Effect of Increased Convective Clearance by On-Line Hemodiafiltration on All Cause Mortality in Chronic Hemodialysis Patients

NCT00205556 | Completed DMC

• 4 other identifiers: METC VUmc 03/097ISRCTN38365125CCMO number P03.1089LDutch Kidney Found C 02.2019
• Study Type: interventional
• Target: 715
• Locations: 3 countries
• Sites: 29

Brief Summary

The purpose of this study is to compare the effect of low flux hemodialysis with online hemodiafiltration on all cause mortality and a combination of cardiovascular morbidity and mortality in chronic hemodialysis patients.

Conditions

End-stage Renal Disease; Cardiovascular Disease

Keywords

online hemodiafiltration; low flux hemodialysis; cardiovascular disease; endothelial dysfunction; uremic toxicity; quality of life; nutritional status

Outcome Measures

Primary Outcomes (1)

• all cause mortality

  entire follow up (until dead or end of study, 1-7 years)

Secondary Outcomes (13)

• fatal and non-fatal cardiovascular events

  entire follow up (until death or end of study, 1-7 years)

• Left ventricular mass index (LVMi), carotid IMT (intima media thickness), aortic pulse wave velocity (PWV)

  first 3 years

• laboratory markers of endothelial dysfunction, micro-inflammation, oxidative stress

  first three years of follow up

• lipid profiles, uremic toxins

  first three years

• quality of life

  entire follow up (until death or end of study, 1-7 years)

Study Arms (2)

1: low flux hemodialysis

OTHER

standard treatment

Procedure: low flux hemodialysis

2 on-line hemodiafiltration

ACTIVE COMPARATOR

Procedure: on-line hemodiafiltration

Interventions

on-line hemodiafiltration PROCEDURE

addition of convective transport to regular dialysis treatment by using on-line hemodiafiltration

2 on-line hemodiafiltration

low flux hemodialysis PROCEDURE

standard treatment

1: low flux hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients treated by HD 2 or 3 times a week, for at least 2 months
• Patients able to understand the study procedures
• Patients willing to provide written informed consent

You may not qualify if:

• Current age \< 18 years
• Treatment by HDF or high flux HD in the preceding 6 months
• Severe incompliance (severe non-adherence to the dialysis procedure and accompanying prescriptions, especially frequency and duration of dialysis treatment and fluid restriction)
• Life expectancy \< 3 months due to non renal disease
• Participation in other clinical intervention trials evaluating cardiovascular outcome

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• UMC Utrecht: collaborator
• Medical Center Alkmaar: collaborator
• Maasstad Hospital: collaborator
• Julius Center for Health Sciences and Primary Care, Utrecht: collaborator
• Dutch Kidney Foundation: collaborator
• Fresenius Medical Care North America: collaborator
• Gambro Renal Products, Inc.: collaborator
• Baxter Healthcare Corporation: collaborator
• Roche Pharma AG: collaborator

Study Sites (29)

Dr Georges-L. Dumont Regional Hospital

Moncton, New Brunswick, Canada

Location

Centre Hospitalier de L'Université de Montreal, Hopital Notre Dame

Montreal, H2L 4M1, Canada

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5200 ME, Netherlands

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 1081 HV, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1090 HM, Netherlands

Location

Academical Medical Center

Amsterdam, 1100 DD, Netherlands

Location

Ziekenhuis Rijnstate

Arnhem, 6800 TA, Netherlands

Location

Dialyse Kliniek Noord

Beilen, 9411 SE, Netherlands

Location

Slingeland Ziekenhuis

Doetinchem, 7009 BL, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, 6710 HN, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, 5602 ZA, Netherlands

