Evaluation of the effect of Cooled HaEmodialysis on Cognitive function in patients suffering with end-stage KidnEy Disease (E-CHECKED): feasibility randomised control trial protocol

Trials

Paul Maruff¹  Niall Fergusson²  George Tadros³  Aghogho Odudu⁴  Helen Griffiths⁵  G Neil Thomas⁶  John Harrison⁷  Samir Youseff⁸  Jyoti Baharani⁹  Indranil Dasgupta^1,10  Gavin Woodhall^1,11 

[1] Cogstate Limited, Melbourne, Australia;Department of Care of the Elderly, Heartlands Hospital, Birmingham, UK;Department of Old Age Psychiatry, Heartlands Hospital, Birmingham, UK;Aston Medical School, Aston University, Birmingham, UK;Division of Cardiovascular Sciences, University of Manchester, Manchester, UK;Manchester University NHS Foundation Trust, Manchester, UK;Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK;Institute of Applied Health Research, University of Birmingham, Birmingham, UK;Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, UK;Patient Representative, Birmingham, UK;Renal Unit, Heartlands Hospital, Bordesley Green East, B9 5SS, Birmingham, UK;Renal Unit, Heartlands Hospital, Bordesley Green East, B9 5SS, Birmingham, UK;Warwick Medical School, University of Warwick, Coventry, UK;School of Neuropharmacology, Aston University, Birmingham, UK;

关键词: Cognition;    Cognitive function;    Cold temperature;    Haemodialysis;    Haemodialysis solutions;    Randomised controlled trial;   

DOI  :  10.1186/s13063-020-04725-0

来源: Springer

【 摘 要 】

BackgroundCognitive impairment is common in haemodialysis (HD) patients and is associated independently with depression and mortality. This association is poorly understood, and no intervention is proven to slow cognitive decline. There is evidence that cooler dialysis fluid (dialysate) may slow white matter changes in the brain, but no study has investigated the effect of cooler dialysate on cognition. This study addresses whether cooler dialysate can prevent the decline in cognition and improve quality of life (QOL) in HD patients.MethodsThis is a multi-site prospective randomised, double-blinded feasibility trial. Setting: Four HD units in the UK. Participants and interventions: Ninety HD patients randomised (1:1) to standard care (dialysate temperature 36.5 °C) or intervention (dialysate temperature 35 °C) for 12 months. Primary outcome measure: Change in cognition using the Montreal Cognitive Assessment (MoCA). Secondary outcome measures: Recruitment and attrition rates, reasons for non-recruitment, frequency of intradialytic hypotension, depressive symptom scores, patient and carers burden, a detailed computerised cognitive test and QOL assessments. Analysis: mixed method approach, utilising measurement of cognition, questionnaires, physiological measurements and semi-structured interviews.DiscussionThe results of this feasibility trial will inform the design of a future adequately powered substantive trial investigating the effect of dialysate cooling on prevention and/or slowing in cognitive decline in patients undergoing haemodialysis using a computerised battery of neuro-cognitive tests. The main hypothesis that would be tested in this future trial is that patients treated with regular conventional haemodialysis will have a lesser decline in cognitive function and a better quality of life over 1 year by using cooler dialysis fluid at 35 °C, versus a standard dialysis fluid temperature of 36.5 °C. This also should reflect in improvements in their abilities for activities of daily living and therefore reduce carers’ burden. If successful, the treatment could be universally applied at no extra cost.Trial registrationClinicalTrials.gov NCT03645733. Registered retrospectively on 24 August 2018.

【 授权许可】

CC BY