Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

Prevalent HDF and HD patients must achieve a single pool Kt/v>1.2 in the month preceding recruitment
Age-matched HD patients
All children 5 - 21 years age undergoing HDF in paediatric dialysis centres (incident and prevalent patients)
Prevalent HDF and HD patients must achieve a single pool Kt/v>1.2 in the month preceding recruitment
Age-matched HD patients
All children 5 - 21 years age undergoing HDF in paediatric dialysis centres (incident and prevalent patients)

Summary

Conditions
  • Children
  • Haemodiafiltration
  • Haemodialysis
Type
Observational
Design
  • Observational Model: Case-Control
  • Time Perspective: Prospective

Participation Requirements

Age
Between 5 years and 21 years
Gender
Both males and females

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 ultrafi...

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.

Inclusion Criterias

Prevalent HDF and HD patients must achieve a single pool Kt/v>1.2 in the month preceding recruitment
Age-matched HD patients
All children 5 - 21 years age undergoing HDF in paediatric dialysis centres (incident and prevalent patients)
Prevalent HDF and HD patients must achieve a single pool Kt/v>1.2 in the month preceding recruitment
Age-matched HD patients
All children 5 - 21 years age undergoing HDF in paediatric dialysis centres (incident and prevalent patients)

Locations

London, WC1N 3JH
London, WC1N 3JH

Tracking Information

NCT #
NCT02063776
Collaborators
Not Provided
Investigators
Study Chair: Rukshana C Shroff, MD FRCPCH PhD Great Ormond Street Hospital for Children NHS Foundation Trust