夜生活研究 - 采用混合方法评估每周三次、延长、中心夜间血液透析与日间血液透析的临床和成本效益：一项随机对照试验研究方案。

The NightLife study - the clinical and cost-effectiveness of thrice-weekly, extended, in-centre nocturnal haemodialysis versus daytime haemodialysis using a mixed methods approach: study protocol for a randomised controlled trial.

机构信息

Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.

John Walls Renal Unit, University Hospitals of Leicester NHS Trust, Leicester, UK.

出版信息

Trials. 2023 Aug 12;24(1):522. doi: 10.1186/s13063-023-07565-w.

DOI:10.1186/s13063-023-07565-w

PMID:37573352

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10422763/

Abstract

BACKGROUND

In-centre nocturnal haemodialysis (INHD) offers extended-hours haemodialysis, 6 to 8 h thrice-weekly overnight, with the support of dialysis specialist nurses. There is increasing observational data demonstrating potential benefits of INHD on health-related quality of life (HRQoL). There is a lack of randomised controlled trial (RCT) data to confirm these benefits and assess safety.

METHODS

The NightLife study is a pragmatic, two-arm, multicentre RCT comparing the impact of 6 months INHD to conventional haemodialysis (thrice-weekly daytime in-centre haemodialysis, 3.5-5 h per session). The primary outcome is the total score from the Kidney Disease Quality of Life tool at 6 months. Secondary outcomes include sleep and cognitive function, measures of safety, adherence to dialysis and impact on clinical parameters. There is an embedded Process Evaluation to assess implementation, health economic modelling and a QuinteT Recruitment Intervention to understand factors that influence recruitment and retention. Adults (≥ 18 years old) who have been established on haemodialysis for > 3 months are eligible to participate.

DISCUSSION

There are 68,000 adults in the UK that need kidney replacement therapy (KRT), with in-centre haemodialysis the treatment modality for over a third of cases. HRQoL is an independent predictor of hospitalisation and mortality in individuals on maintenance dialysis. Haemodialysis is associated with poor HRQoL in comparison to the general population. INHD has the potential to improve HRQoL. Vigorous RCT evidence of effectiveness is lacking. The NightLife study is an essential step in the understanding of dialysis therapies and will guide patient-centred decisions regarding KRT in the future.

TRIAL REGISTRATION

Trial registration number: ISRCTN87042063. Registered: 14/07/2020.

摘要

背景

中心夜间血液透析（INHD）提供了扩展时间血液透析，每周三次，夜间 6 至 8 小时，由透析专科护士提供支持。越来越多的观察性数据表明 INHD 对健康相关生活质量（HRQoL）有潜在益处。目前缺乏随机对照试验（RCT）数据来证实这些益处并评估安全性。

方法

NightLife 研究是一项实用的、双臂、多中心 RCT，比较了 6 个月 INHD 与常规血液透析（每周三次日间中心血液透析，每次 3.5-5 小时）的影响。主要结局是 6 个月时使用肾脏病生活质量工具的总评分。次要结局包括睡眠和认知功能、安全性措施、透析依从性以及对临床参数的影响。还有一个嵌入式的过程评估，以评估实施情况、健康经济建模以及昆泰特招聘干预，以了解影响招聘和保留的因素。已经接受血液透析治疗超过 3 个月的成年人（≥18 岁）有资格参加。

讨论

英国有 68000 名成年人需要肾脏替代治疗（KRT），其中中心血液透析是三分之一以上病例的治疗方式。HRQoL 是维持性透析患者住院和死亡的独立预测因素。与一般人群相比，血液透析与较差的 HRQoL 相关。INHD 有改善 HRQoL 的潜力。目前缺乏关于有效性的强有力 RCT 证据。NightLife 研究是理解透析疗法的重要一步，将指导未来针对 KRT 的以患者为中心的决策。