 126

  8. The-first-in-man randomized trial of a beta3 adrenoceptor agonist in chronic heart failure

    DEFF Research Database (Denmark)

    Bundgaard, Henning; Axelsson, Anna; Hartvig Thomsen, Jakob

    2017-01-01

    agonist mirabegron increases LVEF in patients with HF. METHODS AND RESULTS: In a double-blind trial we randomly assigned 70 patients with NYHA class II-III HF and LVEF mirabegron or placebo for 6 months as add-on to optimized standard therapy. The primary...... targeted with treatment is dependent on the baseline LVEF, patients with LVEF mirabegron had a significant increase in LVEF while no increase was seen in patients given placebo. The changes were significantly different between groups (5.5%, 0.6-10.4%, P ..., there was interaction between baseline LVEF and change in LVEF in the entire group of patients treated with mirabegron (R(2)  = 0.40, β  = -0.63, P

  9. Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial.

    Science.gov (United States)

    Khan, Sikandar H; Wang, Sophia; Harrawood, Amanda; Martinez, Stephanie; Heiderscheit, Annie; Chlan, Linda; Perkins, Anthony J; Tu, Wanzhu; Boustani, Malaz; Khan, Babar

    2017-11-29

    Delirium is a highly prevalent and morbid syndrome in intensive care units (ICUs). Changing the stressful environment within the ICU via music may be an effective and a scalable way to reduce the burden of delirium. The Decreasing Delirium through Music (DDM) study is a three-arm, single-blind, randomized controlled feasibility trial. Sixty patients admitted to the ICU with respiratory failure requiring mechanical ventilation will be randomized to one of three arms (20 participants per arm): (1) personalized music, (2) non-personalized relaxing music, or (3) attention-control. Music preferences will be obtained from all enrolled participants or their family caregivers. Participants will receive two 1-h audio sessions a day through noise-cancelling headphones and mp3 players. Our primary aim is to determine the feasibility of the trial design (recruitment, adherence, participant retention, design and delivery of the music intervention). Our secondary aim is to estimate the potential effect size of patient-preferred music listening in reducing delirium, as measured by the Confusion Assessment Method for the ICU (CAM-ICU). Participants will receive twice daily assessments for level of sedation and presence of delirium. Enrolled participants will be followed in the hospital until death, discharge, or up to 28 days, and seen in the Critical Care Recovery Clinic at 90 days. DDM is a feasibility trial to provide personalized and non-personalized music interventions for critically ill, mechanically ventilated patients. Our trial will also estimate the preliminary efficacy of music interventions on reducing delirium incidence and severity. ClinicalTrials.gov, Identifier: NCT03095443 . Registered on 23 March 2017.

  10. Short-term Effects of High-Dose Caffeine on Cardiac Arrhythmias in Patients With Heart Failure: A Randomized Clinical Trial.

    Science.gov (United States)

    Zuchinali, Priccila; Souza, Gabriela C; Pimentel, Maurício; Chemello, Diego; Zimerman, André; Giaretta, Vanessa; Salamoni, Joyce; Fracasso, Bianca; Zimerman, Leandro I; Rohde, Luis E

    2016-12-01

    The presumed proarrhythmic action of caffeine is controversial. Few studies have assessed the effect of high doses of caffeine in patients with heart failure due to left ventricular systolic dysfunction at high risk for ventricular arrhythmias. To compare the effect of high-dose caffeine or placebo on the frequency of supraventricular and ventricular arrhythmias, both at rest and during a symptom-limited exercise test. Double-blinded randomized clinical trial with a crossover design conducted at the heart failure and cardiac transplant clinic of a tertiary-care university hospital. The trial included patients with chronic heart failure with moderate-to-severe systolic dysfunction (left ventricular ejection fraction Caffeine (100 mg) or lactose capsules, in addition to 5 doses of 100 mL decaffeinated coffee at 1-hour intervals, for a total of 500 mg of caffeine or placebo during a 5-hour protocol. After a 1-week washout period, the protocol was repeated. Number and percentage of ventricular and supraventricular premature beats assessed by continuous electrocardiographic monitoring. We enrolled 51 patients (37 [74%] male; mean [SD] age, 60.6 [10.9] years) with predominantly moderate-to-severe left ventricular systolic dysfunction (mean [SD] left ventricular ejection fraction, 29% [7%]); 31 [61%] had an implantable cardioverter-defibrillator device. No significant differences between the caffeine and placebo groups were observed in the number of ventricular (185 vs 239 beats, respectively; P = .47) and supraventricular premature beats (6 vs 6 beats, respectively; P = .44), as well as in couplets, bigeminal cycles, or nonsustained tachycardia during continuous electrocardiographic monitoring. Exercise test-derived variables, such as ventricular and supraventricular premature beats, duration of exercise, estimated peak oxygen consumption, and heart rate, were not influenced by caffeine ingestion. We observed no increases in ventricular premature beats (91 vs 223

  11. Effects of Vildagliptin on Ventricular Function in Patients With Type 2 Diabetes Mellitus and Heart Failure: A Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    McMurray, John J V; Ponikowski, Piotr; Bolli, Geremia B; Lukashevich, Valentina; Kozlovski, Plamen; Kothny, Wolfgang; Lewsey, James D; Krum, Henry

    2017-10-11

    This study sought to examine the safety of the dipeptidyl peptidase-4 inhibitor, vildagliptin, in patients with heart failure and reduced ejection fraction. Many patients with type 2 diabetes mellitus have heart failure and it is important to know about the safety of new treatments for diabetes in these individuals. Patients 18 to 85 years of age with type 2 diabetes and heart failure (New York Heart Association functional class I to III and left ventricular ejection fraction [LVEF] <0.40) were randomized to 52 weeks treatment with vildagliptin 50 mg twice daily (50 mg once daily if treated with a sulfonylurea) or matching placebo. The primary endpoint was between-treatment change from baseline in echocardiographic LVEF using a noninferiority margin of -3.5%. A total of 254 patients were randomly assigned to vildagliptin (n = 128) or placebo (n = 126). Baseline LVEF was 30.6 ± 6.8% in the vildagliptin group and 29.6 ± 7.7% in the placebo group. The adjusted mean change in LVEF was 4.95 ± 1.25% in vildagliptin treated patients and 4.33 ± 1.23% in placebo treated patients, a difference of 0.62 (95% confidence interval [CI]: -2.21 to 3.44; p = 0.667). This difference met the predefined noninferiority margin of -3.5%. Left ventricular end-diastolic and end-systolic volumes increased more in the vildagliptin group by 17.1 ml (95% CI: 4.6 to 29.5 ml; p = 0.007) and 9.4 ml (95% CI: -0.49 to 19.4 ml; p = 0.062), respectively. Decrease in hemoglobin A1c from baseline to 16 weeks, the main secondary endpoint, was greater in the vildagliptin group: -0.62% (95% CI: -0.93 to -0.30%; p < 0.001; -6.8 mmol/mol; 95% CI: -10.2 to -3.3 mmol/mol). Compared with placebo, vildagliptin had no major effect on LVEF but did lead to an increase in left ventricular volumes, the cause and clinical significance of which is unknown. More evidence is needed regarding the safety of dipeptidyl peptidase-4 inhibitors in patients with heart failure and left ventricular

  12. Computed tomographic coronary angiography for patients with heart failure (CTA-HF): a randomized controlled trial (IMAGE HF Project 1-C).

    Science.gov (United States)

    Chow, Benjamin J W; Green, Rachel E; Coyle, Doug; Laine, Mika; Hanninen, Helena; Leskinen, Hanna; Rajda, Miroslav; Larose, Eric; Hartikainen, Juha; Hedman, Marja; Mielniczuk, Lisa; O'Meara, Eileen; deKemp, Robert A; Klein, Ran; Paterson, Ian; White, James A; Yla-Herttuala, Seppo; Leber, Alex; Tandon, Vikas; Lee, Ting; Al-Hesayen, Abdul; Hessian, Renee; Dowsley, Taylor; Kass, Malek; Kelly, Cathy; Garrard, Linda; Tardif, Jean-Claude; Knuuti, Juhani; Beanlands, Rob S; Wells, George A

    2013-12-26

    The prevalence of heart failure (HF) is rising in industrialized and developing countries. Though invasive coronary angiography (ICA) remains the gold standard for anatomical assessment of coronary artery disease in HF patients, alternatives are being sought. Computed tomographic coronary angiography (CTA) has emerged as an accurate non-invasive diagnostic tool for coronary artery disease (CAD) and has been demonstrated to have prognostic value. Whether or not CTA can be used in HF patients is unknown. Acknowledging the aging population, the growing prevalence of HF and the increasing financial burden of healthcare, we need to identify non-invasive diagnostic tests that are available, safe, accurate and cost-effective. The proposed study aims to provide insight into the efficacy of CTA in HF patients. A multicenter randomized controlled trial will enroll 250 HF patients requiring coronary anatomical definition. Enrolled patients will be randomized to either CTA or ICA (n = 125 per group) as the first test to define coronary anatomy. The primary outcomes will be collected to determine downstream resource utilization. Secondary outcomes will include the composite clinical events and major adverse cardiac events. In addition, the accuracy of CTA for detecting coronary anatomy and obstruction will be assessed in patients who subsequently undergo both CTA and ICA. It is expected that CTA will be a more cost-effective strategy for diagnosis: yielding similar outcomes with fewer procedural risks and improved resource utilization. ClinicalTrials.gov, NCT01283659. Team grant #CIF 99470.

  13. First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT.

    Science.gov (United States)

    Hofmann, Reiner; Völler, Heinz; Nagels, Klaus; Bindl, Dominik; Vettorazzi, Eik; Dittmar, Ronny; Wohlgemuth, Walter; Neumann, Till; Störk, Stefan; Bruder, Oliver; Wegscheider, Karl; Nagel, Eckhard; Fleck, Eckart

    2015-08-11

    Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva®). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months. A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances. CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic

  14. Evaluation of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation: study protocol of a cluster randomized controlled trial.

    Science.gov (United States)

    Meng, Karin; Musekamp, Gunda; Seekatz, Bettina; Glatz, Johannes; Karger, Gabriele; Kiwus, Ulrich; Knoglinger, Ernst; Schubmann, Rainer; Westphal, Ronja; Faller, Hermann

    2013-08-23

    Chronic heart failure requires a complex treatment regimen on a life-long basis. Therefore, self-care/self-management is an essential part of successful treatment and comprehensive patient education is warranted. However, specific information on program features and educational strategies enhancing treatment success is lacking. This trial aims to evaluate a patient-oriented and theory-based self-management educational group program as compared to usual care education during inpatient cardiac rehabilitation in Germany. The study is a multicenter cluster randomized controlled trial in four cardiac rehabilitation clinics. Clusters are patient education groups that comprise HF patients recruited within 2 weeks after commencement of inpatient cardiac rehabilitation. Cluster randomization was chosen for pragmatic reasons, i.e. to ensure a sufficient number of eligible patients to build large-enough educational groups and to prevent contamination by interaction of patients from different treatment allocations during rehabilitation. Rehabilitants with chronic systolic heart failure (n = 540) will be consecutively recruited for the study at the beginning of inpatient rehabilitation. Data will be assessed at admission, at discharge and after 6 and 12 months using patient questionnaires. In the intervention condition, patients receive the new patient-oriented self-management educational program, whereas in the control condition, patients receive a short lecture-based educational program (usual care). The primary outcome is patients' self-reported self-management competence. Secondary outcomes include behavioral determinants and self-management health behavior (symptom monitoring, physical activity, medication adherence), health-related quality of life, and treatment satisfaction. Treatment effects will be evaluated separately for each follow-up time point using multilevel regression analysis, and adjusting for baseline values. This study evaluates the effectiveness of a

  15. Robustness of networks against cascading failures

    Science.gov (United States)

    Dou, Bing-Lin; Wang, Xue-Guang; Zhang, Shi-Yong

    2010-06-01

    Inspired by other related works, this paper proposes a non-linear load-capacity model against cascading failures, which is more suitable for real networks. The simulation was executed on the B-A scale-free network, E-R random network, Internet AS level network, and the power grid of the western United States. The results show that the model is feasible and effective. By studying the relationship between network cost and robustness, we find that the model can defend against cascading failures better and requires a lower investment cost when higher robustness is required.

  16. Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Widdershoven Jos

    2011-10-01

    Full Text Available Abstract Background Frequent rehospitalisations and poorer survival chances in heart failure (HF patients may partly be explained by poor medication adherence. There are multiple medication-related reasons for suboptimal adherence, but psychological reasons may also be important. A novel TELEmonitoring device may improve MEDication adherence in HF patients (TELEMED-HF. TELEMED-HF is a randomized, controlled clinical intervention trial designed to examine (1 the efficacy and cost-efficiency of an electronic medication adherence support system in improving and monitoring HF patients' medication adherence; (2 the effect of medication adherence on hospitalizations and health care consumption; as well as on (3 clinical characteristics, and Quality of Life (QoL; and (4 clinical, sociodemographic, and psychological determinants of medication adherence. Methods/Design Consecutive patients with chronic, systolic HF presenting to the outpatient clinic of the TweeSteden Hospital, The Netherlands, will be approached for study participation and randomly assigned (1:1 following blocked randomization procedures to the intervention (n = 200 or usual care arm (n = 200. Patients in the intervention arm use the medication support device for six months in addition to usual care. Post-intervention, patients return to usual care only and all patients participate in four follow-up occasions over 12 months. Primary endpoints comprise objective and subjective medication adherence, healthcare consumption, number of hospitalizations, and cost-effectiveness. Secondary endpoints include disease severity, physical functioning, and QoL. Discussion The TELEMED-HF study will provide us a comprehensive understanding of medication adherence in HF patients, and will show whether telemonitoring is effective and cost-efficient in improving adherence and preventing hospitalization in HF patients. Trial registration number NCT01347528.

  17. TITRATION: A Randomized Study to Assess 2 Treatment Algorithms with New Insulin Glargine 300 units/mL.

    Science.gov (United States)

    Yale, Jean-François; Berard, Lori; Groleau, Mélanie; Javadi, Pasha; Stewart, John; Harris, Stewart B

    2017-10-01

    It was uncertain whether an algorithm that involves increasing insulin dosages by 1 unit/day may cause more hypoglycemia with the longer-acting insulin glargine 300 units/mL (GLA-300). The objective of this study was to compare safety and efficacy of 2 titration algorithms, INSIGHT and EDITION, for GLA-300 in people with uncontrolled type 2 diabetes mellitus, mainly in a primary care setting. This was a 12-week, open-label, randomized, multicentre pilot study. Participants were randomly assigned to 1 of 2 algorithms: they either increased their dosage by 1 unit/day (INSIGHT, n=108) or the dose was adjusted by the investigator at least once weekly, but no more often than every 3 days (EDITION, n=104). The target fasting self-monitored blood glucose was in the range of 4.4 to 5.6 mmol/L. The percentages of participants reaching the primary endpoint of fasting self-monitored blood glucose ≤5.6 mmol/L without nocturnal hypoglycemia were 19.4% (INSIGHT) and 18.3% (EDITION). At week 12, 26.9% (INSIGHT) and 28.8% (EDITION) of participants achieved a glycated hemoglobin value of ≤7%. No differences in the incidence of hypoglycemia of any category were noted between algorithms. Participants in both arms of the study were much more satisfied with their new treatment as assessed by the Diabetes Treatment Satisfaction Questionnaire. Most health-care professionals (86%) preferred the INSIGHT over the EDITION algorithm. The frequency of adverse events was similar between algorithms. A patient-driven titration algorithm of 1 unit/day with GLA-300 is effective and comparable to the previously tested EDITION algorithm and is preferred by health-care professionals. Copyright © 2017 Diabetes Canada. Published by Elsevier Inc. All rights reserved.

  18. A randomized trial of protocol-directed sedation management for mechanical ventilation in an Australian intensive care unit.

    Science.gov (United States)

    Bucknall, Tracey K; Manias, Elizabeth; Presneill, Jeffrey J

    2008-05-01

    To compare protocol-directed sedation management with traditional non-protocol-directed practice in mechanically ventilated patients. Randomized, controlled trial. General intensive care unit (24 beds) in an Australian metropolitan teaching hospital. Adult, mechanically ventilated patients (n = 312). Patients were randomly assigned to receive sedation directed by formal guidelines (protocol group, n = 153) or usual local clinical practice (control, n = 159). The median (95% confidence interval) duration of ventilation was 79 hrs (56-93 hrs) for patients in the protocol group compared with 58 hrs (44-78 hrs) for patients who received control care (p = .20). Lengths of stay (median [range]) in the intensive care unit (94 [2-1106] hrs vs. 88 (14-962) hrs, p = .58) and hospital (13 [1-113] days vs. 13 (1-365) days, p = .97) were similar, as were the proportions of subjects receiving a tracheostomy (17% vs. 15%, p = .64) or undergoing unplanned self-extubation (1.3% vs. 0.6%, p = .61). Death in the intensive care unit occurred in 32 (21%) patients in the protocol group and 32 (20%) control subjects (p = .89), with a similar overall proportion of deaths in hospital (25% vs. 22%, p = .51). A Cox proportional hazards model, after adjustment for age, gender, Acute Physiology and Chronic Health Evaluation II score, diagnostic category, and doses of commonly used drugs, estimated that protocol sedation management was associated with a 22% decrease (95% confidence interval 40% decrease to 2% increase, p = .07) in the occurrence of successful weaning from mechanical ventilation. This randomized trial provided no evidence of a substantial reduction in the duration of mechanical ventilation or length of stay, in either the intensive care unit or the hospital, with the use of protocol-directed sedation compared with usual local management. Qualified high-intensity nurse staffing and routine Australian intensive care unit nursing responsibility for many aspects of ventilatory

  19. Hydrochlorothiazide in intensive care unit-acquired hypernatremia : A randomized controlled trial

    NARCIS (Netherlands)

    van IJzendoorn, Marjolein M. C. O.; Buter, Hanneke; Kingma, W. Peter; Koopmans, Matty; Navis, Gerjan; Boerma, E. Christiaan

    Purpose: Thiazides are suggested as a treatment for intensive care unit (ICU)-acquired hypernatremia (IAH). The primary aim of the study was reducing serum sodium concentration (sNa) in patients with IAH with hydrochlorothiazide (HCT) in comparison to placebo. Secondary end points were a difference

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

    NARCIS (Netherlands)

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

    2011-01-01

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

  1. Integrated Advanced Microwave Sounding Unit-A (AMSU-A) METOP Stress Analysis Report (Qual Level Random Vibration) A1 Module

    Science.gov (United States)

    Mehitretter, R.

    1996-01-01

    Stress analysis of the primary structure of the Meteorological Satellites Project (METSAT) Advanced Microwave Sounding Units-A, A1 Module performed using the Meteorological Operational (METOP) Qualification Level 9.66 grms Random Vibration PSD Spectrum is presented. The random vibration structural margins of safety and natural frequency predictions are summarized.

  2. Comparable benefit of β-blocker therapy in heart failure across regions of the world: meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Chatterjee, Saurav; Udell, Jacob A; Sardar, Partha; Lichstein, Edgar; Ryan, John J

    2014-08-01

    There is a concern about geographical region heterogeneity regarding clinical benefit of β-blocker (BB) therapy in heart failure with reduced ejection fraction (HFrEF). This study sought to compare benefits of BB use within randomized controlled trials (RCTs) that enrolled patients with HFrEF from North America (NA) compared with other regions of the world (ROW). We conducted a meta-analysis using MEDLINE, EMBASE, Cochrane Library, Web of Science, and Scopus (inceptions-December 2012) of BB RCTs stratified according to NA vs ROW. The primary end point was all-cause mortality and secondary end points were cardiovascular death, sudden death, death due to pump failure, and premature drug discontinuation. Summary odds ratios (ORs) and 95% confidence intervals (CIs) for each outcome were calculated with interaction terms for region. Two-sided P values were calculated with P analysis included 16 RCTs with 14,452 patients; 7 trials were conducted in NA and 9 trials in ROW with follow-up durations of 3-58 months. All-cause mortality was consistently reduced in NA (OR, 0.82; 95% CI, 0.71-0.96; P = 0.01) and ROW (OR, 0.76; 95% CI, 0.69-0.84; P < 0.001; P-interaction = 0.40). Overall and according to region, all secondary end points including premature drug discontinuation were also less with BB therapy (P-interactions all ≥ 0.10). For the regions represented in the included trials, there is no evidence to suggest that geographic region is a significant moderator of clinical outcomes with BB therapy in HFrEF patients. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  3. Design of a multicentre randomized controlled trial to assess the safety and efficacy of dose titration by specialized nurses in patients with heart failure. ETIFIC study protocol.

    Science.gov (United States)

    Oyanguren, Juana; García-Garrido, LLuisa; Nebot Margalef, Magdalena; Lekuona, Iñaki; Comin-Colet, Josep; Manito, Nicolás; Roure, Julia; Ruiz Rodriguez, Pilar; Enjuanes, Cristina; Latorre, Pedro; Torcal Laguna, Jesús; García-Gutiérrez, Susana

    2017-11-01

    Heart failure (HF) is associated with many hospital admissions and relatively high mortality, rates decreasing with administration of beta-blockers (BBs), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists. The effect is dose dependent, suboptimal doses being common in clinical practice. The 2012 European guidelines recommend close monitoring and dose titration by HF nurses. Our main aim is to compare BB doses achieved by patients after 4 months in intervention (HF nurse-managed) and control (cardiologist-managed) groups. Secondary aims include comparing doses of the other aforementioned drugs achieved after 4 months, adverse events, and outcomes at 6 months in the two groups. We have designed a multicentre (20 hospitals) non-inferiority randomized controlled trial, including patients with new-onset HF, left ventricular ejection fraction ≤40%, and New York Heart Association class II-III, with no contraindications to BBs. We will also conduct qualitative analysis to explore potential barriers to and facilitators of dose titration by HF nurses. In the intervention group, HF nurses will implement titration as prescribed by cardiologists, following a protocol. In controls, cardiologists will both prescribe and titrate doses. The study variables are doses of each of the drugs after 4 months relative to the target dose (%), New York Heart Association class, left ventricular ejection fraction, N-terminal pro B-type natriuretic peptide levels, 6 min walk distance, comorbidities, renal function, readmissions, mortality, quality of life, and psychosocial characteristics. The trial seeks to assess whether titration by HF nurses of drugs recommended in practice guidelines is safe and not inferior to direct management by cardiologists. The results could have an impact on clinical practice. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of

  4. Prevention of pressure ulcers in the intensive care unit: a randomized trial of 2 viscoelastic foam support surfaces.

    Science.gov (United States)

    Ozyurek, Pakize; Yavuz, Meryem

    2015-01-01

    The aim of this study is to compare whether differences exist between 2 viscoelastic foam support surfaces in the development of new pressure ulcers. There is evidence to support the use of viscoelastic foam over standard hospital foam to reduce pressure. A comparative effectiveness study was done to compare 2 viscoelastic foam support surfaces. A randomized controlled trial was carried out. The study was performed in 2 intensive care units between October 1, 2008, and January 4, 2010. Patients (n = 105) admitted to intensive care unit were randomly assigned to viscoelastic foam 1 (n = 53) or viscoelastic foam 2 support surface (n = 52). In total, 42.8% of all patients developed a new pressure ulcer of stage 1 or worse. By stages, pressure ulcer incidence was 28.6%, 13.3%, and 1.0% for stages 1, 2, and 3, respectively. There was no significant difference in pressure ulcer incidence between the viscoelastic foam 1 and 2 groups (X2 = 0.07, df = 1, P > .05). No difference was found between 2 different viscoelastic foam surfaces in the prevention of pressure ulcers in patients treated in intensive care. Pressure ulcer incidence in critically ill patients remains high. Nurses must compare current products for effectiveness and develop innovative systems, processes, or devices to deliver best practices.

  5. [PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study].

    Science.gov (United States)

    Nydahl, P; Diers, A; Günther, U; Haastert, B; Hesse, S; Kerschensteiner, C; Klarmann, S; Köpke, S

    2017-10-12

    Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

  6. Effectiveness of supporting intensive care units on implementing the guideline 'End-of-life care in the intensive care unit, nursing care': a cluster randomized controlled trial.

    Science.gov (United States)

    Noome, Marijke; Dijkstra, Boukje M; van Leeuwen, Evert; Vloet, Lilian C M

    2017-06-01

    The aim of this study was to examine the effectiveness of supporting intensive care units on implementing the guidelines. Quality of care can be achieved through evidence-based practice. Guidelines can facilitate evidence-based practice, such as the guidelines 'End-of-life care in the intensive care unit, nursing care'. Before intensive care nurses are able to use these guidelines, they needs to be implemented in clinical practice. Implementation is a complex process and may need support. Cluster randomized controlled trial. Intensive care nurses of eight intensive care units in the intervention group followed a supportive programme that educated them on implementation, strategies, goals, project management and leadership. The intervention group focused on a stepwise approach to implement the guidelines. The control group (n = 5) implemented the guidelines independently or used the standard implementation plan supplementary to the guideline. The effectiveness of the programme was measured using questionnaires for nurses, interviews with nurses and a questionnaire for family of deceased patients, in the period from December 2014-December 2015. Overall, an increase in adherence to the guidelines was found in both groups. Overall, use of the guidelines in the intervention group was higher, but on some aspects the control group showed a higher score. Care for the patient and the overall nursing care scored significantly higher according to family in the intervention group. The increase in adherence to the guidelines and the significantly higher satisfaction of family in the intervention group indicate that the supportive programme had a more positive effect. © 2016 John Wiley & Sons Ltd.

  7. Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial.

    Science.gov (United States)

    Demetri, George D; von Mehren, Margaret; Jones, Robin L; Hensley, Martee L; Schuetze, Scott M; Staddon, Arthur; Milhem, Mohammed; Elias, Anthony; Ganjoo, Kristen; Tawbi, Hussein; Van Tine, Brian A; Spira, Alexander; Dean, Andrew; Khokhar, Nushmia Z; Park, Youn Choi; Knoblauch, Roland E; Parekh, Trilok V; Maki, Robert G; Patel, Shreyaskumar R

    2016-03-10

    This multicenter study, to our knowledge, is the first phase III trial to compare trabectedin versus dacarbazine in patients with advanced liposarcoma or leiomyosarcoma after prior therapy with an anthracycline and at least one additional systemic regimen. Patients were randomly assigned in a 2:1 ratio to receive trabectedin or dacarbazine intravenously every 3 weeks. The primary end point was overall survival (OS), secondary end points were disease control-progression-free survival (PFS), time to progression, objective response rate, and duration of response-as well as safety and patient-reported symptom scoring. A total of 518 patients were enrolled and randomly assigned to either trabectedin (n = 345) or dacarbazine (n = 173). In the final analysis of PFS, trabectedin administration resulted in a 45% reduction in the risk of disease progression or death compared with dacarbazine (median PFS for trabectedin v dacarbazine, 4.2 v 1.5 months; hazard ratio, 0.55; P < .001); benefits were observed across all preplanned subgroup analyses. The interim analysis of OS (64% censored) demonstrated a 13% reduction in risk of death in the trabectedin arm compared with dacarbazine (median OS for trabectedin v dacarbazine, 12.4 v 12.9 months; hazard ratio, 0.87; P = .37). The safety profiles were consistent with the well-characterized toxicities of both agents, and the most common grade 3 to 4 adverse effects were myelosuppression and transient elevation of transaminases in the trabectedin arm. Trabectedin demonstrates superior disease control versus conventional dacarbazine in patients who have advanced liposarcoma and leiomyosarcoma after they experience failure of prior chemotherapy. Because disease control in advanced sarcomas is a clinically relevant end point, this study supports the activity of trabectedin for patients with these malignancies. © 2015 by American Society of Clinical Oncology.

  8. Effects of Statin Treatment on Inflammation and Cardiac Function in Heart Failure: An Adjusted Indirect Comparison Meta-Analysis of Randomized Trials.

    Science.gov (United States)

    Bonsu, Kwadwo Osei; Reidpath, Daniel Diamond; Kadirvelu, Amudha

    2015-12-01

    Statins are known to prevent heart failure (HF). However, it is unclear whether statins as class or type (lipophilic or hydrophilic) improve outcomes of established HF. The current meta-analysis was performed to compare the treatment effects of lipophilic and hydrophilic statins on inflammation and cardiac function in HF. Outcomes were indicators of cardiac function [changes in left ventricular ejection fraction (LVEF) and B-type natriuretic peptide (BNP)] and inflammation [changes in highly sensitive C-reactive protein (hsCRP) and interluekin-6 (IL-6)]. We conducted a search of PubMed, EMBASE, and the Cochrane databases until December 31, 2014 for randomized control trials (RCTs) of statin versus placebo in patients with HF. RCTs with their respective extracted information were dichotomized into statin type evaluated and analyzed separately. Outcomes were pooled with random effect approach, producing standardized mean differences (SMD) for each statin type. Using these pooled estimates, we performed adjusted indirect comparisons for each outcome. Data from 6214 patients from 19 trials were analyzed. Lipophilic statin was superior to hydrophilic statin treatment regarding follow-up LVEF (SMD, 4.54; 95% CI, 4.16-4.91; P statin produces greater treatment effects on cardiac function and inflammation compared with hydrophilic statin in patients with HF. Until data from adequately powered head-to-head trial of the statin types are available, our meta-analysis brings clinicians and researchers a step closer to the quest on which statin--lipophilic or hydrophilic--is associated with better outcomes in HF. © 2015 John Wiley & Sons Ltd.

  9. MOTIVATional intErviewing to improve self-care in Heart Failure patients (MOTIVATE-HF): Study protocol of a three-arm multicenter randomized controlled trial.

    Science.gov (United States)

    Vellone, Ercole; Paturzo, Marco; D'Agostino, Fabio; Petruzzo, Antonio; Masci, Stefano; Ausili, Davide; Rebora, Paola; Alvaro, Rosaria; Riegel, Barbara

    2017-04-01

    Heart Failure (HF) self-care improves patient outcomes but trials designed to improve HF self-care have shown inconsistent results. Interventions may be more effective in improving self-care if they mobilize support from providers, promote self-efficacy, increase understanding of HF, increase the family involvement, and are individualized. All of these elements are emphasized in motivational interviewing (MI); few trials have been conducted using MI in HF patients and rarely have caregivers been involved in MI interventions. The aim of this study will be to evaluate if MI improves self-care maintenance in HF patients, and to determine if MI improves the following secondary outcomes: a) in HF patients: self-care management, self-care confidence, symptom perception, quality of life, anxiety/depression, cognition, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; b) in caregivers: caregiver contribution to self-care, quality of life, anxiety/depression, sleep, mutuality with patient, preparedness, and social support. A three-arm randomized controlled trial will be conducted in a sample of 240 HF patients and caregivers. Patients and caregivers will be randomized to the following arms: 1) MI intervention to patients only; 2) MI intervention to patients and caregivers; 3) standard of care to patients and caregivers. The primary outcome will be measured in patients 3months after enrollment. Primary and secondary outcomes also will be evaluated 6, 9 and 12months after enrollment. This study will contribute to understand if MI provided to patients and caregivers can improve self-care. Because HF is rising in prevalence, findings can be useful to reduce the burden of the disease. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Multicenter, randomized, placebo-controlled, double-blind study of the safety and efficacy of oral delapril in patients with congestive heart failure.

    Science.gov (United States)

    Circo, A; Platania, F; Mangiameli, S; Putignano, E

    1995-06-16

    A total of 101 patients (67 delapril, 34 placebo) with congestive heart failure, New York Heart Association (NYHA) classes II and III, entered a multicenter, randomized (2:1), double-blind, placebo-controlled study to determine the minimum effective and maximum tolerated doses of delapril. Patients received placebo or increasing doses of delapril. After a 2-week run-in period on placebo, patients were randomly assigned to delapril or placebo. The dose of delapril was 7.5 mg twice daily for 2 weeks, 15 mg twice daily for another 2 weeks, followed by 30 mg twice daily for 4 weeks. The dose was increased only if the patient did not present any symptoms of orthostatic hypotension. If such symptoms developed, the code was broken and an open treatment was continued on the minimum effective dose (delapril group). Patients with symptoms of orthostatic hypotension in the placebo group were withdrawn. At the end of the 8-week treatment, 36 (54.5%) patients in the delapril group completed the study on 30 mg twice daily, 12 (18.2%) on 15 mg twice daily, and 18 (27.3%) on 7.5 mg twice daily. Seven patients on placebo were withdrawn because of insufficient therapeutic response; one patient on delapril was lost to follow-up. There was a significant improvement (p < 0.01) in bicycle ergometric performance involving an increase in the exercise duration and the maximum workload tolerated in those patients completing the study on delapril 30 mg twice daily and those finishing on 15 mg twice daily.(ABSTRACT TRUNCATED AT 250 WORDS)

  11. Effect of fluid and dietary sodium restriction in the management of patients with heart failure and preserved ejection fraction: study protocol for a randomized controlled trial.

    Science.gov (United States)

    d'Almeida, Karina S M; Rabelo-Silva, Eneida R; Souza, Gabriela C; Trojahn, Melina M; Barilli, Sofia L S; Mansson, Jessica V; Biolo, Andreia; Rohde, Luis E P; Clausell, Nadine; Beck-da-Silva, Luís

    2014-09-04

    Although half of all patients with heart failure (HF) have a normal or near-normal ejection fraction and their prognosis differs little from that of patients with a reduced ejection fraction, the pathophysiology of HF with preserved ejection fraction (HF-PEF) is still poorly understood, and its management poorly supported by clinical trials. Sodium and fluid restriction is the most common self-care measure prescribed to HF patients for management of congestive episodes. However, its role in the treatment of HF-PEF remains unclear. This trial seeks to compare the effects of a sodium- and fluid-restricted diet versus an unrestricted diet on weight loss, neurohormonal activation, and clinical stability in patients admitted for decompensated HF-PEF. This is a randomized, parallel trial with blinded outcome assessment. The sample will include adult patients (aged ≥18 years) with a diagnosis of HF-PEF admitted for HF decompensation. The patients will be randomized to receive a diet with sodium and fluid intake restricted to 0.8 g/day and 800 mL/day respectively (intervention group) or an unrestricted diet, with 4 g/day sodium and unlimited fluid intake (control group), and followed for 7 days or until hospital discharge. The primary outcome shall consist of weight loss at 7 days or discharge. The secondary outcome includes assessment of clinical stability, neurohormonal activation, daily perception of thirst and readmission rate at 30 days. Assessment of the effects of sodium and fluid restriction on neurohormonal activation and clinical course of HF-PEF can promote a deeper understanding of the pathophysiology and progression of this complex syndrome. ClinicalTrials.gov identifier: NCT01896908 (date of registration: 8 August 2013).

  12. Pro-HEART - a randomized clinical trial to test the effectiveness of a high protein diet targeting obese individuals with heart failure: rationale, design and baseline characteristics.

