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

Great Ormond Street Hospital for Children NHS Foundation Trust, London, WC1N 3JH, UK. Rukshana.Shroff@gosh.nhs.uk. Cukurova University, Adana, Turkey. A & P Kyriakou Children's Hospital, Athens, Greece. Clinic of Paediatrics, Vilnius University, Vilnius, Lithuania. Cerrahpasa School of Medicine, Istanbul, Turkey. Armand Trousseau Hospital, Paris, France. Gazi University Hospital, Ankara, Turkey. Great Ormond Street Hospital for Children NHS Foundation Trust, London, WC1N 3JH, UK. Medical University of Gdansk, Gdansk, Poland. Ege University Faculty of Medicine, Izmir, Turkey. University Children Hospital Essen, Essen, Germany. Hacettepe University, Ankara, Turkey. University Hospital Cologne, Cologne, Germany. University Hospital of Wales, Cardiff, UK. Hôpital Necker-Enfants Malades, Paris, France. Hospital for Sick Children, Toronto, Canada. Children's Memorial Health Institute, Warsaw, Poland. Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. Bambino Gesù' Children Research Hospital, IRCCS, Rome, Italy. Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Bron, France. Hôpital Jeanne De Flandre, Lille Cedex, France. Royal Manchester Children's Hospital, Manchester, UK. Evelina Children's Hospital, London, UK. Institute for Global Health, UCL, London, UK. University Children's Hospital, Belgrade, Serbia. Pediatric Dialysis and Transplant Unit, Padova, Italy. University Hospital Motol, Prague, Czech Republic. Istanbul University Faculty of Medical, Istanbul, Turkey. Children's Dialysis Center, Strasbourg, France. Center for Pediatrics and Adolescent Medicine, Heidelberg, Germany.

BMC nephrology. 2018;(1):199
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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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