Comparison of Post-dilution On-line Hemodiafiltration and Hemodialysis

Phase 4

Completed

• Conditions: End-Stage Renal Disease
• Interventions: Procedure: post-dilution on-line hemodiafiltration; Procedure: high flux hemodialysis

• Registration Number: NCT00411177
• Lead Sponsor: Ercan OK

Brief 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.

Study Timeline

• Study First Submitted: 2006-12-12
• Study First Submitted QC: 2006-12-12
• Study First Posted: 2006-12-13
• Study Start: 2007-01
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-06
• Last Update Posted: 2013-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 782

Inclusion Criteria

• older than 18 years
• on maintenance bicarbonate HD scheduled thrice weekly 12 hours/week,achieved mean single pool Kt/V above 1.2
• willingness to participate in the study with a written informed consent

Exclusion Criteria

• To be scheduled for living donor renal transplantation
• To have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
• Pregnancy or lactating
• Current requirement for HD more than three times per week due to medical comorbidity
• GFR greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours
• Use of temporary catheter
• Insufficient vascular access (blood flow rate lower than 250 ml/min)
• Mental incompetence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-dilution on-line hemodiafiltration	post-dilution on-line hemodiafiltration	Post-dilution on-line hemodiafiltration
High-flux hemodialysis	high flux hemodialysis	High-flux hemodialysis

Primary Outcome Measures

Name	Time	Method
composite of overall mortality and new cardiovascular events to include myocardial infarction, stroke, revascularization, and unstable angina pectoris requiring hospitalization.	two years

Secondary Outcome Measures

Name	Time	Method
cardiovascular mortality	two years
hospitalization rate	two years
intradialytic complications including hypotension and cramp	two years
health-related quality of life, depression burden, cognitive function	two years
required medications	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	two years
postdialysis total body water determined by bioimpedance analysis	two years

Trial Locations

Locations (2)

Ege University School of Medicine; 🇹🇷 Bornova, Izmir, Turkey

FMC Clinics Turkey; 🇹🇷 Adana, Turkey