    Science.gov (United States)

    Motie, Marjan; Evangelista, Lorraine S; Horwich, Tamara; Hamilton, Michele; Lombardo, Dawn; Cooper, Dan M; Galassetti, Pietro R; Fonarow, Gregg C

    2013-11-01

    There is ample research to support the potential benefits of a high protein diet on clinical outcomes in overweight/obese, diabetic subjects. However, nutritional management of overweight/obese individuals with heart failure (HF) and type 2 diabetes mellitus (DM) or metabolic syndrome (MS) is poorly understood and few clinical guidelines related to nutritional approaches exist for this subgroup. This article describes the design, methods, and baseline characteristics of study participants enrolled in Pro-HEART, a randomized clinical trial to determine the short term and long term effects of a high protein diet (30% protein [~110 g/day], 40% carbohydrates [150 g/day], 30% fat [~50 g/day]) versus a standard protein diet (15% protein [~55 g/day], 55% carbohydrates [~200 g/day], 30% fat [~50 g/day]) on body weight and adiposity, cardiac structure and function, functional status, lipid profile, glycemic control, and quality of life. Between August, 2009 and May, 2013, 61 individuals agreed to participate in the study; 52 (85%) - mean age 58.2 ± 9.8 years; 15.4% Blacks; 57.7% Whites; 19.2% Hispanics; 7.7% Asians; 73.1% male; weight 112.0 ± 22.6 kg - were randomized to a 3-month intensive weight management program of either a high protein or standard protein diet; data were collected at baseline, 3 months, and 15 months. This study has the potential to reveal significant details about the role of macronutrients in weight management of overweight/obese individuals with HF and DM or MS. © 2013 Elsevier Inc. All rights reserved.

  13. Risk of heart failure among postmenopausal women: a secondary analysis of the randomized trial of vitamin D plus calcium of the women's health initiative.

    Science.gov (United States)

    Donneyong, Macarius M; Hornung, Carlton A; Taylor, Kira C; Baumgartner, Richard N; Myers, John A; Eaton, Charles B; Gorodeski, Eiran Z; Klein, Liviu; Martin, Lisa W; Shikany, James M; Song, Yiqing; Li, Wenjun; Manson, JoAnn E

    2015-01-01

    Vitamin D supplementation may be an inexpensive intervention to reduce heart failure (HF) incidence. However, there are insufficient data to support this hypothesis. This study evaluates whether vitamin D plus calcium (CaD) supplementation is associated with lower rates of HF in postmenopausal women and whether the effects differ between those at high versus low risk for HF. Analyses were restricted to 35 983 (of original 36 282) women aged 50 to 79 years old in the Women's Health Initiative randomized trial of CaD supplementation who were randomized 1:1 in a double-blinded fashion to receive 1000 mg/d of calcium plus 400 IU/d of vitamin D3 or placebo. Overall, 744 adjudicated incident HF cases (intervention, 363; control, 381) occurred during a median follow-up of 7.1 (interquartile range, 1.6) years. CaD supplementation, compared with placebo, was not associated with reduced HF risk in the overall population, hazard ratio, 0.95; P=0.46. However, CaD supplementation had differential effects (P interaction=0.005) in subgroups stratified by baseline risk status of HF defined by the presence (high risk=17 449) or absence (low risk=18 534) of pre-existing HF precursors including coronary heart diseases, diabetes mellitus, or hypertension: 37% (hazard ratio, 0.63 [95% confidence interval, 0.46-0.87]) lower risk of HF in the low-risk versus hazard ratio, 1.06; P=0.51, in the high-risk subgroups. CaD supplementation did not significantly reduce HF incidence in the overall cohort, however, it was beneficial among postmenopausal women without major HF precursors while of little value in high-risk subgroups. Additional studies are warranted to confirm these findings and investigate the underlying mechanism. http://www.clinicaltrials.gov. Unique identifier: NCT00000611. © 2014 American Heart Association, Inc.

  14. A reevaluation of the costs of heart failure and its implications for allocation of health resources in the United States.

    Science.gov (United States)

    Voigt, Jeff; Sasha John, M; Taylor, Andrew; Krucoff, Mitchell; Reynolds, Matthew R; Michael Gibson, C

    2014-05-01

    The annual cost of heart failure (HF) is estimated at $39.2 billion. This has been acknowledged to underestimate the true costs for care. The objective of this analysis is to more accurately assess these costs. Publicly available data sources were used. Cost calculations incorporated relevant factors such as Medicare hospital cost-to-charge ratios, reimbursement from both government and private insurance, and out-of-pocket expenditures. A recently published Atherosclerosis Risk in Communities (ARIC) HF scheme was used to adjust the HF classification scheme. Costs were calculated with HF as the primary diagnosis (HF in isolation, or HFI) or HF as one of the diagnoses/part of a disease milieu (HF syndrome, or HFS). Total direct costs for HF were calculated at $60.2 billion (HFI) and $115.4 billion (HFS). Indirect costs were $10.6 billion for both. Costs attributable to HF may represent a much larger burden to US health care than what is commonly referenced. These revised and increased costs have implications for policy makers.

  15. Data and Statistics: Heart Failure

    Science.gov (United States)

    ... High Blood Pressure Salt Cholesterol Million Hearts® WISEWOMAN Heart Failure Fact Sheet Recommend on Facebook Tweet Share Compartir ... not mean that the heart has stopped beating. Heart Failure in the United States About 5.7 million ...

  16. Effects of Endurance Exercise Training and Crataegus Extract WS® 1442 in Patients with Heart Failure with Preserved Ejection Fraction – A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Sascha Härtel

    2014-09-01

    Full Text Available Impaired exercise capacity is the core symptom of heart failure with preserved ejection fraction (HFpEF. We assessed effects of exercise training and Crataegus extract WS 1442 in HFpEF and aimed to identify mechanisms of action in an exploratory trial (German Clinical Trials Register DRKS00000259. 140 sedentary HFpEF NYHA II patients on standard treatment received eight weeks of aerobic endurance training and half were randomized to WS 1442 900 mg/day. Symptoms, 2 km walking time (T2km, parameters of exercise tolerance, cardiac and vascular function, muscular efficiency and skeletal muscular haemoglobin oxygen saturation (SO2 measured during a treadmill protocol were captured at baseline and after eight weeks. Adverse events were recorded during the trial. Mechanisms of action were explored by correlation and path analyses of changes. Symptoms and exercise capacity improved with training, but correlations between improvements were low and path models were rejected. SO2 increased, decreased or undulated with increasing exercise intensity in individual patients and was not altered by training. WS 1442 improved T2km (-12.7% vs. -8.4%, p = 0.019, tended to improve symptoms and to pronounce SO2-decrease with increasing exercise, an indicator of oxygen utilisation. Endurance training and WS 1442 were safe and well tolerated in combination with standard drug treatment.

  17. Effects of tailored telemonitoring on heart failure patients' knowledge, self-care, self-efficacy and adherence: a randomized controlled trial.

    Science.gov (United States)

    Boyne, Josiane J J; Vrijhoef, Hubertus J M; Spreeuwenberg, Marieke; De Weerd, Gerjan; Kragten, Johannes; Gorgels, Anton P M

    2014-06-01

    The education of patients with heart failure (HF) is an essential part of disease management. The perspectives of an increasing number of patients and a shortage of professionals force healthcare to explore new strategies in supporting patients to be better informed and more active. Three hundred and eighty-two patients with HF (age 71±SD 11.2 years) were randomly assigned to either a telemonitoring or a usual care group. Patients received four postal questionnaires to assess their levels of self-reported knowledge, self-care, self-efficacy and adherence. Generalized estimating equations analysis was performed to assess the effects of telemonitoring during the 1-year follow-up. Corrections for baseline were performed if needed. Baseline differences between groups were found for self-care (p=0.001) and self-efficacy (p=0.024). Knowledge of patients in the telemonitoring group significantly improved with 0.9 point on a 15-points scale (ppatients receiving usual care (ppatients in the intervention group improved significantly after 6 months yet was not significantly different after 3 months and 1 year. For patients in the intervention group adherence improved for daily weighing (ptelemonitoring was found to educate patients with HF and to improve their self-care abilities and sense of self-efficacy.

  18. The short-term and long-term effects of tolvaptan in patients with heart failure: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Xiong, Bo; Huang, Yuwen; Tan, Jie; Yao, Yuanqing; Wang, Chunbin; Qian, Jun; Rong, Shunkang; Deng, Shimin; Cao, Yin; Zou, Yanke; Huang, Jing

    2015-11-01

    A comprehensive evaluation of the benefits of tolvaptan for the management of heart failure (HF) is lacking. The objective of this meta-analysis was to assess the short-term and long-term effects of tolvaptan in patients with HF. Articles were searched from PubMed, MEDLINE and Cochrane Library before March 31, 2015. Randomized controlled trials enrolling adult HF patients and reporting the all-cause mortality, cardiac events, body weight change or changes of serum electrolytes including sodium, potassium and creatinine were included in our meta-analysis. Ten studies covering 5574 patients met the inclusion criteria. Based on the data of meta-analysis, tolvaptan had no impact on the all-cause mortality [relative risk (RR) 0.96; 95 % confidence interval (CI) 0.87-1.06; P = 0.40] and incidence of cardiac events (RR 1.03; 95 % CI 0.96-1.11; P = 0.40) of HF patients. Furthermore, in comparison with control treatments, tolvaptan significantly decreased the body weight [weight mean difference (WMD), -0.87; 95 % CI -1.03 to -0.71; P tolvaptan (WMD, 0.05; 95 % CI 0.03-0.07; P tolvaptan may not bring long-term benefits, but it effectively improves the volume overload and hyponatremia without obvious increases in serum potassium and creatinine. Hence, tolvaptan is likely to be a promising diuretic for the treatment of HF.

  19. The effect of executive walk rounds on nurse safety climate attitudes: A randomized trial of clinical units

    Directory of Open Access Journals (Sweden)

    Frankel Allan

    2005-04-01

    Full Text Available Abstract Background Executive walk rounds (EWRs are a widely used but unstudied activity designed to improve safety culture in hospitals. Therefore, we measured the impact of EWRs on one important part of safety culture – provider attitudes about the safety climate in the institution. Methods Randomized study of EWRs for 23 clinical units in a tertiary care teaching hospital. All providers except physicians participated. EWRs were conducted at each unit by one of six hospital executives once every four weeks for three visits. Providers were asked about their concerns regarding patient safety and what could be done to improve patient safety. Suggestions were tabulated and when possible, changes were made. Provider attitudes about safety climate measured by the Safety Climate Survey before and after EWRs. We report mean scores, percent positive scores (percentage of providers who responded four or higher on a five point scale (agree slightly or agree strongly, and the odds of EWR participants agreeing with individual survey items when compared to non-participants. Results Before EWRs the mean safety climate scores for nurses were similar in the control units and EWR units (78.97 and 76.78, P = 0.458 as were percent positive scores (64.6% positive and 61.1% positive. After EWRs the mean safety climate scores were not significantly different for all providers nor for nurses in the control units and EWR units (77.93 and 78.33, P = 0.854 and (56.5% positive and 62.7% positive. However, when analyzed by exposure to EWRs, nurses in the control group who did not participate in EWRs (n = 198 had lower safety climate scores than nurses in the intervention group who did participate in an EWR session (n = 85 (74.88 versus 81.01, P = 0.02; 52.5% positive versus 72.9% positive. Compared to nurses who did not participate, nurses in the experimental group who reported participating in EWRs also responded more favorably to a majority of items on the survey

  20. Prophylactic fluconazole in very low birth weight infants admitted to neonatal intensive care unit: randomized controlled trial.

    Science.gov (United States)

    Kirpal, Harita; Gathwala, Geeta; Chaudhary, Uma; Sharma, Deepak

    2016-01-01

    To evaluate the effect of fluconazole prophylaxis on invasive fungal infection (IFI) in very low birth weight (VLBW) infants in the Neonatal Intensive Care Unit (NICU). VLBW infants receiving antibiotics for more than 3 days were randomized to receive either fluconazole (6 mg/kg) or placebo, every other day for 7 days followed by everyday till day 28 or discharge whichever was earlier. The primary outcome was IFI, and secondary outcome was fungal attributable mortality and all-cause mortality. The incidence of IFI was significantly lower (21%) in the fluconazole group compared to the control group (43.2%, 95%CI 0.09-0.37, p fluconazole group (2.6% versus 18.9%, 95%CI 0.003-0.52, p fluconazole prophylaxis decreases IFI and fungal attributable mortality.

  1. Effects of lyric analysis interventions on treatment motivation in patients on a detoxification unit: a randomized effectiveness study.

    Science.gov (United States)

    Silverman, Michael J

    2015-01-01

    Treatment motivation is a key component in the early rehabilitative stages for people with substance use disorders. To date, no music therapy researcher has studied how lyric analysis interventions might affect motivation in a randomized controlled design. The primary purpose of this study was to determine the effect of lyric analysis interventions on treatment motivation in patients on a detoxification unit using a single-session wait-list control design. A secondary purpose was to determine if there were between-group differences concerning two contrasting songs used for the lyric analyses. Participants (N=104) were cluster randomized to a group lyric analysis condition or a wait-list control condition. Participants received either a "Hurt" or a "How to Save a Life" lyric analysis treatment. The Texas Christian University Treatment Motivation Scale-Client Evaluation of Self at Intake (CESI) (Simpson, 2008[2005]) was used to measure aspects of treatment motivation: problem recognition, desire for help, treatment readiness, pressures for treatment, and total motivation. Results indicated significant between-group differences in measures of problem recognition, desire for help, treatment readiness, and total motivation, with experimental participants having higher treatment motivation means than control participants. There was no difference between the two lyric analysis interventions. Although the song used for lyric analysis interventions did not affect outcome, a single group-based music therapy lyric analysis session can be an effective psychosocial treatment intervention to enhance treatment motivation in patients on a detoxification unit. Limitations, implications for clinical practice, and suggestions for future research are provided. © the American Music Therapy Association 2015. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  2. Non-random expression of ribosomal DNA units in a grasshopper showing high intragenomic variation for the ITS2 region.

    Science.gov (United States)

    Ruiz-Estévez, M; Ruiz-Ruano, F J; Cabrero, J; Bakkali, M; Perfectti, F; López-León, M D; Camacho, J P M

    2015-06-01

    We analyse intragenomic variation of the ITS2 internal transcribed spacer of ribosomal DNA (rDNA) in the grasshopper Eyprepocnemis plorans, by means of tagged PCR 454 amplicon sequencing performed on both genomic DNA (gDNA) and RNA-derived complementary DNA (cDNA), using part of the ITS2 flanking coding regions (5.8S and 28S rDNA) as an internal control for sequencing errors. Six different ITS2 haplotypes (i.e. variants for at least one nucleotide in the complete ITS2 sequence) were found in a single population, one of them (Hap4) being specific to a supernumerary (B) chromosome. The analysis of both gDNA and cDNA from the same individuals provided an estimate of the expression efficiency of the different haplotypes. We found random expression (i.e. about similar recovery in gDNA and cDNA) for three haplotypes (Hap1, Hap2 and Hap5), but significant underexpression for three others (Hap3, Hap4 and Hap6). Hap4 was the most extremely underexpressed and, remarkably, it showed the lowest sequence conservation for the flanking 5.8-28S coding regions in the gDNA reads but the highest conservation (100%) in the cDNA ones, suggesting the preferential expression of mutation-free rDNA units carrying this ITS2 haplotype. These results indicate that the ITS2 region of rDNA is far from complete homogenization in this species, and that the different rDNA units are not expressed at random, with some of them being severely downregulated. © 2015 The Royal Entomological Society.

  3. Random Acts of Violence? Examining Probabilistic Independence of the Temporal Distribution of Mass Killing Events in the United States.

    Science.gov (United States)

    King, Douglas M; Jacobson, Sheldon H

    2017-12-01

    Recent mass killings, such as those in Newtown, Connecticut, and Aurora, Colorado, have brought new attention to mass killings in the United States. This article examines 323 mass killings taking place between January 1, 2006, and October 4, 2016, to assess how they are distributed over time. In particular, we find that they appear to be uniformly distributed over time, which suggests that their rate has remained stable over the past decade. Moreover, analysis of subsets of these mass killings sharing a common trait (e.g., family killings, public killings) suggests that they exhibit a memoryless property, suggesting that mass killing events within each category are random in the sense that the occurrence of a mass killing event does not signal whether another mass killing event is imminent. However, the same memoryless property is not found when combining all mass killings into a single analysis, consistent with earlier research that found evidence of a contagion effect among mass killing events. Because of the temporal randomness of public mass killings and the wide geographic area over which they can occur, these results imply that these events may be best addressed by systemic infrastructure-based interventions that deter such events, incorporate resiliency into the response system, or impede such events until law enforcement can respond when they do occur.

  4. identical stations and random failures

    Directory of Open Access Journals (Sweden)

    Dennis E. Blumenfeld

    2005-01-01

    line with identical workstations and buffers of equal size. It is a closed-form expression that shows the mathematical relationships between the system parameters, and that can be used to gain basic insight into system behavior at the initial design stage.

  5. Respiratory Filter Reduces the Cardiovascular Effects Associated With Diesel Exhaust Exposure: A Randomized, Prospective, Double-Blind, Controlled Study of Heart Failure: The FILTER-HF Trial.

    Science.gov (United States)

    Vieira, Jefferson L; Guimaraes, Guilherme V; de Andre, Paulo A; Cruz, Fátima D; Saldiva, Paulo H Nascimento; Bocchi, Edimar A

    2016-01-01

    The goal of this study was to test the effects of a respiratory filter intervention (filter) during controlled pollution exposure. Air pollution is considered a risk factor for heart failure (HF) decompensation and mortality. This study was a double-blind, randomized to order, controlled, 3-way crossover, single-center clinical trial. It enrolled 26 patients with HF and 15 control volunteers. Participants were exposed in 3 separate sessions to clean air, unfiltered diesel exhaust exposure (DE), or filtered DE. Endpoints were endothelial function assessed by using the reactive hyperemia index (RHi), arterial stiffness, serum biomarkers, 6-min walking distance, and heart rate variability. In patients with HF, DE was associated with a worsening in RHi from 2.17 (interquartile range [IQR]: 1.8 to 2.5) to 1.72 (IQR: 1.5 to 2.2; p = 0.002) and an increase in B-type natriuretic peptide (BNP) from 47.0 pg/ml (IQR: 17.3 to 118.0 pg/ml) to 66.5 pg/ml (IQR: 26.5 to 155.5 pg/ml; p = 0.004). Filtration reduced the particulate concentration (325 ± 31 μg/m(3) vs. 25 ± 6 μg/m(3); p HF, filter was associated with an improvement in RHi from 1.72 (IQR: 1.5 to 2.2) to 2.06 (IQR: 1.5 to 2.6; p = 0.019) and a decrease in BNP from 66.5 pg/ml (IQR: 26.5 to 155.5 pg/ml) to 44.0 pg/ml (IQR: 20.0 to 110.0 pg/ml; p = 0.015) compared with DE. In both groups, DE decreased the 6-min walking distance and arterial stiffness, although filter did not change these responses. DE had no effect on heart rate variability or exercise testing. To our knowledge, this trial is the first to show that a filter can reduce both endothelial dysfunction and BNP increases in patients with HF during DE. Given these potential benefits, the widespread use of filters in patients with HF exposed to traffic-derived air pollution may have beneficial public health effects and reduce the burden of HF. (Effects of Air Pollution Exposure Reduction by Filter Mask on Heart Failure; NCT01960920). Copyright © 2016

  6. Clinical Application of the Quick Sepsis-Related Organ Failure Assessment Score at Intensive Care Unit Admission in Patients with Bacteremia: A Single-Center Experience of Korea

    Directory of Open Access Journals (Sweden)

    Hae Jung Na

    2017-08-01

    Full Text Available Background We evaluated the clinical usefulness of the quick Sepsis-Related Organ Failure Assessment (qSOFA score (based on the 2016 definition of sepsis at intensive care unit admission in Korean patients with bacteremia. Methods We retrospectively analyzed clinical data from 236 patients between March 2011 and February 2016. In addition to the qSOFA, the Modified Early Warning score (MEWS and systemic inflammatory response syndrome (SIRS criteria were calculated. Results The patients’ median age was 69 years, and 61.0% were male. Of the patients, 127 (53.8% had a qSOFA score ≥2 points. They had significantly higher rates of septic shock, thrombocytopenia, and hyperlactatemia, and increased requirements for ventilator care, neuromuscular blocking agents, vasopressors, and hemodialysis within 72 hours after intensive care unit admission. They also had a significantly higher 28-day mortality rate. When analyzed using common thresholds (MEWS ≥5 and ≥2 SIRS criteria, patients with a MEWS ≥5 had the same results as those with a qSOFA score ≥2 (P < 0.05. However, patients with ≥2 SIRS criteria showed no significant differences. Conclusions Our results show that a qSOFA score ≥2 at admission is a useful screening tool for predicting disease severity and medical resource usage within 72 hours after admission, and for predicting 28-day mortality rates in patients with bacteremia. In addition, qSOFA scores may be more useful than SIRS criteria in terms of prognostic utility.

  7. Early Mobilization Reduces Duration of Mechanical Ventilation and Intensive Care Unit Stay in Patients With Acute Respiratory Failure.

    Science.gov (United States)

    Lai, Chih-Cheng; Chou, Willy; Chan, Khee-Siang; Cheng, Kuo-Chen; Yuan, Kuo-Shu; Chao, Chien-Ming; Chen, Chin-Ming

    2017-05-01

    To evaluate the effects of a quality improvement program to introduce early mobilization on the outcomes of patients with mechanical ventilation (MV) in the intensive care unit (ICU). A retrospective observational study. Nineteen-bed ICU at a medical center. Adults patients with MV (N=153) admitted to a medical ICU. A multidisciplinary team (critical care nurse, nursing assistant, respiratory therapist, physical therapist, patient's family) initiated the protocol within 72 hours of MV when patients become hemodynamically stable. We did early mobilization twice daily, 5d/wk during family visits (30min each time), and cooperated with family, if possible. MV duration, rate of successful weaning, and length of ICU and hospital stay. We enrolled 63 patients in the before protocol group and 90 in the after protocol group. The 2 groups were well matched in age, sex, body height, body weight, body mass index, disease severity, cause of intubation, number of comorbidities, and most underlying diseases. After protocol group patients had shorter MV durations (4.7d vs 7.5d; PICU stays (6.9d vs 9.9d; P=.001) than did before protocol group patients. Early mobilization was negatively associated with the duration of MV (β=-.269; PICU shortened MV durations and ICU stays. A multidisciplinary team that includes the patient's family can work together to improve the patient's clinical outcomes. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  8. Complex Failure Forewarning System - DHS Conference Proceedings

    Energy Technology Data Exchange (ETDEWEB)

    Abercrombie, Robert K [ORNL; Hively, Lee M [ORNL; Prowell, Stacy J [ORNL; Schlicher, Bob G [ORNL; Sheldon, Frederick T [ORNL

    2011-01-01

    As the critical infrastructures of the United States have become more and more dependent on public and private networks, the potential for widespread national impact resulting from disruption or failure of these networks has also increased. Securing the nation s critical infrastructures requires protecting not only their physical systems but, just as important, the cyber portions of the systems on which they rely. A failure is inclusive of random events, design flaws, and instabilities caused by cyber (and/or physical) attack. One such domain, aging bridges, is used to explain the Complex Structure Failure Forewarning System. We discuss the workings of such a system in the context of the necessary sensors, command and control and data collection as well as the cyber security efforts that would support this system. Their application and the implications of this computing architecture are also discussed, with respect to our nation s aging infrastructure.

  9. Growth hormone replacement delays the progression of chronic heart failure combined with growth hormone deficiency: an extension of a randomized controlled single-blind study.

    Science.gov (United States)

    Cittadini, Antonio; Marra, Alberto M; Arcopinto, Michele; Bobbio, Emanuele; Salzano, Andrea; Sirico, Domenico; Napoli, Raffaele; Colao, Annamaria; Longobardi, Salvatore; Baliga, Ragavendra R; Bossone, Eduardo; Saccà, Luigi

    2013-08-01

    This study sought to evaluate the efficacy and safety of long-term growth hormone (GH) replacement therapy in GH-deficient patients with chronic heart failure (CHF). Recent evidence indicates that growth hormone deficiency (GHD) affects as many as 40% of patients with CHF, and short-term GH replacement causes functional benefit. Whether long-term GH replacement also affects CHF progression is unknown. The study is an extension of a previous randomized, controlled single-blind trial that screened 158 consecutive CHF patients (New York Heart Association classes II to IV) and identified 63 who had GHD by the growth hormone releasing hormone plus arginine test. Fifty-six patients were randomized to receive either GH therapy or standard CHF therapy. Patients were evaluated at baseline and after a 4-year follow-up. The primary endpoint was peak oxygen consumption (VO2). Secondary endpoints included left ventricular (LV) ejection fraction and volumes, serum amino terminal fragment of the pro-hormone brain-type natriuretic peptide, quality of life, and safety. Seventeen patients in the GH group and 14 in the control group completed the study. In the GH group, peak VO2 improved over the 4-year follow-up. The treatment effect was 7.1 ± 0.7 ml/kg/min versus -1.8 ± 0.5 ml/kg/min in the GH and control groups, respectively. At 4 years, LV ejection fraction increased by 10 ± 3% in the GH group, whereas it decreased by 2 ± 5% in control patients. The treatment effect on LV end-systolic volume index was -22 ± 6 ml and 8 ± 3 ml/m(2) in the GH and control groups, respectively (all p < 0.001). No major adverse events were reported in the patients who received GH. Although this is a preliminary study, the finding suggests a new therapeutic approach to a large proportion of GHD patients with CHF. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  10. Prolonged impact of home versus clinic-based management of chronic heart failure: extended follow-up of a pragmatic, multicentre randomized trial cohort.

    Science.gov (United States)

    Stewart, Simon; Carrington, Melinda J; Horowitz, John D; Marwick, Thomas H; Newton, Phillip J; Davidson, Patricia M; Macdonald, Peter; Thompson, David R; Chan, Yih-Kai; Krum, Henry; Reid, Christopher; Scuffham, Paul A

    2014-07-01

    We compared the longer-term impact of the two most commonly applied forms of post-discharge management designed to minimize recurrent hospitalization and prolong survival in typically older patients with chronic heart failure (CHF). We followed a multi-center randomized controlled trial cohort of Australian patients hospitalized with CHF and initially allocated to home-based or specialized CHF clinic-based intervention for 1368 ± 216 days. Blinded endpoints included event-free survival from all-cause emergency hospitalization or death, all-cause mortality and rate of all-cause hospitalization and stay. 280 patients (73% male, aged 71 ± 14 years and 73% left ventricular systolic dysfunction) were initially randomized to home-based (n=143) or clinic-based (n=137) intervention. During extended follow-up (complete for 274 patients), 1139 all-cause hospitalizations (7477 days of hospital stay) and 121 (43.2%) deaths occurred. There was no difference in the primary endpoint; 20 (14.0%) home-based versus 13 (7.4%) clinic-based patients remained event-free (adjusted HR 0.89, 95% CI 0.70 to 1.15; p=0.378). Significantly fewer home-based (51/143, 35.7%) than clinic-based intervention (71/137, 51.8%) patients died (adjusted HR 0.62, 95% CI 0.42 to 0.90: p=0.012). Home-based versus clinic-based intervention patients accumulated 592 and 547 all-cause hospitalizations (p=0.087) associated with 3067 (median 4.0, IQR 2.0 to 6.8) versus 4410 (6.0, IQR 3.0 to 12.0) days of hospital stay (p<0.01 for rate and duration of hospital stay). Relative to clinic-based intervention, home-based intervention was not associated with prolonged event-free survival. Home-based intervention was, however, associated with significantly fewer all-cause deaths and significantly fewer days of hospital stay in the longer-term. Australian New Zealand Clinical Trials Registry number 12607000069459 (http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81803). Copyright © 2013 Elsevier Ireland

  11. Pilot Randomized Study of a Gratitude Journaling Intervention on Heart Rate Variability and Inflammatory Biomarkers in Patients With Stage B Heart Failure.

    Science.gov (United States)

    Redwine, Laura S; Henry, Brook L; Pung, Meredith A; Wilson, Kathleen; Chinh, Kelly; Knight, Brian; Jain, Shamini; Rutledge, Thomas; Greenberg, Barry; Maisel, Alan; Mills, Paul J

    2016-01-01

    Stage B, asymptomatic heart failure (HF) presents a therapeutic window for attenuating disease progression and development of HF symptoms, and improving quality of life. Gratitude, the practice of appreciating positive life features, is highly related to quality of life, leading to development of promising clinical interventions. However, few gratitude studies have investigated objective measures of physical health; most relied on self-report measures. We conducted a pilot study in Stage B HF patients to examine whether gratitude journaling improved biomarkers related to HF prognosis. Patients (n = 70; mean [standard deviation] age = 66.2 [7.6] years) were randomized to an 8-week gratitude journaling intervention or treatment as usual. Baseline (T1) assessments included the six-item Gratitude Questionnaire, resting heart rate variability (HRV), and an inflammatory biomarker index. At T2 (midintervention), the six-item Gratitude Questionnaire was measured. At T3 (postintervention), T1 measures were repeated but also included a gratitude journaling task. The gratitude intervention was associated with improved trait gratitude scores (F = 6.0, p = .017, η = 0.10), reduced inflammatory biomarker index score over time (F = 9.7, p = .004, η = 0.21), and increased parasympathetic HRV responses during the gratitude journaling task (F = 4.2, p = .036, η = 0.15), compared with treatment as usual. However, there were no resting preintervention to postintervention group differences in HRV (p values > .10). Gratitude journaling may improve biomarkers related to HF morbidity, such as reduced inflammation; large-scale studies with active control conditions are needed to confirm these findings. Clinicaltrials.govidentifier:NCT01615094.

  12. Non-Invasive Positive Pressure Ventilation in Acute Hypercapnic Respiratory Failure: Ten-Year’s Clinical Experience of a Respiratory Semi-Intensive Care Unit

    Directory of Open Access Journals (Sweden)

    Raffaele Scala, M.D., esp.

    2007-12-01

    Full Text Available BackgroundAlthough several prospective controlled randomizedtrials demonstrated the success of non-invasive positive pressure ventilation (NIPPV in selected cases of acute hypercapnic respiratory failure (ARF in setting with different care levels, clinical practice data about the use of VNI in the “real world” are limited.AimTo report the results of our clinical experiencein NIPPV applied for ARF in the Respiratory Semi-Intensive Care Unit (UTSIR allocated within the Respiratory Division of Arezzo betweenthe years 1996-2006 in terms of: patient tolerance, effects upon arterial blood gases, successrate and predictors of failure. Methods: Three hundred and filthy out of the 1484 patients (23.6% consecutively admittedfor ARF to our Respiratory Division during the study period received NIPPV in addition to standard therapy, according to the predeterminedroutinely used criteria. Results: Eight patients (2.3% did not tolerateNIPPV because of mask discomfort, while the remaining 342 (M: 240, F: 102; median (interquartilesage: 74.0 (68.0-79.3 yrs; COPD: 69.3% were ventilated for >1 hour. Arterial blood gases significantly improved after two hours of NIPPV (mean (standard deviation pH: 7.33 (0.07 versus 7.28 (7.25-7.31, p 48 hrs of ventilation after an initial positive response. Conclusions: As results of ten years of clinicalexperience at our UTSIR, NIPPV was shown to be well tolerated, effective in improving arterialblood gases and useful in avoiding intubationin most ARF episodes non-responsive to standard therapy.

  13. Effect of Conservative vs Conventional Oxygen Therapy on Mortality Among Patients in an Intensive Care Unit: The Oxygen-ICU Randomized Clinical Trial.

    Science.gov (United States)

    Girardis, Massimo; Busani, Stefano; Damiani, Elisa; Donati, Abele; Rinaldi, Laura; Marudi, Andrea; Morelli, Andrea; Antonelli, Massimo; Singer, Mervyn

    2016-10-18

    Despite suggestions of potential harm from unnecessary oxygen therapy, critically ill patients spend substantial periods in a hyperoxemic state. A strategy of controlled arterial oxygenation is thus rational but has not been validated in clinical practice. To assess whether a conservative protocol for oxygen supplementation could improve outcomes in patients admitted to intensive care units (ICUs). Oxygen-ICU was a single-center, open-label, randomized clinical trial conducted from March 2010 to October 2012 that included all adults admitted with an expected length of stay of 72 hours or longer to the medical-surgical ICU of Modena University Hospital, Italy. The originally planned sample size was 660 patients, but the study was stopped early due to difficulties in enrollment after inclusion of 480 patients. Patients were randomly assigned to receive oxygen therapy to maintain Pao2 between 70 and 100 mm Hg or arterial oxyhemoglobin saturation (Spo2) between 94% and 98% (conservative group) or, according to standard ICU practice, to allow Pao2 values up to 150 mm Hg or Spo2 values between 97% and 100% (conventional control group). The primary outcome was ICU mortality. Secondary outcomes included occurrence of new organ failure and infection 48 hours or more after ICU admission. A total of 434 patients (median age, 64 years; 188 [43.3%] women) received conventional (n = 218) or conservative (n = 216) oxygen therapy and were included in the modified intent-to-treat analysis. Daily time-weighted Pao2 averages during the ICU stay were significantly higher (P < .001) in the conventional group (median Pao2, 102 mm Hg [interquartile range, 88-116]) vs the conservative group (median Pao2, 87 mm Hg [interquartile range, 79-97]). Twenty-five patients in the conservative oxygen therapy group (11.6%) and 44 in the conventional oxygen therapy group (20.2%) died during their ICU stay (absolute risk reduction [ARR], 0.086 [95% CI, 0.017-0.150]; relative risk [RR], 0

  14. Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    DeWalt Darren A

    2009-06-01

    Full Text Available Abstract Background Heart failure (HF is common, costly and associated with significant morbidity and poor quality of life, particularly for patients with low socioeconomic status. Self-management training has been shown to reduce HF related morbidity and hospitalization rates, but there is uncertainty about how best to deliver such training and what patients benefit. This study compares a single session self-management HF training program against a multiple session training intervention and examines whether their effects differ by literacy level. Methods/Design In this randomized controlled multi-site trial, English and Spanish-speaking patients are recruited from university-affiliated General Internal Medicine and Cardiology clinics at 4 sites across the United States. Eligible patients have HF with New York Heart Association class II-IV symptoms and are prescribed a loop diuretic. Baseline data, including literacy level, are collected at enrollment and follow-up surveys are conducted at 1, 6 and 12 months Upon enrollment, both the control and intervention groups receive the same 40 minute, literacy-sensitive, in-person, HF education session covering the 4 key self-management components of daily self assessment and having a plan, salt avoidance, exercise, and medication adherence. All participants also receive a literacy-sensitive workbook and a digital bathroom scale. After the baseline education was completed, patients are randomly allocated to return to usual care or to receive ongoing education and training. The intervention group receives an additional 20 minutes of education on weight and symptom-based diuretic self-adjustment, as well as periodic follow-up phone calls from the educator over the course of 1 year. These phone calls are designed to reinforce the education, assess participant knowledge of the education and address barriers to success. The primary outcome is the combined incidence of all cause hospitalization and death

  15. Music Listening Among Postoperative Patients in the Intensive Care Unit: A Randomized Controlled Trial with Mixed-Methods Analysis

    Directory of Open Access Journals (Sweden)

    Nancy Ames

    2017-07-01

    Full Text Available Background: Music listening may reduce the physiological, emotional, and mental effects of distress and anxiety. It is unclear whether music listening may reduce the amount of opioids used for pain management in critical care, postoperative patients or whether music may improve patient experience in the intensive care unit (ICU. Methods: A total of 41 surgical patients were randomized to either music listening or controlled non-music listening groups on ICU admission. Approximately 50-minute music listening interventions were offered 4 times per day (every 4-6 hours during the 48 hours of patients’ ICU stays. Pain, distress, and anxiety scores were measured immediately before and after music listening or controlled resting periods. Total opioid intake was recorded every 24 hours and during each intervention. Results: There was no significant difference in pain, opioid intake, distress, or anxiety scores between the control and music listening groups during the first 4 time points of the study. However, a mixed modeling analysis examining the pre- and post-intervention scores at the first time point revealed a significant interaction in the Numeric Rating Scale (NRS for pain between the music and the control groups ( P  = .037. The Numeric Rating Score decreased in the music group but remained stable in the control group. Following discharge from the ICU, the music group’s interviews were analyzed for themes. Conclusions: Despite the limited sample size, this study identified music listening as an appropriate intervention that improved patients’ post-intervention experience, according to patients’ self-report. Future mixed methods studies are needed to examine both qualitative patient perspectives and methodology to improve music listening in critical care units.

