NCT00411177

Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis

Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis (TURKISH HDF STUDY)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 782 (actual)
• Sponsor: Ercan OK · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• End-Stage Renal Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-01-01
• Completion: 2010-03-01
• First posted: 2006-12-13
• Last updated: 2013-09-09

Locations

2 sites across 1 country: Turkey (Türkiye)