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.

A and P Kyriakou Children's Hospital Athens Greece

Armand Trousseau Hospital Paris France

Bambino Gesù' Children Research Hospital IRCCS Rome Italy

Center for Pediatrics and Adolescent Medicine Heidelberg Germany

Cerrahpasa School of Medicine Istanbul Turkey

Children's Dialysis Center Strasbourg France

Children's Memorial Health Institute Warsaw Poland

Clinic of Paediatrics Vilnius University Vilnius Lithuania

Cukurova University Adana Turkey

Ege University Faculty of Medicine Izmir Turkey

Evelina Children's Hospital London UK

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy

Gazi University Hospital Ankara Turkey

Great Ormond Street Hospital for Children NHS Foundation Trust London WC1N 3JH UK

Hacettepe University Ankara Turkey

Hôpital Femme Mère Enfant Hospices Civils de Lyon Bron France

Hôpital Jeanne De Flandre Lille Cedex France

Hôpital Necker Enfants Malades Paris France

Hospital for Sick Children Toronto Canada

Institute for Global Health UCL London UK

Istanbul University Faculty of Medical Istanbul Turkey

Medical University of Gdansk Gdansk Poland

Pediatric Dialysis and Transplant Unit Padova Italy

Royal Manchester Children's Hospital Manchester UK

University Children Hospital Essen Essen Germany

University Children's Hospital Belgrade Serbia

University Hospital Cologne Cologne Germany

University Hospital Motol Prague Czech Republic

University Hospital of Wales Cardiff UK

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ClinicalTrials.gov
NCT02063776