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Clinical Trial
. 2018 Aug 10;19(1):199.
doi: 10.1186/s12882-018-0998-y.

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

Rukshana Shroff  1 , Aysun Bayazit  2 , Constantinos J Stefanidis  3 , Varvara Askiti  3 , Karolis Azukaitis  4 , Nur Canpolat  5 , Ayse Agbas  5 , Ali Anarat  2 , Bilal Aoun  6 , Sevcan Bakkaloglu  7 , Devina Bhowruth  8 , Dagmara Borzych-Dużałka  9 , Ipek Kaplan Bulut  10 , Rainer Büscher  11 , Claire Dempster  8 , Ali Duzova  12 , Sandra Habbig  13 , Wesley Hayes  8 , Shivram Hegde  14 , Saoussen Krid  15 , Christoph Licht  16 , Mieczyslaw Litwin  17 , Mark Mayes  8 , Sevgi Mir  10 , Rose Nemec  16 , Lukasz Obrycki  17 , Fabio Paglialonga  18 , Stefano Picca  19 , Bruno Ranchin  20 , Charlotte Samaille  21 , Mohan Shenoy  22 , Manish Sinha  23 , Colette Smith  24 , Brankica Spasojevic  25 , Enrico Vidal  26 , Karel Vondrák  27 , Alev Yilmaz  28 , Ariane Zaloszyc  29 , Michel Fischbach  29 , Franz Schaefer  30 , Claus Peter Schmitt  30
Affiliations
Clinical Trial

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

Rukshana Shroff et al. BMC Nephrol. .

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.

Keywords: Cardiovascular; Carotid intima media thickness (IMT); Children; Growth; Haemodiafiltration (HDF); Haemodialysis (HD).

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Conflict of interest statement

The study was performed according to the principles of the declaration of Helsinki. It has been approved by the NRES (National Research Ethics Service) Committee London – Bloomsbury, a Research Ethics Committee established by the Health Research Authority, England. Full written informed consent has been obtained from all parents or carers, and assent from children, where applicable.

Not applicable.

The authors declare that they have no competing interests. The study was part sponsored by Fresenius Medical Care, who approved the study protocol, but had no role in data collection, data analysis or drafting the present manuscript.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
a Blood flow, expressed as litres/m2 body surface area, in children on HD and HDF with central venous lines (CVLs), arteriovenous fistulae (AVFs) and arteriovenous grafts (AVGs). b The relationship between blood flow and convection volume in children on HDF with CVLs, AVFs and AVGs. Convection volume is independent of the type of vascular access
Fig. 2
Fig. 2
Convection volume showed a linear association with blood flow, expressed as litres/m2 body surface area
See this image and copyright information in PMC

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