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


BACKGROUND: Cognitive 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. METHODS: This 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov NCT03645733 . Registered retrospectively on 24 August 2018.

Publication DOI: https://doi.org/10.1186/s13063-020-04725-0
Divisions: College of Health & Life Sciences > Aston Pharmacy School
College of Health & Life Sciences
College of Health & Life Sciences > Clinical and Systems Neuroscience
College of Health & Life Sciences > Aston Medical School
Additional Information: © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Uncontrolled Keywords: Cognition,Cognitive function,Cold temperature,Haemodialysis,Haemodialysis solutions,Randomised controlled trial
Publication ISSN: 1745-6215
Last Modified: 14 May 2024 07:17
Date Deposited: 15 Oct 2020 10:46
Full Text Link:
Related URLs: https://trialsj ... 063-020-04725-0 (Publisher URL)
PURE Output Type: Article
Published Date: 2020-09-30
Accepted Date: 2020-09-03
Authors: Dasgupta, Indranil
Odudu, Aghogho
Baharani, Jyoti
Fergusson, Niall
Griffiths, Helen
Harrison, John
Maruff, Paul
Thomas, G Neil
Woodhall, Gavin (ORCID Profile 0000-0003-1281-9008)
Youseff, Samir
Tadros, George (ORCID Profile 0000-0001-5820-7643)



Version: Published Version

License: Creative Commons Attribution

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