Investigating the effects of 6 months extended duration, in-centre nocturnal versus conventional haemodialysis treatment: a non-randomised, controlled feasibility study.
In-centre nocturnal haemodialysis (INHD) is an underutilised dialysis regimen that can potentially provide patients with better clinical outcomes due to extended treatment times. We have established an INHD programme within our clinical network, fulfilling a previously unmet patient need. This feasibility study aims to gather sufficient data on numerous outcome measures to inform the design of a multicentre randomised controlled trial that will establish the potential benefits of INHD and increase the availability of this service nationally and internationally.



This will be a non-randomised controlled study. Prevalent patients on haemodialysis (HD) will electively change from a conventional in-centre HD regimen of 4 hours thrice weekly to a regimen of extended treatment times (5-8 hours) delivered in-centre overnight thrice weekly. After recruitment of the INHD cohort, a group of patients matched for age, gender and dialysis vintage will be selected from patients remaining on a conventional daytime dialysis programme. Outcome measures will include left ventricular mass as measured by MRI, physical performance measured by the short physical performance battery and physical activity measured by accelerometry. Additionally we will measure quality of life using validated questionnaires, nutritional status by bioimpedance spectroscopy and food diaries, and blood sampling for markers of cardiovascular disease, systemic inflammation. Suitable statistical tests shall be used to analyse the data. We will use omnibus tests to observe changes over the duration of the intervention and between groups. We will also look for associations between outcome measures that may warrant further investigation. These data will be used to inform the power calculation for future studies.



A favourable opinion was granted by Northampton Research Ethics Committee (15/EM/0268). It is anticipated that results of this study will be presented at national and international meetings, with reports being published in journals during 2017.



ISRCTN16672784.
John Walls Renal Unit, Leicester General Hospital, Leicester, UK Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, UK.
Darren R
0000-0003-4674-186X
DR
Churchward
John Walls Renal Unit, Leicester General Hospital, Leicester, UK Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, UK.
Matthew P M
MP
Graham-Brown
John Walls Renal Unit, Leicester General Hospital, Leicester, UK.
Robert
R
Preston
John Walls Renal Unit, Leicester General Hospital, Leicester, UK.
Warren
W
Pickering
Department of Cardiology, NIHR Leicester Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK.
Gerry P
GP
McCann
John Walls Renal Unit, Leicester General Hospital, Leicester, UK Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, UK.
James O
0000-0003-1176-7592
JO
Burton
D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D006435:Renal Dialysis / Q000379:methods*; D012107:Research Design; D011795:Surveys and Questionnaires; D013995:Time; D016896:Treatment Outcome