Tolerance of "on Line" Hemodiafiltration in Chronic Renal Failure Patients (on-line-HDF)

December 5, 2014 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

415

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: day 0, 180, 365, 730
day 0, 180, 365, 730
Incidence of cardiovascular events
Time Frame: day 180, 365, 730
day 180, 365, 730
Influence of the technic on mineral metabolism disturbances
Time Frame: day 180, 365, 730
measure of mineral metabolism parameters (Ca, PO4, PTH)
day 180, 365, 730
All cause and cardiovascular mortality
Time Frame: day 180, 365, 730
day 180, 365, 730
Influence of the technic on inflammatory parameters
Time Frame: day 180, 365, 730
measure of pro-inflammatory cytokines and acute phase reactant proteins
day 180, 365, 730
Influence of the technic on microbiological safety
Time Frame: day 180, 365, 730
measure of microbiological purity of dialysate
day 180, 365, 730
Influence of the technic on oxidative stress parameters
Time Frame: day 180, 365, 730
measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E)
day 180, 365, 730

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Ministry of Health, France

Investigators

  • Study Chair: Didier AGUILERA, Dr, CHG Vichy France
  • Study Chair: Lynda AZZOUZ, Dr, CH Roanne France
  • Study Chair: Jean-Marie BATHO, Dr, CH privé Saint Martin Caen France
  • Study Chair: Francois COMBARNOUS, Dr, Clinique du Tonkin Villeurbanne France
  • Study Chair: Lotfi CHALABI, Dr, AIDER Montpellier France
  • Study Chair: Guy DEGREMONT, Dr, CHG Cambrai France
  • Study Chair: Maxime HOFFMANN, Dr, Clinique de la Louvière Lille France
  • Study Chair: Gérard DESCHODT, Dr, AIDER Nimes France
  • Study Chair: Assia DJEMA, Dr, CHG Cholet France
  • Study Chair: Alain DUBOUST, Dr, Clinique du Vert Galant, Tremblay en France, France
  • Study Chair: Alexandre DUMOULIN, Dr, CHLM Beziers France
  • Study Chair: Baya FADEL-BABBA, Dr, AGDUC La Tronche France
  • Study Chair: Enrique FIGUEROA, Dr, CH Briancon France
  • Study Chair: Thierry HAAS, Dr, CMCO Evry France
  • Study Chair: Jean-Michel HARDIN, Dr, CH Soissons France
  • Study Chair: Daniel HILLION, Dr, CHI Poissy France
  • Study Chair: Guillaume JEAN, Dr, CRAT Tassin La Demi Lune France
  • Study Chair: Véronique JOYEUX, Pr, CHU Pontchaillou Rennes France
  • Study Chair: Kristian KUNZ, Dr, AURAL France
  • Study Chair: Antoine LACAILLE, Dr, UNHEP Aulnay sous Bois France
  • Study Chair: Jacques LEBLEU, Dr, Clinique néphrologique Pont Allant Maubeuge France
  • Study Chair: Vincent LEMAITRE, Dr, CHG Valenciennes France
  • Study Chair: Mehadji MAAZ, Dr, CH Louis Pasteur Colmar France
  • Study Chair: Philippe NICOUD, Dr, Clinique Centre Vallée Blanche Chamonix France
  • Study Chair: Jean-Paul ORTIZ, Dr, Polyclinique Saint Roch Cabestany France
  • Study Chair: Jacky POTIER, Dr, CH Louis Pasteur Cherbourg France
  • Study Chair: Olivier PUYOO, Dr, Clinique Néphrologique Occitanie Muret France
  • Study Chair: Véronique QUERON, Dr, Polyclinique Francheville Perigueux France
  • Study Chair: Gilles SCHUTZ, Dr, Centre HD Provence Aubagne France
  • Study Chair: Francois MAURICE, Dr, CHLM Montpellier France
  • Study Chair: Bruno SEIGNEURIC, Dr, CHU Larrey Toulouse France
  • Study Chair: Frederic TOLLIS, Dr, CHU Angers France
  • Study Chair: Carlos VELA, Dr, CH Perpignan France
  • Study Chair: Francois WAMBERGUE, Dr, Clinique du Bois Lille France
  • Study Chair: Christian WOLF, Dr, CH Toulon France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 14, 2008

First Submitted That Met QC Criteria

March 31, 2011

First Posted (Estimate)

April 1, 2011

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 7753

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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