Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Renal unit, Southmead Hospital, North Bristol NHS Trust, Bristol, BS10 5NB, UK.
Trials. 2022 Jun 27;23(1):532. doi: 10.1186/s13063-022-06357-y.
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 h. 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.
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).
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.
ISRCTN10997319 . Registered on 10 October 2017.
在英国，超过 65000 名肾衰竭患者每周接受 2-5 次透析，每次透析时长 3-5 小时，以清除血液中的毒素。在血液透析（HD）中，毒素通过扩散被清除，使用高通量透析器可以增强这种扩散效果。在血液透析滤过（HDF）中，对流可以增强扩散效果，并且已经有研究报道称，能够实现高对流量的患者的治疗效果更好。本研究比较了大容量 HDF 与高通量 HD 在肾衰竭治疗中的临床效果和成本效益。
这是一项英国多中心、非盲随机对照试验。已接受 HD 或 HDF 治疗的成年患者将被随机分为 1:1 组，分别接受大容量 HDF（目标为 21+L 基于体表面积调整的替代液）或高通量 HD 治疗。排除标准包括无能力同意、预期寿命不足 3 个月、HD/HDF 治疗不足 4 周、计划在 3 个月内进行活体供肾移植或家庭透析、既往对 HDF 不耐受以及由于其他临床原因不适合大容量 HDF。主要结局是从常规数据中确定的随访期间（最短 32 个月，最长 91 个月）的非癌症死亡率或心血管事件或感染导致的住院复合终点。次要结局包括全因死亡率、心血管和感染相关发病率和死亡率、健康相关生活质量、成本效益和环境影响。基线数据将由现场研究人员收集。通过与常规医疗保健数据库（英格兰的医院入院统计、民事登记、英国公共卫生部和英国肾脏登记处（UKRR），以及苏格兰和威尔士的必要情况下的等效数据库）的链接以及中央管理的患者完成的调查问卷收集随访数据。此外，现场研究人员将监测不良事件并收集遵守方案的数据（招募期间每月一次，随访期间每季度一次）。
本研究将提供 HD 与 HDF 相比在中心 HD 或 HDF 治疗肾衰竭成人患者中的有效性和成本效益证据。这将为英国和国际上的该患者群体的管理提供信息。
ISRCTN82106046。于 2017 年 10 月 10 日注册。
