Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis
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.
|End-Stage Renal Disease||Procedure: post-dilution on-line hemodiafiltration Procedure: high flux hemodialysis||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis (TURKISH HDF STUDY)|
- 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 ]
|Study Start Date:||January 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Post-dilution on-line hemodiafiltration
Post-dilution on-line hemodiafiltration
Procedure: post-dilution on-line hemodiafiltration
post-dilution on-line hemodiafiltration, 3 times a week 4 hours
Procedure: high flux hemodialysis
High-flux hemodialysis, 3 times a week 4 hours
Other Name: High-flux hemodialysis
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:
- Post-dilution on-line hemodiafiltration,
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411177
|Ege University School of Medicine|
|Bornova, Izmir, Turkey, 35100|
|FMC Clinics Turkey|
|Adana, Turkey, 01000|
|Principal Investigator:||Ercan Ok, MD||Ege University|