  16. Unsteady Fast Random Particle Mesh method for efficient prediction of tonal and broadband noises of a centrifugal fan unit

    Directory of Open Access Journals (Sweden)

    Seung Heo

    2015-09-01

    Full Text Available In this study, efficient numerical method is proposed for predicting tonal and broadband noises of a centrifugal fan unit. The proposed method is based on Hybrid Computational Aero-Acoustic (H-CAA techniques combined with Unsteady Fast Random Particle Mesh (U-FRPM method. The U-FRPM method is developed by extending the FRPM method proposed by Ewert et al. and is utilized to synthesize turbulence flow field from unsteady RANS solutions. The H-CAA technique combined with U-FRPM method is applied to predict broadband as well as tonal noises of a centrifugal fan unit in a household refrigerator. Firstly, unsteady flow field driven by a rotating fan is computed by solving the RANS equations with Computational Fluid Dynamic (CFD techniques. Main source regions around the rotating fan are identified by examining the computed flow fields. Then, turbulence flow fields in the main source regions are synthesized by applying the U-FRPM method. The acoustic analogy is applied to model acoustic sources in the main source regions. Finally, the centrifugal fan noise is predicted by feeding the modeled acoustic sources into an acoustic solver based on the Boundary Element Method (BEM. The sound spectral levels predicted using the current numerical method show good agreements with the measured spectra at the Blade Pass Frequencies (BPFs as well as in the high frequency range. On the more, the present method enables quantitative assessment of relative contributions of identified source regions to the sound field by comparing predicted sound pressure spectrum due to modeled sources.

  17. Randomized trial of a novel game-based appointment system for a university hospital venereology unit: study protocol.

    Science.gov (United States)

    Gabarron, Elia; Serrano, J Artur; Fernandez-Luque, Luis; Wynn, Rolf; Schopf, Thomas

    2015-04-08

    Chlamydia is the most common reportable sexually transmitted disease (STD) in Norway, and its incidence in the two northernmost counties has been disclosed to be nearly the double of the Norwegian average. The latest publicly available rates showed that 85.6% of the new cases were diagnosed in people under 29 years old. The information and communication technologies are among the most powerful influences in the lives of young people. The Internet can potentially represent a way to educate on sexual health and encourage young people, and especially youth, to be tested for STDs. If hospital websites include an easy and anonymous system for scheduling appointments with the clinic, it is possible that this could lead to an increase in the number of people tested for STDs. The purpose of the study is to assess the impact of a game-based appointment system on the frequency of consultations at a venereology unit and on the use of an educational web app. An A/B testing methodology is used. Users from the city of Tromsø, in North Norway, will be randomized to one of the two versions of the game-style web app on sexual health at www.sjekkdeg.no. Group A will have access to educational content only, while group B will have, in addition, access to a game-based appointment system with automatic prioritization. After one year of the trial, it will be analyzed if the game-based appointment system increases the number of consultations at the venereology unit and if health professionals deem the system useful. This study will explore if facilitating the access to health services for youth through the use of a game-based appointment system integrated in a game-style web app on sexual health education can have an impact on appointment rates. The trial is registered at clinicaltrials.org under the identifier ClinicalTrials.gov NCT:02128620.

  18. Music Listening Among Postoperative Patients in the Intensive Care Unit: A Randomized Controlled Trial with Mixed-Methods Analysis

    Science.gov (United States)

    Ames, Nancy; Shuford, Rebecca; Yang, Li; Moriyama, Brad; Frey, Meredith; Wilson, Florencia; Sundaramurthi, Thiruppavai; Gori, Danelle; Mannes, Andrew; Ranucci, Alexandra; Koziol, Deloris; Wallen, Gwenyth R

    2017-01-01

    Background: Music listening may reduce the physiological, emotional, and mental effects of distress and anxiety. It is unclear whether music listening may reduce the amount of opioids used for pain management in critical care, postoperative patients or whether music may improve patient experience in the intensive care unit (ICU). Methods: A total of 41 surgical patients were randomized to either music listening or controlled non-music listening groups on ICU admission. Approximately 50-minute music listening interventions were offered 4 times per day (every 4-6 hours) during the 48 hours of patients’ ICU stays. Pain, distress, and anxiety scores were measured immediately before and after music listening or controlled resting periods. Total opioid intake was recorded every 24 hours and during each intervention. Results: There was no significant difference in pain, opioid intake, distress, or anxiety scores between the control and music listening groups during the first 4 time points of the study. However, a mixed modeling analysis examining the pre- and post-intervention scores at the first time point revealed a significant interaction in the Numeric Rating Scale (NRS) for pain between the music and the control groups (P = .037). The Numeric Rating Score decreased in the music group but remained stable in the control group. Following discharge from the ICU, the music group’s interviews were analyzed for themes. Conclusions: Despite the limited sample size, this study identified music listening as an appropriate intervention that improved patients’ post-intervention experience, according to patients’ self-report. Future mixed methods studies are needed to examine both qualitative patient perspectives and methodology to improve music listening in critical care units. PMID:28904523

  19. Predictive performance of the quick Sequential Organ Failure Assessment score as a screening tool for sepsis, mortality, and intensive care unit admission in patients with febrile neutropenia.

    Science.gov (United States)

    Kim, Minsoo; Ahn, Shin; Kim, Won Young; Sohn, Chang Hwan; Seo, Dong Woo; Lee, Yoon-Seon; Lim, Kyung Soo

    2017-05-01

    In Sepsis-3, the quick Sequential Organ Failure Assessment (qSOFA) score was developed as criteria to use for recognizing patients who may have poor outcomes. This study was performed to evaluate the predictive performance of the qSOFA score as a screening tool for sepsis, mortality, and intensive care unit (ICU) admission in patients with febrile neutropenia (FN). We also tried to compare its performance with that of the systemic inflammatory response syndrome (SIRS) criteria and Multinational Association of Supportive Care in Cancer (MASCC) score for FN. We used a prospectively collected adult FN data registry. The qSOFA and SIRS scores were calculated retrospectively using the preexisting data. The primary outcome was the development of sepsis. The secondary outcomes were ICU admission and 28-day mortality. Of the 615 patients, 100 developed sepsis, 20 died, and 38 were admitted to ICUs. In multivariate analysis, qSOFA was an independent factor predicting sepsis and ICU admission. However, compared to the MASCC score, the area under the receiver operating curve of qSOFA was lower. qSOFA showed a low sensitivity (0.14, 0.2, and 0.23) but high specificity (0.98, 0.97, and 0.97) in predicting sepsis, 28-day mortality, and ICU admission. Performance of the qSOFA score was inferior to that of the MASCC score. The preexisting risk stratification tool is more useful for predicting outcomes in patients with FN.

  20. Predictors of mortality of patients with acute respiratory failure secondary to chronic obstructive pulmonary disease admitted to an intensive care unit: A one year study

    Directory of Open Access Journals (Sweden)

    Banga Amit

    2004-11-01

    Full Text Available Abstract Background Patients with acute exacerbation of chronic obstructive pulmonary disease (COPD commonly require hospitalization and admission to intensive care unit (ICU. It is useful to identify patients at the time of admission who are likely to have poor outcome. This study was carried out to define the predictors of mortality in patients with acute exacerbation of COPD and to device a scoring system using the baseline physiological variables for prognosticating these patients. Methods Eighty-two patients with acute respiratory failure secondary to COPD admitted to medical ICU over a one-year period were included. Clinical and demographic profile at the time of admission to ICU including APACHE II score and Glasgow coma scale were recorded at the time of admission to ICU. In addition, acid base disorders, renal functions, liver functions and serum albumin, were recorded at the time of presentation. Primary outcome measure was hospital mortality. Results Invasive ventilation was required in 69 patients (84.1%. Fifty-two patients survived to hospital discharge (63.4%. APACHE II score at the time of admission to ICU {odds ratio (95 % CI: 1.32 (1.138–1.532; p Conclusion APACHE II score at admission and SA levels with in 24 hrs after admission are independent predictors of mortality for patients with COPD admitted to ICU. The equation derived from these two parameters is useful for predicting outcome of these patients.

  1. The association of intensivists with failure-to-rescue rates in outlier hospitals: results of a national survey of intensive care unit organizational characteristics.

    Science.gov (United States)

    Wakeam, Elliot; Asafu-Adjei, Denise; Ashley, Stanley W; Cooper, Zara; Weissman, Joel S

    2014-12-01

    Critical care is often an integral part of rescue for patients with surgical complications. We sought to understand critical care characteristics predictive of failure-to-rescue (FTR) performance at the hospital level. Using 2009 to 2011 FTR data from Hospital Compare, we identified 144 outlier hospitals with significantly better/worse performance than the national average. We surveyed intensive care unit (ICU) directors and nurse managers regarding physical structures, patient composition, staffing, care protocols, and rapid response teams (RRTs). Hospitals were compared using descriptive statistics and logistic regression. Of 67 hospitals completing the survey, 56.1% were low performing, and 43.9% were high performing. Responders were more likely to be teaching hospitals (40.9% vs 25.0%; P=.05) but were similar to nonresponders in terms of size, region, ownership, and FTR performance. Poor performers were more likely to serve higher proportions of Medicaid patients (68.4% vs 20.7%; PHospitals with high Medicaid burden fare poorly on the FTR metric. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Lundgren, Johan Gustav; Dahlström, Örjan; Andersson, Gerhard; Jaarsma, Tiny; Kärner Köhler, Anita; Johansson, Peter

    2016-08-03

    Depressive symptoms, and the associated coexistence of symptoms of anxiety and decreased quality of life (QoL), are common in patients with heart failure (HF). However, treatment strategies for depressive symptoms in patients with HF still remain to be established. Internet-based cognitive behavioral therapy (ICBT), as guided self-help CBT programs, has shown good effects in the treatment of depression. Until now, ICBT has not been evaluated in patients with HF with depressive symptoms. The aims of this study were to (1) evaluate the effect of a 9-week guided ICBT program on depressive symptoms in patients with HF; (2) investigate the effect of the ICBT program on cardiac anxiety and QoL; and (3) assess factors associated with the change in depressive symptoms. Fifty participants were randomized into 2 treatment arms: ICBT or a Web-based moderated discussion forum (DF). The Patient Health Questionnaire-9 was used to measure depressive symptoms, the Cardiac Anxiety Questionnaire (CAQ) was used to measure cardiac-related anxiety, and the Minnesota Living with Heart Failure questionnaire was used to measure QoL. Data were collected at baseline and at follow-up at the end of the 9-week intervention. Intention-to-treat analysis was used, and missing data were imputed by the Expectation-Maximization method. Between-group differences were determined by analysis of covariance with control for baseline score and regression to the mean. No significant difference in depressive symptoms between the ICBT and the DF group at the follow-up was found, [F(1,47)=1.63, P=.21] and Cohen´s d=0.26. Secondary within-group analysis of depressive symptoms showed that such symptoms decreased significantly in the ICBT group from baseline to the follow-up (baseline M=10.8, standard deviation [SD]=5.7 vs follow-up M=8.6, SD=4.6, t(24)=2.6, P=.02, Cohen´s d=0.43), whereas in the DF group, there was no significant change (baseline M=10.6, SD=5.0, vs follow-up M=9.8, SD=4.3, t(24)=0.93, P=.36

  3. Randomized controlled trial of toothbrushing to reduce ventilator-associated pneumonia pathogens and dental plaque in a critical care unit.

    Science.gov (United States)

    Needleman, Ian G; Hirsch, Nicholas P; Leemans, Michele; Moles, David R; Wilson, Michael; Ready, Derren R; Ismail, Salim; Ciric, Lena; Shaw, Michael J; Smith, Martin; Garner, Anne; Wilson, Sally

    2011-03-01

    To investigate the effect of a powered toothbrush on colonization of dental plaque by ventilator-associated pneumonia (VAP)-associated organisms and dental plaque removal. Parallel-arm, single-centre, examiner- and analyst-masked randomized controlled trial. Forty-six adults were recruited within 48 h of admission. Test intervention: powered toothbrush, control intervention: sponge toothette, both used four times per day for 2 min. Groups received 20 ml, 0.2% chlorhexidine mouthwash at each time point. The results showed a low prevalence of respiratory pathogens throughout with no statistically significant differences between groups. A highly statistically significantly greater reduction in dental plaque was produced by the powered toothbrush compared with the control treatment; mean plaque index at day 5, powered toothbrush 0.75 [95% confidence interval (CI) 0.53, 1.00], sponge toothette 1.35 (95% CI 0.95, 1.74), p=0.006. Total bacterial viable count was also highly statistically significantly lower in the test group at day 5; Log(10) mean total bacterial counts: powered toothbrush 5.12 (95% CI 4.60, 5.63), sponge toothette 6.61 (95% CI 5.93, 7.28), p=0.002. Powered toothbrushes are highly effective for plaque removal in intubated patients in a critical unit and should be tested for their potential to reduce VAP incidence and health complications. © 2011 John Wiley & Sons A/S.

  4. Randomization modeling to ascertain clustering patterns of human papillomavirus types detected in cervicovaginal samples in the United States.

    Directory of Open Access Journals (Sweden)

    Troy David Querec

    Full Text Available Detection of multiple human papillomavirus (HPV types in the genital tract is common. Associations among HPV types may impact HPV vaccination modeling and type replacement. The objectives were to determine the distribution of concurrent HPV type infections in cervicovaginal samples and examine type-specific associations. We analyzed HPV genotyping results from 32,245 cervicovaginal specimens collected from women aged 11 to 83 years in the United States from 2001 through 2011. Statistical power was enhanced by combining 6 separate studies. Expected concurrent infection frequencies from a series of permutation models, each with increasing fidelity to the real data, were compared with the observed data. Statistics were computed based on the distributional properties of the randomized data. Concurrent detection occurred more than expected with 0 or ≥3 HPV types and less than expected with 1 and 2 types. Some women bear a disproportionate burden of the HPV type prevalence. Type associations were observed that exceeded multiple hypothesis corrected significance. Multiple HPV types were detected more frequently than expected by chance and associations among particular HPV types were detected. However vaccine-targeted types were not specifically affected, supporting the expectation that current bivalent/quadrivalent HPV vaccination will not result in type replacement with other high-risk types.

  5. Mesenchymal stem cells versus mesenchymal stem cells combined with cord blood for engraftment failure after autologous hematopoietic stem cell transplantation: a pilot prospective, open-label, randomized trial.

    Science.gov (United States)

    Xiong, Yi-Ying; Fan, Qian; Huang, Fen; Zhang, Yu; Wang, Yu; Chen, Xiao-Yong; Fan, Zhi-Ping; Zhou, Hong-Sheng; Xiao, Yang; Xu, Xiao-Jun; Dai, Min; Xu, Na; Sun, Jing; Xiang, Peng; Huang, Xiao-Jun; Liu, Qi-Fa

    2014-02-01

    Engraftment failure (EF) after autologous hematopoietic stem cell transplantation is a serious complication. We prospectively evaluated the effects and safeties of mesenchymal stem cells (MSCs) alone and MSCs combined with cord blood (CB) for EF. Twenty-two patients were randomized to receive MSCs (MSC group; n = 11) or MSCs plus CB (CB group; n = 11). Patients with no response (NR) to MSCs received the therapeutic schedule in the CB group, and those patients with partial response (PR) in the MSC group and patients without complete remission (CR) in the CB group received another cycle of MSC treatment. Patients who did not achieve CR after 2 cycles of treatments received other treatments, including allogeneic HSCT. After the first treatment cycle, response was seen in 7 of 11 patients in the MSC group and in 9 of 11 in the CB group (P = .635), with a significant difference in neutrophil reconstruction between the 2 groups (P = .030). After 2 treatment cycles, 16 patients achieved CR, 3 achieved PR, and 3 had NR. No patient experienced graft-versus-host disease (GVHD). With a median follow-up of 345 d (range, 129 to 784 d) post-transplantation, 18 patients remained alive and 4 had died (3 from primary disease relapse and 1 from cytomegalovirus pneumonia). The 2-year overall survival, disease-free survival, and cumulative incidence of tumor relapse post-transplantation were 75.2% ± 12.0%, 79.5% ± 9.4%, and 20.5% ± 9.4%, respectively. Our data indicate that the 2 strategies are effective for EF and do not result in GVHD or increase the risk of tumor relapse, but the MSC plus CB regimen has a superior effect on neutrophil reconstruction. Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  6. Enumeration of Escherichia coli cells on chicken carcasses as a potential measure of microbial process control in a random selection of slaughter establishments in the United States

    Science.gov (United States)

    The purpose of this study was to evaluate whether the measurement of Escherichia coli levels at two points during the chicken slaughter process has utility as a measure of quality control. A one year long survey was conducted during 2004 and 2005 in 20 randomly selected United States chicken slaught...

  7. Comparative cost-effectiveness of the HeartWare versus HeartMate II left ventricular assist devices used in the United Kingdom National Health Service bridge-to-transplant program for patients with heart failure.

    Science.gov (United States)

    Pulikottil-Jacob, Ruth; Suri, Gaurav; Connock, Martin; Kandala, Ngianga-Bakwin; Sutcliffe, Paul; Maheswaran, Hendramoorthy; Banner, Nicholas R; Clarke, Aileen

    2014-04-01

    Patients with advanced heart failure may receive a left ventricular assist device (LVAD) as part of a bridge-to-transplant (BTT) strategy. The United Kingdom National Health Service (UK NHS) has financed a BTT program in which the predominant LVADs used have been the HeartMate II (HM II; Thoratec, Pleasanton, CA) and HeartWare (HW; HeartWare International, Inc. Framingham, MA). We aimed to compare the cost-effectiveness of the use of these within the NHS program. Individual patient data from the UK NHS Blood and Transplant Data Base were analyzed with Kaplan-Meier and competing outcomes methodologies. Outcomes were time to death, time to heart transplant (HT), and cumulative incidences of HT, death on LVAD support, and LVAD explantation. A semi-Markov multistate economic model was built to assess cost-effectiveness. The perspective was from the NHS, discount rates were 3.5%. Outcomes were quality-adjusted life-years (QALYs) and incremental cost (2011 prices in GB£) per QALY (ICER) for HW vs HM II. Survival was better with HW support than with HM II. Cumulative incidence of HT was low for both groups (11% at ~2 years). HW patients accrued 4.99 lifetime QALYs costing £258,913 ($410,970), HM II patients accrued 3.84 QALYs costing £231,871 ($368,048); deterministic and probabilistic ICERs for HW vs HM II were £23,530 ($37,349) and £20,799 ($33,014), respectively. Patients In the UK BTT program who received the HW LVAD had a better clinical outcome than those who received the HM II, and the HW was more cost-effective. This result needs to be reassessed in a randomized controlled trial comparing the 2 devices. Crown Copyright © 2014. Published by Elsevier Inc. All rights reserved.

  8. Effectiveness of an interactive platform, and the ESC/HFA heartfailurematters.org website in patients with heart failure : Design of the multicentre randomized e-Vita heart failure trial

    NARCIS (Netherlands)

    Wagenaar, Kim P.; Broekhuizen, Berna D L|info:eu-repo/dai/nl/304821306; Dickstein, Kenneth; Jaarsma, Tiny; Hoes, Arno W.|info:eu-repo/dai/nl/101111762; Rutten, Frans H.|info:eu-repo/dai/nl/189152753

    2015-01-01

    Aims Electronic health support (e-health) may improve self-care of patients with heart failure (HF). We aim to assess whether an adjusted care pathway with replacement of routine consultations by e-health improves self-care as compared with usual care. In addition, we will determine whether the

  9. Fracture Strength, Failure Types, and Weibull Characteristics of Three-Unit Zirconia Fixed Dental Prostheses After Cyclic Loading: Effects of Veneering and Air-Abrasion Protocols.

    Science.gov (United States)

    Campos, Fernanda; Souza, Rodrigo Oa; Bottino, Marco A; Özcan, Mutlu

    The required connector dimension for zirconia fixed dental prostheses (FDPs) may be a clinical limitation due to limited space in the occlusogingival direction. Using no veneering in the gingival regions of the pontics and connectors may solve this problem. This study evaluated the mechanical durability of zirconia FDPs with and without veneering in the gingival area of the connectors and pontics and subsequent air abrasion of this region with different protocols. Models were made of resin abutments (diameter = 6 or 8 mm, height = 6 mm, 6 degrees convergence) and embedded in polyurethane resin (distance = 11 mm). Zirconia frameworks were milled and randomly distributed by veneering (veneering of the entire framework [VEN] or no veneering at gingival regions of the pontic and connector [NVEN]) and by air-abrasion (Al₂O₃/SiO₂, 30 μm; or 45 μm Al₂O₃. FDPs were adhesively cemented and subjected to mechanical cycling (1,200,000 cycles, 200 N, 4 Hz, with water cooling). Specimens were tested until fracture (1 mm/min), and failure modes were classified. Data (N) were subjected to one-way analysis of variance in two sets, Tukey test (α = .05) and Weibull analysis. While veneering did not significantly affect the results (VEN: 1,958 ± 299 N; NVEN: 1,788 ± 152 N; P = .094), air abrasion did (P = .006), with the worst results for the groups conditioned with 45 μm Al₂O₃ (SiO₂: 1,748 ± 273 N; Al₂O₃: 1,512 ± 174 N). The NVEN group demonstrated the highest Weibull modulus (12.8) compared with the other groups (5.3-7.2). Fractures commonly initiated from the gingival side of the connector. Veneering of the gingival region of the connectors and pontics in zirconia FDPs did not diminish the fracture strength, but air-abrasion of this area with 45 μm Al₂O₃ decreased the results.

  10. A randomized clinical trial of hospital-based, comprehensive cardiac rehabilitation versus usual care for patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease (the DANREHAB trial)--design, intervention, and population

    DEFF Research Database (Denmark)

    Zwisler, Ann-Dorthe Olsen; Soja, Anne Merete Boas; Brønnum-Hansen, Henrik

    2005-01-01

    randomized clinical trial to clarify whether hospital-based comprehensive CR is superior to usual care for patients with congestive heart failure, ischemic heart disease, or high risk for ischemic heart disease. A combined primary outcome measure included total mortality, myocardial infarction...... management, and clinical assessment. STUDY POPULATION: Of 5060 discharged patients, 1614 (32%) were eligible for the trial and 770 patients were randomized (47% of those eligible). Participants were younger (P ... that a large-scale, centrally randomized clinical trial on comprehensive CR can be conducted among a broadly defined patient group, but reaching the stipulated number of 1800 patients was difficult. Although the study included relatively many women and older people, elderly patients and patients with high...

  11. Therapy of alcohol withdrawal syndrome in intensive care unit patients following trauma: results of a prospective, randomized trial.

    Science.gov (United States)

    Spies, C D; Dubisz, N; Neumann, T; Blum, S; Müller, C; Rommelspacher, H; Brummer, G; Specht, M; Sanft, C; Hannemann, L; Striebel, H W; Schaffartzik, W

    1996-03-01

    To assess the effect of three different alcohol withdrawal therapy regimens in traumatized chronic alcoholic patients with respect to the duration of mechanical ventilation and the frequency of pneumonia and cardiac disorders during their intensive care unit (ICU) stay. A prospective, randomized, blinded, controlled clinical trial. A university hospital ICU. Multiple-injured alcohol-dependent patients (n=180) transferred to the ICU after admission to the emergency room and operative management. A total of 180 patients were included in the study; however, 21 patients were excluded from the study after assignment. Patients who developed actual alcohol withdrawal syndrome were randomized to one of the following treatment regimens: flunitrazepam/clonidine (n=54); chlormethiazole/haloperidol (n=50); or flunitrazepam/haloperidol (n=55). The need for administration of medication was determined, using a validated measure of the severity of alcohol withdrawal (Revised Clinical Institute Withdrawal Assessment for Alcohol Scale). The duration of mechanical ventilation and major intercurrent complications, such as pneumonia, sepsis, cardiac disorders, bleeding disorders, and death, were documented. Patients did not differ significantly between groups regarding age, Revised Trauma and Injury Severity Score and Acute Physiology and Chronic Health Evaluation II score on admission. In all except four patients in the flunitrazepam/clonidine group, who continued to hallucinate, the Revised Clinical Institute Withdrawal Assessment for Alcohol Scale decreased to <20 after initiation of therapy. ICU stay did not significantly differ between groups (p=.1669). However, mechanical ventilation was significantly prolonged in the chlormethiazole/haloperidol group (p=.0315) due to an increased frequency of pneumonia (p=.0414). Cardiac complications were significantly (p=.0047) increased in the flunitrazepam/clonidine group. There was some advantage in the flunitrazepam/clonidine regimen with

  12. Addition of dexmedetomidine to benzodiazepines for patients with alcohol withdrawal syndrome in the intensive care unit: a randomized controlled study.

    Science.gov (United States)

    Bielka, Kateryna; Kuchyn, Iurii; Glumcher, Felix

    2015-12-01

    Dexmedetomidine (DEX) is a centrally acting alpha-2-adrenoceptor agonist that has potential in the management of alcohol withdrawal syndrome (AWS) owing to its ability to produce arousable sedation and to inhibit the adrenergic system without respiratory depression. The objective of this randomized controlled study was to evaluate whether addition of DEX to benzodiazepine (BZD) therapy is effective and safe for AWS patients in the intensive care unit (ICU). Eligible participants were randomly assigned to intervention (Group D; n = 36) or control (Group C; n = 36). In Group D, DEX infusion was started at a dose of 0.2-1.4 μg/kg/h and titrated to achieve the target sedation level (-2 to 0 on the Richmond Agitation Sedation Scale (RASS)) with symptom-triggered BZD (10 mg diazepam bolus) was used as needed. Patients in Group C received only symptom-triggered 10 mg boluses of diazepam. The primary efficacy outcomes were 24-h diazepam consumption and cumulative diazepam dose required over the course of the ICU stay; secondary outcomes included length of ICU stay, sedation and communication quality and haloperidol requirements. Median 24-h diazepam consumption during the study was significantly lower in Group D (20 vs. 40 mg, p < 0.001), as well as median cumulative diazepam dose during the ICU stay (60 vs. 90 mg, p < 0.001). The median percentage of time in the target sedation range was higher in Group D (median 90 % (90-95) vs. 64.5 % (60-72.5; p < 0.001). DEX infusion was also associated with better nurse-assessed patient communication (<0.001) and fewer patients requiring haloperidol treatment (2 vs. 10 p = 0.02). One patient in Group D and four in Group C were excluded owing to insufficient control of AWS symptoms and use of additional sedatives (p = 0.36). There were no severe adverse events in either group. Spontaneous breathing remained normal in all patients. Bradycardia was a common adverse event in Group D (10 vs. 2; p = 0.03). DEX

  13. Comparison of in-vivo failure of single-thread and dual-thread temporary anchorage devices over 18 months: A split-mouth randomized controlled trial.

    Science.gov (United States)

    Durrani, Owais Khalid; Shaheed, Sohrab; Khan, Arsalan; Bashir, Ulfat

    2017-10-01

    The purpose of this study was to compare the in-vivo failure rates of single-thread and dual-thread temporary anchorage device (TAD) designs over 18 months. Thirty patients with skeletal Class II Division 1 malocclusion requiring anchorage from TADs for retraction of maxillary incisors into the extracted premolar space were recruited in this parallel group, split-mouth, randomized controlled trial. A block randomization sequence was generated with Random Allocation Software (version 2.0; Isfahan, Iran) with the allocations concealed in sequentially numbered, opaque, sealed envelopes. A total of 60 TADs (diameter, 2 mm; length, 10 mm) were placed in the maxillary arches of these patients with random allocation of the 2 types to the left and the right sides in a 1:1 ratio. All TADs were placed between the roots of the second premolar and the first molar and were immediately loaded. Patients were followed for a minimum of 12 months and a maximum of 18 months for the failure of the TADs. Data were analyzed blindly on an intention-to-treat basis. Four TADs (13.3%) failed in the single-thread group, and 6 TADs (20%) failed in the dual-thread group. The McNemar test showed an insignificant difference (P = 0.72) between the 2 groups. An odds ratio of 1.6 (95% confidence interval, 0.39-6.97) showed no significant associations among the variables. Most TADs failed in the first month after insertion (50%). The failure rate of dual-thread TADs compared with single-thread TADs is statistically insignificant when placed in the maxilla for retraction of the anterior segment. Registration: The trial was not registered before commencement. The protocol was not published before the trial. Copyright © 2016 American Association of Orthodontists. Published by Elsevier Inc. All rights reserved.

  14. Impact of high-flow nasal cannula oxygen therapy on intensive care unit patients with acute respiratory failure: a prospective observational study.

    Science.gov (United States)

    Sztrymf, Benjamin; Messika, Jonathan; Mayot, Thomas; Lenglet, Hugo; Dreyfuss, Didier; Ricard, Jean-Damien

    2012-06-01

    The purpose of this study was to determine the impact of high-flow nasal cannula oxygen (HFNC) on patients with acute respiratory failure (ARF) in comparison with conventional oxygen therapy. This was a prospective observational study. Patients with persistent ARF despite oxygen with conventional facemask without indication for immediate intubation were treated with HFNC oxygen. Clinical respiratory parameters and arterial blood gases were compared under conventional and HFNC oxygen therapy. Twenty patients, aged 59 years (38-75 years) and SAPS2 (simplified acute physiology score) 33 (26.5-38), were included in the study. Etiology of ARF was mainly pneumonia (n = 11), sepsis (n = 3), and miscellaneous (n = 6). Use of HFNC enabled a significant reduction of respiratory rate, 28 (26-33) vs 24.5 (23-28.5) breath per minute (P = .006), and a significant increase in oxygen saturation, oxygen saturation as measured by pulse oximetry 93.5% (90-98.5) vs 98.5% (95.5-100) (P = .0003). Use of HFNC significantly increased Pao(2) from 8.73 (7.13-11.13) to 15.27 (9.66-25.6) kPa (P = .001) and moderately increased Paco(2), 5.26 (4.33-5.66) to 5.73 (4.8-6.2) kPa (P = .005) without affecting pH. Median duration of HFNC was 26.5 (17-121) hours. Six patients were secondarily intubated, and 3 died in the intensive care unit. Use of HFNC in patients with persistent ARF was associated with significant and sustained improvement of both clinical and biologic parameters. Copyright © 2012 Elsevier Inc. All rights reserved.

  15. Time Interval from Symptom Onset to Hospital Care in Patients with Acute Heart Failure: A Report from the Tokyo Cardiac Care Unit Network Emergency Medical Service Database.

    Science.gov (United States)

    Shiraishi, Yasuyuki; Kohsaka, Shun; Harada, Kazumasa; Sakai, Tetsuro; Takagi, Atsutoshi; Miyamoto, Takamichi; Iida, Kiyoshi; Tanimoto, Shuzou; Fukuda, Keiichi; Nagao, Ken; Sato, Naoki; Takayama, Morimasa

    2015-01-01

    There seems to be two distinct patterns in the presentation of acute heart failure (AHF) patients; early- vs. gradual-onset. However, whether time-dependent relationship exists in outcomes of patients with AHF remains unclear. The Tokyo Cardiac Care Unit Network Database prospectively collects information of emergency admissions via EMS service to acute cardiac care facilities from 67 participating hospitals in the Tokyo metropolitan area. Between 2009 and 2011, a total of 3811 AHF patients were registered. The documentation of symptom onset time was mandated by the on-site ambulance team. We divided the patients into two groups according to the median onset-to-hospitalization (OH) time for those patients (2h); early- (presenting ≤2h after symptom onset) vs. gradual-onset (late) group (>2h). The primary outcome was in-hospital mortality. The early OH group had more urgent presentation, as demonstrated by a higher systolic blood pressure (SBP), respiratory rate, and higher incidence of pulmonary congestion (48.6% vs. 41.6%; P<0.001); whereas medical comorbidities such as stroke (10.8% vs. 7.9%; P<0.001) and atrial fibrillation (30.0% vs. 26.0%; P<0.001) were more frequently seen in the late OH group. Overall, 242 (6.5%) patients died during hospitalization. Notably, a shorter OH time was associated with a better in-hospital mortality rate (odds ratio, 0.71; 95% confidence interval, 0.51-0.99; P = 0.043). Early-onset patients had rather typical AHF presentations (e.g., higher SBP or pulmonary congestion) but had a better in-hospital outcome compared to gradual-onset patients.

  16. Expiratory flow-volume loop profile and patient outcome in chronic obstructive pulmonary disease in acute respiratory failure: a prospective observational study in a single intensive care unit.

    Science.gov (United States)

    Porot, Véronique; Ernesto, Sylvie; Leray, Véronique; Delannoy, Bertrand; Bourdin, Gael; Bayle, Frédérique; Richard, Jean-Christophe; Guérin, Claude

    2012-01-01

    Expiratory flow-volume (EFV) loops are continuously displayed on the screen of intensive care unit (ICU) ventilators. It was the aim of this study to investigate the relationships of EFV to chronic obstructive pulmonary disease (COPD) patient outcome. This is a prospective study on COPD patients who received invasive mechanical ventilation for acute respiratory failure in the ICU. Within the 24-hour post-intubation period, the angle of the EFV slope during the last 50% of expiration was computed and patients were stratified into 4 quartiles. Resistance, compliance of the respiratory system and change in end-expiratory lung volume above relaxation volume were assessed. Patients were followed up to hospital discharge. The main outcome was hospital mortality. Secondary outcomes were ICU mortality, length of ICU stay, duration of invasive ventilation, number of intubations, oxygen and non-invasive ventilation. Thirty-eight patients were analysed. The first quartile comprised 9 patients (median angle 11°, interquartile range 8-12), the second 10 patients (median angle 26°, range 19-30), the third 10 patients (median angle 42°, range 39-46), and the fourth 9 patients (median angle 53°, range 49-64). Hospital and ICU mortality were not different between groups. Lengths of ICU and hospital stay and length of invasive ventilation were significantly different between groups, with the highest values observed in the first quartile. The rate of oxygen use and non-invasive ventilation in the ICU and at hospital discharge was significantly different between groups, with the highest rate observed in the first quartile. There was a significant negative correlation between angle and resistance, compliance of the respiratory system and change in end-expiratory lung volume above the relaxation volume. The slope of the angle during the last 50% of expired volume in the COPD patients was associated with worsened respiratory mechanics and higher morbidity. Copyright © 2011 S. Karger

  17. Individually optimized hemodynamic therapy reduces complications and length of stay in the intensive care unit: a prospective, randomized controlled trial.

