End-Stage Renal Disease Clinical Trial
Official title:
Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis (TURKISH HDF STUDY)
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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