A mixed-method feasibility study of a novel transitional regime of incremental haemodialysis: study design and protocol

Abstract

<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>Incremental 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. </jats:p> </jats:sec><jats:sec> <jats:title>Method</jats:title> <jats:p>We 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). </jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>Data 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.</jats:p> </jats:sec><jats:sec> <jats:title>Conclusion</jats:title> <jats:p>Results from this study will address a significant knowledge gap in the prescription HD therapy and inform the development novel future therapy regimens. </jats:p> </jats:sec>