Location

Oosterscheldeziekenhuis

Goes, 4460 BB, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

Martini Ziekenhuis

Groningen, 9700 RM, Netherlands

Location

Rijnland Ziekenhuis

Leiderdorp, Netherlands

Location

University Medical Center St Radboud

Nijmegen, 6500 HB, Netherlands

Location

Franciscus Ziekenhuis

Roosendaal, 4700 AZ, Netherlands

Location

Sint Franciscus Gasthuis

Rotterdam, 3045 PM, Netherlands

Location

Medisch Centrum Rijnmond Zuid - locatie Clara

Rotterdam, 3075 EA, Netherlands

Location

Orbis Medisch en Zorgcentrum

Sittard, 6130 MB, Netherlands

Location

Ziekenhuis Zeeuws-Vlaanderen

Terneuzen, 4535 PA, Netherlands

Location

Haga Ziekenhuis (locatie Leyenburg)

The Hague, 2545 CH, Netherlands

Location

St Elisabeth Ziekenhuis

Tilburg, 5000 LC, Netherlands

Location

Stichting Dianet

Utrecht, 3524 BN, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

VieCuri Medisch Centrum

Venlo, 5912 BL, Netherlands

Location

Isala Klinieken

Zwolle, 8000 GM, Netherlands

Location

Haukeland Universitetssykehus

Bergen, 5021, Norway

Location

Related Publications (21)

• Penne EL, Blankestijn PJ, Bots ML, van den Dorpel MA, Grooteman MP, Nube MJ, van der Tweel I, Ter Wee PM; the CONTRAST study group. 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 May 20;6(1):8. doi: 10.1186/1468-6708-6-8.

  PMID: 15907201 BACKGROUND

• Penne EL, Blankestijn PJ, Bots ML, van den Dorpel MA, Grooteman MP, Nube MJ, ter Wee PM; CONTRAST Group. Resolving controversies regarding hemodiafiltration versus hemodialysis: the Dutch Convective Transport Study. Semin Dial. 2005 Jan-Feb;18(1):47-51. doi: 10.1111/j.1525-139X.2005.18107.x.

  PMID: 15663765 BACKGROUND

• Penne EL, Blankestijn PJ, Bots ML, van den Dorpel MA, Grooteman MP, Nube MJ, ter Wee PM. [New study evaluating online haemodiafiltration for the reduction of cardiovascular morbidity and mortality in patients undergoing chronic haemodialysis]. Ned Tijdschr Geneeskd. 2006 Jul 15;150(28):1583-5. Dutch.

  PMID: 16886698 BACKGROUND

• 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 Feb;23(2):438-43. doi: 10.1093/ndt/gfm791. Epub 2007 Nov 28. No abstract available.

  PMID: 18045819 BACKGROUND

• Penne EL, van Berkel T, van der Weerd NC, Grooteman MP, Blankestijn PJ. Optimizing haemodiafiltration: tools, strategy and remaining questions. Nephrol Dial Transplant. 2009 Dec;24(12):3579-81. doi: 10.1093/ndt/gfp333. Epub 2009 Jul 13. No abstract available.

  PMID: 19596741 BACKGROUND

• van der Weerd NC, Penne EL, Grooteman MP. Effect of hemofiltration on mortality: no definite answer yet. Am J Kidney Dis. 2009 Mar;53(3):562-3; author reply 563. doi: 10.1053/j.ajkd.2008.09.029. No abstract available.

  PMID: 19231743 BACKGROUND

• Penne EL, Visser L, van den Dorpel MA, van der Weerd NC, Mazairac AH, van Jaarsveld BC, Koopman MG, Vos P, Feith GW, Kremer Hovinga TK, van Hamersvelt HW, Wauters IM, Bots ML, Nube MJ, Ter Wee PM, Blankestijn PJ, Grooteman MP. Microbiological quality and quality control of purified water and ultrapure dialysis fluids for online hemodiafiltration in routine clinical practice. Kidney Int. 2009 Sep;76(6):665-72. doi: 10.1038/ki.2009.245. Epub 2009 Jul 15.

