This study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications. The investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration may provide better outcome, less morbidity, higher quality of life, and lesser requirement of medications.
The proposed controlled, randomized study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications. Seven hundred and eighty HD patients will be taken into the study. The study will last for two years with an intermediate analysis at the first year. The patients will be randomly placed in two groups: 1. Post-dilution on-line hemodiafiltration, 2. High-flux hemodialysis. In both groups, FX series high-flux helixone membranes will be used, duration of each session 240 minutes, and blood flow rates 250-400 ml/min. ONLINEplus integrated Fresenius 4008S machines will be used for on-line post-dilution HDF. Substitution volume will be above 15 liters in hemodiafiltration sessions. Echocardiography for determination of left ventricular geometry, pulse wave velocity analysis to assess arterial stiffness, evaluation of nutritional and inflammatory state, assessment of life quality, depression and cost analysis will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
782
post-dilution on-line hemodiafiltration, 3 times a week 4 hours
High-flux hemodialysis, 3 times a week 4 hours
Ege University School of Medicine
Bornova, İzmir, Turkey (Türkiye)
FMC Clinics Turkey
Adana, Turkey (Türkiye)
composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization.
Time frame: two years
cardiovascular mortality
Time frame: two years
hospitalization rate
Time frame: two years
intradialytic complications including hypotension and cramp
Time frame: two years
health-related quality of life, depression burden, cognitive function
Time frame: two years
required medications
Time frame: two years
changes in blood pressure, left ventricular geometry, arterial stiffness, post-dialysis body weight, upper mid-arm circumference, hematocrit and related rHu-EPO doses, the levels of phosphorus, albumin, lipid parameters, hsCRP, and β-2 microglobulin
Time frame: two years
postdialysis total body water determined by bioimpedance analysis
Time frame: two years
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