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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Montpellier.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01327391
First received: January 14, 2008
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Procedure: On line Hemodiafiltration
Procedure: Hemodialysis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tolerance of "on Line" Hemodiafiltration and Impact on Morbidity and Cardiovascular Risk Factors in Chronic Renal Failure Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life evaluated with the KDQOL questionnaire [ Time Frame: day 0, 180, 365, 730 ] [ Designated as safety issue: No ]
  • Incidence of cardiovascular events [ Time Frame: day 180, 365, 730 ] [ Designated as safety issue: No ]
  • Influence of the technic on mineral metabolism disturbances [ Time Frame: day 180, 365, 730 ] [ Designated as safety issue: No ]
    measure of mineral metabolism parameters (Ca, PO4, PTH)

  • All cause and cardiovascular mortality [ Time Frame: day 180, 365, 730 ] [ Designated as safety issue: No ]
  • Influence of the technic on inflammatory parameters [ Time Frame: day 180, 365, 730 ] [ Designated as safety issue: No ]
    measure of pro-inflammatory cytokines and acute phase reactant proteins

  • Influence of the technic on microbiological safety [ Time Frame: day 180, 365, 730 ] [ Designated as safety issue: No ]
    measure of microbiological purity of dialysate

  • Influence of the technic on oxidative stress parameters [ Time Frame: day 180, 365, 730 ] [ Designated as safety issue: No ]
    measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E)


Estimated Enrollment: 600
Study Start Date: May 2005
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 Name: conventional hemodialysis

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

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327391

Contacts
Contact: Bernard CANAUD, Prof 00 33 4 67 33 84 95 b-canaud@chu-montpellier.fr

Locations
France
Centre Hospitalier Universitaire Recruiting
Montpellier, France, 34295
Contact: Bernard CANAUD, Pr    00 33 4 67 33 84 95    b-canaud@chu-montpellier.fr   
Principal Investigator: Bernard CANAUD, Pr         
Sponsors and Collaborators
University Hospital, Montpellier
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 Chair: Jean-Paul CRISTOL, Pr CHU Lapeyronie Montpellier France
Principal Investigator: Bernard CANAUD, Pr CHU Lapeyronie Montpellier France
  More Information

No publications provided

Responsible Party: Prof Bernard CANAUD, Centre Hospitalier Universitaire Montpellier France
ClinicalTrials.gov Identifier: NCT01327391     History of Changes
Other Study ID Numbers: UF 7753
Study First Received: January 14, 2008
Last Updated: March 31, 2011
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Montpellier:
on line hemodiafiltration
tolerance
quality of life
cardiovascular risk
Hemodialysis patients

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 23, 2014