Tolerance of on Line Hemodiafiltration in Chronic Renal Failure Patients

Tolerance of on Line Hemodiafiltration and Impact on Morbidity and Cardiovascular Risk Factors in Chronic Renal Failure Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01327391

Acronym

on-line-HDF

Enrollment

415

Registered

2011-04-01

Start date

2005-05-31

Completion date

2014-05-31

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

on line hemodiafiltration, tolerance, quality of life, cardiovascular risk, Hemodialysis patients

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

Interventions

PROCEDUREOn line Hemodiafiltration

3 sessions/week; 3-4 hours per session

PROCEDUREHemodialysis

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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	—
Quality of life evaluated with the KDQOL questionnaire	day 0, 180, 365, 730	—
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)
Influence of the technic on inflammatory parameters	day 180, 365, 730	measure of pro-inflammatory cytokines and acute phase reactant proteins

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026