    Science.gov (United States)

    Goepfert, Matthias S; Richter, Hans Peter; Zu Eulenburg, Christine; Gruetzmacher, Janna; Rafflenbeul, Erik; Roeher, Katharina; von Sandersleben, Alexandra; Diedrichs, Stefan; Reichenspurner, Herrmann; Goetz, Alwin E; Reuter, Daniel A

    2013-10-01

    The authors hypothesized that goal-directed hemodynamic therapy, based on the combination of functional and volumetric hemodynamic parameters, improves outcome in patients with cardiac surgery. Therefore, a therapy guided by stroke volume variation, individually optimized global end-diastolic volume index, cardiac index, and mean arterial pressure was compared with an algorithm based on mean arterial pressure and central venous pressure. This prospective, controlled, parallel-arm, open-label trial randomized 100 coronary artery bypass grafting and/or aortic valve replacement patients to a study group (SG; n = 50) or a control group (CG; n = 50). In the SG, hemodynamic therapy was guided by stroke volume variation, optimized global end-diastolic volume index, mean arterial pressure, and cardiac index. Optimized global end-diastolic volume index was defined before and after weaning from cardiopulmonary bypass and at intensive care unit (ICU) admission. Mean arterial pressure and central venous pressure served as hemodynamic goals in the CG. Therapy was started immediately after induction of anesthesia and continued until ICU discharge criteria, serving as primary outcome parameter, were fulfilled. Intraoperative need for norepinephrine was decreased in the SG with a mean (±SD) of 9.0 ± 7.6 versus 14.9 ± 11.1 µg/kg (P = 0.002). Postoperative complications (SG, 40 vs. CG, 63; P = 0.004), time to reach ICU discharge criteria (SG, 15 ± 6 h; CG, 24 ± 29 h; P therapy based on cardiac index, stroke volume variation, and optimized global end-diastolic volume index reduces complications and length of ICU stay after cardiac surgery.

  18. Respiratory Failure

    Science.gov (United States)

    Respiratory failure happens when not enough oxygen passes from your lungs into your blood. Your body's organs, ... brain, need oxygen-rich blood to work well. Respiratory failure also can happen if your lungs can' ...

  19. Heart Failure

    Science.gov (United States)

    ... heart failure due to systolic dysfunction. http://www.uptodate.com/home. Accessed Sept. 26, 2014. Colucci WS. ... patient with heart failure or cardiomyopathy. http://www.uptodate.com/home. Accessed Sept. 26, 2014. Colucci WS. ...

  20. Heart Failure

    DEFF Research Database (Denmark)

    Jorsal, Anders; Wiggers, Henrik; McMurray, John J V

    2018-01-01

    This article briefly discusses the epidemiology of heart failure and diabetes and summarizes the key findings from the recent cardiovascular outcome trials in patients with type 2 diabetes, with a focus on heart failure as an endpoint.......This article briefly discusses the epidemiology of heart failure and diabetes and summarizes the key findings from the recent cardiovascular outcome trials in patients with type 2 diabetes, with a focus on heart failure as an endpoint....

  1. On Failure

    Science.gov (United States)

    2009-06-01

    assigned to the Acquisition Chief Process Office at SAF/AQ. He holds degrees in electrical engineering, engineering management , and systems engineering...failure. Failure Types Exposure to Loss Opportunity to Learn Optimal Low High Negative High Low Acquisition project leaders would obviously prefer to...of failure a major defense acquisi- Acquisition project leaders would obviously prefer to succeed but should remember that failure is inevitable

  2. Heart Failure

    Science.gov (United States)

    Heart failure is a condition in which the heart can't pump enough blood to meet the body's needs. Heart failure does not mean that your heart has stopped ... and shortness of breath Common causes of heart failure are coronary artery disease, high blood pressure and ...

  3. Health-related quality of life in a multicenter randomized controlled comparison of telephonic disease management and automated home monitoring in patients recently hospitalized with heart failure: SPAN-CHF II trial.

    Science.gov (United States)

    Konstam, Varda; Gregory, Douglas; Chen, Jie; Weintraub, Andrew; Patel, Ayan; Levine, Daniel; Venesy, David; Perry, Kathleen; Delano, Christine; Konstam, Marvin A

    2011-02-01

    Although disease management programs have been shown to provide a number of clinical benefits to patients with heart failure (HF), the incremental impact of an automated home monitoring (AHM) system on health-related quality of life (HRQL) is unknown. We performed a prospective randomized investigation, examining the additive value of AHM to a previously described nurse-directed HF disease management program (SPAN-CHF), with attention to HRQL, in patients with a recent history of decompensated HF. A total of 188 patients were randomized to receive the SPAN-CHF intervention for 90 days, either with (AHM group) or without (NAHM, standard-care group) AHM, with a 1:1 randomization ratio after HF-related hospitalization. HRQL, measured by the Minnesota Living With Heart Failure Questionnaire (MLHFQ) (Physical, Emotional, and Total scores on MLHFQ) was assessed at 3 time points: baseline, 45 days, and 90 days. Although both treatments (AHM and NAHM) improved HRQL at 45 and 90 days compared with baseline with respect to Physical, Emotional, and Total domain scales, no significant difference emerged between AHM and NAHM groups. AHM and NAHM treatments demonstrated improved HRQL scores at 45 and 90 days after baseline assessment. When comparing 2 state-of the-art disease management programs regarding HRQL outcomes, our results did not support the added value of AHM. Copyright © 2011. Published by Elsevier Inc.

  4. Comparison of heparin to citrate as a catheter locking solution for non-tunneled central venous hemodialysis catheters in patients requiring renal replacement therapy for acute renal failure (VERROU-REA study): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Bruyère, Rémi; Soudry-Faure, Agnès; Capellier, Gilles; Binquet, Christine; Nadji, Abdelouaid; Torner, Stephane; Blasco, Gilles; Yannaraki, Maria; Barbar, Saber Davide; Quenot, Jean-Pierre

    2014-11-19

    The incidence of acute kidney injury (AKI) is estimated at 10 to 20% in patients admitted to intensive care units (ICU) and often requires renal replacement therapy (RRT). ICU mortality in AKI patients can exceed 50%. Venous catheters are the preferred vascular access method for AKI patients requiring RRT, but carry a risk of catheter thrombosis or infection. Catheter lock solutions are commonly used to prevent such complications. Heparin and citrate locks are both widely used for tunneled, long-term catheters, but few studies have compared citrate versus heparin for patients with short-term, non-tunneled catheters. We aim to compare citrate 4% catheter lock solution versus heparin in terms of event-free survival of the first non-tunneled hemodialysis catheter inserted in ICU patients with AKI requiring RRT. Secondary objectives are the rate of fibrinolysis, incidence of catheter thrombosis and catheter-related infection per 1,000 catheter days, length of stay in ICU and in-hospital and 28-day mortality. The VERROU-REA study is a randomized, prospective, multicenter, double-blind, parallel-group, controlled superiority study carried out in the medical, surgical and nephrological ICUs of two large university hospitals in eastern France. A catheter lock solution composed of trisodium citrate at 4% will be compared to unfractionated heparin at a concentration of 5,000 IU/mL. All consecutive adult patients with AKI requiring extracorporeal RRT, and in whom a first non-tunneled catheter is to be inserted by the jugular or femoral approach, will be eligible. Catheters inserted by the subclavian approach, patients with acute liver failure, thrombopenia or contraindication to systemic anticoagulation will be excluded. Patients will be followed up daily in accordance with standard practices for RRT until death or discharge. Data is scarce regarding the use of non-tunneled catheters in the ICU setting in patients with AKI. This study will provide an evidence base for

  5. Effect of intracoronary administration of AAV1/SERCA2a on ventricular remodelling in patients with advanced systolic heart failure: results from the AGENT-HF randomized phase 2 trial.

    Science.gov (United States)

    Hulot, Jean-Sébastien; Salem, Joe-Elie; Redheuil, Alban; Collet, Jean-Philippe; Varnous, Shaida; Jourdain, Patrick; Logeart, Damien; Gandjbakhch, Estelle; Bernard, Claude; Hatem, Stéphane N; Isnard, Richard; Cluzel, Philippe; Le Feuvre, Claude; Leprince, Pascal; Hammoudi, Nadjib; Lemoine, François M; Klatzmann, David; Vicaut, Eric; Komajda, Michel; Montalescot, Gilles; Lompré, Anne-Marie; Hajjar, Roger J

    2017-11-01

    Restoration of sarco/endoplasmic reticulum Ca2+ ATPase (SERCA2a) activity through gene transfer improved cardiac function in experimental and pilot studies in humans with heart failure. The AGENT-HF (NCT01966887) trial investigated the impact of adeno-associated virus (AAV1)/SERCA2a on ventricular remodelling using multimodality non-invasive cardiac imaging. AGENT-HF was a single centre, randomized, double-blind, placebo-controlled trial in adult patients with NYHA class III-IV ischaemic or non-ischaemic heart failure and left ventricular ejection fraction ≤35%. Eligible patients were randomized to receive a single intracoronary infusion of either 1 × 1013 DNase-resistant particles of AAV1/SERCA2a or placebo. The primary endpoint was change in left ventricular end-systolic volume (LVESV), measured by cardiac computed tomography at 6 month follow-up. We planned to include 40 patients but the trial was terminated prematurely as the sponsor suspended further enrolment following neutral results of the CUPID-2 outcome trial. At the time of termination, nine patients were randomized with five patients infused with AAV1/SERCA2a and four with placebo. At 6 months, LVESV was increased in both groups compared with baseline: median (interquartile range) in AAV1/SERCA2a vs. placebo: 13 (13;14) mL vs. 3.5 (-36;36) mL, P = 0.74, with a mean difference between groups of 11.4 mL in favour of placebo. No safety issues were noted. AGENT-HF failed to demonstrate any improvement in ventricular remodelling in response to AAV1/SERCA2a at the dose studied. However, because of premature termination, the study was underpowered to demonstrate an effect of AAV1/SERCA2a and these data should be interpreted with caution. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

  6. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease

    DEFF Research Database (Denmark)

    Filippatos, Gerasimos; Anker, Stefan D; Böhm, Michael

    2016-01-01

    Aims To evaluate oral doses of the non-steroidal mineralocorticoid receptor antagonist finerenone given for 90 days in patients with worsening heart failure and reduced ejection fraction and chronic kidney disease and/or diabetes mellitus. Methods and results Miner Alocorticoid Receptor antagonist...

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

    Science.gov (United States)

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

    2016-07-01

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

  8. [Cardiac insufficiency: acute right heart failure].

    Science.gov (United States)

    Wetsch, Wolfgang A; Lahm, Tim; Hinkelbein, Jochen; Happel, Christoph M; Padosch, Stephan A

    2011-11-01

    Acute right heart failure (RHF) is a frequent and severe complication during perioperative and intensive care treatment in intensive care units (ICUs). The most common causes are pulmonary hypertension, left heart failure, pulmonary embolism, sepsis, acute lung injury (ALI) and thoracosurgical procedures. Acute RHF is not only a major contributor to morbidity and mortality; it also influences efficacy and outcome of routinely performed procedures, such as vasopressors, in critically ill patients. In contrast to the left ventricle, the right ventricle's physiology and pathophysiology are understudied, and the diagnosis of acute RHF is frequently challenging. Although many drugs are available for the treatment of RHF, randomized trials for this setting are still missing. This article gives an overview of aetiology and pathogenesis of RHF and reviews the diagnostic and therapeutic interventions currently available for providers in anaesthesiology and critical care. © Georg Thieme Verlag Stuttgart · New York.

  9. Quick Sepsis-related Organ Failure Assessment, Systemic Inflammatory Response Syndrome, and Early Warning Scores for Detecting Clinical Deterioration in Infected Patients outside the Intensive Care Unit.

    Science.gov (United States)

    Churpek, Matthew M; Snyder, Ashley; Han, Xuan; Sokol, Sarah; Pettit, Natasha; Howell, Michael D; Edelson, Dana P

    2017-04-01

    The 2016 definitions of sepsis included the quick Sepsis-related Organ Failure Assessment (qSOFA) score to identify high-risk patients outside the intensive care unit (ICU). We sought to compare qSOFA with other commonly used early warning scores. All admitted patients who first met the criteria for suspicion of infection in the emergency department (ED) or hospital wards from November 2008 until January 2016 were included. The qSOFA, Systemic Inflammatory Response Syndrome (SIRS), Modified Early Warning Score (MEWS), and the National Early Warning Score (NEWS) were compared for predicting death and ICU transfer. Of the 30,677 included patients, 1,649 (5.4%) died and 7,385 (24%) experienced the composite outcome (death or ICU transfer). Sixty percent (n = 18,523) first met the suspicion criteria in the ED. Discrimination for in-hospital mortality was highest for NEWS (area under the curve [AUC], 0.77; 95% confidence interval [CI], 0.76-0.79), followed by MEWS (AUC, 0.73; 95% CI, 0.71-0.74), qSOFA (AUC, 0.69; 95% CI, 0.67-0.70), and SIRS (AUC, 0.65; 95% CI, 0.63-0.66) (P score of patients, ≥2 SIRS had a sensitivity of 91% and specificity of 13% for the composite outcome compared with 54% and 67% for qSOFA ≥2, 59% and 70% for MEWS ≥5, and 67% and 66% for NEWS ≥8, respectively. Most patients met ≥2 SIRS criteria 17 hours before the combined outcome compared with 5 hours for ≥2 and 17 hours for ≥1 qSOFA criteria. Commonly used early warning scores are more accurate than the qSOFA score for predicting death and ICU transfer in non-ICU patients. These results suggest that the qSOFA score should not replace general early warning scores when risk-stratifying patients with suspected infection.

  10. Contraceptive failure

    DEFF Research Database (Denmark)

    Rasch, Vibeke

    2002-01-01

    Most studies focusing on contraceptive failure in relation to pregnancy have focused on contraceptive failure among women having induced abortions, thereby neglecting those women who, despite contraceptive failure, accept the pregnancy and intend to carry the fetus to term. To get a more complete...... picture of the problem of contraceptive failure, this study focuses on contraceptive failure among women with diverse pregnancy outcomes. In all, 3520 pregnant women attending Odense University Hospital were included: 373 had induced abortions, 435 had spontaneous abortions, 97 had ectopic pregnancies......, and 2614 received antenatal care. The variables studied comprise age, partner relationship, number of births, occupational and economical situation, and contraceptive use.Contraceptive failure, defined as contraceptive use (condom, diaphragm, IUD, oral contraception, or another modern method...

  11. Effect of fluid and dietary sodium restriction in the management of patients with heart failure and preserved ejection fraction: study protocol for a randomized controlled trial

    OpenAIRE

    D'Almeida, Karina Sanches Machado; Silva, Eneida Rejane Rabelo da; Souza, Gabriela Corrêa; Trojahn, Melina Maria; Barilli,Sofia Louise Santin; Mansson, Jessica V.; Biolo, Andreia; Rohde, Luis Eduardo Paim; Clausell, Nadine Oliveira; Silva, Luis Beck da

    2014-01-01

    Background Although half of all patients with heart failure (HF) have a normal or near-normal ejection fraction and their prognosis differs little from that of patients with a reduced ejection fraction, the pathophysiology of HF with preserved ejection fraction (HF-PEF) is still poorly understood, and its management poorly supported by clinical trials. Sodium and fluid restriction is the most common self-care measure prescribed to HF patients for management of congestive episodes. However, it...

  12. Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) IMAGE HF Project I-A: study protocol for a randomized controlled trial

    OpenAIRE

    O?Meara, Eileen; Mielniczuk, Lisa M; Wells, George A; deKemp, Robert A; Klein, Ran; Coyle, Doug; Mc Ardle, Brian; Paterson, Ian; White, James A; Arnold, Malcolm; Friedrich, Matthias G; Larose, Eric; Dick, Alexander; Chow, Benjamin; Dennie, Carole

    2013-01-01

    This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background: Ischemic heart disease (IHD) is the most common cause of heart failure (HF); however, the role of revascularization in these patients is still unclear. Consensus on proper use of cardiac imaging to help determ...

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

    Science.gov (United States)

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

    2014-01-01

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

  14. Effects of aerobic interval training on measures of anxiety, depression and quality of life in patients with ischaemic heart failure and an implantable cardioverter defibrillator: A prospective non-randomized trial.

    Science.gov (United States)

    Isaksen, Kjetil; Munk, Peter Scott; Giske, Rune; Larsen, Alf Inge

    2016-03-01

    To evaluate the short- and long-term effects of aerobic interval training on quality of life and on symptoms of anxiety and depression among patients with ischaemic heart failure and an implantable cardioverter defibrillator. Prospective, non-randomized controlled study. Patients with ischaemic heart failure and an implantable cardioverter defibrillator, willing to undergo an aerobic interval training programme. A total of 31 patients were enrolled (19 were assigned to the aerobic interval training group and 12 to the control group). The aerobic interval training group performed a 12-week exercise training programme. All patients were evaluated with the Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale (HADS) and the International Physical Activity Questionnaire at baseline, after 12 weeks and at 2 years. The aerobic interval training group showed significant improvements in several SF-36 subscores at 12 weeks. There was an unadjusted significant reduction in the HADS depression (HADS-D) score. At follow-up, results in the aero-bic interval training group moved towards baseline or remained stable, whereas in the control group HADS-D scores and some SF-36 subscores deteriorated. Participation in a 12-week aerobic interval training programme resulted in significant improvements in several measures of quality of life and the unadjusted HADS-D score in patients with ischaemic heart failure with an implantable cardioverter defibrillator. At follow-up there was significantly less sedentary activity in the aerobic interval training group, while psychometric measures were no longer significantly different from baseline.

  15. Ramipril and Losartan Exert a Similar Long-Term Effect upon Markers of Heart Failure, Endogenous Fibrinolysis, and Platelet Aggregation in Survivors of ST-Elevation Myocardial Infarction: A Single Centre Randomized Trial.

    Science.gov (United States)

    Marinšek, Martin; Sinkovič, Andreja

    2016-01-01

    Blocking the renin-angiotensin-aldosterone system in ST-elevation myocardial infarction (STEMI) patients prevents heart failure and recurrent thrombosis. Our aim was to compare the effects of ramipril and losartan upon the markers of heart failure, endogenous fibrinolysis, and platelet aggregation in STEMI patients over the long term. After primary percutaneous coronary intervention (PPCI), 28 STEMI patients were randomly assigned ramipril and 27 losartan, receiving therapy for six months with dual antiplatelet therapy (DAPT). We measured N-terminal proBNP (NT-proBNP), ejection fraction (EF), plasminogen-activator-inhibitor type 1 (PAI-1), and platelet aggregation by closure times (CT) at the baseline and after six months. Baseline NT-proBNP ≥ 200 pmol/mL was observed in 48.1% of the patients, EF losartan resulted in a similar effect upon PAI-1, NT-proBNP, EF, and CT levels in survivors of STEMI, but in comparison to control group, receiving DAPT alone, ramipril or losartan treatment with DAPT significantly increased mean CT (226.7 ± 80.3 sec versus 158.1 ± 80.3 sec, p losartan exert a similar effect upon markers of heart failure and endogenous fibrinolysis, and, with DAPT, a more efficient antiplatelet effect in long term than DAPT alone.

  16. Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial.

    Science.gov (United States)

    Bekelman, David B; Allen, Larry A; Peterson, Jamie; Hattler, Brack; Havranek, Edward P; Fairclough, Diane L; McBryde, Connor F; Meek, Paula M

    2016-11-01

    While contemporary heart failure management has led to some improvements in morbidity and mortality, patients continue to report poor health status (i.e., burdensome symptoms, impaired function, and poor quality of life). The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial is a NIH-funded, three-site, randomized clinical trial that examines the effect of the CASA intervention compared to usual care on the primary outcome of patient-reported health status at 6months in patients with heart failure and poor health status. The CASA intervention involves a nurse who works with patients to treat symptoms (e.g., shortness of breath, fatigue, pain) using disease-specific and palliative approaches, and a social worker who provides psychosocial care targeting depression and adjustment to illness. The intervention uses a collaborative care team model of health care delivery and is structured and primarily phone-based to enhance reproducibility and scalability. This article describes the rationale and design of the CASA trial, including several decision points: (1) how to design a patient-centered intervention to improve health status; (2) how to structure the intervention so that it is reproducible and scalable; and (3) how to systematically identify outpatients with heart failure most likely to need and benefit from the intervention. The results should provide valuable information to providers and health systems about the use of team care to manage symptoms and provide psychosocial care in chronic illness. Published by Elsevier Inc.

  17. Double-blind, randomized, placebo-controlled study of high-dose HMG CoA reductase inhibitor therapy on ventricular remodeling, pro-inflammatory cytokines and neurohormonal parameters in patients with chronic systolic heart failure.

    Science.gov (United States)

    Krum, Henry; Ashton, Emma; Reid, Christopher; Kalff, Victor; Rogers, Jim; Amarena, John; Singh, Bhuwan; Tonkin, Andrew

    2007-02-01

    Statins decrease mortality in patients with coronary artery disease. However, chronic heart failure (CHF) patients were often excluded in such trials. Statins possess pharmacologic properties (independent of cholesterol lowering) that may be beneficial on ventricular remodeling in such patients. We conducted a 6-month randomized placebo (PBO)-controlled study of rosuvastatin (ROS) in patients with systolic (left ventricular ejection fraction [LVEF] ventriculogram. Secondary end points included change in echocardiographic parameters, neurohormonal and inflammatory markers, Packer composite score, death, and heart failure hospitalization. Patients were well matched for baseline values. Compared with PBO (n = 46), ROS patients (n = 40) had a decrease in low-density lipoprotein cholesterol (PBO +3, ROS -54%, P ventriculogram (PBO +5.3, ROS +3.2%), fractional shortening by echocardiographic (PBO +2.7, ROS +1.8%), left ventricular end-diastolic diameter (PBO -1.7, ROS +0.8 mm), left ventricular end-systolic diameter (PBO -1.9, ROS +0.1 mm). Plasma norepinephrine, endothelin-1, brain natriuretic peptide, hsCRP, tumor necrosis factor-alpha and interleukin-6, patient global assessment, Packer composite, death/heart failure hospitalization, and adverse events were similar between PBO and ROS. Despite being safe and effective at decreasing plasma cholesterol, high-dose ROS did not beneficially alter parameters of LV remodeling. Reasons for absence of benefit are uncertain, but may include patient population studied, high dose of ROS used or high use of effective background CHF medications.

  18. Effectiveness of supporting intensive care units on implementing the guideline 'End-of-life care in the intensive care unit, nursing care': a cluster randomized controlled trial

    NARCIS (Netherlands)

    Noome, M.; Dijkstra, B.M.; Leeuwen, E. van; Vloet, L.C.M.

    2017-01-01

    AIM: The aim of this study was to examine the effectiveness of supporting intensive care units on implementing the guidelines. BACKGROUND: Quality of care can be achieved through evidence-based practice. Guidelines can facilitate evidence-based practice, such as the guidelines 'End-of-life care in

  19. Effect of Administration of Single Dose GnRH Agonist in Luteal Phase on Outcome of ICSI-ET Cycles in Women with Previous History of IVF/ICSI Failure: A Randomized Controlled Trial

    Science.gov (United States)

    Zafardoust, Simin; Jeddi-Tehrani, Mahmood; Akhondi, Mohammad Mehdi; Sadeghi, Mohammad Reza; Kamali, Koroush; Mokhtar, Sara; Badehnoosh, Bita; Arjmand-Teymouri, Fatemeh; Fatemi, Farnaz; Mohammadzadeh, Afsaneh

    2015-01-01

    Background GnRH agonist administration in the luteal phase has been suggested to beneficially affect the outcome of intracytoplasmic sperm injection (ICSI) and embryo transfer (ET) cycles. This blind randomized controlled study evaluates the effect of GnRH (Gonadotropine Releasing Hormone) agonist administration on ICSI outcome in GnRH antagonist ovarian stimulation protocol in women with 2 or more previous IVF/ICSI-ET failures. Methods One hundred IVF failure women who underwent ICSI cycles and stimulated with GnRH antagonist ovarian stimulation protocol, were included in the study. Women were randomly assigned to intervention (received a single dose injection of GnRH agonist (0.1 mg of Decapeptil) subcutaneously 6 days after oocyte retrieval) and control (did not receive GnRH agonist) groups. Implantation and clinical pregnancy rates were the primary outcome measures. Results Although the age of women, the number of embryos transferred in the current cycle and the quality of the transferred embryos were similar in the two groups, there was a significantly higher rate of implantation (Mann Whitney test, p = 0.041) and pregnancy (32.6% vs. 12.5%, p = 0.030, OR = 3.3, 95%CI, 1.08 to 10.4) in the intervention group. Conclusion Our results suggested that, in addition to routine luteal phase support using progesterone, administration of 0.1 mg of Decapeptil 6 days after oocyte retrieval in women with previous history of 2 or more IVF/ICSI failures led to a significant improvement in implantation and pregnancy rates after ICSI following ovarian stimulation with GnRH antagonist protocol. PMID:25927026

  20. Central oxygen pipeline failure

    African Journals Online (AJOL)

    was welding in the presence of an unidentified oxygen leak, which caused an explosion and the subsequent failure of the main oxygen valve. This happened while I was on duty in the surgical intensive care unit (ICU), with two patients on full ventilation and four patients breathing spontaneously on 40% oxygen face masks.

  1. [Efficacy of the Boussignac continuous positive airway pressure device in patients with acute respiratory failure attended by an emergency medical service: a randomized clinical trial].

    Science.gov (United States)

    Pérez Regueiro, Irene; Mosteiro Díaz, María Pilar; Herrero Puente, Pablo; Argüelles Luis, Juan; Campa García, Ana María; García Fernández, José Antonio

    2016-02-01

    To assess the efficacy of the Boussignac continuous positive airway pressure (CPAP) device for treating patients with acute respiratory failure transported by an emergency medical service. Retrospective, descriptive study of a series of patients treated with the Boussignac CPAP system by emergency medical service responders in Asturias between February 1, 2006, and March 19, 2012. We recorded demographic data, diagnosis, techniques and drugs used, technique failure and reasons, vital constants, (heart rate [HR], respiratory frequency [RF], systolic and diastolic blood pressures, and arterial oxygen saturation by pulse oximetry [SpO2]) at 5 times during the event (on contact without oxygen therapy in place, with conventional oxygen therapy, 5 and 15 minutes after starting CPAP, and on hospital transfer), and the duration of prehospital care. A total of 203 patients with a mean (SD) age of 74.5 (10.6) years were enrolled; 133 (65.5%) were men. One hundred five (81.3%) had acute heart failure. The device failed in 28 patients (13.8%), 13 (6.4%) of whom required intubation. One (0.5%) died while still in prehospital care. All vital constants improved with CPAP. SpO2 values increased at all 5 recording times (P<.001); HR and RF improved significantly at 5 and 15 minutes of CPAP and on transfer (P<.001). Systolic and diastolic pressures were significantly lower than baseline after 15 minutes of CPAP and on transfer. Duration of care was significantly longer in patients who did not tolerate CPAP and in patients who were intubated (P<.001). Most patients tolerated treatment with the Boussignac CPAP device and improved clinically. Few required intubation and mortality was very low.

  2. Increasing exercise capacity and quality of life of patients with heart failure through Wii gaming: the rationale, design and methodology of the HF-Wii study; a multicentre randomized controlled trial.

    Science.gov (United States)

    Jaarsma, Tiny; Klompstra, Leonie; Ben Gal, Tuvia; Boyne, Josiane; Vellone, Ercole; Bäck, Maria; Dickstein, Kenneth; Fridlund, Bengt; Hoes, Arno; Piepoli, Massimo F; Chialà, Oronzo; Mårtensson, Jan; Strömberg, Anna

    2015-07-01

    Exercise is known to be beneficial for patients with heart failure (HF), and these patients should therefore be routinely advised to exercise and to be or to become physically active. Despite the beneficial effects of exercise such as improved functional capacity and favourable clinical outcomes, the level of daily physical activity in most patients with HF is low. Exergaming may be a promising new approach to increase the physical activity of patients with HF at home. The aim of this study is to determine the effectiveness of the structured introduction and access to a Wii game computer in patients with HF to improve exercise capacity and level of daily physical activity, to decrease healthcare resource use, and to improve self-care and health-related quality of life. A multicentre randomized controlled study with two treatment groups will include 600 patients with HF. In each centre, patients will be randomized to either motivational support only (control) or structured access to a Wii game computer (Wii). Patients in the control group will receive advice on physical activity and will be contacted by four telephone calls. Patients in the Wii group also will receive advice on physical activity along with a Wii game computer, with instructions and training. The primary endpoint will be exercise capacity at 3 months as measured by the 6 min walk test. Secondary endpoints include exercise capacity at 6 and 12 months, level of daily physical activity, muscle function, health-related quality of life, and hospitalization or death during the 12 months follow-up. The HF-Wii study is a randomized study that will evaluate the effect of exergaming in patients with HF. The findings can be useful to healthcare professionals and improve our understanding of the potential role of exergaming in the treatment and management of patients with HF. NCT01785121. © 2015 The Authors. European Journal of Heart Failure © 2015 European Society of Cardiology.

  3. Design and methodology of the NorthStar Study: NT-proBNP stratified follow-up in outpatient heart failure clinics -- a randomized Danish multicenter study

    DEFF Research Database (Denmark)

    Schou, Morten; Gustafsson, Finn; Videbaek, Lars

    2008-01-01

    from 2006 to 2009. At present (March 2008), 720 patients are randomized. Results expect to be presented in the second half of 2010. CONCLUSIONS: This article outlines the design of the NorthStar study. If our hypotheses are confirmed, the results will help cardiologists and nurses in HFCs to identify...

  4. Serum cystatin C-A useful endogenous marker of renal function in intensive care unit patients at risk for or with acute renal failure?

    NARCIS (Netherlands)

    Royakkers, Annick A. N. M.; van Suijlen, Jeroen D. E.; Hofstra, Lieuwe S.; Kuiper, Michael A.; Bouman, Catherine S. C.; Spronk, Peter E.; Schultz, Marcus J.

    2007-01-01

    Critically ill patients are at high risk for developing acute renal failure (ARF). The prevention of ARF is of outmost importance in order to improve the increased morbidity and mortality associated with ARF. Unfortunately, there is lack of adequate endogenous markers that can identify renal

  5. A double-blind, randomized clinical trial comparing soybean oil–based versus olive oil–based lipid emulsions in adult medical–surgical intensive care unit patients requiring parenteral nutrition

    Science.gov (United States)

    Spiegelman, Ronnie; Zhao, Vivian; Smiley, Dawn D.; Pinzon, Ingrid; Griffith, Daniel P.; Peng, Limin; Morris, Timothy; Luo, Menghua; Garcia, Hermes; Thomas, Christopher; Newton, Christopher A.; Ziegler, Thomas R.

    2013-01-01

    Objective Parenteral nutrition has been associated with metabolic and infectious complications in intensive care unit patients. The underlying mechanism for the high risk of complications is not known but may relate to the proinflammatory effects of soybean oil–based lipid emulsions, the only Food and Drug Administration–approved lipid formulation for clinical use. Design Prospective, double-blind, randomized, controlled trial. Setting Medical–surgical intensive care units from a major urban teaching hospital and a tertiary referral university hospital. Patients Adult medical–surgical intensive care unit patients. Intervention Parenteral nutrition containing soybean oil–based (Intralipid) or olive oil–based (ClinOleic) lipid emulsions. Measurements Differences in hospital clinical outcomes (nosocomial infections and noninfectious complications), hospital length of stay, glycemic control, inflammatory and oxidative stress markers, and granulocyte and monocyte functions between study groups. Results A total of 100 patients were randomized to either soybean oil–based parenteral nutrition or olive oil–based parenteral nutrition for up to 28 days. A total of 49 patients received soybean oil–based parenteral nutrition (age 51 ± 15 yrs, body mass index 27 ± 6 kg/m2, and Acute Physiology and Chronic Health Evaluation II score 15.5 ± 7 [±SD]), and a total of 51 patients received olive oil–based lipid emulsion in parenteral nutrition (age 46 ± 19 yrs, body mass index 27 ± 8 kg/m2, and Acute Physiology and Chronic Health Evaluation II score 15.1 ± 6 [±SD]) for a mean duration of 12.9 ± 8 days. The mean hospital blood glucose concentration during parenteral nutrition was 129 ± 14 mg/dL, without differences between groups. Patients treated with soybean oil–based and olive oil–based parenteral nutrition had a similar length of stay (47 ± 47 days and 41 ± 36 days, p = .49), mortality (16.3% and 9.8%, p = .38), nosocomial infections (43% vs. 57

  6. The effect of anaesthetist grade and frequency of insertion on epidural failure: a service evaluation in a United Kingdom teaching hospital.

    Science.gov (United States)

    Heinink, Thomas P; Baker, Benjamin G; Yates, Victoria F; Addison, Dorothea C; Williams, John P

    2015-01-21

    Despite being a commonly performed procedure, epidural catheter insertion has a significant failure rate. There is a lack of guidance as to how regularly the procedure should be performed in order to maintain competence. This study aimed to quantify whether increasing frequency of practice is associated with a reduction in failure rates. Data were collected prospectively on all patients undergoing intra-abdominal or thoraco-abdominal surgery who received epidural analgesia as part of their post-operative analgesic regimen over a 36 month period. Records were examined to identify the reason for epidural catheter removal, classified according to standardised definitions, the seniority of the inserting anaesthetist, and whether or not they were a permanent member of the anaesthetic department. Data were analysed using independent t tests, Mann-Whitney tests and Fisher's test. 881 epidurals were inserted during the study period. 48 hour failure rate was 27.2%, whilst by 96 hours 33.9% of epidurals had failed. Increasing frequency of epidural insertion did not show a significant decrease in failure rate at either 48 (p = 0.36) or 96 hours (p = 0.28). However, long-term survival of epidurals at 96 hours was greater if inserted by permanent rather than temporary members of staff (non-permanent 60/141, 42.6% vs permanent 228/715, 31.9%, OR 1.58 (CI 1.09-2.29) p = 0.02). This study demonstrates that failure rates for postoperative epidural analgesia in major surgery are not dependent upon the frequency with which practitioners insert epidural catheters. However, failure rates are dependent on permanency of anaesthetic staff. These findings are significant when placed in the context of the General Medical Council's requirements for clinicians to maintain competence in their clinical practice, suggesting that institutional factors may have greater bearing on epidural success or failure than frequency of task performance.

  7. Music and biological stress dampening in mechanically-ventilated patients at the intensive care unit ward-a prospective interventional randomized crossover trial.

