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| [ Print-friendly version ] |
| Effect of increased convective clearance by on-line haemodiafiltration on all cause and cardiovascular mortality in chronic haemodialysis patients: the Dutch CONvective TRAnsport STudy |
| ISRCTN | ISRCTN38365125 |
| ClinicalTrials.gov identifier | NCT00205556 |
| Public title | Effect of increased convective clearance by on-line haemodiafiltration on all cause and cardiovascular mortality in chronic haemodialysis patients: the Dutch CONvective TRAnsport STudy |
| Scientific title | |
| Acronym | CONTRAST |
| Serial number at source | NTR24 |
| Study hypothesis | The high incidence of cardiovascular disease in patients with End Stage Renal Disease (ESRD) is related with the accumulation of uremic toxins in the middle and large-middle molecular weight range. As online Haemodiafiltration (HDF) lowers these molecules more effectively than standard Haemodialysis (HD), it is suggested that this treatment may improve cardiovascular outcome. |
| Lay summary | |
| Ethics approval | The Medical Ethics Review Committee of the Vrije Universiteit Medical Center in Amsterdam, the Netherlands. Approved on 3 July 2007 (ref: 2003/97). Amendment to protocol approved on 28 June 2007. |
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Chronic haemodialysis (HD) |
| Participants - inclusion criteria |
1. Patients treated by HD 2 or 3 times a week, for at least 2 months
2. Patients able to understand the study procedures 3. Patients willing to provide written informed consent |
| Participants - exclusion criteria |
1. Current age less than 18 years treatment by Haemodiafiltration (HDF) or high flux HD in the preceding 6 months
2. Severe incompliance life expectancy less than 3 months due to non-renal disease 3. Participation to other clinical intervention trials evaluating cardiovascular outcome |
| Anticipated start date | 01/06/2004 |
| Anticipated end date | 31/12/2010 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | Amended as of 24 January 2008: 700; Target number provided at time of registration: 800 |
| Interventions |
Please note that, as of 24 January 2008, the anticipated end date of this trial was extended from 31 December 2009 to 31 December 2010.
Interventions: Patients will be randomised between: 1. Online haemodiafiltration 2. (Continuation with) low-flux haemodialysis Added as of 24 January 2008: Follow up: Variable follow up period of 1-7 years (in previous version of protocol: fixed follow up of 3 years) Joint Sponsor: University Medical Center Utrecht (UMCU) (The Netherlands) P.O. Box 85500 Utrecht 3508 GA The Netherlands Tel: +31 (0)30 250 9111 |
| Primary outcome measure(s) | Cardiovascular morbidity and mortality. This is a composite endpoint comprising fatal and non-fatal myocardial infarction and stroke, and vascular death (death due to vascular disease). Also all-cause mortality is considered a primary endpoint. |
| Secondary outcome measure(s) |
Current secondary outcome measures as of 20/01/2011:
Changes in: 1. Carotid Intima Media Thickness (cIMT) 2. Aortic Pulse Wave Velocity (PWV) 3. Left Ventricular Mass index (LVMi) 4. Interdialytic blood pressure 5. Laboratory assessments (oxidative stress; acute phase response; lipid profile; various) 6. Quality of life 7. Nutritional state 8. Anemia management: hemoglobin levels and erythropoietin use/resistance (addendum to the protocol on this issue has been approved by ethical committee in October, 2003) 9. Cost utility analysis (addendum to the protocol on this issue has been approved by the ethical committee in April, 2008) 10. Hospitalization days 11. Hospital admission for infection 12. Hospital admission for any cause 13. Blood pressure and antihypertensive medication 14. Residual kidney function 15. Laboratory parameters on mineral bone disease and medication 16. Treatment delivery (dialysis efficiency Kt/V urea, ultrafiltration volume, and only HDF: convection volume) Previous secondary outcome measures: Changes in: 1. Carotid Intima Media Thickness (cIMT) 2. Aortic Pulse Wave Velocity (PWV) 3. Left Ventricular Mass index (LVMi) 4. Interdialytic blood pressure 5. Laboratory assessments (oxidative stress; acute phase response; lipid profile; various) 6. Quality of life 7. Nutritional state |
| Sources of funding |
1. Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands) (ref: C02.2019)
2. Fresenius Medical Care (The Netherlands) 3. Gambro (The Netherlands) 4. Dr E.E. Twiss Fund (The Netherlands) 5. Roche (The Netherlands) 6. The International Society of Nephrology (The Netherlands) - Baxter Extramural Grant Program |
| Trial website | http://www.contrast-ned.nl/ |
| Publications |
1. Study protocol:
1.1. http://www.ncbi.nlm.nih.gov/pubmed/15663765 1.2. http://www.ncbi.nlm.nih.gov/pubmed/15907201 2. Review (this trial mentioned) in http://www.ncbi.nlm.nih.gov/pubmed/18045819 3. Interim report: http://www.ncbi.nlm.nih.gov/entrez/pubmed/16886698 |
| Contact name | Dr M.P.C. Grooteman |
| Address |
Vrije University Medical Centre (VUMC)
Department of Nephrology P.O. Box 7057 |
| City/town | Amsterdam |
| Zip/Postcode | 1007 MB |
| Country | Netherlands |
| Tel | +31 (0)20 444 2673 |
| Fax | +31 (0)20 444 2675 |
| mpc.grooteman@vumc.nl | |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Address |
Department of Nephrology
P.O. Box 7057 |
| City/town | Amsterdam |
| Zip/Postcode | 1007 MB |
| Country | Netherlands |
| Tel | +31 (0)20 444 2673 |
| Fax | +31 (0)20 444 2675 |
| mpc.grooteman@vumc.nl | |
| Sponsor website: | http://www.vumc.nl/english/ |
| Date applied | 16/05/2005 |
| Last edited | 20/01/2011 |
| Date ISRCTN assigned | 16/05/2005 |
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