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

NCT ID: NCT01327391

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

415 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2014-05-31

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

Conditions

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Cardiovascular Disease

Keywords

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on line hemodiafiltration tolerance quality of life cardiovascular risk Hemodialysis patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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On line Hemodiafiltration

Hemodialysis patients treated with on line hemodiafiltration technic

Group Type ACTIVE_COMPARATOR

On line Hemodiafiltration

Intervention Type PROCEDURE

3 sessions/week; 3-4 hours per session

hemodialysis

Hemodialysis patients treated with conventional hemodialysis technic using high flux dialyzers

Group Type OTHER

Hemodialysis

Intervention Type PROCEDURE

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

Interventions

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On line Hemodiafiltration

3 sessions/week; 3-4 hours per session

Intervention Type PROCEDURE

Hemodialysis

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

Intervention Type PROCEDURE

Other Intervention Names

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on line HDF HDF conventional hemodialysis

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Didier AGUILERA, Dr

Role: STUDY_CHAIR

CHG Vichy France

Lynda AZZOUZ, Dr

Role: STUDY_CHAIR

CH Roanne France

Jean-Marie BATHO, Dr

Role: STUDY_CHAIR

CH privé Saint Martin Caen France

Francois COMBARNOUS, Dr

Role: STUDY_CHAIR

Clinique du Tonkin Villeurbanne France

Lotfi CHALABI, Dr

Role: STUDY_CHAIR

AIDER Montpellier France

Guy DEGREMONT, Dr

Role: STUDY_CHAIR

CHG Cambrai France

Maxime HOFFMANN, Dr

Role: STUDY_CHAIR

Clinique de la Louvière Lille France

Gérard DESCHODT, Dr

Role: STUDY_CHAIR

AIDER Nimes France

Assia DJEMA, Dr

Role: STUDY_CHAIR

CHG Cholet France

Alain DUBOUST, Dr

Role: STUDY_CHAIR

Clinique du Vert Galant, Tremblay en France, France

Alexandre DUMOULIN, Dr

Role: STUDY_CHAIR

CHLM Beziers France

Baya FADEL-BABBA, Dr

Role: STUDY_CHAIR

AGDUC La Tronche France

Enrique FIGUEROA, Dr

Role: STUDY_CHAIR

CH Briancon France

Thierry HAAS, Dr

Role: STUDY_CHAIR

CMCO Evry France

Jean-Michel HARDIN, Dr

Role: STUDY_CHAIR

CH Soissons France

Daniel HILLION, Dr

Role: STUDY_CHAIR

CHI Poissy France

Guillaume JEAN, Dr

Role: STUDY_CHAIR

CRAT Tassin La Demi Lune France

Véronique JOYEUX, Pr

Role: STUDY_CHAIR

CHU Pontchaillou Rennes France

Kristian KUNZ, Dr

Role: STUDY_CHAIR

AURAL France

Antoine LACAILLE, Dr

Role: STUDY_CHAIR

UNHEP Aulnay sous Bois France

Jacques LEBLEU, Dr

Role: STUDY_CHAIR

Clinique néphrologique Pont Allant Maubeuge France

Vincent LEMAITRE, Dr

Role: STUDY_CHAIR

CHG Valenciennes France

Mehadji MAAZ, Dr

Role: STUDY_CHAIR

CH Louis Pasteur Colmar France

Philippe NICOUD, Dr

Role: STUDY_CHAIR

Clinique Centre Vallée Blanche Chamonix France

Jean-Paul ORTIZ, Dr

Role: STUDY_CHAIR

Polyclinique Saint Roch Cabestany France

Jacky POTIER, Dr

Role: STUDY_CHAIR

CH Louis Pasteur Cherbourg France

Olivier PUYOO, Dr

Role: STUDY_CHAIR

Clinique Néphrologique Occitanie Muret France

Véronique QUERON, Dr

Role: STUDY_CHAIR

Polyclinique Francheville Perigueux France

Gilles SCHUTZ, Dr

Role: STUDY_CHAIR

Centre HD Provence Aubagne France

Francois MAURICE, Dr

Role: STUDY_CHAIR

CHLM Montpellier France

Bruno SEIGNEURIC, Dr

Role: STUDY_CHAIR

CHU Larrey Toulouse France

Frederic TOLLIS, Dr

Role: STUDY_CHAIR

CHU Angers France

Carlos VELA, Dr

Role: STUDY_CHAIR

CH Perpignan France

Francois WAMBERGUE, Dr

Role: STUDY_CHAIR

Clinique du Bois Lille France

Christian WOLF, Dr

Role: STUDY_CHAIR

CH Toulon France

Jean-Paul CRISTOL, Pr

Role: STUDY_CHAIR

CHU Lapeyronie Montpellier France

Bernard CANAUD, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Lapeyronie Montpellier France

Locations

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Centre Hospitalier Universitaire

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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UF 7753

Identifier Type: -

Identifier Source: org_study_id