Abstract
BackgroundIncremental haemodialysis/haemodiafiltration (HD) may help reduce early mortality rates in patients starting HD. This mixed-method feasibility study aims to test the acceptability, tolerance and safety of a novel incremental HD regime, and to study its impact on parameters of patient wellbeing.MethodWe aim to enrol 20 patients who will commence HD twice-weekly with progressive increases in duration and frequency, achieving conventional treatment times over 15 weeks (incremental group). Participants will be followed-up for 6 months and will undergo regular tests including urine collections, bio-impedance analyses and quality-of-life questionnaires. Semi-structured interviews will be conducted to explore patients’ prior expectations from HD, their motivations for participation and experiences of receiving incremental HD. For comparison of safety and indicators of dialysis adequacy, a cohort of 40 matched patients who previously received conventional HD will be constructed from local dialysis records (historical controls).ResultsData will be recorded on the numbers screened and proportions consented and completing the study (primary outcome). Incremental and conventional groups will be compared in terms of differences in blood pressure control, interdialytic weight changes, indicators of dialysis adequacy and differences in adverse and serious adverse events. In analyses restricted to incremental group, measurements of RRF, fluid load and quality-of-life during follow-up will be compared with baseline values. From patient interviews, a narrative description of key themes along with anonymised quotes will be presented.ConclusionResults from this study will address a significant knowledge gap in the prescription HD therapy and inform the development novel future therapy regimens.
Highlights
In patients with advanced chronic kidney disease (CKD), the start of haemodialysis/haemodiafiltration (HD) therapy marks the start of a critical transitional period
Its role in estimating GFR in new HD starters remains unexplored and the current study presents a unique opportunity to correlate RRF estimates from Cystatin C levels and urine collections over the first 6 months of dialysis
We have proposed a novel and pragmatic study that simplifies incremental HD by focusing on key elements of patient welfare and safety using commonly used measures in the care of dialysis patients
Summary
In patients with advanced chronic kidney disease (CKD), the start of haemodialysis/haemodiafiltration (HD) therapy marks the start of a critical transitional period. A randomised control trial (RCT), testing incremental HD vs standard care will be needed to definitively address if starting HD incrementally reduces mortality in. The level of patient interest and demand for incremental HD require further exploration This information is needed for planning of resources in the future RCT. D. Given the time constraints that come with the delivery of each dialysis session and the already high frequency of patient exposure to healthcare environment, which additional tests should be included in the future RCT to help fully understand the impact of incremental HD on patient’s health. To pave the way for a future RCT of incremental HD vs standard care, a feasibility study is being conducted which aims to establish the acceptability, tolerance and safety of a novel incremental HD regime; and to explore the feasibility of data collection and follow-up of the participants
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