    Science.gov (United States)

    Beaulieu-Boire, Genevieve; Bourque, Solange; Chagnon, Frederic; Chouinard, Lucie; Gallo-Payet, Nicole; Lesur, Olivier

    2013-08-01

    To evaluate the impact of slow-tempo music listening periods in mechanically ventilated intensive care unit patients. A randomized crossover study was performed in a 16-bed, adult critical care unit at a tertiary care hospital. Still-sedated patients, mandating at least 3 more days of mechanical ventilation, were included. The intervention consisted in two 1-hour daily periods of music-vs-sham-MP3 listening which were performed on Day 1 or 3 post-inclusion, with a Day 2 wash-out. "Before-after" collection of vital signs, recording of daily sedative drug consumption and measurement of stress and inflammatory blood markers were performed. Of 55 randomized patients, 49 were included in the final analyses. Along with music listening, (i) vital signs did not consistently change, whereas narcotic consumption tended to decrease to a similar sedation (P = .06 vs sham-MP3); (ii) cortisol and prolactin blood concentrations decreased, whereas Adreno Cortico Trophic Hormone (ACTH)/cortisol ratio increased (P = .02; P = .038; and P = .015 vs sham-MP3, respectively), (iii) cortisol responders exhibited reversed associated changes in blood mehionine (MET)-enkephalin content (P = .01). In the present trial, music listening is a more sensitive stress-reliever in terms of biological vs clinical response. The hypothalamus-pituitary adrenal axis stress axis is a quick sensor of music listening in responding mechanically ventilated intensive care unit patients, through a rapid reduction in blood cortisol. Copyright © 2013 Elsevier Inc. All rights reserved.

  8. CD4+ and viral load outcomes of antiretroviral therapy switch strategies after virologic failure of combination antiretroviral therapy in perinatally HIV-infected youth in the United States.

    Science.gov (United States)

    Fairlie, Lee; Karalius, Brad; Patel, Kunjal; van Dyke, Russell B; Hazra, Rohan; Hernán, Miguel A; Siberry, George K; Seage, George R; Agwu, Allison; Wiznia, Andrew

    2015-10-23

    This study compared 12-month CD4 and viral load outcomes in HIV-infected children and adolescents with virological failure, managed with four treatment switch strategies. This observational study included perinatally HIV-infected (PHIV) children in the Pediatric HIV/AIDS Cohort Study (PHACS) and Pediatric AIDS Clinical Trials (PACTG) Protocol 219C. Treatment strategies among children with virologic failure were compared: continue failing combination antiretroviral therapy (cART); switch to new cART; switch to drug-sparing regimen; and discontinue all ART. Mean changes in CD4% and viral load from baseline (time of virologic failure) to 12 months follow-up in each group were evaluated using weighted linear regression models. Virologic failure occurred in 939 out of 2373 (40%) children. At 12 months, children switching to new cART (16%) had a nonsignificant increase in CD4% from baseline, 0.59 percentage points [95% confidence interval (95% CI) -1.01 to 2.19], not different than those who continued failing cART (71%) (-0.64 percentage points, P = 0.15) or switched to a drug-sparing regimen (5%) (1.40 percentage points, P = 0.64). Children discontinuing all ART (7%) experienced significant CD4% decline -3.18 percentage points (95% CI -5.25 to -1.11) compared with those initiating new cART (P = 0.04). All treatment strategies except discontinuing ART yielded significant mean decreases in log10VL by 12 months, the new cART group having the largest drop (-1.15 log10VL). In PHIV children with virologic failure, switching to new cART was associated with the best virological response, while stopping all ART resulted in the worst immunologic and virologic outcomes and should be avoided. Drug-sparing regimens and continuing failing regimens may be considered with careful monitoring.

  9. Efficacy and safety of bisoprolol fumarate compared with carvedilol in Japanese patients with chronic heart failure: results of the randomized, controlled, double-blind, Multistep Administration of bisoprolol IN Chronic Heart Failure II (MAIN-CHF II) study.

    Science.gov (United States)

    Hori, Masatsugu; Nagai, Ryozo; Izumi, Tohru; Matsuzaki, Masunori

    2014-03-01

    Bisoprolol fumarate (bisoprolol) is a β-blocker widely used to treat chronic heart failure (CHF). However, few studies have compared its efficacy and safety with those of the widely used β-blocker carvedilol in Japanese patients with CHF. We designed a confirmatory trial of bisoprolol using carvedilol as a control drug; however, the trial was discontinued after an off-label use of bisoprolol was approved during the study. Bisoprolol and carvedilol were administered for 32 weeks in 31 and 28 patients, respectively. The mean maintenance doses of bisoprolol and carvedilol were 3.3 and 13.6 mg/day, respectively, and the mean durations of treatment were 188.2 and 172.9 days, respectively. Heart-rate changes were similar in both groups. The mean changes from baseline to Week 32 in left ventricular (LV) ejection fraction (EF) (bisoprolol vs carvedilol groups; 11.7 % ± 8.6 % vs 10.1 % ± 10.5 %), LV end-diastolic volume (-37.5 ± 48.7 vs -24.7 ± 29.4 ml), and LV end-systolic volume (-41.9 ± 43.0 vs -29.3 ± 25.9 ml) revealed a decrease in LV volume and an increase in LVEF in both groups. The cumulative event-free rate for a composite of cardiovascular death or admissions to hospital for worsening of CHF was 92.4 % and 94.7 % in the bisoprolol and carvedilol groups, respectively. Overall, 90.3 % and 85.7 % of patients were titrated up to the maintenance doses of bisoprolol and carvedilol, respectively. Bisoprolol, at half the dose used in other countries, is well tolerated and is as effective as carvedilol for treating Japanese patients with mild to moderate CHF.

  10. One-Session Treatment of Specific Phobias in Youth: A Randomized Clinical Trial in the United States and Sweden

    Science.gov (United States)

    Ollendick, Thomas H.; Ost, Lars-Goran; Reuterskiold, Lena; Costa, Natalie; Cederlund, Rio; Sirbu, Cristian; Davis, Thompson E., III; Jarrett, Matthew A.

    2009-01-01

    One hundred and ninety-six youth, ages 7-16, who fulfilled "Diagnostic and Statistical Manual of Mental Disorders" (4th ed.) criteria for various specific phobias were randomized to a one-session exposure treatment, education support treatment, or a wait list control group. After the waiting period, the wait list participants were…

  11. The Effect of Randomized Homework Contingencies on College Students' Daily Homework and Unit Exam Performance

    Science.gov (United States)

    Galyon, Charles E.; Voils, Kyle L.; Blondin, Carolyn A.; Williams, Robert L.

    2015-01-01

    Students in an introductory educational psychology course submitted answers to daily homework questions for which they received credit either for percentage of questions answered in every homework assignment or for the accuracy of their answers to 10% of randomly selected questions. Potential credit was the same under both homework contingencies,…

  12. Efficacy of long-term noninvasive positive pressure ventilation in stable hypercapnic COPD patients with respiratory failure: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Liao H

    2017-10-01

    Full Text Available Hao Liao,* Wendi Pei,* Hongfu Li,* Yuwen Luo, Kai Wang, Rui Li, Limei Xu, Xin Chen Department of Respiratory Medicine, Zhujiang Hospital, Southern Medical University, Guangzhou, People’s Republic of China *These authors contributed equally to this work Introduction: The efficacy of long-term noninvasive positive pressure ventilation (NPPV in stable hypercapnic COPD patients with respiratory failure remains unclear. The aim of this meta-analysis was to critically assess the efficacy of long-term NPPV on mortality, acute exacerbation, exercise capacity, symptoms and significant physiological parameters (lung function, respiratory muscle function and gas exchange.Patients and methods: We performed an electronic literature search using the PubMed, Cochrane Library, Embase, OVID and Chinese Biomedical Literature Database in May 2017. Studies comparing treatment effects of NPPV with oxygen therapy in stable hypercapnic COPD patients with respiratory failure were conducted, and at least one of the following parameters were reviewed: frequency of acute exacerbation, mortality, lung function, respiratory muscle function, gas exchange, exercise capacity.Results: Seven studies with 810 subjects were identified. The partial pressure of arterial carbon dioxide (PaCO2 significantly decreased in patients who received long-term NPPV (weighted mean difference [WMD] −3.73, 95% CI: −5.83 to −1.64, P=0.0005. No significant difference was found in mortality, partial pressure of arterial oxygen (PaO2, frequency of acute exacerbation, lung function, respiratory muscle function and exercise capacity. The subgroup analysis showed that NPPV significantly improved the survival of patients when it was targeted at greatly reducing hypercapnia (WMD 0.35, 95% CI: 0.19 to 0.64, P=0.0006.Conclusion: The results indicate that long-term NPPV decreases the PaCO2 of stable hypercapnic COPD patients with respiratory failure and improves mortality with the aim of reducing Pa

  13. Methodological Quality of Randomized Clinical Trials of Respiratory Physiotherapy in Coronary Artery Bypass Grafting Patients in the Intensive Care Unit: a Systematic Review.

    Science.gov (United States)

    Lorscheitter, Jaqueline; Stein, Cinara; Plentz, Rodrigo Della Méa

    2017-01-01

    To assess methodological quality of the randomized controlled trials of physiotherapy in patients undergoing coronary artery bypass grafting in the intensive care unit. The studies published until May 2015, in MEDLINE, Cochrane and PEDro were included. The primary outcome extracted was proper filling of the Cochrane Collaboration's tool's items and the secondary was suitability to the requirements of the CONSORT Statement and its extension. From 807 studies identified, 39 were included. Most at CONSORT items showed a better adequacy after the statement's publication. Studies with positive outcomes presented better methodological quality. The methodological quality of the studies has been improving over the years. However, many aspects can still be better designed.

  14. The Effect of the Educational Program on Iranian Premature Infants’ Parental Stress in a Neonatal Intensive Care Unit: A Double-Blind Randomized Controlled Trial

    OpenAIRE

    Beheshtipour, Noushin; Baharlu, Seyedeh Marzieh; Montaseri, Sedigheh; Razavinezhad Ardakani, Seyed Mostajab

    2014-01-01

    Background: Hospitalization in neonatal intensive care unit (NICU) leads to a lot of stress and shock to the parents. Nurses, as the primary sources of information, could play an important role in reducing their stress. The aim of this study was to determine the effect of educational program on the premature infants’ parental stress in NICU. Methods: This double-blind randomized controlled trial study with a pre-and post-test and follow up design was conducted from February 2013 to March 2014...

  15. Why is the United States Losing the War of Words in the Global War on Terror? Identifying Causes of Failure in U.S. Communication Strategy

    Science.gov (United States)

    2010-05-17

    1James K. Glassman , “How to Win the War of Ideas,” Foreign Policy, 10 March 2010, 1-5, available at http...the U.S. is losing the war on terror due to a failure “in a number of key areas of national security, including public diplomacy, intelligence , and...officials from Defense, State, Justice, Commerce, and the Treasury, as well as the Central Intelligence Agency, to establish an International Public

  16. Comparison of two strategies for initiating renal replacement therapy in the intensive care unit: study protocol for a randomized controlled trial (AKIKI).

    Science.gov (United States)

    Gaudry, Stéphane; Hajage, David; Schortgen, Fréderique; Martin-Lefevre, Laurent; Tubach, Florence; Pons, Bertrand; Boulet, Eric; Boyer, Alexandre; Lerolle, Nicolas; Chevrel, Guillaume; Carpentier, Dorothée; Lautrette, Alexandre; Bretagnol, Anne; Mayaux, Julien; Thirion, Marina; Markowicz, Philippe; Thomas, Guillemette; Dellamonica, Jean; Richecoeur, Jack; Darmon, Michael; de Prost, Nicolas; Yonis, Hodane; Megarbane, Bruno; Loubières, Yann; Blayau, Clarisse; Maizel, Julien; Zuber, Benjamin; Nseir, Saad; Bigé, Naïke; Hoffmann, Isabelle; Ricard, Jean-Damien; Dreyfuss, Didier

    2015-04-17

    There is currently no validated strategy for the timing of renal replacement therapy (RRT) for acute kidney injury (AKI) in the intensive care unit (ICU) when short-term life-threatening metabolic abnormalities are absent. No adequately powered prospective randomized study has addressed this issue to date. As a result, significant practice heterogeneity exists and may expose patients to either unnecessary hazardous procedures or undue delay in RRT. This is a multicenter, prospective, randomized, open-label parallel-group clinical trial that compares the effect of two RRT initiation strategies on overall survival of critically ill patients receiving intravenous catecholamines or invasive mechanical ventilation and presenting with AKI classification stage 3 (KDIGO 2012). In the 'early' strategy, RRT is initiated immediately. In the 'delayed' strategy, clinical and metabolic conditions are closely monitored and RRT is initiated only when one or more events (severity criteria) occur, including: oliguria or anuria for more than 72 hours after randomization, serum urea concentration >40 mmol/l, serum potassium concentration >6 mmol/l, serum potassium concentration >5.5 mmol/l persisting despite medical treatment, arterial blood pH 5 l/min to maintain SpO2 > 95% or FiO2 > 50% under invasive or noninvasive mechanical ventilation. The primary outcome measure is overall survival, measured from randomization (D0) until death, regardless of the cause. The minimum follow-up duration for each patient will be 60 days. Two interim analyses are planned, blinded to group allocation. It is expected that there will be 620 subjects in all. The AKIKI study will be one of the very few large randomized controlled trials evaluating mortality according to the timing of RRT in critically ill patients with AKI classification stage 3 (KDIGO 2012). Results should help clinicians decide when to initiate RRT. ClinicalTrials.gov NCT01932190.

  17. A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR - implications for therapeutic failure and drug resistance.

    Science.gov (United States)

    Sengaloundeth, Sivong; Green, Michael D; Fernández, Facundo M; Manolin, Ot; Phommavong, Khamlieng; Insixiengmay, Vongsavanh; Hampton, Christina Y; Nyadong, Leonard; Mildenhall, Dallas C; Hostetler, Dana; Khounsaknalath, Lamphet; Vongsack, Latsamy; Phompida, Samlane; Vanisaveth, Viengxay; Syhakhang, Lamphone; Newton, Paul N

    2009-07-28

    Counterfeit oral artesunate has been a major public health problem in mainland SE Asia, impeding malaria control. A countrywide stratified random survey was performed to determine the availability and quality of oral artesunate in pharmacies and outlets (shops selling medicines) in the Lao PDR (Laos). In 2003, 'mystery' shoppers were asked to buy artesunate tablets from 180 outlets in 12 of the 18 Lao provinces. Outlets were selected using stratified random sampling by investigators not involved in sampling. Samples were analysed for packaging characteristics, by the Fast Red Dye test, high-performance liquid chromatography (HPLC), mass spectrometry (MS), X-ray diffractometry and pollen analysis. Of 180 outlets sampled, 25 (13.9%) sold oral artesunate. Outlets selling artesunate were more commonly found in the more malarious southern Laos. Of the 25 outlets, 22 (88%; 95%CI 68-97%) sold counterfeit artesunate, as defined by packaging and chemistry. No artesunate was detected in the counterfeits by any of the chemical analysis techniques and analysis of the packaging demonstrated seven different counterfeit types. There was complete agreement between the Fast Red dye test, HPLC and MS analysis. A wide variety of wrong active ingredients were found by MS. Of great concern, 4/27 (14.8%) fakes contained detectable amounts of artemisinin (0.26-115.7 mg/tablet). This random survey confirms results from previous convenience surveys that counterfeit artesunate is a severe public health problem. The presence of artemisinin in counterfeits may encourage malaria resistance to artemisinin derivatives. With increasing accessibility of artemisinin-derivative combination therapy (ACT) in Laos, the removal of artesunate monotherapy from pharmacies may be an effective intervention.

  18. A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR – implications for therapeutic failure and drug resistance

    Science.gov (United States)

    Sengaloundeth, Sivong; Green, Michael D; Fernández, Facundo M; Manolin, Ot; Phommavong, Khamlieng; Insixiengmay, Vongsavanh; Hampton, Christina Y; Nyadong, Leonard; Mildenhall, Dallas C; Hostetler, Dana; Khounsaknalath, Lamphet; Vongsack, Latsamy; Phompida, Samlane; Vanisaveth, Viengxay; Syhakhang, Lamphone; Newton, Paul N

    2009-01-01

    Background Counterfeit oral artesunate has been a major public health problem in mainland SE Asia, impeding malaria control. A countrywide stratified random survey was performed to determine the availability and quality of oral artesunate in pharmacies and outlets (shops selling medicines) in the Lao PDR (Laos). Methods In 2003, 'mystery' shoppers were asked to buy artesunate tablets from 180 outlets in 12 of the 18 Lao provinces. Outlets were selected using stratified random sampling by investigators not involved in sampling. Samples were analysed for packaging characteristics, by the Fast Red Dye test, high-performance liquid chromatography (HPLC), mass spectrometry (MS), X-ray diffractometry and pollen analysis. Results Of 180 outlets sampled, 25 (13.9%) sold oral artesunate. Outlets selling artesunate were more commonly found in the more malarious southern Laos. Of the 25 outlets, 22 (88%; 95%CI 68–97%) sold counterfeit artesunate, as defined by packaging and chemistry. No artesunate was detected in the counterfeits by any of the chemical analysis techniques and analysis of the packaging demonstrated seven different counterfeit types. There was complete agreement between the Fast Red dye test, HPLC and MS analysis. A wide variety of wrong active ingredients were found by MS. Of great concern, 4/27 (14.8%) fakes contained detectable amounts of artemisinin (0.26–115.7 mg/tablet). Conclusion This random survey confirms results from previous convenience surveys that counterfeit artesunate is a severe public health problem. The presence of artemisinin in counterfeits may encourage malaria resistance to artemisinin derivatives. With increasing accessibility of artemisinin-derivative combination therapy (ACT) in Laos, the removal of artesunate monotherapy from pharmacies may be an effective intervention. PMID:19638225

  19. Short-term add-on therapy with angiotensin receptor blocker for end-stage inotrope-dependent heart failure patients: B-type natriuretic peptide reduction in a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Marcelo E. Ochiai

    2014-01-01

    Full Text Available OBJECTIVE: We aimed to evaluate angiotensin receptor blocker add-on therapy in patients with low cardiac output during decompensated heart failure. METHODS: We selected patients with decompensated heart failure, low cardiac output, dobutamine dependence, and an ejection fraction <0.45 who were receiving an angiotensin-converting enzyme inhibitor. The patients were randomized to losartan or placebo and underwent invasive hemodynamic and B-type natriuretic peptide measurements at baseline and on the seventh day after intervention. ClinicalTrials.gov: NCT01857999. RESULTS: We studied 10 patients in the losartan group and 11 patients in the placebo group. The patient characteristics were as follows: age 52.7 years, ejection fraction 21.3%, dobutamine infusion 8.5 mcg/kg.min, indexed systemic vascular resistance 1918.0 dynes.sec/cm5.m2, cardiac index 2.8 L/min.m2, and B-type natriuretic peptide 1,403 pg/mL. After 7 days of intervention, there was a 37.4% reduction in the B-type natriuretic peptide levels in the losartan group compared with an 11.9% increase in the placebo group (mean difference, -49.1%; 95% confidence interval: -88.1 to -9.8%, p = 0.018. No significant difference was observed in the hemodynamic measurements. CONCLUSION: Short-term add-on therapy with losartan reduced B-type natriuretic peptide levels in patients hospitalized for decompensated severe heart failure and low cardiac output with inotrope dependence.

  20. The Home-Heart-Walk study, a self-administered walk test on perceived physical functioning, and self-care behaviour in people with stable chronic heart failure: A randomized controlled trial.

    Science.gov (United States)

    Du, Huiyun; Newton, Phillip J; Budhathoki, Chakra; Everett, Bronwyn; Salamonson, Yenna; Macdonald, Peter S; Davidson, Patricia M

    2017-08-01

    Adherence to self-care recommendations is associated with improved patient outcomes and improved quality of life for people living with heart failure. The Home-Heart-Walk (HHW) is an intervention to promote physical activity adapting the elements of a six minute walk test, a reliable and valid measure. This adaptation was designed to support self-monitoring of physical functioning and promote the self-care of people with heart failure. The primary outcome of the Home-Heart-Walk was perceived physical functioning and the secondary outcomes were six-minute walk test distance, health related quality of life, self-care behaviour, self-efficacy and physical activity level. A multicentre randomized controlled trial. Participants ( N=132) were recruited from three academic hospitals in Sydney, Australia. Participants were randomized to either the Home-Heart-Walk group or the control group. Perceived physical functioning, health related quality of life, self-care behaviour, exercise self-efficacy and physical activity level were measured at baseline and at three- and six-month follow-up. After adjusting for baseline scores, there were no statistically significant between-group differences in perceived physical functioning, six-minute walk test distance, health related quality of life and exercise self-efficacy at follow-up. The intervention group had improvement in self-care behaviour ( F(1,129) = 4.75, p = 0.031) and physical activity level ( U = 1713, z = -2.12, p = 0.034) at the six-month follow-up compared with the control group. The Home-Heart-Walk did not improve the perceived physical functioning of the intervention group. Although the feasibility and acceptability of this strategy to support self-monitoring and improve self-care behaviour was demonstrated, self-reported adherence was unreliable; newer technologies may offer better assessment of adherence.

  1. The effect of a randomized trial of home telemonitoring on medical costs, 30-day readmissions, mortality, and health-related quality of life in a cohort of community-dwelling heart failure patients.

    Science.gov (United States)

    Blum, Kay; Gottlieb, Stephen S

    2014-07-01

    Telemonitoring has been advocated as a way of decreasing costs and improving outcomes, but no study has looked at true Medicare payments and 30-day readmission rates in a randomized group of well treated patients. The aim of this work was to analyze Medicare claims data to identify effects of home telemonitoring on medical costs, 30-day rehospitalization, mortality, and health-related quality of life. A total of 204 subjects were randomized to usual-care and monitored groups and evaluated with the SF-36 and Minnesota Living With Heart Failure Questionnaire (MLHF). Hospitalizations, Medicare payments, and mortality were also assessed. Monitored subjects transmitted weight, blood pressure, and heart rate, which were monitored by an experienced heart failure nurse practitioner. Subjects were followed for 802 ± 430 days; 75 subjects in the usual-care group (316 hospitalizations) and 81 in the monitored group (327 hospitalizations) were hospitalized at least once (P = .51). There were no differences in Medicare payments for inpatient or emergency department visits, and length of stay was not different between groups. There was no difference in 30-day readmissions (P = .627) or mortality (P = .575). Scores for SF-36 and MLHF improved (P patients readmitted within 30 days was lower with telemonitoring for the 1st year, but this did not persist. Telemonitoring did not result in lower total costs, decreased hospitalizations, improved symptoms, or improved mortality. A decrease in 30-day readmission rates for the 1st year did not result in decreased total cost or better outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Rational and design of a randomized, double-blind, multicenter trial to evaluate the safety and tolerability of furosemide withdrawal in stable chronic outpatients with heart failure: The ReBIC-1 trial.

    Science.gov (United States)

    da Rosa, Priscila Raupp; Rohde, Luis E; Doebber, Madeni; Ribeiro, Antonio L P; Prado, Deborah P; Bertoldi, Eduardo G; Figueiredo Neto, Jose A; Kohler, Ilmar; Beck-da-Silva, Luis; Danzmann, Luiz C; Moura, Lidia Zytynski; Rover, Marciane; Simões, Marcus V; Sant'Anna, Roberto T; Biolo, Andréia

    2017-12-01

    Furosemide is commonly prescribed for symptom relief in heart failure (HF) patients. Although few data support the continuous use of loop diuretics in apparently euvolemic HF patients with mild symptoms, there is concern about safety of diuretic withdrawal in these patients. The ReBIC-1 trial was designed to evaluate the safety and tolerability of withdrawing furosemide in stable, euvolemic, chronic HF outpatients. This multicenter initiative is part of the Brazilian Research Network in Heart Failure (ReBIC) created to develop clinical studies in HF and composed predominantly by university tertiary care hospitals. The ReBIC-1 trial is currently enrolling HF patients in NYHA functional class I-II, left ventricular ejection fraction ≤45%, without a HF-related hospital admission within the last 6 months, receiving a stable dose of furosemide (40 or 80 mg per day) for at least 6 months. Eligible patients will be randomized to maintain or withdraw furosemide in a double-blinded protocol. The trial has two co-primary outcomes: (1) dyspnea assessment using a visual-analogue scale evaluated at 4 time points and (2) the proportion of patients maintained without diuretics during the follow-up period. Total sample size was calculated to be 220 patients. Enrolled patients will be followed up to 90 days after randomization, and diuretic will be restarted if clinical deterioration or signs of congestion are detected. Pre-defined sub-group analysis based on NT-proBNP levels at baseline is planned. Evidence-based strategies aiming to simplify HF pharmacotherapy are needed in clinical practice. The ReBIC-1 trial will determine the safety of withdrawing furosemide in stable chronic HF patients. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Sulfonylurea-metformin-combination versus sulfonylurea-insulin-combination in secondary failures of sulfonylurea monotherapy. Results of a prospective randomized study in 50 patients.

    Science.gov (United States)

    Klein, W

    1991-05-01

    50 type II diabetics with secondary failure of a sulfonylurea (SU) treatment have been included in a randomised controlled trial by assigning them either to a Metformin + SU or insulin + SU treatment. At study entry the metabolic control of patients had to be insufficient, as demonstrated by increased fasting or postprandial plasma glucose levels (greater than 130 resp. greater than 180 mg/100 ml). The study lasted for a period of 12 months in which a Metformin treatment of 850, 1,700 or 2,550 mg/day or an insulin therapy of 12-40 IU was added to the existing maximal dose of SU. Both the Metformin and the insulin dosage were adapted to the response of metabolic control. Parameters of metabolic control and security were monitored regularly every two months. 16 patients in the Metformin + SU-group and 19 patients in the insulin + SU-group were observed for the total study period of 12 months. In both groups there was a similar development of metabolic parameters. Stimulated C-peptide reduced in both groups indicating an increase of peripheral insulin sensitivity under both treatment regimes.

  4. Computer Decision Support Software Safely Improves Glycemic Control in the Burn Intensive Care Unit: A Randomized Controlled Clinical Study

    Science.gov (United States)

    2011-01-01

    Inc, Cary, NC) for a reduction of time spent out of range by 10% for a crossover design with no carryover effect, an alpha of 0.05, and a power of...low-fat, semi-elemental enteric formula when tolerated. Two study patients required nutritional support with total parenteral nutrition (TPN) in the...units; ml, milliliter; feed, parenteral and enteral; hr, hours)] Variable Computer Protocol (CP) Paper Protocol (PP) P Value No. of septic events 11 11

  5. Impact of a nurse-led home and clinic-based secondary prevention programme to prevent progressive cardiac dysfunction in high-risk individuals: the Nurse-led Intervention for Less Chronic Heart Failure (NIL-CHF) randomized controlled study.

    Science.gov (United States)

    Stewart, Simon; Chan, Yih-Kai; Wong, Chiew; Jennings, Garry; Scuffham, Paul; Esterman, Adrian; Carrington, Melinda

    2015-06-01

    The aim of this study was to determine the effectiveness of a long-term, nurse-led, multidisciplinary programme of home/clinic visits in preventing progressive cardiac dysfunction in individuals at risk of developing de novo chronic heart failure (CHF). A pragmatic, single-centre (tertiary-referral hospital with specialist cardiological services), open-label, randomized controlled trial with blinded endpoint adjudication was carried out. In total, 624 cardiac inpatients (66 ± 11 years, 71% male, and 70% with CAD) were randomly allocated (1:1) to standard care or the study intervention. The intention-to-treat cohort comprised 310 standard care and 301 intervention participants. During 51.0 ± 8.2 months follow-up, 38/310 (12%) standard care [mean event-free survival 1865 days, 95% confidence interval (CI) 1817-1913 days] vs. 41/301 (14%) intervention participants (1855 days, 95% CI 1804-1906 days) experienced the primary composite endpoint of de novo CHF hospitalization or all-cause mortality (P = 0.574). Although there were no statistically significant differences in the rate of cardiovascular-related and emergency hospitalizations, the NIL-CHF (Nurse-led Intervention for Less Chronic Heart Failure) group accumulated 478 (0.214 ± 0.70 vs. 0.095 ± 0.284 days/participant/month; P = 0.052) and 1097 fewer days of hospital stay (0.391 ± 1.80 vs. 0.199 ± 0.47 days/participant/month; P = 0.023), respectively, compared with standard care. The intervention group also showed better cardiac recovery on echocardiography at 3 years [81/226 (35.8%) vs. 56/225 (24.9%), odds ratio 1.44, 95% CI 1.08-1.92, P = 0.011]. Relative to a high level of standard care, the NIL-CHF intervention was ineffective in preventing CHF and rehospitalization. On the other hand, it was associated with reduced hospital stay and improved cardiac function over the long term. Australian New Zealand Clinical Trials Registry (No. 12608000022369). © 2015 The Authors. European Journal of Heart Failure

  6. A prospective randomized trial of different supplementary local anesthetic techniques after failure of inferior alveolar nerve block in patients with irreversible pulpitis in mandibular teeth.

    Science.gov (United States)

    Kanaa, Mohammad D; Whitworth, John M; Meechan, John Gerard

    2012-04-01

    The objective of this study was to compare the efficacy of supplementary repeat inferior alveolar nerve block with 2% lidocaine and epinephrine, buccal infiltration with 4% articaine with epinephrine, intraligamentary injection, or intraosseous injection (both with 2% lidocaine with epinephrine) after failed inferior alveolar nerve block (IANB) for securing pain-free treatment in patients experiencing irreversible pulpitis in mandibular permanent teeth. This randomized clinical trial included 182 patients diagnosed with irreversible pulpitis in mandibular teeth. Patients received 2.0 mL of 2% lidocaine with 1:80,000 epinephrine as an IANB injection. Patients who did not experience pain-free treatment received randomly 1 of 4 supplementary techniques, namely repeat lidocaine IANB (rIANB), articaine buccal infiltration (ABI), lidocaine intraligamentary injection (PDL), or lidocaine intraosseous injection (IO). Successful pulp anesthesia was considered to have occurred when no response was obtained to the maximum stimulation (80 reading) of the pulp tester, at which time treatment commenced. Treatment was regarded as being successfully completed when it was associated with no pain. Data were analyzed by χ(2) and Fisher exact tests. Of the 182 patients, 122 achieved successful pulpal anesthesia within 10 minutes after initial IANB injection; 82 experienced pain-free treatment. ABI and IO allowed more successful (pain-free) treatment (84% and 68%, respectively) than rIANB or PDL supplementary techniques (32% and 48%, respectively); this was statistically significant (P = .001). IANB injection alone does not always allow pain-free treatment for mandibular teeth with irreversible pulpitis. Supplementary buccal infiltration with 4% articaine with epinephrine and intraosseous injection with 2% lidocaine with epinephrine are more likely to allow pain-free treatment than intraligamentary and repeat IANB injections with 2% lidocaine with epinephrine for patients experiencing

  7. A failure to confirm the effectiveness of a brief group psychoeducational program for mothers of children with high-functioning pervasive developmental disorders: a randomized controlled pilot trial

    Science.gov (United States)

    Suzuki, Masako; Yamada, Atsurou; Watanabe, Norio; Akechi, Tatsuo; Katsuki, Fujika; Nishiyama, Takeshi; Imaeda, Masayuki; Miyachi, Taishi; Otaki, Kazuo; Mitsuda, Yumiko; Ota, Akino; Furukawa, Toshi A

    2014-01-01

    Objective The purpose of this study was to examine the effectiveness of group psychoeducation to relieve the psychological distress of mothers of children with high-functioning pervasive developmental disorders (HFPDD) and to improve the behaviors of the children. Methods Seventy-two mothers of preschool outpatients with HFPDD were randomly assigned to a four-session brief group psychoeducational program (GP). The sessions were held every second week in addition to the usual treatment (GP + treatment as usual [TAU] group), or to a TAU-alone group. The primary outcome was self-reported symptoms of maternal mental health as assessed using the 28-item General Health Questionnaire (GHQ-28) at 21 weeks post-randomization (week 21). The GHQ-28 at the end of the intervention (week 7), Aberrant Behavior Checklist (ABC) for the behavior of the children, the Zarit Burden Interview (ZBI), and the Medical Outcomes Study 36-item Short Form Health Survey (SF-36) were carried out at weeks 7 and 21. We tested the group effects with the interaction between the intervention and the evaluation points. Results The GHQ-28 score at week 21 was significantly higher in the GP + TAU group as compared to that in the TAU-alone group, indicating a greater improvement in the TAU-alone group. There was no evidence that GP + TAU led to a greater improvement of maternal mental health than TAU-alone at week 7. Similarly, no evidence was obtained to indicate that GP + TAU led to a reduction in the ABC or ZBI scores by week 7 or 21. The adjusted scores for the RF (role emotional) and MH (mental health) subscales of the SF-36 at week 21 were also significantly lower in the GP + TAU group, indicating a similar tendency to that of the change of the GHQ-28 score at week 21. Conclusion The psychoeducational program did not alleviate maternal distress, aberrant behaviors of the children, or caregiver burden. PMID:25061301

  8. Da Vinci robot error and failure rates: single institution experience on a single three-arm robot unit of more than 700 consecutive robot-assisted laparoscopic radical prostatectomies.

    Science.gov (United States)

    Zorn, Kevin C; Gofrit, Ofer N; Orvieto, Marcelo A; Mikhail, Albert A; Galocy, R Matthew; Shalhav, Arieh L; Zagaja, Gregory P

    2007-11-01

    Previous reports have suggested that a 2% to 5% device failure rate (FR) be quoted when counseling patients about robot-assisted laparoscopic radical prostatectomy (RLRP). We sought to evaluate our FR on the da Vinci system. Since February 2003, more than 800 RLRPs have been performed at our institution using a single three-armed robotic unit. A prospective database was analyzed to determine the device FR and whether it resulted in case abortion or open conversion. Intuitive Surgical Systems provided data concerning the system's performance, including its fault rate. Error messages were classified as recoverable and non-recoverable faults. Between February 2003 and November 2006, 725 RLRP cases were available for evaluation. There were no intraoperative device failures that resulted in a case conversion. Technical errors resulting in surgeon handicap occurred in 3 cases (0.4%). Four patients (0.5%) had their procedures aborted secondary to system failure at initial set-up prior to patient entrance to the operating room. Data analysis retrieved from the da Vinci console reported on a total of 807 procedures since 2003. Only 4 cases (0.4%) were reported from the Intuitive Surgical database to result in either an aborted or a converted case, which compares favorably with our results. Since the last computer system upgrade (September 2005), the mean recoverable and non-recoverable fault rates per procedure were 0.21 and 0.05, respectively. For all the advanced features the da Vinci system offers, it is surprisingly reliable. Throughout our RLRP experience, device failure resulted in case conversion, procedure abortion, and surgeon handicap in 0, 0.5%, and 0.4% of procedures, respectively. As such, a lowered device FR of 0.5% should be used when counseling patients undergoing RLRP. To avoid futile general anesthesia, a policy should be enforced to ensure that the da Vinci system is completely set up before the patient enters the operating room.

  9. Efficacy and safety of tolvaptan in heart failure patients with volume overload despite the standard treatment with conventional diuretics: a phase III, randomized, double-blind, placebo-controlled study (QUEST study).

    Science.gov (United States)

    Matsuzaki, Masunori; Hori, Masatsugu; Izumi, Tohru; Fukunami, Masatake

    2011-12-01

    Diuretics are recommended to treat volume overload with heart failure (HF), however, they may cause serum electrolyte imbalance, limiting their use. Moreover, patients with advanced HF could poorly respond to these diuretics. In this study, we evaluated the efficacy and safety of Tolvaptan, a competitive vasopressin V2-receptor antagonist developed as a new drug to treat volume overload in HF patients. A phase III, multicenter, randomized, double-blind, placebo-controlled parallel study was performed to assess the efficacy and safety of tolvaptan in treating HF patients with volume overload despite the use of conventional diuretics. One hundred and ten patients were randomly assigned to receive either placebo or 15 mg/day tolvaptan for 7 consecutive days. Compared with placebo, tolvaptan administered for 7 days significantly reduced body weight and improved symptoms associated with volume overload. The safety profile of tolvaptan was considered acceptable for clinical use with minimal adverse effects. Tolvaptan reduced volume overload and improved congestive symptoms associated with HF by a potent water diuresis (aquaresis).

  10. Valproic acid-associated acute liver failure in children: case report and analysis of liver transplantation outcomes in the United States.

    Science.gov (United States)

    Mindikoglu, Ayse L; King, Dale; Magder, Laurence S; Ozolek, John A; Mazariegos, George V; Shneider, Benjamin L

    2011-05-01

    To determine whether valproic acid (VPA)-associated acute liver failure (ALF; VPA-ALF) explains the poor outcomes after liver transplantation (LT) in children. Organ Procurement and Transplantation Network data of pediatric patients who underwent LT for VPA-ALF and ALF caused by other drugs (non-VPA-drug-induced acute liver failure [DIALF]) were analyzed. Pre- and post-transplant variables and post-LT survival were compared between VPA-ALF and non-VPA-DIALF. Seventeen children were transplanted for VPA-ALF. Of the 17 children, 82% died within 1 year of LT. Pre- and post-transplant parameters of VPA versus non-VPA-DIALF were comparable with two exceptions. The median alanine aminotransferase level at transplant was remarkably lower in VPA-ALF compared with non-VPA-DIALF (45 versus 1179 IU/L, P = .004). One-year survival probability was worse in VPA-ALF than non-VPA-DIALF (20% versus 69%, P < .0001). Median post-LT survival time for VPA-ALF was 2.8 months. Children who underwent LT for VPA-ALF had a significantly lower survival probability than children with non-VPA-DIALF. Current data suggest that VPA-ALF in children represents an "unmasking" of mitochondrial disease. VPA-ALF should be a contraindication for LT, even in the absence of a documented mitochondrial disease. Copyright © 2011 Mosby, Inc. All rights reserved.

  11. Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized, multiple-crossover trial.

    Science.gov (United States)

    Semler, Matthew W; Self, Wesley H; Wang, Li; Byrne, Daniel W; Wanderer, Jonathan P; Ehrenfeld, Jesse M; Stollings, Joanna L; Kumar, Avinash B; Hernandez, Antonio; Guillamondegui, Oscar D; May, Addison K; Siew, Edward D; Shaw, Andrew D; Bernard, Gordon R; Rice, Todd W

    2017-03-16

    Saline, the intravenous fluid most commonly administered to critically ill adults, contains a high chloride content, which may be associated with acute kidney injury and death. Whether using balanced crystalloids rather than saline decreases the risk of acute kidney injury and death among critically ill adults remains unknown. The Isotonic Solutions and Major Adverse Renal Events Trial (SMART) is a pragmatic, cluster-level allocation, cluster-level crossover trial being conducted between 1 June 2015 and 30 April 2017 in five intensive care units at Vanderbilt University Medical Center in Nashville, TN, USA. SMART compares saline (0.9% sodium chloride) with balanced crystalloids (clinician's choice of lactated Ringer's solution or Plasma-Lyte A®). Each intensive care unit is assigned to provide either saline or balanced crystalloids each month, with the assigned crystalloid alternating monthly over the course of the trial. All adults admitted to participating intensive care units during the study period are enrolled and followed until hospital discharge or 30 days after enrollment. The anticipated enrollment is approximately 14,000 patients. The primary outcome is Major Adverse Kidney Events within 30 days-the composite of in-hospital death, receipt of new renal replacement therapy, or persistent renal dysfunction (discharge creatinine ≥200% of baseline creatinine). Secondary clinical outcomes include in-hospital mortality, intensive care unit-free days, ventilator-free days, vasopressor-free days, and renal replacement therapy-free days. Secondary renal outcomes include new renal replacement therapy receipt, persistent renal dysfunction, and incidence of stage 2 or higher acute kidney injury. This ongoing pragmatic trial will provide the largest and most comprehensive comparison to date of clinical outcomes with saline versus balanced crystalloids among critically ill adults. For logistical reasons, SMART was prospectively registered separately for the medical

  12. Efficacy and safety of sacubitril/valsartan (LCZ696) in Japanese patients with chronic heart failure and reduced ejection fraction: Rationale for and design of the randomized, double-blind PARALLEL-HF study.

    Science.gov (United States)

    Tsutsui, Hiroyuki; Momomura, Shinichi; Saito, Yoshihiko; Ito, Hiroshi; Yamamoto, Kazuhiro; Ohishi, Tomomi; Okino, Naoko; Guo, Weinong

    2017-09-01

    The prognosis of heart failure patients with reduced ejection fraction (HFrEF) in Japan remains poor, although there is growing evidence for increasing use of evidence-based pharmacotherapies in Japanese real-world HF registries. Sacubitril/valsartan (LCZ696) is a first-in-class angiotensin receptor neprilysin inhibitor shown to reduce mortality and morbidity in the recently completed largest outcome trial in patients with HFrEF (PARADIGM-HF trial). The prospectively designed phase III PARALLEL-HF (Prospective comparison of ARNI with ACE inhibitor to determine the noveL beneficiaL trEatment vaLue in Japanese Heart Failure patients) study aims to assess the clinical efficacy and safety of LCZ696 in Japanese HFrEF patients, and show similar improvements in clinical outcomes as the PARADIGM-HF study enabling the registration of LCZ696 in Japan. This is a multicenter, randomized, double-blind, parallel-group, active controlled study of 220 Japanese HFrEF patients. Eligibility criteria include a diagnosis of chronic HF (New York Heart Association Class II-IV) and reduced ejection fraction (left ventricular ejection fraction ≤35%) and increased plasma concentrations of natriuretic peptides [N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥600pg/mL, or NT-proBNP ≥400pg/mL for those who had a hospitalization for HF within the last 12 months] at the screening visit. The study consists of three phases: (i) screening, (ii) single-blind active LCZ696 run-in, and (iii) double-blind randomized treatment. Patients tolerating LCZ696 50mg bid during the treatment run-in are randomized (1:1) to receive LCZ696 100mg bid or enalapril 5mg bid for 4 weeks followed by up-titration to target doses of LCZ696 200mg bid or enalapril 10mg bid in a double-blind manner. The primary outcome is the composite of cardiovascular death or HF hospitalization and the study is an event-driven trial. The design of the PARALLEL-HF study is aligned with the PARADIGM-HF study and aims to assess

  13. Fusion and failure following anterior cervical plating with dynamic or rigid plates: 6-months results of a multi-centric, prospective, randomized, controlled study

    Science.gov (United States)

    Stulik, Jan; Chrobok, Jan; Ruffing, Sabine; Drumm, Jörg; Sova, Laurentius; Kucera, Ravel; Vyskocil, Tomas; Steudel, Wolf Ingo

    2007-01-01

    Anterior cervical plate fixation is an approved surgical technique for cervical spine stabilization in the presence of anterior cervical instability. Rigid plate design with screws rigidly locked to the plate is widely used and is thought to provide a better fixation for the treated spinal segment than a dynamic design in which the screws may slide when the graft is settling. Recent biomechanical studies showed that dynamic anterior plates provide a better graft loading possibly leading to accelerated spinal fusion with a lower incidence of implant complications. This, however, was investigated in vitro and does not necessarily mean to be the case in vivo, as well. Thus, the two major aspects of this study were to compare the speed of bone fusion and the rate of implant complications using either rigid- or dynamic plates. The study design is prospective, randomized, controlled, and multi-centric, having been approved by respective ethic committees of all participating sites. One hundred and thirty-two patients were included in this study and randomly assigned to one of the two groups, both undergoing routine level-1- or level-2 anterior cervical discectomy with autograft fusion receiving either a dynamic plate with screws being locked in ap - position (ABC, Aesculap, Germany), or a rigid plate (CSLP, Synthes, Switzerland). Segmental mobility and implant complications were compared after 3- and 6 months, respectively. All measurements were performed by an independent radiologist. Mobility results after 6 months were available for 77 patients (43 ABC/34 CSLP). Mean segmental mobility for the ABC group was 1.7 mm at the time of discharge, 1.4 mm after 3 months, and 0.8 mm after 6 months. For the CSLP- group the measurements were 1.0, 1.8, and 1.7 mm, respectively. The differences of mean segmental mobility were statistically significant between both groups after 6 months (P = 0.02). Four patients of the CSLP-group demonstrated surgical hardware complications

  14. Xenotransplantation of Human Cardiomyocyte Progenitor Cells Does Not Improve Cardiac Function in a Porcine Model of Chronic Ischemic Heart Failure. Results from a Randomized, Blinded, Placebo Controlled Trial.

    Science.gov (United States)

    Jansen of Lorkeers, Sanne J; Gho, Johannes M I H; Koudstaal, Stefan; van Hout, Gerardus P J; Zwetsloot, Peter Paul M; van Oorschot, Joep W M; van Eeuwijk, Esther C M; Leiner, Tim; Hoefer, Imo E; Goumans, Marie-José; Doevendans, Pieter A; Sluijter, Joost P G; Chamuleau, Steven A J

    2015-01-01

    Recently cardiomyocyte progenitor cells (CMPCs) were successfully isolated from fetal and adult human hearts. Direct intramyocardial injection of human CMPCs (hCMPCs) in experimental mouse models of acute myocardial infarction significantly improved cardiac function compared to controls. Here, our aim was to investigate whether xenotransplantation via intracoronary infusion of fetal hCMPCs in a pig model of chronic myocardial infarction is safe and efficacious, in view of translation purposes. We performed a randomized, blinded, placebo controlled trial. Four weeks after ischemia/reperfusion injury by 90 minutes of percutaneous left anterior descending artery occlusion, pigs (n = 16, 68.5 ± 5.4 kg) received intracoronary infusion of 10 million fetal hCMPCs or placebo. All animals were immunosuppressed by cyclosporin (CsA). Four weeks after infusion, endpoint analysis by MRI displayed no difference in left ventricular ejection fraction, left ventricular end diastolic and left ventricular end systolic volumes between both groups. Serial pressure volume (PV-)loop and echocardiography showed no differences in functional parameters between groups at any timepoint. Infarct size at follow-up, measured by late gadolinium enhancement MRI showed no difference between groups. Intracoronary pressure and flow measurements showed no signs of coronary obstruction 30 minutes after cell infusion. No premature death occurred in cell treated animals. Xenotransplantation via intracoronary infusion of hCMPCs is feasible and safe, but not associated with improved left ventricular performance and infarct size compared to placebo in a porcine model of chronic myocardial infarction.

  15. Failure Modes

    DEFF Research Database (Denmark)

    Jakobsen, K. P.; Burcharth, H. F.; Ibsen, Lars Bo

    1999-01-01

    The present appendix contains the derivation of ten different limit state equations divided on three different failure modes. Five of the limit state equations can be used independently of the characteristics of the subsoil, whereas the remaining five can be used for either drained or undrained s...

  16. Safety and Efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients With Heart Failure: A Phase 1/2 Randomized Controlled Trial (RIMECARD Trial [Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy]).

    Science.gov (United States)

    Bartolucci, Jorge; Verdugo, Fernando J; González, Paz L; Larrea, Ricardo E; Abarzua, Ema; Goset, Carlos; Rojo, Pamela; Palma, Ivan; Lamich, Ruben; Pedreros, Pablo A; Valdivia, Gloria; Lopez, Valentina M; Nazzal, Carolina; Alcayaga-Miranda, Francisca; Cuenca, Jimena; Brobeck, Matthew J; Patel, Amit N; Figueroa, Fernando E; Khoury, Maroun

    2017-10-27

    Umbilical cord-derived mesenchymal stem cells (UC-MSC) are easily accessible and expanded in vitro, possess distinct properties, and improve myocardial remodeling and function in experimental models of cardiovascular disease. Although bone marrow-derived mesenchymal stem cells have been previously assessed for their therapeutic potential in individuals with heart failure and reduced ejection fraction, no clinical trial has evaluated intravenous infusion of UC-MSCs in these patients. Evaluate the safety and efficacy of the intravenous infusion of UC-MSC in patients with chronic stable heart failure and reduced ejection fraction. Patients with heart failure and reduced ejection fraction under optimal medical treatment were randomized to intravenous infusion of allogenic UC-MSCs (Cellistem, Cells for Cells S.A., Santiago, Chile; 1×10 6 cells/kg) or placebo (n=15 per group). UC-MSCs in vitro, compared with bone marrow-derived mesenchymal stem cells, displayed a 55-fold increase in the expression of hepatocyte growth factor, known to be involved in myogenesis, cell migration, and immunoregulation. UC-MSC-treated patients presented no adverse events related to the cell infusion, and none of the patients tested at 0, 15, and 90 days presented alloantibodies to the UC-MSCs (n=7). Only the UC-MSC-treated group exhibited significant improvements in left ventricular ejection fraction at 3, 6, and 12 months of follow-up assessed both through transthoracic echocardiography ( P =0.0167 versus baseline) and cardiac MRI ( P =0.025 versus baseline). Echocardiographic left ventricular ejection fraction change from baseline to month 12 differed significantly between groups (+7.07±6.22% versus +1.85±5.60%; P =0.028). In addition, at all follow-up time points, UC-MSC-treated patients displayed improvements of New York Heart Association functional class ( P =0.0167 versus baseline) and Minnesota Living with Heart Failure Questionnaire ( P <0.05 versus baseline). At study completion

  17. What Is Heart Failure?

    Science.gov (United States)

    ... Intramural Research Home / Heart Failure Heart Failure Also known as Congestive heart failure What ... diseases for many years that led to heart failure. Heart failure is a leading cause of hospital stays ...

  18. What Causes Heart Failure?

    Science.gov (United States)

    ... Intramural Research Home / Heart Failure Heart Failure Also known as Congestive heart failure What ... diseases for many years that led to heart failure. Heart failure is a leading cause of hospital stays ...

  19. Living with Heart Failure

    Science.gov (United States)

    ... Intramural Research Home / Heart Failure Heart Failure Also known as Congestive heart failure What ... diseases for many years that led to heart failure. Heart failure is a leading cause of hospital stays ...

  20. Messaging to Increase Public Support for Naloxone Distribution Policies in the United States: Results from a Randomized Survey Experiment.

    Directory of Open Access Journals (Sweden)

    Marcus A Bachhuber

    Full Text Available Barriers to public support for naloxone distribution include lack of knowledge, concerns about potential unintended consequences, and lack of sympathy for people at risk of overdose.A randomized survey experiment was conducted with a nationally-representative web-based survey research panel (GfK KnowledgePanel. Participants were randomly assigned to read different messages alone or in combination: 1 factual information about naloxone; 2 pre-emptive refutation of potential concerns about naloxone distribution; and 3 a sympathetic narrative about a mother whose daughter died of an opioid overdose. Participants were then asked if they support or oppose policies related to naloxone distribution. For each policy item, logistic regression models were used to test the effect of each message exposure compared with the no-exposure control group.The final sample consisted of 1,598 participants (completion rate: 72.6%. Factual information and the sympathetic narrative alone each led to higher support for training first responders to use naloxone, providing naloxone to friends and family members of people using opioids, and passing laws to protect people who administer naloxone. Participants receiving the combination of the sympathetic narrative and factual information, compared to factual information alone, were more likely to support all policies: providing naloxone to friends and family members (OR: 2.0 [95% CI: 1.4 to 2.9], training first responders to use naloxone (OR: 2.0 [95% CI: 1.2 to 3.4], passing laws to protect people if they administer naloxone (OR: 1.5 [95% CI: 1.04 to 2.2], and passing laws to protect people if they call for medical help for an overdose (OR: 1.7 [95% CI: 1.2 to 2.5].All messages increased public support, but combining factual information and the sympathetic narrative was most effective. Public support for naloxone distribution can be improved through education and sympathetic portrayals of the population who stands to benefit

  1. A failure to confirm the effectiveness of a brief group psychoeducational program for mothers of children with high-functioning pervasive developmental disorders: a randomized controlled pilot trial

    Directory of Open Access Journals (Sweden)

    Suzuki M

    2014-06-01

    Full Text Available Masako Suzuki,1 Atsurou Yamada,1 Norio Watanabe,1 Tatsuo Akechi,1 Fujika Katsuki,2 Takeshi Nishiyama,3 Masayuki Imaeda,4 Taishi Miyachi,4 Kazuo Otaki,5 Yumiko Mitsuda,6 Akino Ota,6 Toshi A Furukawa7 1Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 2Department of Psychiatric and Mental Health Nursing, Nagoya City University School of Nursing, Nagoya, Japan; 3Clinical Trial Management Center, Nagoya City University Hospital, Nagoya, Japan; 4Department of Neonatology and Pediatrics, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; 5Kazuo Mental Clinic, Toyohashi, Japan; 6Toyokawa Sakura Hospital, Toyokawa Japan; 7Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, Japan Objective: The purpose of this study was to examine the effectiveness of group psychoeducation to relieve the psychological distress of mothers of children with high-functioning pervasive developmental disorders (HFPDD and to improve the behaviors of the children. Methods: Seventy-two mothers of preschool outpatients with HFPDD were randomly assigned to a four-session brief group psychoeducational program (GP. The sessions were held every second week in addition to the usual treatment (GP + treatment as usual [TAU] group, or to a TAU-alone group. The primary outcome was self-reported symptoms of maternal mental health as assessed using the 28-item General Health Questionnaire (GHQ-28 at 21 weeks post-randomization (week 21. The GHQ-28 at the end of the intervention (week 7, Aberrant Behavior Checklist (ABC for the behavior of the children, the Zarit Burden Interview (ZBI, and the Medical Outcomes Study 36-item Short Form Health Survey (SF-36 were carried out at weeks 7 and 21. We tested the group effects with the interaction between the intervention and the evaluation points. Results: The GHQ-28

  2. Reproducibility of tDCS Results in a Randomized Trial: Failure to Replicate Findings of tDCS-Induced Enhancement of Verbal Fluency.

    Science.gov (United States)

    Vannorsdall, Tracy D; van Steenburgh, J Jason; Schretlen, David J; Jayatillake, Rasika; Skolasky, Richard L; Gordon, Barry

    2016-03-01

    Transcranial direct current stimulation (tDCS) has been shown to enhance verbal productivity, but the finding and extent of enhancement vary across studies. Few attempts to replicate positive tDCS findings have been reported, suggesting the possibility of publication bias. We aimed to replicate the tDCS methodology and findings of Cattaneo, Pisoni, and Papagno (2011, Neuroscience 183:64-70) in a new population sample. We hypothesized that our study of anodal tDCS would improve verbal fluency production similarly to the original study. In our single-blind, sham-controlled crossover experiment, 14 healthy young adults were randomly assigned to receive 2 mA of anodal and sham stimulation to the Broca area in counterbalanced order before completing verbal fluency tasks. Participants tolerated the stimulation well. Despite closely mirroring the original study methods, we saw no main effect of stimulation condition: F1,13=0.002, P=0.97, letter fluency sham mean (standard deviation)=16.8 (2.3), letter fluency anodal=17.5 (3.8), category fluency sham=25.3 (5.4), or category fluency anodal=24.7 (5.2), η≤0.01. While tDCS may enhance cerebral functions in general, the lack of consistency between studies suggests either that this tDCS protocol does not affect verbal fluency or, at minimum, that tDCS may be more sensitive to experimental conditions than has been thought. Our findings also highlight the need for replication studies in brain stimulation research. ClinicalTrials.gov (Identifier NCT01602263).

  3. Does endometrial injury enhances implantation in recurrent in-vitro fertilization failures? A prospective randomized control study from tertiary care center

    Directory of Open Access Journals (Sweden)

    Neeta Singh

    2015-01-01

    Full Text Available Background: Though Assisted Reproductive Techniques have overcome many fertility disorders, implantation is still considered, the rate-limiting step for the success of IVF. Aim0 : The aim of this study was to evaluate the role of endometrial scratching in improving the implantation rate in patients undergoing IVF-ET cycles. Design: Prospective randomized control trial. Methods and Material: Sixty infertile women with a history of >1 previous failed IVF-ET cycles were randomizedinto two groups of 30 each. The patients in group 1 underwent endometrial scratching once between days 14-21 of menstrual cycle in the cycle prior to embryo transfer (ET, while in group 2scratching were not done. Implantation rate, ongoing pregnancy rate, abortion rate and live birth rate were comparedbetween both groups. Statistical Analysis: Mean values were compared between two groups using Student′s′t′ independent test. Frequency distributions of categorical variables were compared using Chi-Square/ Fisher′s exact test as appropriate. Results: Implantation rate in group 1 was 19.4% whereas in group 2 it was 8.1%. Difference between two groups was statistically significant (P =0.028. The live birth rate was higher in the group 2 compared to group 1, however this difference was not statistically significant (3.3% vs 10%, P =0.612. No significant difference was observed between the two groups regarding the ongoing pregnancy rate (16.7% vs 0.0%; P =0.052, abortion rate (10.0% vs 3.3%, P =0.612 and miscarriage rate (6.7% vs 3.3%, P =0.99. Conclusions: Implantation rate increases significantly after endometrial scratching in patients with previous failed IVF-ET.

  4. Fourteen-day optimized levofloxacin-based therapy versus classical quadruple therapy for Helicobacter pylori treatment failures: a randomized clinical trial.

    Science.gov (United States)

    Cao, Zhijun; Chen, Qi; Zhang, Wei; Liang, Xiao; Liao, Jingxian; Liu, Wenzhong; Xiao, Shudong; Lu, Hong

    2015-01-01

    To test the efficacy of lansoprazole, bismuth, levofloxacin, and amoxicillin therapy compared to bismuth metronidazole tetracycline (BMT) quadruple therapy for second-line treatment of Helicobacter pylori infection. A total of 284 patients who failed prior H. pylori eradication were randomized to receive 14-day regimens containing lansoprazole 30 mg twice a day (b.i.d.), bismuth subcitrate 240 mg b.i.d., and either amoxcillin, 1 g b.i.d. and levofloxacin 500 mg once daily (qd) (levofloxacin/bismuth therapy) or metronidazole 400 mg four times daily (q.i.d.) and tetracycline, 500 mg q.i.d. (BMT quadruple therapy). Endoscopy and culture were performed before treatment. Antimicrobial susceptibility was by agar dilution. H. pylori status was determined 6 weeks after the end of therapy using a (13)C-urea breath test. The metronidazole, levofloxacin, tetracycline, and amoxicillin resistance rates were 85.3%, 40.2%, 1.1%, and 0.5%, respectively. The intention-to-treat and per-protocol (PP) eradication rates were 83% (95% confidence interval [CI]: 75.9-88.3%) and 88.1% (95% CI: 81.2-92.4%) (p = 0.22) for levofloxacin-bismuth (levo-bismuth) versus BMT quadruple, respectively, and PP rates were 85.4% (95% CI: 78.5-90.3%) and 90.6% (95% CI: 84.6-94.5%) (p = 0.18). Moderate and severe side effects were significantly higher with BMT quadruple than levo-bismuth (22.4% vs. 5%, p < 0.001) and higher in women (28.4%) than men (10.4%) in BMT quadruple therapy group (p = 0.015). Increasing fluoroquinolone resistance has undermined levo-bismuth quadruple therapy making BMT quadruple therapy a better choice empiric second-line therapy for H. pylori infection. However, compliance was significantly higher with levo-bismuth quadruple therapy, especially among women.

  5. Xenotransplantation of Human Cardiomyocyte Progenitor Cells Does Not Improve Cardiac Function in a Porcine Model of Chronic Ischemic Heart Failure. Results from a Randomized, Blinded, Placebo Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Sanne J Jansen of Lorkeers

    Full Text Available Recently cardiomyocyte progenitor cells (CMPCs were successfully isolated from fetal and adult human hearts. Direct intramyocardial injection of human CMPCs (hCMPCs in experimental mouse models of acute myocardial infarction significantly improved cardiac function compared to controls.Here, our aim was to investigate whether xenotransplantation via intracoronary infusion of fetal hCMPCs in a pig model of chronic myocardial infarction is safe and efficacious, in view of translation purposes.We performed a randomized, blinded, placebo controlled trial. Four weeks after ischemia/reperfusion injury by 90 minutes of percutaneous left anterior descending artery occlusion, pigs (n = 16, 68.5 ± 5.4 kg received intracoronary infusion of 10 million fetal hCMPCs or placebo. All animals were immunosuppressed by cyclosporin (CsA. Four weeks after infusion, endpoint analysis by MRI displayed no difference in left ventricular ejection fraction, left ventricular end diastolic and left ventricular end systolic volumes between both groups. Serial pressure volume (PV-loop and echocardiography showed no differences in functional parameters between groups at any timepoint. Infarct size at follow-up, measured by late gadolinium enhancement MRI showed no difference between groups. Intracoronary pressure and flow measurements showed no signs of coronary obstruction 30 minutes after cell infusion. No premature death occurred in cell treated animals.Xenotransplantation via intracoronary infusion of hCMPCs is feasible and safe, but not associated with improved left ventricular performance and infarct size compared to placebo in a porcine model of chronic myocardial infarction.

  6. One-session treatment of specific phobias in youth: a randomized clinical trial in the United States and Sweden.

    Science.gov (United States)

    Ollendick, Thomas H; Ost, Lars-Göran; Reuterskiöld, Lena; Costa, Natalie; Cederlund, Rio; Sirbu, Cristian; Davis, Thompson E; Jarrett, Matthew A

    2009-06-01

    One hundred and ninety-six youth, ages 7-16, who fulfilled Diagnostic and Statistical Manual of Mental Disorders (4th ed.) criteria for various specific phobias were randomized to a one-session exposure treatment, education support treatment, or a wait list control group. After the waiting period, the wait list participants were offered treatment and, if interested, rerandomized to 1 of the 2 active treatments. The phobias were assessed with semistructured diagnostic interviews, clinician severity ratings, and behavioral avoidance tests, whereas fears, general anxiety, depression, and behavior problems were assessed with self- and parent report measures. Assessments were completed pretreatment, posttreatment, and at 6 months following treatment. Results showed that both treatment conditions were superior to the wait list control condition and that 1-session exposure treatment was superior to education support treatment on clinician ratings of phobic severity, percentage of participants who were diagnosis free, child ratings of anxiety during the behavioral avoidance test, and treatment satisfaction as reported by the youth and their parents. There were no differences on self-report measures. Treatment effects were maintained at follow-up. Implications of these findings are discussed. Copyright 2009 APA

  7. A small randomized pilot study of a workplace mindfulness-based intervention for surgical intensive care unit personnel: effects on salivary α-amylase levels.

    Science.gov (United States)

    Duchemin, Anne-Marie; Steinberg, Beth A; Marks, Donald R; Vanover, Kristin; Klatt, Maryanna

    2015-04-01

    To determine whether a workplace stress-reduction intervention decreases reactivity to stress among personnel exposed to a highly stressful occupational environment. Personnel from a surgical intensive care unit were randomized to a stress-reduction intervention or a waitlist control group. The 8-week group mindfulness-based intervention included mindfulness, gentle yoga, and music. Psychological and biological markers of stress were measured 1 week before and 1 week after the intervention. Levels of salivary α-amylase, an index of sympathetic activation, were significantly decreased between the first and second assessments in the intervention group with no changes in the control group. There was a positive correlation between salivary α-amylase levels and burnout scores. These data suggest that this type of intervention could decrease not only reactivity to stress but also the risk of burnout.

  8. A Small Randomized Pilot Study of a Workplace Mindfulness-Based Intervention for Surgical Intensive Care Unit Personnel: Effects on Salivary α-Amylase Levels

    Science.gov (United States)

    Duchemin, Anne-Marie; Steinberg, Beth A.; Marks, Donald R.; Vanover, Kristin; Klatt, Maryanna

    2015-01-01

    Objective To determine if a workplace stress-reduction intervention decreases reactivity to stress among personnel exposed to a highly stressful occupational environment. Methods Personnel from a surgical intensive care unit (SICU) were randomized to a stress reduction intervention or a wait-list control group. The 8-week group mindfulness-based intervention (MBI) included mindfulness, gentle yoga and music. Psychological and biological markers of stress were measured one week before and one week after the intervention. Results Levels of salivary α-amylase, an index of sympathetic activation, were significantly decreased between the 1st and 2nd assessments in the intervention group with no changes in the control group. There was a positive correlation between salivary α-amylase levels and burnout scores. Conclusions These data suggest that this type of intervention could not only decrease reactivity to stress, but also decrease the risk of burnout. PMID:25629803

  9. Treatment of new-onset atrial fibrillation in noncardiac intensive care unit patients: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Kanji, Salmaan; Stewart, Robert; Fergusson, Dean A; McIntyre, Lauralyn; Turgeon, Alexis F; Hébert, Paul C

    2008-05-01

    Atrial fibrillation is a common problem associated with morbidity and mortality in critically ill patients; however, evidence-based treatment recommendations are lacking. The objective of this systematic review was to evaluate the efficacy of pharmacologic rhythm control of new-onset atrial fibrillation in noncardiac, critically ill adults. Citations identified from an electronic search of Medline, the Cochrane register of controlled trials, and Embase databases (1966 to August 2006) were independently reviewed by two investigators. All prospective randomized controlled trials evaluating pharmacologic rhythm conversion regimens for new-onset atrial fibrillation in (noncardiac surgery) critically ill adult patients were included. The primary end point was atrial fibrillation resolution. Using a standardized data extraction form, data related to study design, population characteristics, pharmacologic intervention, and outcome measures were collected. Four trials met inclusion criteria from 1995 citations screened. Of the 143 evaluable patients in these trials 89 (76%) had atrial fibrillation while the remaining ones had other atrial tachyarrhythmias. Drugs evaluated for rhythm conversion included amiodarone (n = 26), procainamide (n = 14), magnesium (n = 18), flecainide (n = 15), esmolol (n = 28), verapamil (n = 15), and diltiazem (n = 27). The definition of treatment success ranged from conversion within 1 hr to conversion within 24 hrs. No study evaluated maintenance of conversion, and one study included hemodynamically unstable patients. Lack of methodologic homogeneity prevented any pooled analysis. Using the current published literature, we cannot recommend a standard treatment for atrial fibrillation in noncardiac critically ill adult patients. Clinical trials evaluating rhythm conversion in critically ill populations outside of cardiac surgery are lacking. Further trials that address goals of care in hemodynamically stable and unstable patients and utilize

  10. Comparison of Metal-Ceramic and All-Ceramic Three-Unit Posterior Fixed Dental Prostheses: A 3-Year Randomized Clinical Trial.

    Science.gov (United States)

    Nicolaisen, Maj H; Bahrami, Golnosh; Schropp, Lars; Isidor, Flemming

    2016-01-01

    The aim of this randomized clinical study was to compare the 3-year clinical outcome of metal-ceramic fixed dental prostheses (MC-FDPs) and zirconia all-ceramic fixed dental prostheses (AC-FDPs) replacing a posterior tooth. A sample of 34 patients with a missing posterior tooth were randomly chosen to receive either a MC-FDP (n = 17) or an AC-FDP (n = 17). The FDPs were evaluated at baseline and yearly until 3 years after cementation. They were assessed using the California Dental Association assessment system. Periodontal parameters were measured at the abutment teeth, and the contralateral teeth served as control. The statistical unit was the FDP/patient. The survival rates for MC-FDPs and AC-FDPs were 100%. The success rate was 76% and 71% for MC-FDPs and AC-FDPs, respectively. Three technical complications were observed in the MC-FDP group and five in the AC-FDP group, all chipping fractures of the ceramic veneer. Furthermore, one biologic complication in the MC-FDP group (an apical lesion) was observed. No framework fractures occurred. All patients had optimal oral hygiene and showed no bleeding on periodontal probing at any of the recalls. Only minor changes in the periodontal parameters were observed during the 3 years of observation. Three-unit posterior MC-FDPs and AC-FDPs showed similar high survival rates and acceptable success rates after 3 years of function, and ceramic veneer chipping fracture was the most frequent complication for both types of restorations.

  11. Minority participation in a school-based randomized clinical trial of tooth decay prevention in the United States.

    Science.gov (United States)

    Nelson, Suchitra; Milgrom, Peter

    2012-01-01

    To describe the strategies-based on the social triad concept of a partnership of researchers, school personnel and community-employed to recruit low-income, minority parent/caregivers of kindergarten children into a school-based tooth decay prevention trial in the United States. The study site was an urban school district with five elementary schools. Recruitment was carried out once each year for three years. Recruitment involved strategies at the school district, school, classroom, and student-parent level. A coalition of researchers, school personnel and community individuals was established for communication and recruitment. Outreach workers from the community were hired to promote, recruit, and disseminate oral health information. Study promotion included both print materials (logos, flyers, pictorial story boards) and presentations at school and community events. The School District Superintendent and administrators approved the study, and all five school principals and kindergarten teachers participated. All children within the classrooms were eligible: the overall participation rate of was 86% (580/672). Community outreach workers actively facilitated the recruitment and participants were recruited at open house for parent-teacher meeting (37% of all participants), sending letters and consent forms home (31%), at a prearranged convenient time during drop off and pick up of the child at their respective schools (30%), curriculum nights and health fairs (2%). Utilizing the social triad concept led to success in planning and carrying out the recruitment of predominantly minority school children with high participation rates. Copyright © 2011 Elsevier Inc. All rights reserved.

  12. Hydrodynamic film thickness measurements and CFD analysis identify the root causes of repetitive thrust bearing failures on a 45 MW hydro generating unit at Hydro-Québec

    Science.gov (United States)

    Gauvin, P.; Huard, P.

    2016-11-01

    High temperature level recorded on the thrust bearing of a 45 MW hydro generating unit was resulting in frequent production stoppage. In spite of improvements brought to the oil cooling system since the rehabilitation in 2008, the operator had to activate the bearing oil lift system to keep the temperature below acceptable limits. Primary root cause analysis first pointed to the design of the shoe that was centrally pivoted, not allowing the formation of a thick hydrodynamic film. The removal of a strip of the soft metal layer near the trailing edge of the shoe resulted in a significant surface temperature reduction (about 15 deg. C), as predicted by a CFD model of the oil film. The goal of this machining was to increase the pivoting angle by moving the centre of hydrodynamic pressure. Proximity sensors were installed at each corner of the redesigned shoe to measure the film thickness and the bearing attitude. Signal analysis revealed a step of a magnitude close to the oil film thickness between the two halves of the rotating thrust block. This was the cause of another failure few hours since restarting the unit. The lessons learnt through these measurements and analyses were carefully applied to the ultimate build. The unit now runs with a robust thrust bearing and even survived a significant cooling flow reduction event. This paper presents the CFD analysis results and the measurements acquired during these events.

