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

University Hospital, Montpellier415 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

415

Conditions

Cardiovascular Disease

Interventions

On line HemodiafiltrationPROCEDURE

3 sessions/week; 3-4 hours per session

HemodialysisPROCEDURE

3 sessions/week; 3-4 hours per session; high flux dialyzers

Eligibility

Sex: ALLMin age: 65 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Universitaire

Montpellier, France

Outcomes

Primary Outcomes

tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions

Time frame: between day 30 and day 120 of treatment

Secondary Outcomes

Quality of life evaluated with the KDQOL questionnaire

Time frame: day 0, 180, 365, 730

Incidence of cardiovascular events

Time frame: day 180, 365, 730

Influence of the technic on mineral metabolism disturbances

measure of mineral metabolism parameters (Ca, PO4, PTH)

Time frame: day 180, 365, 730

All cause and cardiovascular mortality

Time frame: day 180, 365, 730

Influence of the technic on inflammatory parameters

measure of pro-inflammatory cytokines and acute phase reactant proteins

Time frame: day 180, 365, 730

Influence of the technic on microbiological safety

measure of microbiological purity of dialysate

Time frame: day 180, 365, 730

Influence of the technic on oxidative stress parameters

measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E)

Time frame: day 180, 365, 730

Data from ClinicalTrials.gov

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