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Evaluation of effect of cooled haemodialysis on cognition in patients with end-stage kidney disease (ECHECKED) feasibility randomised controlled trial results

Indranil Dasgupta, Aghogho Odudu, Jyoti Baharani, Niall Fergusson, Helen Griffiths, John Harrison, Awais Hameed, Paul Maruff, Louise Ryan, Neil Thomas, Gavin Woodhall, George Tadros

BMC Nephrology, Volume: 25, Start page: 466

Swansea University Author: Helen Griffiths

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DOI (Published version): 10.1186/s12882-024-03883-6

Abstract

Background: Cognitive impairment is common in haemodialysis patients with no known beneficial interventions. Cooler dialysate slows brain white-matter changes, but its effect on cognition is unknown. This feasibility trial was performed to inform a fully-powered, randomised trial to assess this. Met...

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Published in: BMC Nephrology
ISSN: 1471-2369
Published: Springer Nature 2024
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URI: https://cronfa.swan.ac.uk/Record/cronfa68613
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Methods: We aimed to randomise (1:1) 90 haemodialysis patients to this double-blinded, randomised controlled feasibility trial to standard care (dialysate-temperature 36.5 &#xB0;C) or intervention (35 &#xB0;C). Eligible patients were adult chronic haemodialysis recipients with no established diagnosis of dementia or psychiatric disease. The primary outcome was change in Montreal Cognitive Assessment (MoCA) score at 12-months. Secondary outcomes included recruitment and attrition rates, reasons for non-recruitment, intradialytic hypotension, depression, patient burden, computerised cognition test battery, and quality of life. Findings: Of 334 patients screened, 160 were eligible. 99 declined mainly for the extra non-dialysis day study visits. Sixty-one patients consented, 43 randomised &#x2013; 20 in standard care, 23 in intervention arms; 13 withdrew for non-dialysis day visits and 5 without reason before randomisation. 27 patients (12 standard care, 15 intervention) completed the trial &#x2013; 5 died, 1 transplanted, 4 withdrew consent, and 6 could not attend due to the pandemic. Low temperature dialysis was well tolerated. There was no difference in change in MoCA from baseline to 12 months between the standard and intervention arms; 1.0 (-2.8&#x2013;3.0, p = 0.755) and &#x2212; 2.0 (-1.0 - -4.0, p = 0.047) respectively. There were no differences between groups on any secondary measures. There were no significant adverse events reported. Discussion: The trial was significantly affected by the COVID-19 pandemic contributing to an attrition rate of 27%. The non-dialysis day research visits were mainly responsible for low recruitment and consent withdrawal. There are several learning points, described in the article, which will inform design of definitive trials in this area in the future. Trial registration: ClinicalTrials.gov Identifier NCT03645733. 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spelling 2024-12-20T11:41:29.7193506 v2 68613 2024-12-20 Evaluation of effect of cooled haemodialysis on cognition in patients with end-stage kidney disease (ECHECKED) feasibility randomised controlled trial results 0366ea9a689b222146b7d63c6baf8427 Helen Griffiths Helen Griffiths true false 2024-12-20 SMT Background: Cognitive impairment is common in haemodialysis patients with no known beneficial interventions. Cooler dialysate slows brain white-matter changes, but its effect on cognition is unknown. This feasibility trial was performed to inform a fully-powered, randomised trial to assess this. Methods: We aimed to randomise (1:1) 90 haemodialysis patients to this double-blinded, randomised controlled feasibility trial to standard care (dialysate-temperature 36.5 °C) or intervention (35 °C). Eligible patients were adult chronic haemodialysis recipients with no established diagnosis of dementia or psychiatric disease. The primary outcome was change in Montreal Cognitive Assessment (MoCA) score at 12-months. Secondary outcomes included recruitment and attrition rates, reasons for non-recruitment, intradialytic hypotension, depression, patient burden, computerised cognition test battery, and quality of life. Findings: Of 334 patients screened, 160 were eligible. 99 declined mainly for the extra non-dialysis day study visits. Sixty-one patients consented, 43 randomised – 20 in standard care, 23 in intervention arms; 13 withdrew for non-dialysis day visits and 5 without reason before randomisation. 