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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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