  13. Effects of music therapy on drug avoidance self-efficacy in patients on a detoxification unit: a three-group randomized effectiveness study.

    Science.gov (United States)

    Silverman, Michael J

    2014-01-01

    Self-efficacy is a component of Bandura's social cognitive theory and can lead to abstinence and a reduction of relapse potential for people who have substance abuse disorders. To date, no music therapy researcher has utilized this theoretical model to address abstinence and reduce the likelihood of relapse in people who have addictions. The purpose of this study was to determine the effects of music therapy on drug avoidance self-efficacy in a randomized three-group wait-list control design with patients on a detoxification unit. Participants (N = 131) were cluster randomized to one of three single-session conditions: music therapy, verbal therapy, or wait-list control. Music therapy participants received a group lyric analysis intervention, verbal therapy participants received a group talk therapy session, and wait-list control participants eventually received a group recreational music therapy intervention. Although there was no significant between-group difference in drug avoidance self-efficacy, participants in the music therapy condition tended to have the highest mean drug avoidance self-efficacy scores. Posttest written comments supported the use of both music therapy and verbal therapy sessions. Two music therapy participants specifically noted that their initial skepticism had dissipated after receiving music therapy. Despite a lack of significant differences, the theoretical support of self-efficacy for substance abuse rehabilitation suggests that this may be an area of continued clinical focus and empirical investigation. Clinical anecdotes, limitations of the study, and suggestions for future research are provided.

  14. An innovative telemedicine knowledge translation program to improve quality of care in intensive care units: protocol for a cluster randomized pragmatic trial

    Directory of Open Access Journals (Sweden)

    Pinto Ruxandra

    2009-02-01

    Full Text Available Abstract Background There are challenges to timely adoption of, and ongoing adherence to, evidence-based practices known to improve patient care in the intensive care unit (ICU. Quality improvement initiatives using a collaborative network approach may increase the use of such practices. Our objective is to evaluate the effectiveness of a novel knowledge translation program for increasing the proportion of patients who appropriately receive the following six evidence-based care practices: venous thromboembolism prophylaxis; ventilator-associated pneumonia prevention; spontaneous breathing trials; catheter-related bloodstream infection prevention; decubitus ulcer prevention; and early enteral nutrition. Methods and design We will conduct a pragmatic cluster randomized active control trial in 15 community ICUs and one academic ICU in Ontario, Canada. The intervention is a multifaceted videoconferenced educational and problem-solving forum to organize knowledge translation strategies, including comparative audit and feedback, educational sessions from content experts, and dissemination of algorithms. Fifteen individual ICUs (clusters will be randomized to receive quality improvement interventions targeting one of the best practices during each of six study phases. Each phase lasts four months during the first study year and three months during the second. At the end of each study phase, ICUs are assigned to an intervention for a best practice not yet received according to a random schedule. The primary analysis will use patient-level process-of-care data to measure the intervention's effect on rates of adoption and adherence of each best practice in the targeted ICU clusters versus controls. Discussion This study design evaluates a new system for knowledge translation and quality improvement across six common ICU problems. All participating ICUs receive quality improvement initiatives during every study phase, improving buy-in. This study design

  15. Failure Assessment

    Science.gov (United States)

    Lutz, Robyn; Nikora, Allen

    2005-01-01

    Three questions to which software developers want accurate, precise answers are "How can the software system fail?", "mat bad things will happen if the software fails?t', and "How many failures will the software experience?". Numerous techniques have been devised to answer these questions; three of the best known are: 1) Software Fault Tree Analysis (SFTA) 2) Software Failure Modes, Effects, and Criticality Analysis (SFMECA 3) Software Fault/Failure Modeling. SFTA and SFMECA have been successfully used to analyze the flight software for a number of robotic planetary exploration missions, including Galileo, Cassini, and Deep Space 1. Given the increasing interest in reusing software components from mission to mission, one of us has developed techniques for reusing the corresponding portions of the SFTA and SFMECA, reducing the effort required to conduct these analyses. SFTA has also been shown to be effective in analyzing the security aspects of software systems; intrusion mechanisms and effects can easily be modeled using these techniques. The Bi- Directional Safety Analysis (BDSA) method combines a forward search (similar to SFMECA) from potential failure modes to their effects, with a backward search (similar to SFTA) from feasible hazards to the contributing causes of each hazard. BDSA offers an efficient way to identify latent failures. Recent work has extended BDSA to product-line applications such as flight-instrumentation displays and developed tool support for the reuse of the failure-analysis artifacts within a product line. BDSA has also been streamlined to support those projects having tight cost and/or schedule constraints for their failure analysis efforts. We discuss lessons learned from practice, describe available tools, and identi@ some future directions for the topic. A substantial amount of research has been devoted to estimating the number of failures that a software system will experience during test and operations, as well as the number of

  16. Metallization failures

    Science.gov (United States)

    Beatty, R.

    1971-01-01

    Metallization-related failure mechanisms were shown to be a major cause of integrated circuit failures under accelerated stress conditions, as well as in actual use under field operation. The integrated circuit industry is aware of the problem and is attempting to solve it in one of two ways: (1) better understanding of the aluminum system, which is the most widely used metallization material for silicon integrated circuits both as a single level and multilevel metallization, or (2) evaluating alternative metal systems. Aluminum metallization offers many advantages, but also has limitations particularly at elevated temperatures and high current densities. As an alternative, multilayer systems of the general form, silicon device-metal-inorganic insulator-metal, are being considered to produce large scale integrated arrays. The merits and restrictions of metallization systems in current usage and systems under development are defined.

  17. Evaluation of the pharmacoDYNAMIC effects of riociguat in subjects with pulmonary hypertension and heart failure with preserved ejection fraction : Study protocol for a randomized controlled trial.

    Science.gov (United States)

    Mascherbauer, Julia; Grünig, Ekkehard; Halank, Michael; Hohenforst-Schmidt, Wolfgang; Kammerlander, Andreas A; Pretsch, Ingrid; Steringer-Mascherbauer, Regina; Ulrich, Silvia; Lang, Irene M; Wargenau, Manfred; Frey, Reiner; Bonderman, Diana

    2016-12-01

    The presence of pulmonary hypertension (PH) severely aggravates the clinical course of heart failure with preserved ejection fraction (HFPEF) resulting in substantial morbidity and mortality. So far, neither established heart failure therapies nor pulmonary vasodilators have proven to be effective for this condition. Riociguat (Adempas®, BAY 63-2521), a stimulator of soluble guanylate cyclase, is a novel pulmonary and systemic vasodilator that has been approved for the treatment of precapillary forms of PH. With regard to postcapillary PH, the DILATE-1 study was a multicenter, double-blind, randomized, placebo-controlled single-dose study in subjects with PH associated with HFPEF. Although there was no significant change in the primary outcome measure, peak decrease in mean pulmonary artery pressure with riociguat versus placebo, riociguat significantly increased stroke volume without changing heart rate, pulmonary artery wedge pressure, transpulmonary pressure gradient or pulmonary vascular resistance. The present study is designed to test the efficacy of long-term treatment with riociguat in patients with PH associated with HFPEF. The DYNAMIC study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical phase IIb trial evaluating the efficacy, safety and kinetics of riociguat in PH-HFPEF patients. The drug will be given over 26 weeks to evaluate the effects of riociguat versus placebo. The primary efficacy variable will be the change from baseline in cardiac output at rest, measured by right heart catheter after 26 weeks of study drug treatment. Additional efficacy variables will be changes from baseline in further hemodynamic parameters, changes in left and right atrial area, right ventricular volume, as well as right ventricular ejection fraction measured by cardiac magnetic resonance imaging, and changes from baseline in World Health Organization (WHO) class and N‑terminal prohormone B‑type natriuretic peptide (NT

  18. Incidence and outcome of contrast-associated acute kidney injury assessed with Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria in critically ill patients of medical and surgical intensive care units: a retrospective study.

    Science.gov (United States)

    Kim, Myoung Hwa; Koh, Shin Ok; Kim, Eun Jung; Cho, Jin Sun; Na, Sung-Won

    2015-01-01

    Contrast medium used for radiologic tests can decrease renal function. However there have been few studies on contrast-associated acute kidney injury in intensive care unit (ICU) patients. The objective of this study was to evaluate the incidence, characteristics, and outcome of contrast-associated acute kidney injury (CA-AKI) patients using the Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria in critically ill patients in the ICU. We conducted a retrospective study of adult patients who underwent contrast-enhanced radiologic tests from January 2011 to December 2012 in a 30-bed medical ICU and a 24-bed surgical ICU. The study included 335 patients, and the incidence of CA-AKI was 15.5%. The serum creatinine and estimated glomerular filtration rate values in the CA-AKI patients did not recover even at discharge from the hospital compared with the values prior to the contrast use. Among 52 CA-AKI patients, 55.8% (n = 29) had pre-existing kidney injury and 44.2% (n = 23) did not. The CA-AKI patients were divided into risk (31%), injury (31%), and failure (38%) by the RIFLE classification. The percentage of patients in whom AKI progressed to a more severe form (failure, loss, end-stage kidney disease) increased from 38% to 45% during the hospital stay, and the recovery rate of AKI was 17% at the time of hospital discharge. Because the Acute Physiology and Chronic Health Evaluation (APACHE) II score was the only significant variable inducing CA-AKI, higher APACHE II scores were associated with a higher risk of CA-AKI. The ICU and hospital mortality of patients with CA-AKI was significantly higher than in patients without CA-AKI. CA-AKI is associated with increases in hospital mortality, and can be predicted by the APACHE score. NCT01807195 on March. 06. 2013.

  19. Renovascular heart failure: heart failure in patients with atherosclerotic renal artery disease.

    Science.gov (United States)

    Kawarada, Osami; Yasuda, Satoshi; Noguchi, Teruo; Anzai, Toshihisa; Ogawa, Hisao

    2016-07-01

    Atherosclerotic renal artery disease presents with a broad spectrum of clinical features, including heart failure as well as hypertension, and renal failure. Although recent randomized controlled trials failed to demonstrate renal artery stenting can reduce blood pressure or the number of cardiovascular or renal events more so than medical therapy, increasing attention has been paid to flash pulmonary edema and congestive heart failure associated with atherosclerotic renal artery disease. This clinical entity "renovascular heart failure" is diagnosed retrospectively. Given the increasing global burden of heart failure, this review highlights the background and catheter-based therapeutic aspects for renovascular heart failure.

  20. Occupational therapy for delirium management in elderly patients without mechanical ventilation in an intensive care unit: A pilot randomized clinical trial.

    Science.gov (United States)

    Álvarez, Evelyn A; Garrido, Maricel A; Tobar, Eduardo A; Prieto, Stephanie A; Vergara, Sebastian O; Briceño, Constanza D; González, Francisco J

    2017-02-01

    Delirium has negative consequences such as increased mortality, hospital expenses and decreased cognitive and functional status. This research aims to determine the impact of occupational therapy intervention in duration, incidence and severity of delirium in elderly patients in the intensive care unit; secondary outcome was to assess functionality at hospital discharge. This is a pilot randomized clinical trial of patients without mechanical ventilation for 60 years. Patients were assigned to a control group that received standard strategies of prevention (n=70) or to an experimental group that received standard strategies plus occupational therapy twice a day for 5 days (n=70). Delirium was valued with Confusion Assessment Method and Delirium Rating Scale, and functional outcomes at discharge with Functional Independence Measure, Hand Dynamometer, and Mini-Mental State Examination. A total of 140 participants were recruited. The experimental group had lower duration (risk incidence ratios, 0.15 [P=.000; 95% confidence interval, 0.12-0.19] vs 6.6 [P=.000, 95% confidence interval, 5.23-8.3]) and incidence of delirium (3% vs 20%, P=.001), and had higher scores in Motor Functional Independence Measure (59 vs 40 points, Phand (26 vs 18 kg, POccupational therapy is effective in decreasing duration and incidence of delirium in nonventilated elderly patients in the intensive care unit and improved functionality at discharge. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Effect of Hydroxyapatite Nanoparticles on the Degradability of Random Poly(butylene terephthalate-co-aliphatic dicarboxylates Having a High Content of Terephthalic Units

    Directory of Open Access Journals (Sweden)

    Nina Heidarzadeh

    2016-07-01

    Full Text Available Copolyesters derived from 1,4-butanediol and constituted also of aliphatic and aromatic dicarboxylate units in a molar ratio of 3:7 were synthesized by a two-step polycondensation procedure. Succinic, adipic, and sebacic acids were specifically selected as the aliphatic component whereas terephthalic acid was chosen as the aromatic moiety. The second synthesis step was a thermal transesterification between the corresponding homopolymers, always attaining a random distribution as verified by NMR spectroscopy. Hybrid polymer composites containing 2.5 wt % of hydroxyapatite (HAp were also prepared by in situ polymerization. Hydroxyl groups on the nanoparticle surface allowed the grafting of polymer chains in such a way that composites were mostly insoluble in the typical solvents of the parent copolyesters. HAp had some influence on crystallization from the melt, thermal stability, and mechanical properties. HAp also improved the biocompatibility of samples due to the presence of Ca2+ cations and the damping effect of phosphate groups. Interestingly, HAp resulted in a significant increase in the hydrophilicity of samples, which considerably affected both enzymatic and hydrolytic degradability. Slight differences were also found in the function of the dicarboxylic component, as the lowest degradation rates was found for the sample constituted of the most hydrophobic sebacic acid units.

  2. Short-term efficacy of treating hepatitis B virus-related acute-on-chronic liver failure based on cold pattern differentiation with hot herbs: A randomized controlled trial.

    Science.gov (United States)

    Guo, Yu-Ming; Li, Feng-Yi; Gong, Man; Zhang, Lin; Wang, Jia-Bo; Xiao, Xiao-He; Li, Jun; Zhao, Yan-Ling; Wang, Li-Fu; Zhang, Xiao-Feng

    2016-08-01

    To evaluate the clinical efficacy and safety of Yinchen Zhufu Decoction (, YCZFD) in the treatment of acute-on-chronic liver failure caused by hepatitis B virus (HBV-ACLF) with cold pattern in Chinese medicine (CM). This is a multi-center randomized controlled trial of integrative treatment of CM and Western medicine (WM) for the management of HBV-ACLF patients. A total of 200 HBV-ACLF patients with cold pattern were equally randomly assigned to receive YCZFD and WM (integrative treatment) or WM conventional therapy alone respectively for 4 weeks. The primary end point was the mortality for HBV-ACLF patients. Secondary outcome measures included Model for End-Stage Liver disease (MELD) score, liver biochemical function, coagulation function and complications. Adverse events during treatment were reported. The mortality was decreased 14.28% in the integrative treatment group compared with WM group (χ(2) =6.156, P=0.013). The integrative treatment was found to signifificantly improve the MELD score (t=2.353, P=0.020). There were statistically signifificant differences in aspartate transaminase, total bilirubin, indirect bilirubin, direct bilirubin and prothrombin time between the two groups (P<0.05 or P<0.01). The complications of ascites (χ(2)=9.033, P=0.003) and spontaneous bacteria peritonitis (χ(2)=4.194, P=0.041) were improved signifificantly in the integrative treatment group. No serious adverse event was reported. The integrative treatment of CM and WM was effective and safe for HBV-ACLF patients with cold pattern in CM. The Chinese therapeutic principle "treating cold pattern with hot herbs" remains valuable to the clinical therapy. (Trial registration No. ChiCTR-TRC-10000766).

  3. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2).

    Science.gov (United States)

    Yki-Järvinen, Hannele; Bergenstal, Richard; Ziemen, Monika; Wardecki, Marek; Muehlen-Bartmer, Isabel; Boelle, Emmanuelle; Riddle, Matthew C

    2014-12-01

    To compare the efficacy and safety of new insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in people with type 2 diabetes using basal insulin (≥42 units/day) plus oral antihyperglycemic drugs (OADs). EDITION 2 was a multicenter, open-label, two-arm study. Adults receiving basal insulin plus OADs were randomized to Gla-300 or Gla-100 once daily for 6 months. The primary end point was change in HbA1c. The main secondary end point was percentage of participants with one or more nocturnal confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemic events from week 9 to month 6. Randomized participants (n = 811) had a mean (SD) HbA₁c of 8.24% (0.82) and BMI of 34.8 kg/m(2) (6.4). Glycemic control improved similarly with both basal insulins; least squares mean (SD) reduction from baseline was -0.57% (0.09) for Gla-300 and -0.56% (0.09) for Gla-100 (mean difference -0.01% [95% CI -0.14 to 0.12]), with 10% higher dose of Gla-300. Less nocturnal confirmed (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycemia was observed with Gla-300 from week 9 to month 6 (relative risk 0.77 [95% CI 0.61-0.99]; P = 0.038) and during the first 8 weeks. Fewer nocturnal and any time (24 h) hypoglycemic events were reported during the entire 6-month period. Weight gain was lower with Gla-300 than with Gla-100 (P = 0.015). No between-treatment differences in safety parameters were identified. Gla-300 was as effective as Gla-100 and associated with a lower risk of hypoglycemia during the night and at any time of the day. © 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  4. Effect of long-acting testosterone treatment on functional exercise capacity, skeletal muscle performance, insulin resistance, and baroreflex sensitivity in elderly patients with chronic heart failure a double-blind, placebo-controlled, randomized study

    National Research Council Canada - National Science Library

    Caminiti, Giuseppe; Volterrani, Maurizio; Iellamo, Ferdinando; Marazzi, Giuseppe; Massaro, Rosalba; Miceli, Marco; Mammi, Caterina; Piepoli, Massimo; Fini, Massimo; Rosano, Giuseppe M C

    2009-01-01

    ...) in elderly patients with chronic heart failure (CHF). CHF is characterized by a metabolic shift favoring catabolism and impairment in skeletal muscle bulk and function that could be involved in the pathophysiology of heart failure...

  5. Heart failure - tests

    Science.gov (United States)

    CHF - tests; Congestive heart failure - tests; Cardiomyopathy - tests; HF - tests ... the best test to: Identify which type of heart failure (systolic, diastolic, valvular) Monitor your heart failure and ...

  6. Acute kidney failure

    Science.gov (United States)

    ... kidney injury. Alternative Names Kidney failure; Renal failure; Renal failure - acute; ARF; Kidney injury - acute Images Kidney anatomy References Devarajan P. Biomarkers for assessment of renal ...

  7. Short-term vitamin D3 supplementation lowers plasma renin activity in patients with stable chronic heart failure: an open-label, blinded end point, randomized prospective trial (VitD-CHF trial).

    Science.gov (United States)

    Schroten, Nicolas F; Ruifrok, Willem P T; Kleijn, Lennaert; Dokter, Martin M; Silljé, Herman H; Lambers Heerspink, Hiddo J; Bakker, Stephan J L; Kema, Ido P; van Gilst, Wiek H; van Veldhuisen, Dirk J; Hillege, Hans L; de Boer, Rudolf A

    2013-08-01

    Many chronic heart failure (CHF) patients have low vitamin D (VitD) and high plasma renin activity (PRA), which are both associated with poor prognosis. Vitamin D may inhibit renin transcription and lower PRA. We investigated whether vitamin D3 (VitD3) supplementation lowers PRA in CHF patients. We conducted a single-center, open-label, blinded end point trial in 101 stable CHF patients with reduced left ventricular ejection fraction. Patients were randomized to 6 weeks of 2,000 IU oral VitD3 daily or control. At baseline, mean age was 64 ± 10 years, 93% male, left ventricular ejection fraction 35% ± 8%, and 56% had VitD deficiency. The geometric mean (95% CI) of 25-hydroxyvitamin D3 increased from 48 nmol/L (43-54) at baseline to 80 nmol/L (75-87) after 6 weeks in the VitD3 treatment group and decreased from 47 nmol/L (42-53) to 44 nmol/L (39-49) in the control group (P CHF patients had VitD deficiency and high PRA levels. Six weeks of supplementation with 2,000 IU VitD3 increased 25-hydroxyvitamin D3 levels and decreased PRA and plasma renin concentration. Copyright © 2013 Mosby, Inc. All rights reserved.

  8. Effects of reducing exposure to air pollution on submaximal cardiopulmonary test in patients with heart failure: Analysis of the randomized, double-blind and controlled FILTER-HF trial.

    Science.gov (United States)

    Vieira, Jefferson L; Guimaraes, Guilherme V; de Andre, Paulo A; Saldiva, Paulo H Nascimento; Bocchi, Edimar A

    2016-07-15

    Air pollution exposure could mitigate the health benefits of exercise in patients with heart failure (HF). We tested the effects of a respiratory filter on HF patients exposed to air pollution during exercise. Ancillary analysis of the FILTER-HF trial, focused on the exercise outcomes. In a randomized, double-blind, 3-way crossover design, 26 HF patients and 15 control volunteers were exposed to clean air, unfiltered dilute diesel engine exhaust (DE), or filtered DE for 6min during a submaximal cardiopulmonary testing in a controlled-exposure facility. Prospectively collected data included six-minute walking test [6mwt], VO2, VE/VCO2 Slope, O2Pulse, pulmonary ventilation [VE], tidal volume, VD/Vt, oxyhemoglobin saturation and CO2-rebreathing. Compared to clean air, DE adversely affected VO2 (11.0±3.9 vs. 8.4±2.8ml/kg/min; peffects of pollution on VO2 and O2Pulse. Given the worldwide prevalence of exposure to traffic-related air pollution, these findings are relevant for public health especially in this highly susceptible population. The filter intervention holds great promise that needs to be tested in future studies. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. The Borg scale as an important tool of self-monitoring and self-regulation of exercise prescription in heart failure patients during hydrotherapy. A randomized blinded controlled trial.

    Science.gov (United States)

    Carvalho, Vitor Oliveira; Bocchi, Edimar Alcides; Guimarães, Guilherme Veiga

    2009-10-01

    The Borg Scale may be a useful tool for heart failure patients to self-monitor and self-regulate exercise on land or in water (hydrotherapy) by maintaining the heart rate (HR) between the anaerobic threshold and respiratory compensation point. Patients performed a cardiopulmonary exercise test to determine their anaerobic threshold/respiratory compensation points. The percentage of the mean HR during the exercise session in relation to the anaerobic threshold HR (%EHR-AT), in relation to the respiratory compensation point (%EHR-RCP), in relation to the peak HR by the exercise test (%EHR-Peak) and in relation to the maximum predicted HR (%EHR-Predicted) was calculated. Next, patients were randomized into the land or water exercise group. One blinded investigator instructed the patients in each group to exercise at a level between "relatively easy and slightly tiring". The mean HR throughout the 30-min exercise session was recorded. The %EHR-AT and %EHR-predicted did not differ between the land and water exercise groups, but they differed in the %EHR-RCP (95 +/-7 to 86 +/-7, P<0.001) and in the %EHR-Peak (85 +/-8 to 78 +/-9, P=0.007). Exercise guided by the Borg scale maintains the patient's HR between the anaerobic threshold and respiratory compensation point (ie, in the exercise training zone).

  10. A double-blind, randomized, controlled, multicenter study to assess the safety and cardiovascular effects of skeletal myoblast implantation by catheter delivery in patients with chronic heart failure after myocardial infarction.

    Science.gov (United States)

    Povsic, Thomas J; O'Connor, Christopher M; Henry, Timothy; Taussig, Andrew; Kereiakes, Dean J; Fortuin, F David; Niederman, Alan; Schatz, Richard; Spencer, Richard; Owens, Douglas; Banks, Missy; Joseph, Diane; Roberts, Rhonda; Alexander, John H; Sherman, Warren

    2011-10-01

    We sought to determine the safety and preliminary efficacy of transcatheter intramyocardial administration of myoblasts in patients with heart failure (HF). MARVEL is a randomized placebo-controlled trial of image-guided, catheter-based intramyocardial injection of placebo or myoblasts (400 or 800 million) in patients with class II to IV HF and ejection fraction stopping the study for financial reasons. At 6 months, similar numbers of events occurred in each group: 8 (placebo), 7 (low dose), and 8 (high dose), without deaths. Ventricular tachycardia responsive to amiodarone was more frequent in myoblast-treated patients: 1 (placebo), 3 (low dose), and 4 (high dose). A trend toward improvement in functional capacity was noted in myoblast-treated groups (Δ6-minute walk test of -3.6 vs +95.6 vs +85.5 m [placebo vs low dose vs high dose; P = .50]) without significant changes in Minnesota Living With HF scores. In HF patients with chronic postinfarction cardiomyopathy, transcatheter administration of myoblasts in doses of 400 to 800 million cells is feasible and may lead to important clinical benefits. Ventricular tachycardia may be provoked by myoblast injection but appears to be a transient and treatable problem. A large-scale outcome trial of myoblast administration in HF patients with postinfarction cardiomyopathy is feasible and warranted. Copyright © 2011 Mosby, Inc. All rights reserved.

  11. The MMR vaccination and autism controversy in United Kingdom 1998-2005: inevitable community outrage or a failure of risk communication?

    Science.gov (United States)

    Burgess, David C; Burgess, Margaret A; Leask, Julie

    2006-05-01

    The report of an hypothesised link between measles-mumps-rubella (MMR) vaccination and autism in 1998 became a major public health issue in the United Kingdom (UK), leaving most experts surprised by the overwhelming influence it had on public opinion about MMR vaccination. Coverage rates fell dramatically, and did not start to recover until 2004. Could this public reaction have been predicted? We used Sandman's model of components predicting community outrage to assess the MMR controversy. The controversy fulfilled all of Sandman's 12 primary components and six of the eight additional components. The Sandman model provided a useful framework to analyse this controversy and explained a significant portion of the community reaction and subsequent fall in vaccination coverage rates.

  12. Preparation Ferrule Design Effect on Endocrown Failure Resistance.

    Science.gov (United States)

    Einhorn, Michael; DuVall, Nicholas; Wajdowicz, Michael; Brewster, John; Roberts, Howard

    2017-10-06

    To evaluate the effect of preparation ferrule inclusion with fracture resistance of mandibular molar endocrowns. Recently extracted mandibular third molars were randomly divided into 3 groups (n = 12) with the coronal tooth structure removed perpendicular to the root long axis approximately 2 mm above the cemento-enamel junction with a slow-speed diamond saw. The pulp chamber was exposed using a diamond bur in a high-speed handpiece with pulpal remnants removed and canals instrumented using endodontic hand instruments. The chamber floor was restored using a resin core material with a two-step, self-etch adhesive and photopolymerized with a visible light-curing unit to create a 2 mm endocrown preparation pulp chamber extension. One and two millimeter ferrule height groups were prepared using a diamond bur in a high-speed handpiece following CAD/CAM guidelines. Completed preparation surface area was determined using a digital measuring microscope. Scanned preparations were restored with lithium disilicate restorations with a self-adhesive resin luting agent. All manufacturer recommendations were followed. Specimens were stored at 37°C/98% humidity and tested to failure after 24 hours at a 45° angle to the tooth long axis using a universal testing machine. Failure load was converted to MPa using the available bonding surface area with mean data analyzed using Kruskal-Wallis/Dunn (p = 0.05). Calculated failure stress found no difference in failure resistance among the three groups; however, failure load results identified that the endocrown preparations without ferrule had significantly lower fracture load resistance. Failure mode analysis identified that all preparations demonstrated a high number of catastrophic failures. Under the conditions of this study, ferrule-containing endocrown preparations demonstrated significantly greater failure loads than standard endocrown restorations; however, calculated failure stress based on available surface area for adhesive

  13. Effects of alteplase for acute stroke according to criteria defining the European Union and United States marketing authorizations: Individual-patient-data meta-analysis of randomized trials.

    Science.gov (United States)

    Hacke, Werner; Lyden, Patrick; Emberson, Jonathan; Baigent, Colin; Blackwell, Lisa; Albers, Gregory; Bluhmki, Erich; Brott, Thomas; Cohen, Geoffrey; Davis, Stephen M; Donnan, Geoffrey A; Grotta, James C; Howard, George; Kaste, Markku; Koga, Masatoshi; von Kummer, Rüdiger; Lansberg, Maarten G; Lindley, Richard I; Olivot, Jean-Marc; Parsons, Mark; Sandercock, Peter Ag; Toni, Danilo; Toyoda, Kazunori; Wahlgren, Nils; Wardlaw, Joanna M; Whiteley, William N; Del Zoppo, Gregory; Lees, Kennedy R

    2018-02-01

    Background The recommended maximum age and time window for intravenous alteplase treatment of acute ischemic stroke differs between the Europe Union and United States. Aims We compared the effects of alteplase in cohorts defined by the current Europe Union or United States marketing approval labels, and by hypothetical revisions of the labels that would remove the Europe Union upper age limit or extend the United States treatment time window to 4.5 h. Methods We assessed outcomes in an individual-patient-data meta-analysis of eight randomized trials of intravenous alteplase (0.9 mg/kg) versus control for acute ischemic stroke. Outcomes included: excellent outcome (modified Rankin score 0-1) at 3-6 months, the distribution of modified Rankin score, symptomatic intracerebral hemorrhage, and 90-day mortality. Results Alteplase increased the odds of modified Rankin score 0-1 among 2449/6136 (40%) patients who met the current European Union label and 3491 (57%) patients who met the age-revised label (odds ratio 1.42, 95% CI 1.21-1.68 and 1.43, 1.23-1.65, respectively), but not in those outside the age-revised label (1.06, 0.90-1.26). By 90 days, there was no increased mortality in the current and age-revised cohorts (hazard ratios 0.98, 95% CI 0.76-1.25 and 1.01, 0.86-1.19, respectively) but mortality remained higher outside the age-revised label (1.19, 0.99-1.42). Similarly, alteplase increased the odds of modified Rankin score 0-1 among 1174/6136 (19%) patients who met the current US approval and 3326 (54%) who met a 4.5-h revised approval (odds ratio 1.55, 1.19-2.01 and 1.37, 1.17-1.59, respectively), but not for those outside the 4.5-h revised approval (1.14, 0.97-1.34). By 90 days, no increased mortality remained for the current and 4.5-h revised label cohorts (hazard ratios 0.99, 0.77-1.26 and 1.02, 0.87-1.20, respectively) but mortality remained higher outside the 4.5-h revised approval (1.17, 0.98-1.41). Conclusions An age-revised European Union label or 4

  14. Exploring longitudinal shifts in international nurse migration to the United States between 2003 and 2013 through a random effects panel data analysis.

    Science.gov (United States)

    Squires, Allison; Ojemeni, Melissa T; Jones, Simon

    2016-06-30

    No study has examined the longitudinal trends in National Council Licensure Exam for Registered Nurse (NCLEX-RN) applicants and pass rates among internationally-educated nurses (IENs) seeking to work in the United States, nor has any analysis explored the impact of specific events on these trends, including changes to the NCLEX-RN exam, the role of the economic crisis, or the passing of the WHO Code on the International Recruitment of Health Personnel. This study seeks to understand the impact of the three aforementioned factors that may be influencing current and future IEN recruitment patterns in the United States. In this random effects panel data analysis, we analyzed 11 years (2003-2013) of annual IEN applicant numbers and pass rates for registered nurse credentialing. Data were obtained from publicly available reports on exam pass rates. With the global economic crisis and NCLEX-RN changes in 2008 coupled with the WHO Code passage in 2010, we sought to compare if (1) the number of applicants changed significantly after those 2 years and (2) if pass rates changed following exam modifications implemented in 2008 and 2011. A total of 177 countries were eligible for inclusion in this analysis, representing findings from 200,453 IEN applicants to the United States between 2003 and 2013. The majority of applicants were from the Philippines (58 %) and India (11 %), with these two countries combined representing 69 % of the total. Candidates from Sub-Saharan African countries totalled 7133 (3 % of all applications) over the study period, with half of these coming from Nigeria alone. No significant changes were found in the number of candidates following the 2008 economic crisis or the 2010 WHO Code, although pass rates decreased significantly following the 2008 exam modifications and the WHO Code implementation. This study suggests that, while the WHO Code has had an influence on overall IEN migration dynamics to the United States by decreasing candidate

  15. Unit-specific calibration of Actigraph accelerometers in a mechanical setup - is it worth the effort? The effect on random output variation caused by technical inter-instrument variability in the laboratory and in the field

    DEFF Research Database (Denmark)

    Moeller, Niels C; Korsholm, Lars; Kristensen, Peter L

    2008-01-01

    BACKGROUND: Potentially, unit-specific in-vitro calibration of accelerometers could increase field data quality and study power. However, reduced inter-unit variability would only be important if random instrument variability contributes considerably to the total variation in field data. Therefore...... during free living conditions. RESULTS: Calibration reduced inter-instrument variability considerably in the mechanical setup, both in the MTI instruments (raw SDbetween units = 195 counts*min-1 vs. calibrated SDbetween units = 65 counts*min-1) and in the CSA instruments (raw SDbetween units = 343 counts......*min-1 vs. calibrated SDbetween units = 67 counts*min-1). However, the effect of applying the derived calibration to children's and adolescents' free living physical activity data did not alter the coefficient of variation (CV) (children: CVraw = 30.2% vs. CVcalibrated = 30.4%, adolescents: CVraw = 36...

  16. 27 CFR 25.177 - Evasion of or failure to pay tax; failure to file a tax return.

    Science.gov (United States)

    2010-04-01

    ... Pay Tax § 25.177 Evasion of or failure to pay tax; failure to file a tax return. Sections 5671, 5673, 5684, 6651, and 6656 of Title 26 United States Code provide penalties for evasion or failure to pay tax... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Evasion of or failure to...

  17. Heart failure - overview

    Science.gov (United States)

    ... heart failure; Right-sided heart failure - cor pulmonale; Cardiomyopathy - heart failure; HF ... Disease Section. Heart Failure as a newly approved diagnosis for cardiac rehabilitation: challenges and opportunities. J Am ...

  18. Efficacy of carvedilol in pediatric heart failure

    DEFF Research Database (Denmark)

    Christensen, Alex Hørby; Fatkin, Diane

    2013-01-01

    Evaluation of: Huang M, Zhang X, Chen S et al. The effect of carvedilol treatment on chronic heart failure in pediatric patients with dilated cardiomyopathy: a prospective, randomized-controlled study. Pediatr. Cardiol. 34, 680-685 (2013). A role for β-blockers in children with heart failure has...

  19. Implementation of a protocol for integrated management of pain, agitation, and delirium can improve clinical outcomes in the intensive care unit: a randomized clinical trial.

    Science.gov (United States)

    Mansouri, Parisa; Javadpour, Shohreh; Zand, Farid; Ghodsbin, Fariba; Sabetian, Golnar; Masjedi, Mansoor; Tabatabaee, Hamid Reza

    2013-12-01

    Inappropriate diagnosis and treatment of pain, agitation, and delirium (PAD) in intensive care settings results in poor patient outcomes. We designed and used a protocol for systematic assessment and management of PAD by the nurses to improve clinical intensive care unit (ICU) outcomes. A total of 201 patients admitted to 2 mixed medical-surgical ICUs were randomly allocated to protocol and control groups. A multidisciplinary team approved the protocol. Pain was assessed by Numerical Rating Scale and Behavioural Pain Scale, agitation by Richmond Agitation Sedation Scale, and delirium by Confusion Assessment Method in ICU. The Persian version of the scales was prepared and tested for validity, reliability, and feasibility in a preliminary study. The patients in the protocol group were managed pharmacologically according to the protocol, whereas those in the control group were managed according to the ICU routine. The median (interquartile range) for the duration of mechanical ventilation in the protocol and control groups was 19 (9.3-67.8) and 40 (0-217) hours, respectively (P = .038). The median (interquartile range) length of ICU stay was 97 (54.5-189) hours in the protocol group vs 170 (80-408) hours in the control group (P < .001). The mortality rate in the protocol group was significantly reduced from 23.8% to 12.5% (P = .046). The current randomized trial provided evidence for a substantial reduction in the duration of need to ventilatory support, length of ICU stay, and mortality rates in ICU-admitted patients through protocol-directed management of PAD. © 2013.

