H4RT
Research type
Research Study
Full title
The High-volume Haemodiafiltration vs High-flux Haemodialysis Registry Trial
IRAS ID
227067
Contact name
Fergus Caskey
Contact email
Sponsor organisation
Research and Innovation, North Bristol NHS Trust
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
End-stage kidney disease (ESKD) affects ~55,000 people in the UK, with ~7,000 newly affected people each year. It ranks among the most severe of the chronic non-communicable diseases. Morbidity is high, with dialysis patients in the UK admitted to hospital on average ~1.5-2.0 times per year and spending ~15 days in hospital per year. Quality of life on dialysis is also well below that of the general population. There is therefore an unmet and urgent need to improve ESKD patient treatment.\n\nRenal replacement therapy (dialysis or transplantation) is necessary when patients become symptomatic of ESKD. Currently ~90% of dialysis patients are on some form of haemodialysis (HD) or haemodiafiltration (HDF). Although HD and HDF can be performed at home, the majority is performed in-centre.\n\nTreating the 25,000 people on HD costs around £500m of NHS spending each year, with a further £75m spent on hospital admissions and £50m on transport to and from dialysis. Half of patients now starting dialysis are 65 years or older and less likely to be fit for kidney transplantation and in the general population this group is predicted to increase by 60% (from 10.3m to 16.9m) by 2035. While preventing ESKD in the first place should remain a priority, the optimal form of dialysis will remain highly relevant to the NHS.\n\nWe aim to establish the effectiveness and cost-effectiveness of high-volume HDF compared with high-flux HD in adult patients with ESKD on maintenance thrice weekly in-centre HD. We will do this by running a randomised controlled trial using non-cancer mortality or hospital admission due a cardiovascular event or infection as our primary outcome. \n
REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0391
Date of REC Opinion
23 Aug 2017
REC opinion
Favourable Opinion