Multiple Interventions Related to Dialysis Procedures in Order to Reduce Cardiovascular Morbidity and Mortality in HD Patients(EGESTUDY)
|End-stage Renal Disease Hemodialysis||Procedure: high-flux membrane Procedure: low-flux membrane Procedure: conventional dialysate Procedure: ultrapure dialysate||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Multiple Interventions Related to Dialysis Procedures in Order to Reduce Cardiovascular Morbidity and Mortality in Hemodialysis Patients: Prospective, Randomized, Controlled Study|
- cardiovascular mortality, myocardial infarction, stroke, unstable angina pectoris requiring hospitalization, revascularization [ Time Frame: three years ]
- overall mortality [ Time Frame: three years ]
- progression of coronary artery calcification [ Time Frame: three years ]
- progression of carotid artery intima-media thickness [ Time Frame: three years ]
- changes in post-dialysis body weight [ Time Frame: three years ]
- changes in upper mid-arm circumference [ Time Frame: three years ]
- changes in hematocrit and related rHu-EPO doses [ Time Frame: three years ]
- changes in the levels of albumin, transferrin, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, high sensitive CRP, and β-2 microglobulin. [ Time Frame: three years ]
|Study Start Date:||November 2005|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Procedure: high-flux membrane
Active Comparator: 2
Procedure: low-flux membrane
Active Comparator: 3
Procedure: conventional dialysate
Active Comparator: 4
Procedure: ultrapure dialysate
This proposed prospective, randomized, controlled 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.
Their beneficial effects may be directly represented by significantly reduced cardiovascular morbidity and mortality. The proposed additional investigations, such as a possible decrease in the progression of coronary artery calcification and carotid artery intima-media thickness, will help us to understand the mechanisms of the expected reduction or serve as surrogate markers of atherosclerosis, in case the benefit of the interventions cannot be proven with statistical significance.
Seven hundred and four hemodialysis patients treated in Ege University Hospital Dialysis Unit and eight FMC Clinics will be enrolled into the study (3-year follow-up; percentage of yearly expected end-point 10%;expected event-free survival rate for control group during three year is 72.9%,a bilateral alpha risk equal to 5%; an 90% power to detect an increase of 15% in event-free survival at the end of 3-year follow-up in favor of the each intervention group). Annual drop-out rate is estimated as %15-20.
It is designed as 2x2 factorial; the cases, first, will be randomized to high flux dialyser and low flux dialyser arms; then, they will be re-randomized to ultra pure (online-produced by using Diasafe and checked by endotoxin measurement) and standard dialysate arms. The study will last three years; an intermediate analysis will be performed at the 18th month.
Primary end-point is the composite of cardiovascular mortality and myocardial infarction, stroke, revascularization, unstable angina pectoris requiring hospitalization (at 18 ad 36th month).
Secondary end-points are overall mortality, progression of coronary artery calcification, progression of carotid artery intima-media thickness, changes in post-dialysis body weight and upper mid-arm circumference, hematocrit and related rHu-EPO doses, changes in the levels of albumin, transferrin, total cholesterol, triglyceride, HDL cholesterol, LDL cholesterol, high sensitive CRP, and β-2 microglobulin.
At the 0-18-36 months, coronary artery calcification will be assessed by multi-slice CT and carotid artery intima-media thickness by B-mode ultrasonography. Lipids and CRP will be measured in every three months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295191
|Bornova, Izmir, Turkey, 35100|
|Ege University School of Medicine|
|Bornova-Izmir, Turkey, 35100|
|Principal Investigator:||Ercan Ok, M.D||Ege University School of Medicine Nephrology Department|