  20. The Effect of the Educational Program on Iranian Premature Infants’ Parental Stress in a Neonatal Intensive Care Unit: A Double-Blind Randomized Controlled Trial

    Science.gov (United States)

    Beheshtipour, Noushin; Baharlu, Seyedeh Marzieh; Montaseri, Sedigheh; Razavinezhad Ardakani, Seyed Mostajab

    2014-01-01

    Background: Hospitalization in neonatal intensive care unit (NICU) leads to a lot of stress and shock to the parents. Nurses, as the primary sources of information, could play an important role in reducing their stress. The aim of this study was to determine the effect of educational program on the premature infants’ parental stress in NICU. Methods: This double-blind randomized controlled trial study with a pre-and post-test and follow up design was conducted from February 2013 to March 2014. Sixty parents in Hazrat Zainab hospital affiliated to Shiraz University of Medical Sciences were randomly allocated into the intervention (received educational program) and control groups (received routine care). The valid and reliable ”Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)“ was used to measure the parental stress. In the intervention group, information about general condition of the baby, the equipment and unit’s environment, spouse support, and problem solving strategies were given. The data were collected the second day after admission, fifth day after admission, and a week after the intervention. The data were analyzed in SPSS (Version 14), using t-test and repeated measures analysis of variance. Results: In the second day after admission, the mean score of stress in premature infants’ mothers and fathers in the intervention group were 94.79±14.28 and 76.77±16.39, respectively. In the control group, it was 94.48±20.03 and 92.30±21.95 for mothers and fathers. After the intervention in the fifth day of admission, a significant difference was observed between the two groups concerning the premature infants’ maternal (t=-5. 23, P<0.0001) and paternal (t=-6.17, P<0.0001) stress. Moreover, a week after the intervention, the stress mean scores were (in the intervention group: for mothers=59.72±13.55 and for fathers=61.22±18.00), and (in the control group: for mothers=86.75±12.12 and fathers=84.70±18.46). Moreover, a significant

  1. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1).

    Science.gov (United States)

    Riddle, Matthew C; Bolli, Geremia B; Ziemen, Monika; Muehlen-Bartmer, Isabel; Bizet, Florence; Home, Philip D

    2014-10-01

    To compare the efficacy and safety of new insulin glargine 300 units/mL (Gla-300) with glargine 100 units/mL (Gla-100) in people with type 2 diabetes on basal insulin (≥42 units/day) plus mealtime insulin. EDITION 1 (NCT01499082) was a 6-month, multinational, open-label, parallel-group study. Adults with glycated hemoglobin A1c (HbA1c) 7.0-10.0% (53-86 mmol/mol) were randomized to Gla-300 or Gla-100 once daily with dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L. Primary end point was HbA1c change from baseline; main secondary end point was percentage of participants with one or more confirmed (≤3.9 mmol/L) or severe nocturnal hypoglycemia from week 9 to month 6. Participants (n = 807) had mean age 60 years, diabetes duration 16 years, BMI 36.6 kg/m(2), and HbA1c 8.15% (65.6 mmol/mol). HbA1c reduction was equivalent between regimens; least squares mean difference -0.00% (95% CI -0.11 to 0.11) (-0.00 mmol/mol [-1.2 to 1.2]). Fewer participants reported one or more confirmed (≤3.9 mmol/L) or severe nocturnal hypoglycemic events between week 9 and month 6 with Gla-300 (36 vs. 46% with Gla-100; relative risk 0.79 [95% CI 0.67-0.93]; P 300 in the first 8 weeks of treatment. No between-treatment differences in tolerability or safety were identified. Gla-300 controls HbA1c as well as Gla-100 for people with type 2 diabetes treated with basal and mealtime insulin but with consistently less risk of nocturnal hypoglycemia. © 2014 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  2. Random triangles

    OpenAIRE

    Matula, Dominik

    2013-01-01

    The author summarizes some previous results concerning random triangles. He describes the Gaussian triangle and random triangles whose vertices lie in a unit n-dimensional ball, in a rectangle or in a general bounded convex set. In the second part, the author deals with an inscribed triangle in a triangle - let ABC be an equilateral triangle and let M, N, O be three points, each laying on one side of the ABC. We call MNO inscribed triangle (in an equi- laterral triangle). The median triangle ...

  3. The cues and care randomized controlled trial of a neonatal intensive care unit intervention: effects on maternal psychological distress and mother-infant interaction.

    Science.gov (United States)

    Zelkowitz, Phyllis; Feeley, Nancy; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos

    2011-10-01

    This study tested the efficacy of a brief intervention (Cues program) with mothers of very low birth weight (VLBW Care) condition. The Cues program combined training to reduce anxiety and enhance sensitivity. The control group received general information about infant care. Both programs were initiated during the neonatal intensive care unit stay. Maternal anxiety, stress, depression, and demographic variables were evaluated at baseline, prior to randomization. Postintervention outcomes were assessed during a home visit when the infant was ∼6 to 8 weeks of corrected age. Although mothers in the Cues group demonstrated greater knowledge of the content of the experimental intervention than mothers in the Care group, the groups did not differ in levels of anxiety, depression, and symptoms of posttraumatic stress. They were similar in their reports of parental role restrictions and stress related to the infant's appearance and behavior. Cues and Care group mothers were equally sensitive in interaction with their infants. Nonspecific attention was as effective as an early skill-based intervention in reducing maternal anxiety and enhancing sensitive behavior in mothers of VLBW infants.

  4. Peer Support and the HIV Continuum of Care: Results from a Multi-Site Randomized Clinical Trial in Three Urban Clinics in the United States.

    Science.gov (United States)

    Cabral, Howard J; Davis-Plourde, Kendra; Sarango, Mariana; Fox, Jane; Palmisano, Joseph; Rajabiun, Serena

    2018-01-06

    Racial/ethnic minorities living with HIV and behavioral health co-morbidities are more likely to be disengaged from HIV primary care. Peer programs have been effective in HIV outreach and prevention but effectiveness of such programs for retention in care and viral suppression is understudied. Subjects (n = 348) were randomized in equal allocation to a peer navigation and education intervention versus standard clinical care at three urban clinics in the United States. The intervention group received seven structured interventions plus weekly contact to address medical and social needs. Primary outcomes included time-to-first 4-month gap in HIV care and viral suppression up to 12 months of follow-up. Intention-to-treat analysis showed no difference between groups on 4-month gap in HIV primary care, but subgroup analysis showed a suggestive effect of the peer intervention in reducing gaps in care among stably housed subjects. Fully compliant subjects in the peer intervention experienced significantly fewer 4-month gaps in HIV primary care (p load suppression. Attending and completing structured educational sessions along with early, intensive contact with peers could improve retention in HIV primary care for patients. Future peer programs should consider training on housing referral systems to help increase retention for patients who are not stably housed. clinicaltrials.gov registration number: NCT01616940.

  5. Predicting the effect of maternal docosahexaenoic acid (DHA) supplementation to reduce early preterm birth in Australia and the United States using results of within country randomized controlled trials.

    Science.gov (United States)

    Yelland, L N; Gajewski, B J; Colombo, J; Gibson, R A; Makrides, M; Carlson, S E

    2016-09-01

    The DHA to Optimize Mother Infant Outcome (DOMInO) and Kansas DHA Outcomes Study (KUDOS) were randomized controlled trials that supplemented mothers with 800 and 600mg DHA/day, respectively, or a placebo during pregnancy. DOMInO was conducted in Australia and KUDOS in the United States. Both trials found an unanticipated and statistically significant reduction in early preterm birth (ePTB; i.e., birth before 34 weeks gestation). However, in each trial, the number of ePTBs were small. We used a novel Bayesian approach to estimate statistically derived low, moderate or high risk for ePTB, and to test for differences between the DHA and placebo groups. In both trials, the model predicted DHA would significantly reduce the expected proportion of deliveries in the high risk group under the trial conditions of the parent studies. Among the next 300,000 births in Australia we estimated that 1112 ePTB (95% credible interval 51-2189) could be avoided by providing DHA. And in the USA we estimated that 106,030 ePTB (95% credible interval 6400 to 175,700) could be avoided with DHA. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. The Impact of Tai Chi Exercise on Self-Efficacy, Social Support, and Empowerment in Heart Failure: Insights from a Qualitative Sub-Study from a Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Gloria Y Yeh

    Full Text Available To qualitatively explore perceived physical and psychosocial effects and overall patient experience associated with a 12-week tai chi (TC intervention and an education group in a clinical trial of patients with chronic heart failure (HF.We randomized 100 patients with chronic systolic HF (NYHA Class 1-3, ejection fraction≤40% to a 12-week group TC program or an education control. At 12-weeks, semi-structured interviews were conducted on a random subset (n = 32; n = 17 in TC, n = 15 in control, audiorecorded and transcribed verbatim. Two independent reviewers extracted information using grounded-theory methods for emergent themes. We explored similarities and differences in themes/sub-themes between the groups, and examined qualitative association with changes from baseline to post-intervention in previously reported quantitative measures (e.g., Minnesota Living with HF, Cardiac Exercise Self Efficacy and Profile of Mood States.The mean age (±SD of participants was 68±9 years, baseline ejection fraction 29±7%, and median New York Heart Association class 2 HF. We idenitifed themes related to the patient's experience of illness, perceptions of self, and relationship to others. Specific psychosocial and physical benefits were described. Common themes emerged from both groups including: social support and self-efficacy related to activity/exercise and diet. The tai chi group, however, also exhibited a more global empowerment and perceived control. Additional themes in TC included mindfulness/self-awareness, decreased stress reactivity, and renewed social role. These themes mirrored improvements in previously reported quantitative measures (quality-of-life, self-efficacy, and mood in TC compared to control. Patients in TC also reported physical benefits (e.g., decreased pain, improved energy, endurance, flexibility.Positive themes emerged from both groups, although there were qualitative differences in concepts of self-efficacy and perceived

  7. The Impact of Tai Chi Exercise on Self-Efficacy, Social Support, and Empowerment in Heart Failure: Insights from a Qualitative Sub-Study from a Randomized Controlled Trial.

    Science.gov (United States)

    Yeh, Gloria Y; Chan, Caroline W; Wayne, Peter M; Conboy, Lisa

    2016-01-01

    To qualitatively explore perceived physical and psychosocial effects and overall patient experience associated with a 12-week tai chi (TC) intervention and an education group in a clinical trial of patients with chronic heart failure (HF). We randomized 100 patients with chronic systolic HF (NYHA Class 1-3, ejection fraction≤40%) to a 12-week group TC program or an education control. At 12-weeks, semi-structured interviews were conducted on a random subset (n = 32; n = 17 in TC, n = 15 in control), audiorecorded and transcribed verbatim. Two independent reviewers extracted information using grounded-theory methods for emergent themes. We explored similarities and differences in themes/sub-themes between the groups, and examined qualitative association with changes from baseline to post-intervention in previously reported quantitative measures (e.g., Minnesota Living with HF, Cardiac Exercise Self Efficacy and Profile of Mood States). The mean age (±SD) of participants was 68±9 years, baseline ejection fraction 29±7%, and median New York Heart Association class 2 HF. We idenitifed themes related to the patient's experience of illness, perceptions of self, and relationship to others. Specific psychosocial and physical benefits were described. Common themes emerged from both groups including: social support and self-efficacy related to activity/exercise and diet. The tai chi group, however, also exhibited a more global empowerment and perceived control. Additional themes in TC included mindfulness/self-awareness, decreased stress reactivity, and renewed social role. These themes mirrored improvements in previously reported quantitative measures (quality-of-life, self-efficacy, and mood) in TC compared to control. Patients in TC also reported physical benefits (e.g., decreased pain, improved energy, endurance, flexibility). Positive themes emerged from both groups, although there were qualitative differences in concepts of self-efficacy and perceived control

  8. Failure probability under parameter uncertainty.

    Science.gov (United States)

    Gerrard, R; Tsanakas, A

    2011-05-01

    In many problems of risk analysis, failure is equivalent to the event of a random risk factor exceeding a given threshold. Failure probabilities can be controlled if a decisionmaker is able to set the threshold at an appropriate level. This abstract situation applies, for example, to environmental risks with infrastructure controls; to supply chain risks with inventory controls; and to insurance solvency risks with capital controls. However, uncertainty around the distribution of the risk factor implies that parameter error will be present and the measures taken to control failure probabilities may not be effective. We show that parameter uncertainty increases the probability (understood as expected frequency) of failures. For a large class of loss distributions, arising from increasing transformations of location-scale families (including the log-normal, Weibull, and Pareto distributions), the article shows that failure probabilities can be exactly calculated, as they are independent of the true (but unknown) parameters. Hence it is possible to obtain an explicit measure of the effect of parameter uncertainty on failure probability. Failure probability can be controlled in two different ways: (1) by reducing the nominal required failure probability, depending on the size of the available data set, and (2) by modifying of the distribution itself that is used to calculate the risk control. Approach (1) corresponds to a frequentist/regulatory view of probability, while approach (2) is consistent with a Bayesian/personalistic view. We furthermore show that the two approaches are consistent in achieving the required failure probability. Finally, we briefly discuss the effects of data pooling and its systemic risk implications. © 2010 Society for Risk Analysis.

  9. The Effectiveness of a Nurse-Led Cognitive-Behavioral Therapy on the Quality of Life, Self-Esteem and Mood Among Filipino Patients Living With Heart Failure: a Randomized Controlled Trial.

    Science.gov (United States)

    Cajanding, Ruff Joseph Macale

    2016-08-01

    The diagnosis and complications associated with heart failure (HF) have been very well established to adversely impact an individual's physical and psychosocial well-being, and interventions such as cognitive-behavioral techniques have demonstrated potential positive benefits among patients with HF. However, the effects of such interventions among Filipino HF patients have not been studied. This study aimed to determine the effectiveness of a nurse-led cognitive-behavioral intervention program on the quality of life, self-esteem and mood among Filipino patients with HF. A randomized control two-group design with repeated measures and collected data before and after the intervention was used in this study. Participants were assigned to either the control (n=48) or the intervention group (n=52). Control group participants received traditional care. Intervention participants underwent a 12-week nurse-led cognitive-behavioral intervention program focusing on patient education, self-monitoring, skills training, cognitive restructuring and spiritual development. Measures of quality of life, self-esteem and mood were obtained at baseline and after the intervention. At baseline, participants in both groups have poor quality of life, low self-esteem, and moderate depressive symptom scores. After the 12-week intervention period, participants in the intervention group had significant improvement in their quality of life, self-esteem and mood scores compared with those who received only standard care. Nurse-led cognitive-behavioral intervention is an effective strategy in improving the quality of life, self-esteem and mood among Filipino patients living with HF. It is recommended that this intervention be incorporated in the optimal care of patients with this cardiac condition. Copyright © 2015 Elsevier Inc. All rights reserved.

  10. Randomized, open-label, blinded-endpoint, crossover, single-dose study to compare the pharmacodynamics of torasemide-PR 10 mg, torasemide-IR 10 mg, and furosemide-IR 40 mg, in patients with chronic heart failure.

    Science.gov (United States)

    Ballester, Maria Rosa; Roig, Eulàlia; Gich, Ignasi; Puntes, Montse; Delgadillo, Joaquín; Santos, Benjamín; Antonijoan, Rosa Maria

    2015-01-01

    Diuretics are the primary treatment for the management of chronic heart failure (HF) symptoms and for the improvement of acute HF symptoms. The rate of delivery to the site of action has been suggested to affect diuretic pharmacodynamics. The main objective of this clinical trial was to explore whether a prolonged release tablet formulation of torasemide (torasemide-PR) was more natriuretically efficient in patients with chronic HF compared to immediate-release furosemide (furosemide-IR) after a single-dose administration. Moreover, the pharmacokinetics of torasemide-PR, furosemide-IR, and torasemide-IR were assessed in chronic HF patients as well as urine pharmacodynamics. Randomized, open-label, blinded-endpoint, crossover, and single-dose Phase I clinical trial with three experimental periods. Torasemide-PR and furosemide-IR were administered as a single dose in a crossover fashion for the first two periods, and torasemide-IR 10 mg was administered for the third period. Blood and urine samples were collected at fixed timepoints. The primary endpoint was the natriuretic efficiency after administration of torasemide-PR and furosemide-IR, defined as the ratio between the average drug-induced natriuresis and the average drug recovered in urine over 24 hours. Ten patients were included and nine completed the study. Here, we present the results from nine patients. Torasemide-PR was more natriuretically efficient than furosemide-IR (0.096 ± 0.03 mmol/μg vs 0.015 ± 0.0007 mmol/μg; P furosemide-IR. In a study with a limited sample size, our results suggest that 10 mg of torasemide-PR is more natriuretically efficient than 40 mg of furosemide-IR after single-dose administration in patients with chronic HF over a 24-hour collection period. Further studies are necessary to evaluate potential pharmacodynamic differences between torasemide formulations and to assess its impact on clinical therapeutics.

  11. Endometrial scratching in women with implantation failure after a first IVF/ICSI cycle; does it lead to a higher live birth rate? The SCRaTCH study: a randomized controlled trial (NTR 5342).

    Science.gov (United States)

    van Hoogenhuijze, N E; Torrance, H L; Mol, F; Laven, J S E; Scheenjes, E; Traas, M A F; Janssen, C; Cohlen, B; Teklenburg, G; de Bruin, J P; van Oppenraaij, R; Maas, J W M; Moll, E; Fleischer, K; van Hooff, M H; de Koning, C; Cantineau, A; Lambalk, C B; Verberg, M; Nijs, M; Manger, A P; van Rumste, M; van der Voet, L F; Preys-Bosman, A; Visser, J; Brinkhuis, E; den Hartog, J E; Sluijmer, A; Jansen, F W; Hermes, W; Bandell, M L; Pelinck, M J; van Disseldorp, J; van Wely, M; Smeenk, J; Pieterse, Q D; Boxmeer, J C; Groenewoud, E R; Eijkemans, M J C; Kasius, J C; Broekmans, F J M

    2017-07-21

    Success rates of assisted reproductive techniques (ART) are approximately 30%, with the most important limiting factor being embryo implantation. Mechanical endometrial injury, also called 'scratching', has been proposed to positively affect the chance of implantation after embryo transfer, but the currently available evidence is not yet conclusive. The primary aim of this study is to determine the effect of endometrial scratching prior to a second fresh in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) cycle on live birth rates in women with a failed first IVF/ICSI cycle. Multicenter randomized controlled trial in Dutch academic and non-academic hospitals. A total of 900 women will be included of whom half will undergo an endometrial scratch in the luteal phase of the cycle prior to controlled ovarian hyperstimulation using an endometrial biopsy catheter. The primary endpoint is the live birth rate after the 2 nd fresh IVF/ICSI cycle. Secondary endpoints are costs, cumulative live birth rate (after the full 2 nd IVF/ICSI cycle and over 12 months of follow-up); clinical and ongoing pregnancy rate; multiple pregnancy rate; miscarriage rate and endometrial tissue parameters associated with implantation failure. Multiple studies have been performed to investigate the effect of endometrial scratching on live birth rates in women undergoing IVF/ICSI cycles. Due to heterogeneity in both the method and population being scratched, it remains unclear which group of women will benefit from the procedure. The SCRaTCH trial proposed here aims to investigate the effect of endometrial scratching prior to controlled ovarian hyperstimulation in a large group of women undergoing a second IVF/ICSI cycle. NTR 5342 , registered July 31 st , 2015. Version 4.10, January 4th, 2017.

  12. Failure in imperfect anisotropic materials

    DEFF Research Database (Denmark)

    Legarth, Brian Nyvang

    2005-01-01

    The fundamental cause of crack growth, namely nucleation and growth of voids, is investigated numerically for a two phase imperfect anisotropic material. A unit cell approach is adopted from which the overall stress strain is evaluated. Failure is observed as a sudden stress drop and depending on...

  13. A risk score to predict acute renal failure in adult patients after lung transplantation.

    Science.gov (United States)

    Grimm, Joshua C; Lui, Cecillia; Kilic, Arman; Valero, Vicente; Sciortino, Christopher M; Whitman, Glenn J R; Shah, Ashish S

    2015-01-01

    Despite the significant morbidity associated with renal failure after lung transplantation (LTx), no predictive models currently exist. Accordingly, the purpose of this study was to develop a preoperative risk score based on recipient-, donor-, and transplant-specific characteristics to predict postoperative acute renal failure in candidates for transplantation. The United Network of Organ Sharing (UNOS) database was queried for adult patients (≥ 18 years of age) undergoing LTx between 2005 and 2012. The population was randomly divided into derivation (80%) and validation (20%) cohorts. The primary outcome of interest was new-onset renal failure. Variables predictive of acute renal failure (exploratory p value renal failure to construct the risk stratification score (RSS). During the study period, 10,963 patients underwent lung transplantation, and the incidence of renal failure was 5.5% (598 patients). Baseline recipient-, donor-, and transplant-related factors were similar between the cohorts. Eighteen covariates were included in the multivariable model, and 10 were assigned values based on their relative odds ratios (ORs). Scores were stratified into 3 groups, with an observed rate of acute renal failure of 3.1%, 5.3%, and 15.6% in the low-, moderate-, and high-risk groups, respectively. The incidence of renal failure was found to be significantly increased in the highest risk group (p renal failure highly correlated with actual rates observed in the population (r = 0.86). We introduce a novel and simple RSS that is highly predictive of renal failure after LTx. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  14. Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial).

    Science.gov (United States)

    Anstey, Matthew H; Wibrow, Bradley; Thevathasan, Tharusan; Roberts, Brigit; Chhangani, Khushi; Ng, Pauline Yeung; Levine, Alexander; DiBiasio, Alan; Sarge, Todd; Eikermann, Matthias

    2017-03-21

    Patients admitted to intensive care units (ICU) are often treated with intravenous (IV) vasopressors. Persistent hypotension and dependence on IV vasopressors in otherwise resuscitated patients lead to delay in discharge from ICU. Midodrine is an oral alpha-1 adrenergic agonist approved for treatment of symptomatic orthostatic hypotension. This trial aims to evaluate whether oral administration of midodrine is an effective adjunct to standard therapy to reduce the duration of IV vasopressor treatment, and allow earlier discharge from ICU and hospital. The MIDAS trial is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial being conducted in the USA and Australia. We are targeting 120 patients. Adult patients admitted to the ICU who are resuscitated and otherwise stable on low dose IV vasopressors for at least 24 h will be considered for recruitment. Participants will be randomized to receive midodrine (20 mg) or placebo three times a day, in addition to standard care. The primary outcome is time (hours) from initiation of midodrine or placebo to discontinuation of IV vasopressors. Secondary outcomes include time (hours) from ICU admission to discharge readiness, ICU length of stay (LOS) (days), hospital LOS (days), rates of ICU readmission, and rates of adverse events related to midodrine administration. Midodrine is approved by the Food and Drug Administration (FDA) for the treatment of symptomatic orthostatic hypotension. In August 2010, FDA proposed to withdraw approval of midodrine because of lack of studies that verify the clinical benefit of the drug. We obtained Investigational New Drug (IND 113,330) approval to study its effects in critically ill patients who require IV vasopressors but are otherwise ready for discharge from the ICU. A pilot observational study in a cohort of surgical ICU patients showed that the rate of decline in vasopressor requirements increased after initiation of midodrine treatment. We

  15. Cost-effectiveness of home versus clinic-based management of chronic heart failure: Extended follow-up of a pragmatic, multicentre randomized trial cohort - The WHICH? study (Which Heart Failure Intervention Is Most Cost-Effective & Consumer Friendly in Reducing Hospital Care).

    Science.gov (United States)

    Maru, Shoko; Byrnes, Joshua; Carrington, Melinda J; Chan, Yih-Kai; Thompson, David R; Stewart, Simon; Scuffham, Paul A

    2015-12-15

    To assess the long-term cost-effectiveness of two multidisciplinary management programs for elderly patients hospitalized with chronic heart failure (CHF) and how it is influenced by patient characteristics. A trial-based analysis was conducted alongside a randomized controlled trial of 280 elderly patients with CHF discharged to home from three Australian tertiary hospitals. Two interventions were compared: home-based intervention (HBI) that involved home visiting with community-based care versus specialized clinic-based intervention (CBI). Bootstrapped incremental cost-utility ratios were computed based on quality-adjusted life-years (QALYs) and total healthcare costs. Cost-effectiveness acceptability curves were constructed based on incremental net monetary benefit (NMB). We performed multiple linear regression to explore which patient characteristics may impact patient-level NMB. During median follow-up of 3.2 years, HBI was associated with slightly higher QALYs (+0.26 years per person; p=0.078) and lower total healthcare costs (AU$ -13,100 per person; p=0.025) mainly driven by significantly reduced duration of all-cause hospital stay (-10 days; p=0.006). At a willingness-to-pay threshold of AU$ 50,000 per additional QALY, the probability of HBI being better-valued was 96% and the incremental NMB of HBI was AU$ 24,342 (discounted, 5%). The variables associated with increased NMB were HBI (vs. CBI), lower Charlson Comorbidity Index, no hyponatremia, fewer months of HF, fewer prior HF admissions cost-effective in elderly CHF patients with significant comorbidity. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  16. Web-Based STAR E-Learning Course Increases Empathy and Understanding in Dementia Caregivers: Results from a Randomized Controlled Trial in the Netherlands and the United Kingdom.

    Science.gov (United States)

    Hattink, Bart; Meiland, Franka; van der Roest, Henriëtte; Kevern, Peter; Abiuso, Francesca; Bengtsson, Johan; Giuliano, Angele; Duca, Annalise; Sanders, Jennifer; Basnett, Fern; Nugent, Chris; Kingston, Paul; Dröes, Rose-Marie

    2015-10-30

    The doubling of the number of people with dementia in the coming decades coupled with the rapid decline in the working population in our graying society is expected to result in a large decrease in the number of professionals available to provide care to people with dementia. As a result, care will be supplied increasingly by untrained informal caregivers and volunteers. To promote effective care and avoid overburdening of untrained and trained caregivers, they must become properly skilled. To this end, the European Skills Training and Reskilling (STAR) project, which comprised experts from the domains of education, technology, and dementia care from 6 countries (the Netherlands, Sweden, Italy, Malta, Romania, and the United Kingdom), worked together to create and evaluate a multilingual e-learning tool. The STAR training portal provides dementia care training both for informal and formal caregivers. The objective of the current study was to evaluate the user friendliness, usefulness, and impact of STAR with informal caregivers, volunteers, and professional caregivers. For 2 to 4 months, the experimental group had access to the STAR training portal, a Web-based portal consisting of 8 modules, 2 of which had a basic level and 6 additional modules at intermediate and advanced levels. The experimental group also had access to online peer and expert communities for support and information exchange. The control group received free access to STAR after the research had ended. The STAR training portal was evaluated in a randomized controlled trial among informal caregivers and volunteers in addition to professional caregivers (N=142) in the Netherlands and the United Kingdom. Assessments were performed with self-assessed, online, standardized questionnaires at baseline and after 2 to 4 months. Primary outcome measures were user friendliness, usefulness, and impact of STAR on knowledge, attitudes, and approaches of caregivers regarding dementia. Secondary outcome measures

  17. A randomized controlled clinical trial of 3-unit posterior zirconia-ceramic fixed dental prostheses (FDP) with layered or pressed veneering ceramics: 3-year results.

    Science.gov (United States)

    Naenni, Nadja; Bindl, Andreas; Sax, Caroline; Hämmerle, Christoph; Sailer, Irena

    2015-11-01

    The aim of the present pilot study was to test whether or not posterior zirconia-ceramic fixed dental prostheses (FDPs) with pressed veneering ceramic exhibit less chipping than FDPs with layered veneering ceramics. Forty patients (13 female, 27 male; mean age 54 years (range 26.1-80.7 years) in need of one maxillary or mandibular three-unit FDP in the second premolar or molar region were recruited and treated at two separate centers at the University of Zurich according to the same study protocol. The frameworks were made out of zirconia using a CAD/CAM system (Cerec Sirona, Bensheim, Germany). The patients were randomly assigned to either the test group (zirconia frameworks veneered with pressed ceramic; IPS e.max ZirPress, Ivoclar Vivadent AG, Schaan, Liechtenstein; n=20) or the control group (layered veneering ceramic; IPS e.max Ceram, Ivoclar Vivadent AG, Schaan, Liechtenstein; n=20). All FDPs were adhesively cemented and evaluated at baseline (i.e., cementation), at 6 months and at 1 and 3 years of clinical service. The survival of the reconstruction was recorded. The technical outcome was assessed using modified United States Public Health Services (USPHS) criteria. The biologic parameters analyzed at abutment teeth and analogous non-restored teeth included probing pocket depth (PPD), plaque control record (PCR), bleeding on probing (BOP), and tooth vitality (CO2). Data was descriptively analyzed and survival was calculated using Kaplan-Meier statistics. 36 patients (25 female, 11 male; mean age 52.3 years) with 18 test and 18 control FDPs were examined after a mean follow-up of 36 months (95% CI: 32.6-39.1 months). Comparison of groups was done by Crosstabulation showing even distribution of the respective restored teeth amidst the groups. Survival rate was 100% for both test and control FDPs. Chipping of the veneering ceramic tended to occur more frequently in test (n=8; 40%) than in control (n=4; 20%) FDPs, albeit not significantly (p=0.3). No further

  18. Does an additional structured information program during the intensive care unit stay reduce anxiety in ICU patients?: a multicenter randomized controlled trial.

    Science.gov (United States)

    Fleischer, Steffen; Berg, Almuth; Behrens, Johann; Kuss, Oliver; Becker, Ralf; Horbach, Annegret; Neubert, Thomas R

    2014-01-01

    Communication and information in order to reduce anxiety in the intensive care unit (ICU) has been described as area needing improvement. Therefore, the aim of this trial was to evaluate whether a structured information program that intensifies information given in standard care process reduces anxiety in ICU patients. Multicenter, two-armed, non-blinded, parallel-group randomized controlled trial in hospitals in the cities of Marburg, Halle, and Stuttgart (Germany). The trial was performed in cardiac surgery, general surgery, and internal medicine ICUs. Two-hundred and eleven elective and non-elective ICU patients were enrolled in the study (intervention group, n = 104; control group, n = 107). The experimental intervention comprised a single episode of structured oral information that was given in addition to standard care and covered two main parts: (1) A more standardized part about predefined ICU specific aspects - mainly procedural, sensory and coping information, and (2) an individualized part about fears and questions of the patient. The control group received a non-specific episodic conversation of similar length additional to standard care. Both conversations took place at the beginning of the ICU stay and lasted 10-15 minutes. Study nurses administered both interventions. The primary outcome ICU-related anxiety (CINT-Score, 0-100 pts., higher scores indicate higher anxiety) was assessed after admission to a regular ward. The primary outcome could be measured in 82 intervention group participants and 90 control group participants resulting in mean values of 20.4 (SD 14.4) compared to 20.8 (SD 14.7) and a mean difference of -0.2 (CI 95% -4.5 to 4.1). A structured information intervention additional to standard care during ICU stay had no demonstrated additional benefit compared to an unspecific communication of similar duration. Reduction of anxiety in ICU patients will probably require more continuous approaches to information giving and

  19. Comparing effects between music intervention and aromatherapy on anxiety of patients undergoing mechanical ventilation in the intensive care unit: a randomized controlled trial.

    Science.gov (United States)

    Lee, Chiu-Hsiang; Lai, Chiung-Ling; Sung, Yi-Hui; Lai, Mei Yu; Lin, Chung-Ying; Lin, Long-Yau

    2017-07-01

    Using patient-reported outcomes and physiological indicators to test the effects of music intervention and aromatherapy on reducing anxiety for intensive care unit (ICU) patients undergoing mechanical ventilation. Patients with ICU admission duration >24 h were randomly assigned to a Music intervention group (n = 41), Aromatherapy group (n = 47), or Control group (rest only; n = 44). Each patient in the Music group listened to music; each patient in the Aromatherapy group received lavender essential oil massage on his/her back for 5 min; each patient in the Control group wore noise-canceling headphones. Anxiety was measured using the Chinese version of the Stage-Trait Anxiety Inventory (C-STAI) and the Visual Analogue Scale for Anxiety (VAS-A) at baseline, post-test, and 30-min follow-up. Heart rate, breathing rate, and blood pressure were measured every 10 min from baseline to the 30-min follow-up. The Music group had significantly better post-test VAS-A and C-STAI scores, and had lower heart rate and blood pressure than the Control group. The Aromatherapy group had significantly better VAS-A score and lower heart rate than the Control group. The 30-min follow-up showed that both Music and Aromatherapy groups had lower heart rate and blood pressure than the Control group. Music and aromatherapy interventions were both effective for ICU patients. The effects of music intervention were greater than that of aromatherapy; both interventions maintained the effects for at least 30 min.

  20. A systematic review of barriers and facilitators to participation in randomized controlled trials by Indigenous people from New Zealand, Australia, Canada and the United States.

    Science.gov (United States)

    Glover, Marewa; Kira, Anette; Johnston, Vanessa; Walker, Natalie; Thomas, David; Chang, Anne B; Bullen, Chris; Segan, C J; Brown, Ngiare

    2015-03-01

    Many randomized controlled trials (RCTs) are conducted each year but only a small proportion is specifically designed for Indigenous people. In this review we consider the challenges of participation in RCTs for Indigenous peoples from New Zealand, Australia, Canada and the United States and the opportunities for increasing participation. The literature was systematically searched for published articles including information on the barriers and facilitators for Indigenous people's participation in health-related RCTs. Articles were identified using a key word search of electronic databases (Scopus, Medline and EMBASE). To be included, papers had to include in their published work at least one aspect of their RCT that was either a barrier and/or facilitator for participation identified from, for example, design of intervention, or discussion sections of articles. Articles that were reviews, discussions, opinion pieces or rationale/methodology were excluded. Results were analysed inductively, allowing themes to emerge from the data. Facilitators enabling Indigenous people's participation in RCTs included relationship and partnership building, employing Indigenous staff, drawing on Indigenous knowledge models, targeted recruitment techniques and adapting study material. Challenges for participation included both participant-level factors (such as a distrust of research) and RCT-level factors (including inadequately addressing likely participant barriers (phone availability, travel costs), and a lack of recognition or incorporation of Indigenous knowledge systems. The findings from our review add to the body of knowledge on elimination of health disparities, by identifying effective and practical strategies for conducting and engaging Indigenous peoples with RCTs. Future trials that seek to benefit Indigenous peoples should actively involve Indigenous research partners, and respect and draw on pertinent Indigenous knowledge and values. This review has the potential to