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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On line Hemodiafiltration | Active Comparator | Hemodialysis patients treated with on line hemodiafiltration technic |
|
| hemodialysis | Other | Hemodialysis patients treated with conventional hemodialysis technic using high flux dialyzers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| On line Hemodiafiltration | Procedure | 3 sessions/week; 3-4 hours per session |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28318624 | Result | Morena M, Jaussent A, Chalabi L, Leray-Moragues H, Chenine L, Debure A, Thibaudin D, Azzouz L, Patrier L, Maurice F, Nicoud P, Durand C, Seigneuric B, Dupuy AM, Picot MC, Cristol JP, Canaud B; FRENCHIE Study Investigators. Treatment tolerance and patient-reported outcomes favor online hemodiafiltration compared to high-flux hemodialysis in the elderly. Kidney Int. 2017 Jun;91(6):1495-1509. doi: 10.1016/j.kint.2017.01.013. Epub 2017 Mar 18. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006435 | Renal Dialysis |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
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| Hemodialysis | Procedure | 3 sessions/week; 3-4 hours per session; high flux dialyzers |
|
|
measure of mineral metabolism parameters (Ca, PO4, PTH) |
| day 180, 365, 730 |
| All cause and cardiovascular mortality | day 180, 365, 730 |
| Influence of the technic on inflammatory parameters | measure of pro-inflammatory cytokines and acute phase reactant proteins | day 180, 365, 730 |
| Influence of the technic on microbiological safety | measure of microbiological purity of dialysate | day 180, 365, 730 |
| Influence of the technic on oxidative stress parameters | measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E) | day 180, 365, 730 |
| 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 | Study Chair |
| Bernard CANAUD, Pr | CHU Lapeyronie Montpellier France | Principal Investigator |