Can High Convection Volumes be Achieved in Each Patient During Online Post-dilution Hemodiafiltration?

NCT01877499 | Completed

• 3 other identifiers: METc 2013/33not available yetnot yet available
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 7

Brief Summary

Two recent randomized controlled trials (RCT) on online hemodiafiltration (HDF) did not show a treatment effect on patient survival when compared with low- or high-flux hemodialysis. Interestingly, post-hoc (on treatment) analyses from both trials unequivocally showed reduced mortality in the patient group achieving the highest convection volumes. Moreover, a third trial recently found a significant 30% decrease in mortality when HDF was applied with a mean convection volume of 23.7 L per session, which was somewhat higher than the average volumes reached in the aforementioned trials. Altogether, these findings support the concept of a dose-response effect, in which a minimally delivered convection volume is required in order to show a survival benefit. Hence, the question arises whether high convection volumes are achievable in the majority of patients. The aim of this study is thus to test the following hypothesis: high-volume (\>22 liters per treatment) post-dilution on-line hemodiafiltration (HDF) is achievable in the majority (\>75%) of patients treated with chronic intermittent hemodialysis. This will be done through the use of a dedicated standardized protocol, in which the three most important determinants of convection volume will be successively optimized: treatment time, blood flow rate and filtration fraction.

Conditions

End-stage Renal Disease; Renal Replacement Therapy; Hemodiafiltration; Convection Volume

Keywords

Hemodiafiltration; Convection volume; Filtration fraction; Blood flow; Treatment time

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a convection volume of at least 22 liters per treatment

  At the end of the step-up protocol (within 6 weeks from the start of the study)

Secondary Outcomes (4)

• Achieved convection volume

  At the end of the step-up protocol and after a 8-weeks maintenance phase

• Change in convection volume

  At the end of the step-up protocol and after a 8-weeks maintenance phase, vs. baseline

• Change in other HDF parameters

  At the end of the step-up protocol and after a 8-weeks maintenance phase, vs. baseline

• Change in dialysis system pressures

  At the end of the step-up protocol and after a 8-weeks maintenance phase, vs. baseline

Study Arms (1)

optimization of HDF key parameters

The cohort is composed of patients with end-stage renal disease receiving dialysis for at least 6 weeks, either as standard hemodialysis (low- or high-flux) or hemodiafiltration (HDF).

Other: Optimization of HDF key parameters

Interventions

Optimization of HDF key parameters OTHER

First, patients actually receiving standard dialysis will be switched to post-dilution HDF. Then, a stepwise increase in 3 key parameters of the HDF prescription will be applied in a standardized way, in order to obtain the highest achievable convection volume. Precisely, the following 3 parameters will successively be increased towards a maximal target: 1. Treatment time (up to 4 hours per session); 2. Blood flow rate (up to 400 mL/min; 3. Filtration fraction, defined as the ratio between extracted plasma water flow rate and blood flow rate (up to 33%). Maximal values for these parameters will be those achieved within pre-specified safety limits.

optimization of HDF key parameters

Eligibility Criteria

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

Study Population

Patients treated with hemodialysis or hemodiafiltration recruited at dialysis units in 6-7 hospitals in the Netherlands

You may qualify if:

• Patients treated with HD or HDF since \>6 weeks, 3 times a week;
• Patients able to understand the study procedures;
• Patients willing to provide written informed consent.

You may not qualify if:

• Current age \< 18 years;
• Severe incompliance to dialysis procedure and accompanying prescriptions (frequency and duration of dialysis treatment and fluid restriction);
• Life expectancy \< 3 months due to non-renal disease.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• UMC Utrecht: collaborator
• Julius Center: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Martini Hospital Groningen: collaborator
• Diapriva Dialysis Center, Amsterdam: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (7)

Academic Medical Center - Dianet

Amsterdam, Netherlands

Location

Diapriva Dialyse Center

Amsterdam, Netherlands

Location

VUmc

Amsterdam, Netherlands

Location

Catharina Hospital

Eindhoven, Netherlands

Location

Martini Hospital

Groningen, Netherlands

Location

Maasstad Hospital

Rotterdam, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (4)

• Grooteman MP, van den Dorpel MA, Bots ML, Penne EL, van der Weerd NC, Mazairac AH, den Hoedt CH, van der Tweel I, Levesque R, Nube MJ, ter Wee PM, Blankestijn PJ; CONTRAST Investigators. Effect of online hemodiafiltration on all-cause mortality and cardiovascular outcomes. J Am Soc Nephrol. 2012 Jun;23(6):1087-96. doi: 10.1681/ASN.2011121140. Epub 2012 Apr 26.

  PMID: 22539829 BACKGROUND

• Ok E, Asci G, Toz H, Ok ES, Kircelli F, Yilmaz M, Hur E, Demirci MS, Demirci C, Duman S, Basci A, Adam SM, Isik IO, Zengin M, Suleymanlar G, Yilmaz ME, Ozkahya M; Turkish Online Haemodiafiltration Study. Mortality and cardiovascular events in online haemodiafiltration (OL-HDF) compared with high-flux dialysis: results from the Turkish OL-HDF Study. Nephrol Dial Transplant. 2013 Jan;28(1):192-202. doi: 10.1093/ndt/gfs407. Epub 2012 Dec 9.

  PMID: 23229932 BACKGROUND

• Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Carreras J, Soler J, Torres F, Campistol JM, Martinez-Castelao A; ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013 Feb;24(3):487-97. doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14.

  PMID: 23411788 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 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

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

• Peter J Blankestijn, MD PhD

  UMC Utrecht

  STUDY DIRECTOR

• Michiel L Bots, MD PhD

  Julius Center for Health Sciences and Primary Care, UMC Utrecht

  STUDY DIRECTOR

• Marinus A van den Dorpel, MD PhD

  Maasstad Hospital, Rotterdam

  STUDY DIRECTOR

• Menso J Nubé, MD PhD

  Amsterdam UMC, location VUmc

  STUDY CHAIR

• Piet M ter Wee, MD PhD

  Amsterdam UMC, location VUmc

  STUDY DIRECTOR

• Muriel PC Grooteman, MD PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internist-nephrologist

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 13, 2013
• Study Start: March 28, 2013
• Primary Completion: March 6, 2015
• Study Completion: June 30, 2015
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

NL (7)