Professionals

The main aim of the NightLife study is to assess whether in-centre nocturnal haemodialysis can improve the quality of life of individuals with end-stage kidney disease on maintenance haemodialysis compared to conventional haemodialysis. To evaluate this, the primary outcome is the composite score from the Kidney Disease Quality of Life tool (KDQoL) at 6-months.

The secondary outcomes will evaluate the clinical and cost-effectiveness of in-centre nocturnal haemodialysis, and assess the safety of this haemodialysis regimen. To achieve this, the secondary outcomes will include the following:

• Kidney Disease Quality of Life tool (KDQoL) composite scores at 1- and 3- months
• Other patient reports outcome measures regarding quality of life, sleep and recovery from haemodialysis
• Assessment of cognition
• Measures of safety including residual renal function, vascular access events and adverse events
• Adherence to the intervention
• Impact on clinical results such as blood results and medications
• Health economic evaluation

Yes, there are a number of sub-studies that will be completed as part of the NightLife study. Further information regarding the sub-study work can be found here.

i. Embedded process evaluation

An embedded process evaluation will be completed to assess the study processes and activities, and implementation of the intervention. This will be achieved by a mixed methods approach with quantitative and qualitative data collection.

The purpose of this process evaluation is to monitor research procedure, understand why variations develop, particularly across different participating units, and improve and amend these procedures where necessary. For instance, factors that influence the uptake, initiation and implementation of the intervention can be explore.

ii. QuinteT Recruitment Intervention

The QuinteT Recruitment Intervention aims to understand the factors that influence the recruitment process and retention to the NightLife study. In particular, the work will focus on understanding equipoise amongst clinicians and how the study is both communicated to and understood by adults requiring maintenance haemodialysis.

The results generated will be used to improve the recruitment process for the remainder of the study. The work will be completed using a mixed-methods approach.

iii. NightLife-CMR: A cardiac MRI sub-study investigating the impact of in-centre nocturnal haemodialysis on cardiac structure and function.

In-centre nocturnal haemodialysis offers an extended dialysis treatment, with the potential to mitigate non-traditional cardiovascular risk factors in individuals with end-stage kidney disease.

This will be assessed through the NightLife-CMR sub-study, funded by the British Heart Foundation, whereby 100 participants recruited to the main NightLife study with undergo cardiac magnetic resonance imaging and cardiac biomarkers pre- and post- 6-months of either the intervention or control treatment.

Therefore, this sub-study will establish the effects of in-centre nocturnal haemodialysis on cardiovascular structure and function compared to conventional haemodialysis.

Yes, Patient Participation Involvement and Experience (PPIE) panels were consulted before and during the NightLife Study grant application for funding and protocol development. Maddy Warren (@queenofdialysis) is our Patient Consultant and Advocate, and a key part of the research team, as a co-applicant, PPIE representative, member of the Trial Management Group and Trial Steering Committee.

Our PPIE work will continue throughout the NightLife study, from study set-up, recruitment, data collection and dissemination of the results. Further information about the PPIE work can be found here.

To achieve study power (a 5-point difference in the KDQoL between groups at 6-months adjusted for baseline), 252 participants are required. The total number of participants to be recruited is 350 from around 18 dialysis units across the UK to allow for a 25% attrition rate in the intervention group (experience across the Leicester Renal Network has informed us that there is a maximum drop-out of 25% within the first 2 weeks of trying in-centre nocturnal haemodialysis) and 15% loss to follow-up across both arms of the study due to death, kidney transplantation and other factors e.g. moving out of area. The recruitment targets per participating dialysis units are modest, averaging at 20 participants per unit across the study duration, with variation depending upon the size of the dialysis unit.

Adults (≥ 18 years old) requiring maintenance haemodialysis for ≥ 3 months are eligible for participation. The exclusion criteria includes the following:

• Currently on in-centre nocturnal dialysis, or less than 3-months since stopping
• Less than 3-months since stopping extended daytime dialysis
• Individuals for whom extended dialysis is clinically indicated (e.g. calciphylaxis, pregnancy)
• Scheduled for living donor kidney transplant
• Plans to change dialysis modality or centre in the next 6-months
• Life expectancy of <6-months
• Current participation in an interventional trial with conflicting therapies or primary outcomes

There are no limitations on the type of vascular access for participants in the NightLife study; established venous catheters, arteriovenous fistulae and arteriovenous grafts can be used for in-centre nocturnal haemodialysis, as they would be for conventional haemodialysis.

As part of the evaluation to establish safety of in-centre nocturnal haemodialysis in comparison to conventional haemodialysis, data will be collected regarding the type of vascular access participants have and any complications or procedures that are required for the duration of their participation in the NightLife study.

NHS, commercial, hospital-based and satellite haemodialysis units can all participate in the NightLife study. For some units, this will involve developing a local in-centre nocturnal haemodialysis service, for others, the service will already be available.

Haemodialysis is an established NHS treatment and the intervention of in-centre nocturnal haemodialysis poses no extra cost to the NHS. This is because there are no additional consumables required to extend haemodialysis from an average of 4 hours to between 6 to 8 hours, and the infrastructure is in place to extend the service in dialysis units.

There are increased staffing costs due to the time (additional haemodialysis treatment time) and night working supplements. These have been agreed as Excess Treatment Costs and can be claimed through your NHS Trust.

For more information on Excess Treatment Costs, please click here

Participants will be randomised to either the intervention or the control group in a ratio of 1.33 to 1. This considers the possible 25% drop-out from the intervention group during the first 2 weeks of experiencing in-centre nocturnal haemodialysis, as outlined in question 5.

Randomisation will be performed by the delegated research nurse/enrolling physician using a validated web-based system provided and managed through the Leicester Clinical Trials Unit.

Experience from the Leicester Renal Network has demonstrated a number of practical benefits from establishing an in-centre nocturnal haemodialysis service. Overnight haemodialysis treatments increase the total number of dialysis slots available to adults with end-stage kidney disease requiring maintenance haemodialysis.

It also adds to the smooth running of the day and helps the dialysis staff to finish their shifts on time. This is because the unit essentially becomes staffed on a 24 hour basis for 6 days of the week, and so shift handovers means staff avoid staying late after the twilight shift and the dialysis machines are prepped and ready for the start of early haemodialysis shift.

Staff to patient ratios are maintained during in-centre nocturnal haemodialysis shifts and medical emergencies are approached exactly as they would be with daytime haemodialysis.

Yes, the NightLife study is part of the NIHR Clinical Research Network (CRN) portfolio and is eligible to the support that is offered via the NIHR CRN.

For further information about the NIHR CRN, please click here.

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