This trial is active, not recruiting.

Conditions children, haemodialysis, haemodiafiltration
Sponsor Great Ormond Street Hospital for Children NHS Foundation Trust
Start date February 2014
End date May 2017
Trial size 150 participants
Trial identifier NCT02063776, 13NU02


Children on conventional haemodialysis (HD) die of heart disease. Also, they can be malnourished and short. Haemodiafiltration (HDF) is a newer type of dialysis that achieves better removal of toxins and excess fluid than HD. On HDF, adults have a longer survival and children show improved growth, but mechanisms are not understood.

We will follow children in the UK and Europe to compare HDF and HD. We will monitor growth, heart and blood vessel scans, blood markers and quality of life. If the 3H (HDF-Hearts-Height) study shows reduced cardiovascular morbidity and better growth, HDF may be adopted as the preferred type of dialysis in children.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

1. Change in carotid artery intima-media thickness (cIMT) standard deviation score (SDS)
time frame: 12 months
Change in height SDS
time frame: 12 months

Secondary Outcomes

For nutritional status 1. Body mass index SDS 2. Markers of appetite regulation and nutritional status
time frame: 6 months
For cardiovascular status 1. 24-hour mean arterial BP SDS 2. Left ventricular mass index 3. Pulse wave velocity SDS 4. Biomarkers of cardiovascular disease
time frame: 12 months
Quality of life (QoL) questionnaires
time frame: 12 months

Eligibility Criteria

Male or female participants from 5 years up to 21 years old.

Inclusion Criteria: 1. All children 5 - 21 years age undergoing HDF in paediatric dialysis centres (incident and prevalent patients) 2. Age-matched HD patients 3. Prevalent HDF and HD patients must achieve a single pool Kt/v>1.2 in the month preceding recruitment Exclusion Criteria: 1. Children in whom a living donor kidney transplant is planned within 6-months of start of dialysis

Additional Information

Official title The Effects of Haemodiafiltration (HDF) vs Conventional Haemodialysis (HD) on Growth and Cardiovascular Markers in Children - 3H (HDF, Hearts and Height) Study
Description Background: Children on conventional haemodialysis (HD) have a 1000-fold higher mortality than their healthy peers and can have malnutrition and growth retardation. Haemodiafiltration (HDF) achieves better clearance of uraemic solutes across a wide molecular-weight range and performs greater ultrafiltration than conventional HD. Randomised controlled trials in adults have shown 35-45% improved survival and reduced cardiovascular mortality on HDF with high convection volumes. Excellent catch-up growth has been demonstrated in children on HDF, but mechanisms are poorly understood. Hypothesis: HDF improves the cardiovascular risk profile, growth and quality of life (QoL) compared to conventional HD. Primary outcome measures are carotid intima-media thickness (cIMT) and height standard deviation score (SDS). Plan of investigation: Incident and prevalent patients on HDF or HD who are expected to remain on dialysis for >6-months and who have a single pool Kt/v>1.2 will be compared in a 1:1 study design. Anthropometric measures (height SDS, body mass index SDS) and QoL questionnaires will be monitored at baseline and 6-monthly. Cardiovascular measures (cIMT, pulse wave velocity, left ventricular mass index and 24-hour BP) will be measured annually. 6-monthly blood tests will measure nutritional biomarkers, mineral dysregulation, inflammation and middle-molecule clearance. Outcome measures will be standardised to the convective clearance dose per m2 body surface area. Recruitment will continue for 2½ years with minimum follow-up of 6-months. Children will be recruited from all UK dialysis units, but small patient numbers (10-12/year) necessitate collaborations with European centres. HDF and HD patients across Europe who are part of the Cardiovascular Comorbidity in Childhood CKD (4C) study will be included and vascular scans will be captured from this study. From ESPN/ERA-EDTA registry data we estimate ~100 children on HDF over the study period. Outcomes: If the 3H (HDF-Hearts-Height) study shows that HDF reduces cardiovascular morbidity and improves growth it may lead to HDF being adopted as the standard for in-centre dialysis.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Great Ormond Street Hospital for Children NHS Foundation Trust.