Comparison of pre- vs post-dilution haemadiafiltration in children
Research type
Research Study
Full title
Comparison of pre- and post-dilution haemodiafiltration modalities – effects on biocompatibility and solute clearance in children
IRAS ID
273895
Contact name
Rukshana Shroff
Contact email
Sponsor organisation
Great Ormond Street Hospital for Children NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Background: Cardiovascular morbidity and mortality are increased in children on conventional haemodialysis. Haemodiafiltration (HDF) is a newer type of dialysis which has two main types (post-dilution and pre-dilution HDF). We have shown that post-dilution HDF improves heart health, blood pressure and growth in children. Recent studies in adults have shown that pre-dilution HDF removes more kidney toxins compared to post-dilution HDF. We need more data to define the optimum dialysis modality for children.
Aims: To study if pre-dilution HDF (pre-HDF) achieves better removal of kidney toxins compared to post-dilution HDF (post-HDF).
Plan of Investigation: Children who are receiving dialysis will have a conditioning period of 4-weeks on post-HDF and then be randomized to enter either study arm A (pre-HDF, post-HDF) or B (post-HDF, pre-HDF). Each patient will be in the first study arm for 4-weeks and then switch over to the other study arm for a further period of 4-weeks. We will keep all aspects of the dialysis prescription constant between the two study arms, so that only the pre-HDF or post-HDF modality is tested. Blood tests will be taken just before and immediately after a mid-week dialysis session at 3 time points: baseline, and at the end of each 4-week treatment in arm A and arm B. The removal of kidney toxins will be compared between two types of dialysis. Assessment of blood pressure and patient wellbeing (questionnaire) will be performed at the end of each period.
Children will be recruited from 4 dialysis units (London, Istanbul, Heidelberg and Lyon) with possible extension to other centres.
Outcomes: If the results of this study demonstrate better toxin removal with pre-dilution HDF compared to post-dilution HDF, this will inform a future long-term outcome study comparing different HDF modalities and will contribute to defining the best type of dialysis for children.REC name
London - City & East Research Ethics Committee
REC reference
20/LO/0835
Date of REC Opinion
21 Jul 2020
REC opinion
Further Information Favourable Opinion