  PMID: 19606080 BACKGROUND

• den Hoedt CH, Mazairac AHA, van den Dorpel MA, Grooteman MPC, Blankestijn PJ. Effect of hemodiafiltration on mortality, inflammation and quality of life. Contrib Nephrol. 2011;168:39-52. doi: 10.1159/000321743. Epub 2010 Oct 7.

  PMID: 20938124 BACKGROUND

• Penne EL, van der Weerd NC, Bots ML, van den Dorpel MA, Grooteman MP, Levesque R, Nube MJ, Ter Wee PM, Blankestijn PJ; CONTRAST investigators. Patient- and treatment-related determinants of convective volume in post-dilution haemodiafiltration in clinical practice. Nephrol Dial Transplant. 2009 Nov;24(11):3493-9. doi: 10.1093/ndt/gfp265. Epub 2009 Jun 10.

  PMID: 19515802 RESULT

• Penne EL, van der Weerd NC, van den Dorpel MA, Grooteman MP, Levesque R, Nube MJ, Bots ML, Blankestijn PJ, ter Wee PM; CONTRAST Investigators. Short-term effects of online hemodiafiltration on phosphate control: a result from the randomized controlled Convective Transport Study (CONTRAST). Am J Kidney Dis. 2010 Jan;55(1):77-87. doi: 10.1053/j.ajkd.2009.09.023. Epub 2009 Dec 5.

  PMID: 19962805 RESULT

• Mazairac AH, de Wit GA, Penne EL, van der Weerd NC, Grooteman MP, van den Dorpel MA, Nube MJ, Buskens E, Levesque R, Ter Wee PM, Bots ML, Blankestijn PJ; CONTRAST investigators. Protein-energy nutritional status and kidney disease-specific quality of life in hemodialysis patients. J Ren Nutr. 2011 Sep;21(5):376-386.e1. doi: 10.1053/j.jrn.2010.08.004. Epub 2010 Dec 30.

  PMID: 21194971 RESULT

• Penne EL, van der Weerd NC, Grooteman MP, Mazairac AH, van den Dorpel MA, Nube MJ, Bots ML, Levesque R, ter Wee PM, Blankestijn PJ; CONTRAST investigators. Role of residual renal function in phosphate control and anemia management in chronic hemodialysis patients. Clin J Am Soc Nephrol. 2011 Feb;6(2):281-9. doi: 10.2215/CJN.04480510. Epub 2010 Oct 28.

  PMID: 21030579 RESULT

• Penne EL, van der Weerd NC, Blankestijn PJ, van den Dorpel MA, Grooteman MP, Nube MJ, Ter Wee PM, Levesque R, Bots ML; CONTRAST investigators. Role of residual kidney function and convective volume on change in beta2-microglobulin levels in hemodiafiltration patients. Clin J Am Soc Nephrol. 2010 Jan;5(1):80-6. doi: 10.2215/CJN.03340509. Epub 2009 Nov 12.

  PMID: 19965537 RESULT

• Mazairac AH, de Wit GA, Grooteman MP, Penne EL, van der Weerd NC, van den Dorpel MA, Nube MJ, Levesque R, Ter Wee PM, Bots ML, Blankestijn PJ; CONTRAST investigators. A composite score of protein-energy nutritional status predicts mortality in haemodialysis patients no better than its individual components. Nephrol Dial Transplant. 2011 Jun;26(6):1962-7. doi: 10.1093/ndt/gfq643. Epub 2010 Oct 14.

  PMID: 20947533 RESULT

• Mazairac AH, de Wit GA, Penne EL, van der Weerd NC, de Jong B, Grooteman MP, van den Dorpel MA, Buskens E, Dekker FW, Nube MJ, Ter Wee PM, Boeschoten EW, Bots ML, Blankestijn PJ; CONTRAST investigators. Changes in quality of life over time--Dutch haemodialysis patients and general population compared. Nephrol Dial Transplant. 2011 Jun;26(6):1984-9. doi: 10.1093/ndt/gfq680. Epub 2010 Nov 4.

