Cardiovascular Disease
Conditions
Keywords
on line hemodiafiltration, tolerance, quality of life, cardiovascular risk, Hemodialysis patients
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
Interventions
PROCEDUREOn line Hemodiafiltration
3 sessions/week; 3-4 hours per session
PROCEDUREHemodialysis
3 sessions/week; 3-4 hours per session; high flux dialyzers
Sponsors
University Hospital, Montpellier
Ministry of Health, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | day 180, 365, 730 | measure of mineral metabolism parameters (Ca, PO4, PTH) |
| All cause and cardiovascular mortality | day 180, 365, 730 | — |
| Influence of the technic on inflammatory parameters | day 180, 365, 730 | measure of pro-inflammatory cytokines and acute phase reactant proteins |
| Influence of the technic on microbiological safety | day 180, 365, 730 | measure of microbiological purity of dialysate |
| Influence of the technic on oxidative stress parameters | day 180, 365, 730 | measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E) |
Countries
France
Contacts
STUDY_CHAIRDidier AGUILERA, Dr
CHG Vichy France
STUDY_CHAIRLynda AZZOUZ, Dr
CH Roanne France
STUDY_CHAIRJean-Marie BATHO, Dr
CH privé Saint Martin Caen France
STUDY_CHAIRFrancois COMBARNOUS, Dr
Clinique du Tonkin Villeurbanne France
STUDY_CHAIRLotfi CHALABI, Dr
AIDER Montpellier France
STUDY_CHAIRGuy DEGREMONT, Dr
CHG Cambrai France
STUDY_CHAIRMaxime HOFFMANN, Dr
Clinique de la Louvière Lille France
STUDY_CHAIRGérard DESCHODT, Dr
AIDER Nimes France
STUDY_CHAIRAssia DJEMA, Dr
CHG Cholet France
STUDY_CHAIRAlain DUBOUST, Dr
Clinique du Vert Galant, Tremblay en France, France
STUDY_CHAIRAlexandre DUMOULIN, Dr
CHLM Beziers France
STUDY_CHAIRBaya FADEL-BABBA, Dr
AGDUC La Tronche France
STUDY_CHAIREnrique FIGUEROA, Dr
CH Briancon France
STUDY_CHAIRThierry HAAS, Dr
CMCO Evry France
STUDY_CHAIRJean-Michel HARDIN, Dr
CH Soissons France
STUDY_CHAIRDaniel HILLION, Dr
CHI Poissy France
STUDY_CHAIRGuillaume JEAN, Dr
CRAT Tassin La Demi Lune France
STUDY_CHAIRVéronique JOYEUX, Pr
CHU Pontchaillou Rennes France
STUDY_CHAIRKristian KUNZ, Dr
AURAL France
STUDY_CHAIRAntoine LACAILLE, Dr
UNHEP Aulnay sous Bois France
STUDY_CHAIRJacques LEBLEU, Dr
Clinique néphrologique Pont Allant Maubeuge France
STUDY_CHAIRVincent LEMAITRE, Dr
CHG Valenciennes France
STUDY_CHAIRMehadji MAAZ, Dr
CH Louis Pasteur Colmar France
STUDY_CHAIRPhilippe NICOUD, Dr
Clinique Centre Vallée Blanche Chamonix France
STUDY_CHAIRJean-Paul ORTIZ, Dr
Polyclinique Saint Roch Cabestany France
STUDY_CHAIRJacky POTIER, Dr
CH Louis Pasteur Cherbourg France
STUDY_CHAIROlivier PUYOO, Dr
Clinique Néphrologique Occitanie Muret France
STUDY_CHAIRVéronique QUERON, Dr
Polyclinique Francheville Perigueux France
STUDY_CHAIRGilles SCHUTZ, Dr
Centre HD Provence Aubagne France
STUDY_CHAIRFrancois MAURICE, Dr
CHLM Montpellier France
STUDY_CHAIRBruno SEIGNEURIC, Dr
CHU Larrey Toulouse France
STUDY_CHAIRFrederic TOLLIS, Dr
CHU Angers France
STUDY_CHAIRCarlos VELA, Dr
CH Perpignan France
STUDY_CHAIRFrancois WAMBERGUE, Dr
Clinique du Bois Lille France
STUDY_CHAIRChristian WOLF, Dr
CH Toulon France
STUDY_CHAIRJean-Paul CRISTOL, Pr
CHU Lapeyronie Montpellier France
PRINCIPAL_INVESTIGATORBernard CANAUD, Pr
CHU Lapeyronie Montpellier France
Outcome results
None listed