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End Stage Renal Disease clinical trials

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NCT ID: NCT00442429 Recruiting - Depression Clinical Trials

Morbidity and Mortality Among Dialysis Patients After Treatment for Depression

Start date: July 2004
Phase: Phase 4
Study type: Observational

Morbidity and Mortality among Dialysis Patients after Treating Depression Objectives Our investigation has two objectives: 1. To assess whether treatment and recovery from depression decreases adverse clinical events in chronic hemodialysis patients. Significant morbidity is associated with depression in dialysis patients, but subsequent impact on outcome after treatment of depression has not been reported. 2. To examine the rates of recovery from depression over a 6-month and 12-month period among prevalent dialysis patients. Rates of recovery among dialysis patients with depression are unclear. The natural history of depression among dialysis patients may help long-term management. Plan and Methods This project is a longitudinal prospective cohort study comprised of dialysis patients from outpatient dialysis units in the Portland, Oregon metropolitan area. Patients must be aged 18 or older and have started dialysis at least 90 days prior to enrollment. Patients are excluded if they are delirious, demented, cannot speak English, or have a prior psychiatric diagnosis other than depression. Baseline data collection includes patient demographics, etiology of renal disease, nutritional status, past medical and psychiatric history and baseline health status. Social support and quality of life assessments are obtained from direct interview. All patients are assessed for depression by the Beck Depression Index, a depression scale particularly useful in those with chronic illness, and the Diagnostic Interview Scale, a gold standard for depression assessment. Those that are depressed will undergo pharmacologic treatment with an SSRI, if they agree, and be reassessed at 2 and 6 months for improvement. Patients who do not respond are referred for psychiatric therapy. The primary outcome of our study is the combined rate of prespecified morbidity and mortality at 18 months between two groups: depressed subjects agreeing to treatment and depressed subjects not agreeing to treatment. Prespecified morbidities include rates of 1) cardiovascular and cerebrovascular events, 2) infections, 3) vascular access complications, and 4) death. These were selected based on prior studies suggesting that depression increases cardiovascular and cerebrovascular events, suppresses the immune system, and up-regulates coagulation factors and platelet aggregation. , , , , , , Chi-square tests and T-tests will be used to compare baseline variables among those who are and are not depressed. A multivariable Cox proportional hazards model will compare survival among groups, with adjustments for baseline variables. Calculations derived from the Neyman-Pearson equation determined a sample size of 120 subjects. Findings to date We have enrolled 134 subjects to date, including 47 from the PVAMC, and 87 from outside dialysis units. Twenty-percent of them have been depressed. (We need to enroll 120 depressed patients.) No further results have been obtained this year. No further characteristics have been analyzed to date. All adverse events have been reported, none were unexpected. Significance We hope to demonstrate a reduction in adverse clinical outcomes with treatment of depression. If so, we would advocate that depression is a modifiable risk factor that warrants therapy for well-being in dialysis patients.

NCT ID: NCT00421785 Recruiting - ESRD Clinical Trials

Effect of N-Acetylcysteine on Peritoneal Membrane Function in Chronic Peritoneal Dialysis Patients

Start date: February 2007
Phase: N/A
Study type: Interventional

The aim of our study is to investigate the effect of N-acetylcysteine on peritoneal small solute clearance and removal of salt and water in prevalent CAPD patients.

NCT ID: NCT00407368 Recruiting - Clinical trials for Cardiovascular Disease

Platelets Function and Cardiovascular Events in Patients With End Stage Renal Disease

Start date: September 2006
Phase: N/A
Study type: Observational

The purpose of this study is to perform a prospective evaluation regarding the relationship between platelets function and cardiovascular events in patients with ESRD. The study will include 100-200 patients with ESRD, age 18 years or older, treated in the nephrology division of Assaf Harofeh medical center. The primary end points of the study are cardiovascular events including acute myocardial infarction (defined as symptoms + acute elevation of TnI), need for coronary artery disease revascularization, or acute cerebrovascular event (TIA or CVA) and mortality. The secondary end points are any hospitalization due to acute coronary syndrome, active bleeding with the need for blood transfusion and dialysis access graft thrombosis (time to thrombosis). Blood will be taken for complete blood count including platelets count and mean platelets volume, serum electrolytes, albumin, blood lipids, Kt/V, troponin and two 5 ml aliquots from each blood collection will be separated and stored at -70co until analyzed for oxidative stress, homocysteine and highly sensitive CRP will be performed. Five mL of blood will be sent for platelets function assessment. During the follow up period the correlation between platelets function an cardiovascular events will be assessed.

