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 (NCT)	NCT00205556
Protocol serial number	NTR24
Sponsors	Vrije University Medical Centre (VUMC) (The Netherlands), University Medical Center Utrecht (UMCU) (The Netherlands), VU University Medical Center
Funders	Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands) (ref: C02.2019), Fresenius Medical Care (The Netherlands), Gambro (The Netherlands), Dr E.E. Twiss Fund (The Netherlands), Roche (The Netherlands), The International Society of Nephrology (The Netherlands) - Baxter Extramural Grant Program

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

Vrije University Medical Centre (VUMC)
Department of Nephrology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 2673
Email	mpc.grooteman@vumc.nl

Study information

Primary study design	Interventional
Study design	Multicentre randomised active-controlled parallel-group trial
Secondary study design	Randomised parallel trial
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(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.
Key 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
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
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
Study website	Study website	11/11/2025	11/11/2025	No	Yes