Incremental start of haemodialysis versus standard care
Research type
Research Study
Full title
Effect of incremental introduction of dialysis versus standard care in patients with end-stage renal disease (ENDURE): a feasibility study
IRAS ID
257151
Contact name
Adil Hazara
Contact email
Sponsor organisation
Hull and East Yorkshire Hospitals NHS Trust
Duration of Study in the UK
3 years, 0 months, 31 days
Research summary
Summary of Research
Patients who start haemodialysis (HD) therapy for end-stage renal disease (ESRD) are at risk of increased mortality in the first 6 months of starting treatment. One reason suggested for this may be that abruptly starting HD at ‘full dose’ may be too intense. Starting HD in a more gradual fashion (incrementally) may mitigate some of the risks. A large randomised controlled trial of incremental HD (vs. conventional treatment) is not yet possible due to the complexities involved in setting up such a trial.The objective of this feasibility study is to demonstrate the acceptability, tolerance and safety of starting patients on HD using an incremental approach. Over a period of 18-months, we aim to start 40 patients on an incremental HD regime (incremental HD group). Their outcomes will be compared to a cohort of 40 matched patients who previously started HD in the conventional manner (historical cohort, conventional HD group). All patients will be followed-up for 12 months after their first dialysis.
Acceptability and tolerance will be gauged by documenting rates of participation and retention in the study, and the rates of completion of various tests performed as part of the study. These include 24-hour urine collection to measure residual renal function (RRF), estimation of fluid load using bio-impedance, quality-of-life questionnaire and six-minute walk test to monitor performance status. Blood tests for estimation of RRF and markers of renal anaemia, bone disease and cardiac load will be performed at regular intervals on HD and will be compared to conventional HD group. The numbers of pre-defined safety events will be documented. We will test the feasibility of using deaths (or a combination of deaths and cardiovascular events) as the main outcome measure in a future definitive trial; our data should enable us to calculate sample size for a future trial.
Summary of Results
: Background: The start of haemodialysis (HD) treatment can be a difficult time for patients with advanced kidney conditions. Early patient outcomes, in the weeks and months after the start of dialysis treatment, can be poor in these early days and may be related to the intensity of dialysis at the start. Starting HD with reduced frequency, with planned increments in treatment as any remaining kidney function declines, is termed incremental HD; it may provide a less demanding course to full treatment.
Aims: To introduce a novel transitional regime of incremental HD, to contextualise its use against current global practices, and to pave the way towards a randomised controlled trial (RCT) by studying its feasibility.
Methods: A systematic review of the global literature has been conducted examining different approaches to practicing incremental HD. Then, an evaluation of the feasibility of this new incremental HD regime has been conducted; it aims to set patients on long-term HD in four pre-specified incremental steps (Phases 1 to 4) over 14 weeks. We have used an approach called ‘mixed-method’ evaluations, which has enabled us to integrate both the quantitative (i.e., studying outcomes in numbers and figures) and qualitative information (i.e., analysis of the experiences of participants) regarding the new regime.
Findings: Systematic review (14 studies; 91,928 participants) showed incremental HD practices vary widely. Survival is comparable in recipients of incremental and standard HD; limited data suggests incremental HD’s superiority when treatment goals are pre-specified. In the feasibility study, 127 patients were screened over 18-months; eligible: 54 (43%); enrolled: 25 (46% of eligible). 15 started HD within the study timeframe; 14 were retained until 6-months. In 13, the regime was altered (mostly during Phase 2) for clinical or scheduling reasons. Comparative analyses, with historical matched controls (n=29), revealed no signals for harm in clinical and laboratory parameters in incremental HD recipients. In semi-structured interviews (n=11), participants overwhelmingly liked the gradual HD introduction as an aid to becoming normalised to dialysis routines; they were very positive about their interactions with the research process and would recommend incremental HD to others.
Conclusion: There is high patient demand for incremental HD. It is feasible to enrol and retain participants in the proposed programme. Alterations to treatment do not associate with adverse patient experiences; the regime may be implemented flexibly. Given that there no signals that our version of incremental HD was inferior to standard care, it is feasible to progress to full RCT with some modifications.REC name
West of Scotland REC 4
REC reference
19/WS/0019
Date of REC Opinion
19 Mar 2019
REC opinion
Further Information Favourable Opinion