Abstract: INFO15
NightLife Study: Randomised Controlled Trial Assessing the Effectiveness Thrice-Weekly In-Centre Nocturnal Hemodialysis vs. Standard Care
Session Information
- Informational Posters
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- No subcategory defined
Authors
- Hull, Katherine Leigh, University of Leicester Department of Cardiovascular Sciences, Leicester, Leicester, United Kingdom
- Quann, Niamh A., University of Leicester Clinical Trials Unit, Leicester, Leicester, United Kingdom
- Cluley, Victoria, University of Leicester Department of Cardiovascular Sciences, Leicester, Leicester, United Kingdom
- Burton, James, University of Leicester Department of Cardiovascular Sciences, Leicester, Leicester, United Kingdom
Group or Team Name
- NightLife Study Trial Management Group
Description
Introduction
In-centre nocturnal hemodialysis (INHD) offers extended-hours HD (6-8 hours thrice weekly) overnight with the support of dialysis nurses. Observational data demonstrates potential significant benefits of INHD. There is a lack of randomised controlled trial (RCT) data to confirm these benefits and robustly assess safety. The NightLife study will address this lack of knowledge.
Methods
The NightLife study is a pragmatic, two-arm, multicentre RCT comparing the impact of 6 months INHD to standard care (i.e. thrice-weekly daytime in-centre HD, ~4 hours per session). Primary outcome: the composite score from the Kidney Disease Quality of Life tool at 6-months. Secondary outcomes: patient reported outcome measures to assess quality of life, sleep and cognitive function, measures of safety, adherence to HD, impact on clinical parameters and cost-effectiveness. Additionally, there will be a Process Evaluation to assess facilitators and barriers to implementation, and a QuinteT Recruitment Intervention to understand factors that influence recruitment.
Recruitment sample size is 350 participants. Adults (≥18 years) who have been established on HD for >3 months are eligible. Exclusion criteria: currently receiving or <3 months since stopping INHD, extended HD clinically indicated (e.g. pregnancy), scheduled living donor kidney transplant, plan to change dialysis modality or centre within 6-months, life expectancy <6 months, conflicting trial participation.
Results
The NightLife study has been awarded funding via the National Institute for Health Research (NIHR) Health Technology Assessment (trial registration: ISRCTN87042063, funder reference: NIHR127440) and recruitment will open in October 2021.
Discussion
Health-related quality of life is an independent predictor of hospitalisation and mortality in individuals on maintenance dialysis. HD is associated with poor health-related quality of life in comparison to the general population. INHD has the potential to improve the factors that contribute to poorer health-related quality of life. However, RCT evidence of efficacy and safety is lacking. The NightLife study is an essential step in our understanding of dialysis therapies and will guide patient-centred decisions.
Funding
- National Institute for Health Research (NIHR) Health Technology Assessment (trial registration: ISRCTN87042063, funder reference: NIHR127440)