Clinical trial NCT01327391: Tolerance of "on Line" Hemodiafiltration in Chronic Renal Failure Patients
Official title: Tolerance of "on Line" Hemodiafiltration and Impact on Morbidity and Cardiovascular Risk Factors in Chronic Renal Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Disease
Keywords: on line hemodiafiltration
tolerance
quality of life
cardiovascular risk
Hemodialysis patients
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-04-01
Enrollment: 415
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions
timeFrame: between day 30 and day 120 of treatment
Secondary outcomes:
measure: Quality of life evaluated with the KDQOL questionnaire
timeFrame: day 0, 180, 365, 730
measure: Incidence of cardiovascular events
timeFrame: day 180, 365, 730
measure: Influence of the technic on mineral metabolism disturbances
timeFrame: day 180, 365, 730
measure: All cause and cardiovascular mortality
timeFrame: day 180, 365, 730
measure: Influence of the technic on inflammatory parameters
timeFrame: day 180, 365, 730
measure: Influence of the technic on microbiological safety
timeFrame: day 180, 365, 730
measure: Influence of the technic on oxidative stress parameters
timeFrame: day 180, 365, 730
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CHG Vichy France
name: Didier AGUILERA, Dr
role: STUDY_CHAIR
affiliation: CH Roanne France
name: Lynda AZZOUZ, Dr
role: STUDY_CHAIR
affiliation: CH privé Saint Martin Caen France
name: Jean-Marie BATHO, Dr
role: STUDY_CHAIR
affiliation: Clinique du Tonkin Villeurbanne France
name: Francois COMBARNOUS, Dr
role: STUDY_CHAIR
affiliation: AIDER Montpellier France
name: Lotfi CHALABI, Dr
role: STUDY_CHAIR
affiliation: CHG Cambrai France
name: Guy DEGREMONT, Dr
role: STUDY_CHAIR
affiliation: Clinique de la Louvière Lille France
name: Maxime HOFFMANN, Dr
role: STUDY_CHAIR
affiliation: AIDER Nimes France
name: Gérard DESCHODT, Dr
role: STUDY_CHAIR
affiliation: CHG Cholet France
name: Assia DJEMA, Dr
role: STUDY_CHAIR
affiliation: Clinique du Vert Galant, Tremblay en France, France
name: Alain DUBOUST, Dr
role: STUDY_CHAIR
affiliation: CHLM Beziers France
name: Alexandre DUMOULIN, Dr
role: STUDY_CHAIR
affiliation: AGDUC La Tronche France
name: Baya FADEL-BABBA, Dr
role: STUDY_CHAIR
affiliation: CH Briancon France
name: Enrique FIGUEROA, Dr
role: STUDY_CHAIR
affiliation: CMCO Evry France
name: Thierry HAAS, Dr
role: STUDY_CHAIR
affiliation: CH Soissons France
name: Jean-Michel HARDIN, Dr
role: STUDY_CHAIR
affiliation: CHI Poissy France
name: Daniel HILLION, Dr
role: STUDY_CHAIR
affiliation: CRAT Tassin La Demi Lune France
name: Guillaume JEAN, Dr
role: STUDY_CHAIR
affiliation: CHU Pontchaillou Rennes France
name: Véronique JOYEUX, Pr
role: STUDY_CHAIR
affiliation: AURAL France
name: Kristian KUNZ, Dr
role: STUDY_CHAIR
affiliation: UNHEP Aulnay sous Bois France
name: Antoine LACAILLE, Dr
role: STUDY_CHAIR
affiliation: Clinique néphrologique Pont Allant Maubeuge France
name: Jacques LEBLEU, Dr
role: STUDY_CHAIR
affiliation: CHG Valenciennes France
name: Vincent LEMAITRE, Dr
role: STUDY_CHAIR
affiliation: CH Louis Pasteur Colmar France
name: Mehadji MAAZ, Dr
role: STUDY_CHAIR
affiliation: Clinique Centre Vallée Blanche Chamonix France
name: Philippe NICOUD, Dr
role: STUDY_CHAIR
affiliation: Polyclinique Saint Roch Cabestany France
name: Jean-Paul ORTIZ, Dr
role: STUDY_CHAIR
affiliation: CH Louis Pasteur Cherbourg France
name: Jacky POTIER, Dr
role: STUDY_CHAIR
affiliation: Clinique Néphrologique Occitanie Muret France
name: Olivier PUYOO, Dr
role: STUDY_CHAIR
affiliation: Polyclinique Francheville Perigueux France
name: Véronique QUERON, Dr
role: STUDY_CHAIR
affiliation: Centre HD Provence Aubagne France
name: Gilles SCHUTZ, Dr
role: STUDY_CHAIR
affiliation: CHLM Montpellier France
name: Francois MAURICE, Dr
role: STUDY_CHAIR
affiliation: CHU Larrey Toulouse France
name: Bruno SEIGNEURIC, Dr
role: STUDY_CHAIR
affiliation: CHU Angers France
name: Frederic TOLLIS, Dr
role: STUDY_CHAIR
affiliation: CH Perpignan France
name: Carlos VELA, Dr
role: STUDY_CHAIR
affiliation: Clinique du Bois Lille France
name: Francois WAMBERGUE, Dr
role: STUDY_CHAIR
affiliation: CH Toulon France
name: Christian WOLF, Dr
role: STUDY_CHAIR
affiliation: CHU Lapeyronie Montpellier France
name: Jean-Paul CRISTOL, Pr
role: STUDY_CHAIR
affiliation: CHU Lapeyronie Montpellier France
name: Bernard CANAUD, Pr
role: PRINCIPAL_INVESTIGATOR
References: