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

Abstract

BackgroundCardiovascular 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.Methods190 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).DiscussionThis 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 registrationClinicalTrials.gov: NCT02063776. The trial was prospectively registered on the 14 Feb 2014.

Effects of Hemodiafiltration versus Conventional Hemodialysis in Children with ESKD: The HDF, Heart and Height Study

“…Details of the dialysis procedures, study organization, investigational plan, data acquisition and handling, and statistical analyses have been previously described. 29 The trial is registered with Clinicaltrials.gov, under identifier NCT02063776. This study was performed in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines and was approved by both a central medical research committee and local ethics boards at each participating center.…”

“…Multiple exploratory end points relating to cardiovascular measures, nutrition, growth, and quality of life were assessed as previously described. 29…”

“…Standardized procedures for HD and HDF were provided. 29 Efforts to achieve the highest possible blood flow rate in both groups, and a target convection volume of 12-15 L/m 2 body surface area in the HDF cohort was aimed for. Ultrapure dialysate (defined as containing ,0.1 CFU/ml and ,0.03 endotoxin unit/ml) was used for all HDF and some HD procedures…”

“…A detailed statistical analysis plan is previously described 29 and detailed in the Supplemental Material. and Czech Republic, two).…”

“…We performed a multicenter, prospective, observational cohort study to test the hypothesis that HDF dialysis modality is associated with an improved cardiovascular risk profile, growth, and quality of life, compared with use of conventional HD in children. 29 The HDF, Heart and Height (3H) study includes the largest cohort of children and adolescents on dialysis to date, and compares cardiac and vascular function, growth, biochemical markers, and patient-related outcome measures in children receiving postdilution online HDF versus conventional HD.…”