Hull York Medical School, Hull, UK.
Hull University Teaching Hospitals NHS Trust, Anlaby Road, Hull, HU3 2JZ, UK.
Clin Exp Nephrol. 2021 Oct;25(10):1131-1141. doi: 10.1007/s10157-021-02072-1. Epub 2021 Jun 8.
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.
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).
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.
Results from this study will address a significant knowledge gap in the prescription HD therapy and inform the development novel future therapy regimens.
递增式血液透析/血液透析滤过（HD）可能有助于降低开始 HD 治疗的患者的早期死亡率。本混合方法可行性研究旨在测试新型递增式 HD 方案的可接受性、耐受性和安全性，并研究其对患者健康相关参数的影响。
我们计划招募 20 名患者，他们将每周接受两次 HD 治疗，逐渐延长治疗时间和增加治疗频率，在 15 周内达到常规治疗时间（递增组）。参与者将接受 6 个月的随访，并定期进行尿液收集、生物阻抗分析和生活质量问卷等检查。将进行半结构化访谈，以探讨患者对 HD 的先前期望、参与的动机以及接受递增式 HD 的体验。为了比较安全性和透析充分性指标，将从当地透析记录中构建一个由 40 名匹配的先前接受常规 HD 治疗的患者组成的队列（历史对照）。
将记录筛选人数、同意并完成研究的比例（主要结局）。递增组和常规组将在血压控制、透析间体重变化、透析充分性指标以及不良和严重不良事件方面的差异进行比较。在对递增组进行的分析中，将比较随访期间 RRF、液体负荷和生活质量的测量值与基线值。从患者访谈中，将呈现主要主题的叙述描述以及匿名引用。
本研究的结果将解决 HD 治疗方案中的一个重要知识空白，并为新型未来治疗方案的开发提供信息。
