Hemodialysis Clinical Trial
Official title:
Multiple Interventions Related to Dialysis Procedures in Order to Reduce Cardiovascular Morbidity and Mortality in Hemodialysis Patients: Prospective, Randomized, Controlled Study
Verified date | October 2011 |
Source | Ege University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Interventional |
This study aims to investigate the effects of high flux dialyser use and ultra pure dialysate utilization on cardiovascular disease by evaluating cardiovascular morbidity and mortality, progression of carotid artery intima-media thickness and coronary artery calcifications, inflammatory state, lipid levels, nutritional status, and erythropoietin requirement in hemodialysis patient population. It is hypothesized that both interventions in this project may diminish cardiovascular disease in hemodialysis patients.
Status | Completed |
Enrollment | 704 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Aged between 18 and 80 years - On maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week - Willingness to participate in the study with a written informed consent. Exclusion Criteria: - To be scheduled for living donor renal transplantation - To have serious life-limiting co-morbid situations; namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease; pregnancy or lactating |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Turkey | FMC Clinics | Bornova | Izmir |
Turkey | Ege University School of Medicine | Bornova-Izmir |
Lead Sponsor | Collaborator |
---|---|
Ege University | Fresenius Medical Care North America |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cardiovascular mortality, myocardial infarction, stroke, unstable angina pectoris requiring hospitalization, revascularization | three years | No | |
Secondary | overall mortality | three years | No | |
Secondary | progression of coronary artery calcification | three years | No | |
Secondary | progression of carotid artery intima-media thickness | three years | No | |
Secondary | changes in post-dialysis body weight | three years | No | |
Secondary | changes in upper mid-arm circumference | three years | No | |
Secondary | changes in hematocrit and related rHu-EPO doses | three years | No | |
Secondary | changes in the levels of albumin, transferrin, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, high sensitive CRP, and ß-2 microglobulin. | three years | No |
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