NCT ID: NCT00380848 Recruiting - Clinical trials for End Stage Renal Disease

Impact of Different Dialysis on Sleep Apnea in Patients With Renal Failure

Start date: March 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether hemodiafiltration, a new form of hemodialysis can improve sleep apnea in patients with end stage kidney disease.

NCT ID: NCT00243958 Recruiting - Clinical trials for End-Stage Renal Disease (ESRD)

Aluminum and Auditory Function in ESRD

Start date: October 2005
Phase: N/A
Study type: Observational

Hearing impairment either clinical or subclinical is a characteristic of some renal disease patients. The hearing impairment could be result from specific etiologies or chronic renal failure itself. The causes of hearing impairment in renal disease patients ranged from drugs intoxication in both auditory and renal function, like gentamycin or isoniazid, congenital disease like Alport syndrome or other collagen-defective renal disease, or just aging related. End-stage renal disease (ESRD) patients are special in many parts to general population who have hearing impairment. First, inflammation in ESRD patients is well-documented, second, they suffered from various underlying diseases which auditory function was potentially impaired, third, they need to undergo renal replacement therapy either hemodialysis (HD) or peritoneal dialysis (PD) to maintain their life. Dialysis itself was found to be a cause of hearing impairment, too. The biochemical change and constitutive inflammation status are thought to be implicated in the pathogenesis of hearing impairment in ESRD patients. Aluminum (Al) is a well-documented heavy metal, which predisposes to Alzheimer’s disease, dementia or some neurologic diseases. Al intoxication is very rare in general health population but elevated serum Al level is easily found in ESRD patients since they can not excrete Al by damaged kidneys and dialyzers. Inner ear per se is a neurologic tissue, so if serum Al level in ESRD patients has any association in their haring function needs to be studied.

NCT ID: NCT00182117 Recruiting - Clinical trials for End Stage Renal Disease

Pilot Bleeding Study: Risk and Protective Factors Associated With Bleeding in the Hemodialysis Population

Start date: October 2003
Phase: N/A
Study type: Observational

This study is examining the risk and protective factors associated with bleeding in the hemodialysis population.

NCT ID: NCT00155363 Recruiting - Clinical trials for End-Stage Renal Disease

Effect of Different Hemodialysis Modality on Adiponectin,Vascular Function and Clinical Prognosis

Start date: September 2004
Phase: Phase 4
Study type: Interventional

Adiponectin, an adipose tissue derived protein, with anti-inflammatory properties that is secreted from adipose tissue, is associated with insulin resistance. It has been shown to be a predictor of cardiovascular events in both the general population and patients undergoing hemodialysis. Adiponectin levels were inversely related to body mass index values, plasma leptin levels, insulin levels, serum triglyceride levels, and homeostatic model assessment index values. In addition to it’s ability in increasing insulin sensitivity, adiponectin was demonstrated to have anti-inflammatory and anti-atherogenic properties. In patients with ESRD, renal replacement method was either peritoneal dialysis or HD. High efficient dialysis methods such as high flux HD and HDF had been used more and more popularly. High flux HD and HDF have the advantages in middle to large molecule removal, and better hemodynamic stability. Better clinical prognosis has been shown in patients undergoing high flux HD or HDF. Although studies have demonstrated that the plasma adiponectin levels were elevated in patients receiving HD, whether different dialysis modality will interfere the plasma adiponectin levels and patients’ prognosis remain unknown. The current project is planned to investigate the effects of different HD modality on the plasma adiponectin levels and its correlation other serum inflammatory markers and vascular function. Patients’ long term prognosis will also be assessed in the present study.