NightLife Trial

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Key information

Trial title

A randomised controlled trial assessing the effectiveness and cost effectiveness of thrice weekly, extended, in-centre nocturnal haemodialysis versus standard care using a mixed methods approach (NightLife).

Chief investigator

Professor James Burton

Sponsor

University of Leicester

Funder

NIHR Health Technology Assessment (HTA) Programme

Summary

Kidney dialysis is a lifesaving treatment for patients with kidney failure. Around 24,000 patients receive regular haemodialysis at a hospital or in a satellite clinic in the UK. Most patients have a set dialysis appointment time lasting for 4 hours, 3 times per week. This is mainly because it is convenient for the hospital and not the patient. Studies have shown that being treated with the dialysis machine for longer has benefits. However, medical teams struggle to schedule more flexible or extended dialysis due to the volume of patients along with finite numbers of machines and staff.

Night-time “in-centre” haemodialysis offers patients something different; the opportunity to have their treatment overnight in a hospital or satellite dialysis clinic while they sleep. As overnight dialysis (typically 6-8 hours) is a lengthier treatment, it rids the blood of more waste and excess water, acting more like a patient’s normal kidneys which would be working 24/7. As it removes fluid more slowly, it also helps heart function. Importantly, it frees the person up during the day to socialise, work and care for others.

What we know about having dialysis for longer is not perfect. People who choose to have more dialysis may feel better and live longer for other, completely unrelated reasons. The only way to know for sure is to compare longer treatment times overnight with the standard 4-hour daytime treatment in a well-designed clinical trial.

This study asks the question whether 6-months of overnight dialysis, performed 3 times a week improves the quality of life of patients with kidney failure, as compared to those who have shorter dialysis sessions during the day. People who are eligible to take part will be allocated at random to either daytime dialysis or night-time dialysis.

Quality of life will be measured after 6-months of treatment using questionnaires that have been specifically designed for kidney patients. We will also collect information on the extra costs of night-time dialysis, to see whether the new treatment is more cost-effective than daytime dialysis, for the person and the health service. Finally, we will evaluate the experiences of patients who are enrolled in the study to identify barriers to how the treatment would be rolled out across the NHS, if we were to find that it does benefit patients.

Number of participants

350 participants will be allocated at random to either extended hours night-time haemodialysis (6-8 hours) or daytime haemodialysis (3.5-5 hours), meaning their treatment will be determined by chance.

Trial design

Pragmatic, two-arm, multi-centre, randomised controlled trial with a health economic analysis. An internal pilot, an on-going process evaluation and QuinteT Recruitment Intervention (QRI) are embedded in this study.