Tolerance of on Line Hemodiafiltration in Chronic Renal Failure Patients

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Procedure: On line Hemodiafiltration
* Procedure: Hemodialysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: On line Hemodiafiltration<br>Hemodialysis patients treated with on line hemodiafiltration technic | Procedure: On line Hemodiafiltration<br>* 3 sessions/week; 3-4 hours per session<br>* Other names: HDF;|
| Other: hemodialysis<br>Hemodialysis patients treated with conventional hemodialysis technic using high flux dialyzers | Procedure: Hemodialysis<br>* 3 sessions/week; 3-4 hours per session; high flux dialyzers<br>* Other names: conventional hemodialysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | measure of mineral metabolism parameters (Ca, PO4, PTH) | day 180, 365, 730 | 
| All cause and cardiovascular mortality |  | day 180, 365, 730 | 
| Influence of the technic on inflammatory parameters | measure of pro-inflammatory cytokines and acute phase reactant proteins | day 180, 365, 730 | 
| Influence of the technic on microbiological safety | measure of microbiological purity of dialysate | day 180, 365, 730 | 
| Influence of the technic on oxidative stress parameters | measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E) | day 180, 365, 730 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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on line hemodiafiltration, tolerance, quality of life, cardiovascular risk, Hemodialysis patients