Condition category
Urological and Genital Diseases
Date applied
16/05/2005
Date assigned
16/05/2005
Last edited
07/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.contrast-ned.nl/

Contact information

Type

Scientific

Primary contact

Dr M.P.C. Grooteman

ORCID ID

Contact details

Vrije University Medical Centre (VUMC)
Department of Nephrology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2673
mpc.grooteman@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00205556

Protocol/serial number

NTR24

Study information

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

Acronym

CONTRAST

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.

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

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.

Study design

Multicentre randomised active-controlled parallel-group trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2004

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

700

Participant 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

Recruitment start date

01/06/2004

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Vrije University Medical Centre (VUMC)
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

Department of Nephrology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2673
mpc.grooteman@vumc.nl

Sponsor type

University/education

Website

http://www.vumc.nl/english/

Organisation

University Medical Center Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Dutch Kidney Foundation (Nierstichting Nederland) (The Netherlands) (ref: C02.2019)

Alternative name(s)

Dutch Kidney Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Funder name

Fresenius Medical Care (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Gambro (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dr E.E. Twiss Fund (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Roche (The Netherlands)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

Switzerland

Funder name

The International Society of Nephrology (The Netherlands) - Baxter Extramural Grant Program

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Protocol in:
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
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23124783
5. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24458074
6. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24505249
7. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24408114

Publication citations

  1. Results

    Mazairac AH, de Wit GA, Grooteman MP, Penne EL, van der Weerd NC, den Hoedt CH, Lévesque R, van den Dorpel MA, Nubé MJ, ter Wee PM, Bots ML, Blankestijn PJ, , Effect of hemodiafiltration on quality of life over time., Clin J Am Soc Nephrol, 2013, 8, 1, 82-89, doi: 10.2215/CJN.00010112.

  2. Results

    den Hoedt CH, Bots ML, Grooteman MP, van der Weerd NC, Penne EL, Mazairac AH, Levesque R, Blankestijn PJ, Nubé MJ, ter Wee PM, van den Dorpel MA, , Clinical predictors of decline in nutritional parameters over time in ESRD., Clin J Am Soc Nephrol, 2014, 9, 2, 318-325, doi: 10.2215/CJN.04470413.

  3. Results

    Mostovaya IM, Bots ML, van den Dorpel MA, Goldschmeding R, den Hoedt CH, Kamp O, Levesque R, Mazairac AH, Penne EL, Swinkels DW, van der Weerd NC, Ter Wee PM, Nubé MJ, Blankestijn PJ, Grooteman MP, Left ventricular mass in dialysis patients, determinants and relation with outcome. Results from the COnvective TRansport STudy (CONTRAST)., PLoS ONE, 2014, 9, 2, e84587, doi: 10.1371/journal.pone.0084587.

  4. Results

    Mostovaya IM, Bots ML, van den Dorpel MA, Grooteman MP, Kamp O, Levesque R, Ter Wee PM, Nubé MJ, Blankestijn PJ, A randomized trial of hemodiafiltration and change in cardiovascular parameters., Clin J Am Soc Nephrol, 2014, 9, 3, 520-526, doi: 10.2215/CJN.07140713.

  5. Penne EL, Blankestijn PJ, Bots ML, van den Dorpel MA, Grooteman MP, Nubé MJ, ter Wee PM, , Resolving controversies regarding hemodiafiltration versus hemodialysis: the Dutch Convective Transport Study., Semin Dial, 18, 1, 47-51, doi: 10.1111/j.1525-139X.2005.18107.x.

  6. Penne EL, Blankestijn PJ, Bots ML, van den Dorpel MA, Grooteman MP, Nubé MJ, van der Tweel I, Ter Wee PM, , Effect of increased convective clearance by on-line hemodiafiltration on all cause and cardiovascular mortality in chronic hemodialysis patients - the Dutch CONvective TRAnsport STudy (CONTRAST): rationale and design of a randomised controlled trial [ISRCTN38365125]., Curr Control Trials Cardiovasc Med, 2005, 6, 1, 8, doi: 10.1186/1468-6708-6-8.

  7. van der Weerd NC, Penne EL, van den Dorpel MA, Grooteman MP, Nube MJ, Bots ML, ter Wee PM, Blankestijn PJ, Haemodiafiltration: promise for the future?, Nephrol. Dial. Transplant., 2008, 23, 2, 438-443, doi: 10.1093/ndt/gfm791.

Additional files

Editorial Notes