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Kidney Week

Abstract: INFO09-SA

The NightLife Study: A Randomised Controlled Trial Assessing the Effectiveness of Thrice-Weekly In-Centre Nocturnal Hemodialysis vs. Standard Care

Session Information

  • Informational Posters - III
    November 04, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

  • No subcategory defined

Authors

  • Hull, Katherine Leigh, University of Leicester College of Life Sciences, Leicester, United Kingdom
  • Burton, James, University of Leicester College of Life Sciences, Leicester, United Kingdom

Group or Team Name

  • NightLife study investigators
Description

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.

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.

The NightLife study is funded via the National Institute for Health Research (NIHR) Health Technology Assessment (trial registration: ISRCTN87042063, funder reference: NIHR127440) and recruitment commenced in October 2021.

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)