Abstract
Background
More than a third of the 65,000 people living with kidney failure in the UK attend a dialysis unit 2-5 times a week to have their blood cleaned for 3-5 hours. In haemodialysis (HD) toxins are removed by diffusion, which can be enhanced using a high-flux dialyser. This can be augmented with convection, as occurs in haemodiafiltration (HDF) and improved outcomes have been reported in people who are able to achieve high volumes of convection. This study compares the clinical- and cost-effectiveness of high-volume HDF compared with high-flux HD in the treatment of kidney failure.
Methods
This is a UK-based, multi-centre, non-blinded randomised controlled trial. Adult patients already receiving HD or HDF will be randomised 1:1 to high-volume HDF (aiming for 21+L of substitution fluid adjusted for body surface area) or high-flux HD. Exclusion criteria include lack of capacity to consent, life expectancy less than 3 months, on HD/HDF for less than 4 weeks, planned living kidney donor transplant or home dialysis scheduled within 3 months, prior intolerance of HDF, and not suitable for high-volume HDF for other clinical reasons. The primary outcome is a composite of non-cancer mortality or hospital admission with a cardiovascular event or infection during follow-up (minimum 32 months, maximum 91 months) determined from routine data. Secondary outcomes include all-cause mortality, cardiovascular and infection related morbidity and mortality, health-related quality of life, cost-effectiveness and environmental impact. Baseline data will be collected by research personnel on-site. Follow up data will be collected by linkage to routine healthcare databases – Hospital Episode Statistics, Civil Registration, Public Health England, and the UK Renal Registry (UKRR) in England, and equivalent databases in Scotland and Wales, as necessary – and centrally administered patient completed questionnaires. In addition, research personnel on-site will monitor for adverse events and collect data on adherence to the protocol (monthly during recruitment and quarterly during follow-up).
Discussion
This study will provide evidence of the effectiveness and cost effectiveness of HD as compared to HDF for adults with kidney failure in-centre HD or HDF. It will inform management for this patient group in the UK and internationally.
More than a third of the 65,000 people living with kidney failure in the UK attend a dialysis unit 2-5 times a week to have their blood cleaned for 3-5 hours. In haemodialysis (HD) toxins are removed by diffusion, which can be enhanced using a high-flux dialyser. This can be augmented with convection, as occurs in haemodiafiltration (HDF) and improved outcomes have been reported in people who are able to achieve high volumes of convection. This study compares the clinical- and cost-effectiveness of high-volume HDF compared with high-flux HD in the treatment of kidney failure.
Methods
This is a UK-based, multi-centre, non-blinded randomised controlled trial. Adult patients already receiving HD or HDF will be randomised 1:1 to high-volume HDF (aiming for 21+L of substitution fluid adjusted for body surface area) or high-flux HD. Exclusion criteria include lack of capacity to consent, life expectancy less than 3 months, on HD/HDF for less than 4 weeks, planned living kidney donor transplant or home dialysis scheduled within 3 months, prior intolerance of HDF, and not suitable for high-volume HDF for other clinical reasons. The primary outcome is a composite of non-cancer mortality or hospital admission with a cardiovascular event or infection during follow-up (minimum 32 months, maximum 91 months) determined from routine data. Secondary outcomes include all-cause mortality, cardiovascular and infection related morbidity and mortality, health-related quality of life, cost-effectiveness and environmental impact. Baseline data will be collected by research personnel on-site. Follow up data will be collected by linkage to routine healthcare databases – Hospital Episode Statistics, Civil Registration, Public Health England, and the UK Renal Registry (UKRR) in England, and equivalent databases in Scotland and Wales, as necessary – and centrally administered patient completed questionnaires. In addition, research personnel on-site will monitor for adverse events and collect data on adherence to the protocol (monthly during recruitment and quarterly during follow-up).
Discussion
This study will provide evidence of the effectiveness and cost effectiveness of HD as compared to HDF for adults with kidney failure in-centre HD or HDF. It will inform management for this patient group in the UK and internationally.
| Original language | English |
|---|---|
| Article number | 532 |
| Journal | Trials |
| Volume | 23 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 27 Jun 2022 |
Bibliographical note
Funding Information:This study was designed and delivered in collaboration with the Bristol Randomised Trials Collaboration, a UKCRC-registered clinical trial unit which, as part of the Bristol Trials Centre, is in receipt of the National Institute for Health Research CTU support funding. The authors would like to thank all participants, PIs and their teams at each H4RT study site for their involvement. The authors would also like to thank the TSC, DMC and PAG. FC is the CI; he conceived the study, led the proposal and protocol development, contributed to writing the manuscript and approved the final version for publication. SP is the trial manager; she has supported all aspects of trial design and delivery. JT is the senior trial manager and has provided oversight for trial delivery and governance-related aspects. JAL was the lead trial methodologist; she has supported all aspects of the trial design and delivery. LR, JW and JD led on the QRI, including input to the protocol and analysis plan and trial delivery. YL and SMac led on statistical aspects of developing the protocol and analysis plan. AA and WH led on health economics aspects of developing the protocol and analysis plan. KL led on patient and public involvement aspects of the development of the protocol. YBS led on epidemiological aspects of developing the protocol and analysis plan. AD, KF, SMi, AP and DW provided clinical input into the study design, intervention and protocol development. All named authors adhere to the authorship guidelines of Trials. All authors have approved the final manuscript and agreed to publication. This project was funded by the NIHR Research Health Technology Assessment Programme (project 15/80/52). The funding body had no role in the design of the study, the collection of data or the writing of this paper, nor will the funding body have a role in the analysis, interpretation of data or writing of future manuscripts. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health and Social Care. The University of Bristol will hold the final dataset. External groups will be able to apply to the trial management group to request access to anonymised patient-level data, as permitted by the data sharing agreements for data that has been provided through linkage.
Funding Information:
This project was funded by the NIHR Research Health Technology Assessment Programme (project 15/80/52). The funding body had no role in the design of the study, the collection of data or the writing of this paper, nor will the funding body have a role in the analysis, interpretation of data or writing of future manuscripts. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health and Social Care.
Publisher Copyright:
© 2022, The Author(s).
Research Groups and Themes
- HEHP@Bristol
Keywords
- Adult
- Cost-Benefit Analysis
- Delivery of Health Care
- Hemodiafiltration/adverse effects
- Humans
- Kidney Failure, Chronic/diagnosis
- Quality of Life
- Registries
- Renal Dialysis/adverse effects
- Renal Insufficiency/etiology
Access to Document
- Full-text PDF (final published version)
This is the final published version of the article (version of record). It first appeared online via BMC at https://doi.org/10.1186/s13063-022-06357-y . Please refer to any applicable terms of use of the publisher.