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BMC Nephrology
Published in: BMC Nephrology 1/2018

Open Access 01-12-2018 | Study protocol

Effect of haemodiafiltration vs conventional haemodialysis on growth and cardiovascular outcomes in children – the HDF, heart and height (3H) study

Authors: Rukshana Shroff, Aysun Bayazit, Constantinos J. Stefanidis, Varvara Askiti, Karolis Azukaitis, Nur Canpolat, Ayse Agbas, Ali Anarat, Bilal Aoun, Sevcan Bakkaloglu, Devina Bhowruth, Dagmara Borzych-Dużałka, Ipek Kaplan Bulut, Rainer Büscher, Claire Dempster, Ali Duzova, Sandra Habbig, Wesley Hayes, Shivram Hegde, Saoussen Krid, Christoph Licht, Mieczyslaw Litwin, Mark Mayes, Sevgi Mir, Rose Nemec, Lukasz Obrycki, Fabio Paglialonga, Stefano Picca, Bruno Ranchin, Charlotte Samaille, Mohan Shenoy, Manish Sinha, Colette Smith, Brankica Spasojevic, Enrico Vidal, Karel Vondrák, Alev Yilmaz, Ariane Zaloszyc, Michel Fischbach, Franz Schaefer, Claus Peter Schmitt

Published in: BMC Nephrology | Issue 1/2018

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Abstract

Background

Cardiovascular disease is prevalent in children on dialysis and accounts for almost 30% of all deaths. Randomised trials in adults suggest that haemodiafiltration (HDF) with high convection volumes is associated with reduced cardiovascular mortality compared to high-flux haemodialysis (HD); however paediatric data are scarce. We designed the haemodiafiltration, heart and height (3H) study to test the hypothesis that children on HDF have an improved cardiovascular risk profile, growth and nutritional status and quality of life, compared to those on conventional HD.
We performed a non-randomised parallel-arm intervention study within the International Paediatric Haemodialysis Network Registry comparing children on HDF and conventional HD to determine annualised change in cardiovascular end-points and growth. Here we present the 3H study design and baseline characteristics of the study population.

Methods

190 children were screened and 177 (106 on HD and 71 on HDF) recruited from 28 centres in 10 countries. There was no difference in age, underlying diagnosis, comorbidities, previous dialysis therapy, dialysis vintage, residual renal function, type of vascular access or blood flow between HD and HDF groups. High flux dialysers were used in 63% of HD patients and ultra-pure water was available in 52%. HDF patients achieved a median convection volume of 13.3 L/m2; this was associated with the blood flow rate only ((p = 0.0004, r = 0.42) and independent of access type (p = 0.38).

Discussion

This is the largest study on dialysis outcomes in children that involves deep phenotyping across a wide range of cardiovascular, anthropometric, nutritional and health-related quality of life measures, to test the hypothesis that HDF leads to improved cardiovascular and growth outcomes compared to conventional HD.

Trial registration

ClinicalTrials.gov: NCT02063776. The trial was prospectively registered on the 14 Feb 2014.
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Metadata
Title
Effect of haemodiafiltration vs conventional haemodialysis on growth and cardiovascular outcomes in children – the HDF, heart and height (3H) study
Authors
Rukshana Shroff
Aysun Bayazit
Constantinos J. Stefanidis
Varvara Askiti
Karolis Azukaitis
Nur Canpolat
Ayse Agbas
Ali Anarat
Bilal Aoun
Sevcan Bakkaloglu
Devina Bhowruth
Dagmara Borzych-Dużałka
Ipek Kaplan Bulut
Rainer Büscher
Claire Dempster
Ali Duzova
Sandra Habbig
Wesley Hayes
Shivram Hegde
Saoussen Krid
Christoph Licht
Mieczyslaw Litwin
Mark Mayes
Sevgi Mir
Rose Nemec
Lukasz Obrycki
Fabio Paglialonga
Stefano Picca
Bruno Ranchin
Charlotte Samaille
Mohan Shenoy
Manish Sinha
Colette Smith
Brankica Spasojevic
Enrico Vidal
Karel Vondrák
Alev Yilmaz
Ariane Zaloszyc
Michel Fischbach
Franz Schaefer
Claus Peter Schmitt
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Nephrology / Issue 1/2018
Electronic ISSN: 1471-2369
DOI
https://doi.org/10.1186/s12882-018-0998-y

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