  PMID: 21051503 RESULT

• de Roij van Zuijdewijn CL, Ter Wee PM. Assessment of Protein-Energy Wasting: Quest for the Gold Standard. J Ren Nutr. 2016 May;26(3):204-5. doi: 10.1053/j.jrn.2016.01.012. Epub 2016 Feb 20. No abstract available.

  PMID: 26908190 DERIVED

• de Roij van Zuijdewijn CL, Grooteman MP, Bots ML, Blankestijn PJ, Steppan S, Buchel J, Groenwold RH, Brandenburg V, van den Dorpel MA, Ter Wee PM, Nube MJ, Vervloet MG. Serum Magnesium and Sudden Death in European Hemodialysis Patients. PLoS One. 2015 Nov 23;10(11):e0143104. doi: 10.1371/journal.pone.0143104. eCollection 2015.

  PMID: 26600017 DERIVED

• de Roij van Zuijdewijn CL, Grooteman MP, Bots ML, Blankestijn PJ, van den Dorpel MA, Nube MJ, ter Wee PM. Comparing Tests Assessing Protein-Energy Wasting: Relation With Quality of Life. J Ren Nutr. 2016 Mar;26(2):111-7. doi: 10.1053/j.jrn.2015.09.003. Epub 2015 Oct 23.

  PMID: 26584787 DERIVED

• den Hoedt CH, Grooteman MP, Bots ML, Blankestijn PJ, van der Tweel I, van der Weerd NC, Penne EL, Mazairac AH, Levesque R, ter Wee PM, Nube MJ, van den Dorpel MA; CONTRAST investigators. The Effect of Online Hemodiafiltration on Infections: Results from the CONvective TRAnsport STudy. PLoS One. 2015 Aug 19;10(8):e0135908. doi: 10.1371/journal.pone.0135908. eCollection 2015.

  PMID: 26288091 DERIVED

• van der Weerd NC, Den Hoedt CH, Blankestijn PJ, Bots ML, van den Dorpel MA, Levesque R, Mazairac AH, Nube MJ, Penne EL, ter Wee PM, Grooteman MP; CONTRAST Investigators. Resistance to erythropoiesis stimulating agents in patients treated with online hemodiafiltration and ultrapure low-flux hemodialysis: results from a randomized controlled trial (CONTRAST). PLoS One. 2014 Apr 17;9(4):e94434. doi: 10.1371/journal.pone.0094434. eCollection 2014.

  PMID: 24743493 DERIVED

• van der Weerd NC, Grooteman MP, Blankestijn PJ, Mazairac AH, van den Dorpel MA, den Hoedt CH, Nube MJ, Penne EL, van der Tweel I, Ter Wee PM, Bots ML; CONTRAST investigators. Poor compliance with guidelines on anemia treatment in a cohort of chronic hemodialysis patients. Blood Purif. 2012;34(1):19-27. doi: 10.1159/000338919. Epub 2012 Aug 8.

  PMID: 22889943 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Menso J Nubé, MD PhD

  Medical Center Alkmaar

  STUDY DIRECTOR

• Piet M ter Wee, MD PhD

  Vrije Universiteit Medical Center, Amsterdam

  STUDY CHAIR

• Peter J Blankestijn, MD PhD

  Universityr Medical Center Utrecht

  STUDY CHAIR

• René A van den Dorpel, MD PhD

  Medisch Centrum Rijnmond Zuid - locatie Clara, Rotterdam

  STUDY DIRECTOR

• Michiel L Bots, MD PhD

  Julius Center for Health Sciences and Primary Care, Utrecht

  STUDY DIRECTOR

• Muriel PC Grooteman, MD PhD

  Vrije Universiteit Medical Center, Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: January 21, 2011

Record last verified: 2011-01

Locations

CA (2); NL (26); NO (1)