Tolerance of "on Line" Hemodiafiltration in Chronic Renal Failure Patients

Phase 4

Completed

• Conditions: Cardiovascular Disease
• Interventions: Procedure: On line Hemodiafiltration; Procedure: Hemodialysis

• Registration Number: NCT01327391
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The aim of this study is to appreciate the tolerance of "on line" hemodiafiltration and its impact on morbidity and cardiovascular risk factors in chronic renal failure patient.

Detailed Description

The aim of this study is to appreciate the tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions between day 30 and day 120 of treatment and to evaluate:

* Quality of life evaluated with the KDQOL questionnaire

* Incidence of cardiovascular events

* Influence of the technic on cardiovascular, inflammatory and infectious risk factors

* Mortality

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-01-14
• Status Verified: 2011-03
• Study First Submitted QC: 2011-03-31
• Study First Posted: 2011-04-01
• Primary Completion: 2013-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

Inclusion Criteria

• Patient who has signed the written consent form
• Patient aged > 65 and < 90 years
• With creatinine clearance < 10 mL/min
• On dialysis for a minimum of 3 months, with 3 times a week hemodialysis sessions
• Erythropoietin dosage needed to maintain hemoglobin at a constant level (range of hemoglobin: 9-13 g/dL without any variation of more than 2g/dL for less than 3 months)
• Without any problem of vascular access

Exclusion Criteria

• Patient aged < 65 and > 90 years
• Presence of severe malnutrition (albumin < 20 g/L)
• Unstable clinical condition
• Unipuncture or failed vascular access flow
• Known problems of coagulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
On line Hemodiafiltration	On line Hemodiafiltration	Hemodialysis patients treated with on line hemodiafiltration technic
hemodialysis	Hemodialysis	Hemodialysis patients treated with conventional hemodialysis technic using high flux dialyzers

Primary Outcome Measures

Name	Time	Method
tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions	between day 30 and day 120 of treatment

Secondary Outcome Measures

Name	Time	Method
Quality of life evaluated with the KDQOL questionnaire	day 0, 180, 365, 730
Incidence of cardiovascular events	day 180, 365, 730
Influence of the technic on mineral metabolism disturbances	day 180, 365, 730	measure of mineral metabolism parameters (Ca, PO4, PTH)
All cause and cardiovascular mortality	day 180, 365, 730
Influence of the technic on inflammatory parameters	day 180, 365, 730	measure of pro-inflammatory cytokines and acute phase reactant proteins
Influence of the technic on microbiological safety	day 180, 365, 730	measure of microbiological purity of dialysate
Influence of the technic on oxidative stress parameters	day 180, 365, 730	measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E)

Trial Locations

Locations (1)

Centre Hospitalier Universitaire; 🇫🇷 Montpellier, France