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Hull et al. Nightlife protocol paper Tirals 2023.pdf (1.29 MB)

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

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posted on 2023-09-25, 09:41 authored by KL Hull, K Bramham, CL Brookes, V Cluley, C Conefrey, NJ Cooper, H Eborall, J Fotheringham, MPM Graham-Brown, LJ Gray, PB Mark, S Mitra, GJ Murphy, N Quann, L Rooshenas, M Warren, JO Burton

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.

Funding

National Institute for Health Research (NIHR) Health Technology Assessment (HTA) award [HTA (NIHR127440)]

History

Author affiliation

Department of Cardiovascular Sciences, University of Leicester

Version

  • VoR (Version of Record)

Published in

Trials

Volume

24

Issue

1

Pagination

522

Publisher

Springer Science and Business Media LLC

issn

1745-6215

eissn

1745-6215

Copyright date

2023

Available date

2023-09-25

Spatial coverage

England

Language

eng

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