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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38365125 |
| ClinicalTrials.gov number | NCT00205556 |
| Secondary identifying numbers | NTR24 |
- Submission date
- 16/05/2005
- Registration date
- 16/05/2005
- Last edited
- 07/01/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M.P.C. Grooteman
Scientific
Scientific
Vrije University Medical Centre (VUMC)
Department of Nephrology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 2673 |
|---|---|
| mpc.grooteman@vumc.nl |
Study information
| Study design | Multicentre randomised active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific 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 |
| Study acronym | CONTRAST |
| Study objectives | 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. On 24/01/2008 the following changes were made to the trial record: 1. The anticipated end date was changed from 31/12/2009 to 31/12/2010. 2. The target number of participants was changed from 800 to 700. |
| Ethics approval(s) | The Medical Ethics Review Committee of the Vrije Universiteit Medical Center in Amsterdam, the Netherlands. Approved on 31/07/2003, ref: 2003/97. Amendment to protocol approved on 28/06/2007. |
| Health condition(s) or problem(s) studied | Chronic haemodialysis (HD) |
| Intervention | Patients will be randomised between: 1. Online haemodiafiltration 2. (Continuation with) low-flux haemodialysis Added 24/01/2008: Follow up: Variable follow-up period of 1-7 years (in previous version of protocol: fixed follow up of 3 years) |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/06/2004 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 700 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije University Medical Centre (VUMC)
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
University/education
University/education
Department of Nephrology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 2673 |
|---|---|
| mpc.grooteman@vumc.nl | |
| Website | http://www.vumc.nl/english/ |
University Medical Center Utrecht (UMCU) (The Netherlands)
University/education
University/education
P.O. Box 85500
Utrecht
3508 GA
Netherlands
VU University Medical Center
Not defined
Not defined
| Website | http://www.vumc.nl/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Industry
Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands) (ref: C02.2019)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Dutch Kidney Foundation
- Location
- Netherlands
Fresenius Medical Care (The Netherlands)
No information available
Gambro (The Netherlands)
No information available
Dr E.E. Twiss Fund (The Netherlands)
No information available
Roche (The Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- F. Hoffmann-La Roche Ltd, F. Hoffmann-La Roche & Co, F. Hoffmann-La Roche AG, Roche Holding AG, Roche Holding Ltd, Roche Holding, Roche Holding A.G., Roche Holding, Limited, F. Hoffmann-La Roche & Co.
- Location
- Switzerland
The International Society of Nephrology (The Netherlands) - Baxter Extramural Grant Program
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | 1.1. | 01/01/2005 | Yes | No | |
| Other publications | 1.2. | 20/05/2005 | Yes | No | |
| Other publications | Interim report: | 15/06/2006 | Yes | No | |
| Other publications | Review (this trial mentioned) | 01/02/2008 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No | |
| Results article | results | 01/02/2014 | Yes | No | |
| Results article | results | 05/02/2014 | Yes | No | |
| Results article | results | 01/03/2014 | Yes | No |
