|
Welcome
|
|
21 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Influence of different types of dialysis membranes on parameters of chronic inflammation |
| ISRCTN | ISRCTN47228763 |
| ClinicalTrials.gov identifier | |
| Public title | Influence of different types of dialysis membranes on parameters of chronic inflammation |
| Scientific title | |
| Acronym | INFLUX |
| Serial number at source | POL-FRA-1 |
| Study hypothesis | The aim of the study is to evaluate the influence of dialysis membrane permeability on biological parameters that predict morbidity and mortality of hemodialysis patients with moderate chronic inflammation |
| Lay summary | |
| Ethics approval | Consulting committee for the protection of people in biomedical research, Bordeaux A (Comité Consultatif pour la Protection des Personnes dans la Recherche Biomédicale [CCPPRB] de Bordeaux A) - number 2004/49, June 18, 2004. |
| Study design | Prospective, multicenter, randomised |
| Countries of recruitment | France |
| Disease/condition/study domain | End-stage renal disease |
| Participants - inclusion criteria |
1. Medically stable end-stage renal disease patients on hemodialysis for 6 months or more 2. Age ≥18 years 3. C-reactive protein between 5 and 50 mg/l maximum one week before inclusion 4. Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) serologies negative 5. Not under guardianship 6. AgHbs negative 7. Absence of vascular access thrombosis 8. Absence of clinically identifiable cause of chronic inflammation 9. Treatment in a dialysis unit providing water quality according to the European Pharmacopoeia 10. Statin medication allowed, but no introduction or modification during the study 11. Hemodialysis blood flow rates between 200 and 500 ml/min possible 12. Dialysis frequency 3-4 per week |
| Participants - exclusion criteria |
1. Age >75 years 2. Known pregnancy 3. Severe comorbidities with life expectancy <1 year 4. Cancer except skin cancer 5. Severe digestive pathologies 6. Chronic inflammatory diseases 7. Medication interfering with nutritional or inflammatory status 8. Treatment or intention to treat with immunosuppressive medication 9. Dialysis dose Kt/V <1.2, and dialysis time <10 hours per week 10. Treatment with hemofiltration or hemodiafiltration 11. Participation in another study during the preceding 30 days 12. Physically or mentally disabled patients |
| Anticipated start date | 10/02/2005 |
| Anticipated end date | 31/12/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 180 |
| Interventions | Hemodialysis treatment with high-flux versus low-flux dialysers of the same type of chemical composition |
| Primary outcome measure(s) | Plasma concentration of C-reactive protein |
| Secondary outcome measure(s) | Advanced glycation end products, carboxymethyl lysine, asymmetric dimethyl arginine, fibrinogen, albumin and prealbumin, phosphate |
| Sources of funding | Gambro SAS |
| Trial website | |
| Publications | |
| Contact name | Prof Christian Combe |
| Address |
Hôpital Pellegrin Service de Néphrologie Place Amélie Raba-Léon |
| City/town | Bordeaux |
| Zip/Postcode | 33076 |
| Country | France |
| christian.combe@chu-bordeaux.fr | |
| Sponsor | Gambro SAS (France) |
| Address | 1-3, Boulevard Charles-de-Gaulle |
| City/town | Colombes |
| Zip/Postcode | 92707 |
| Country | France |
| georges.martin@gambro.com | |
| Date applied | 17/03/2006 |
| Last edited | 24/03/2006 |
| Date ISRCTN assigned | 24/03/2006 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|