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

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

Interventions

OTHER

Optimization of HDF key parameters

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.

Sponsors & Collaborators

• UMC Utrecht

  collaborator OTHER

• Julius Center

  collaborator OTHER

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Martini Hospital Groningen

  collaborator OTHER

• Diapriva Dialysis Center, Amsterdam

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Amsterdam UMC, location VUmc

  lead OTHER

Principal Investigators

• Peter J Blankestijn, MD PhD · UMC Utrecht

• Michiel L Bots, MD PhD · Julius Center for Health Sciences and Primary Care, UMC Utrecht

• Marinus A van den Dorpel, MD PhD · Maasstad Hospital, Rotterdam

• Menso J Nubé, MD PhD · Amsterdam UMC, location VUmc

• Piet M ter Wee, MD PhD · Amsterdam UMC, location VUmc

• Muriel PC Grooteman, MD PhD · Amsterdam UMC, location VUmc

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-03-28

Primary Completion

2015-03-06

Completion

2015-06-30

Countries

• Netherlands

Study Locations