27 patients (12 standard care, 15 intervention) completed the trial – 5 died, 1 transplanted, 4 withdrew consent, and 6 could not attend due to the pandemic. Low temperature dialysis was well tolerated. There was no difference in change in MoCA from baseline to 12 months between the standard and intervention arms; 1.0 (-2.8–3.0, p = 0.755) and − 2.0 (-1.0 - -4.0, p = 0.047) respectively. There were no differences between groups on any secondary measures. There were no significant adverse events reported. Discussion: The trial was significantly affected by the COVID-19 pandemic contributing to an attrition rate of 27%. The non-dialysis day research visits were mainly responsible for low recruitment and consent withdrawal. There are several learning points, described in the article, which will inform design of definitive trials in this area in the future. Trial registration: ClinicalTrials.gov Identifier NCT03645733. Registration date 24/08/2018. Journal Article BMC Nephrology 25 466 Springer Nature 1471-2369 Cognition, Cooled dialysate, Feasibility trial, Haemodialysis, Randomised controlled trial 19 12 2024 2024-12-19 10.1186/s12882-024-03883-6 COLLEGE NANME Senior Leadership Team COLLEGE CODE SMT Swansea University Another institution paid the OA fee The study is funded by a National Institute for Health Research (NIHR) for Patients Benefit grant (PB-PG-1215-20008). The study is also supported by the NIHR Clinical Research Network West Midlands, UK. 2024-12-20T11:41:29.7193506 2024-12-20T11:31:37.2799547 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Indranil Dasgupta 1 Aghogho Odudu 2 Jyoti Baharani 3 Niall Fergusson 4 Helen Griffiths 5 John Harrison 6 Awais Hameed 7 Paul Maruff 8 Louise Ryan 9 Neil Thomas 10 Gavin Woodhall 11 George Tadros 12
title Evaluation of effect of cooled haemodialysis on cognition in patients with end-stage kidney disease (ECHECKED) feasibility randomised controlled trial results
spellingShingle Evaluation of effect of cooled haemodialysis on cognition in patients with end-stage kidney disease (ECHECKED) feasibility randomised controlled trial results
Helen Griffiths
title_short Evaluation of effect of cooled haemodialysis on cognition in patients with end-stage kidney disease (ECHECKED) feasibility randomised controlled trial results
title_full Evaluation of effect of cooled haemodialysis on cognition in patients with end-stage kidney disease (ECHECKED) feasibility randomised controlled trial results
title_fullStr Evaluation of effect of cooled haemodialysis on cognition in patients with end-stage kidney disease (ECHECKED) feasibility randomised controlled trial results
title_full_unstemmed Evaluation of effect of cooled haemodialysis on cognition in patients with end-stage kidney disease (ECHECKED) feasibility randomised controlled trial results
title_sort Evaluation of effect of cooled haemodialysis on cognition in patients with end-stage kidney disease (ECHECKED) feasibility randomised controlled trial results
author_id_str_mv 0366ea9a689b222146b7d63c6baf8427
author_id_fullname_str_mv 0366ea9a689b222146b7d63c6baf8427_***_Helen Griffiths
author Helen Griffiths
author2 Indranil Dasgupta
Aghogho Odudu
Jyoti Baharani
Niall Fergusson
Helen Griffiths
John Harrison
Awais Hameed
Paul Maruff
Louise Ryan
Neil Thomas
Gavin Woodhall
George Tadros
format Journal article
container_title BMC Nephrology
container_volume 25
container_start_page 466
publishDate 2024
institution Swansea University
issn 1471-2369
doi_str_mv 10.1186/s12882-024-03883-6
publisher Springer Nature
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
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description Background: Cognitive impairment is common in haemodialysis patients with no known beneficial interventions. Cooler dialysate slows brain white-matter changes, but its effect on cognition is unknown. This feasibility trial was performed to inform a fully-powered, randomised trial to assess this. Methods: We aimed to randomise (1:1) 90 haemodialysis patients to this double-blinded, randomised controlled feasibility trial to standard care (dialysate-temperature 36.5 °C) or intervention (35 °C). Eligible patients were adult chronic haemodialysis recipients with no established diagnosis of dementia or psychiatric disease. The primary outcome was change in Montreal Cognitive Assessment (MoCA) score at 12-months. Secondary outcomes included recruitment and attrition rates, reasons for non-recruitment, intradialytic hypotension, depression, patient burden, computerised cognition test battery, and quality of life. Findings: Of 334 patients screened, 160 were eligible. 99 declined mainly for the extra non-dialysis day study visits. Sixty-one patients consented, 43 randomised – 20 in standard care, 23 in intervention arms; 13 withdrew for non-dialysis day visits and 5 without reason before randomisation. 27 patients (12 standard care, 15 intervention) completed the trial – 5 died, 1 transplanted, 4 withdrew consent, and 6 could not attend due to the pandemic. Low temperature dialysis was well tolerated. There was no difference in change in MoCA from baseline to 12 months between the standard and intervention arms; 1.0 (-2.8–3.0, p = 0.755) and − 2.0 (-1.0 - -4.0, p = 0.047) respectively. There were no differences between groups on any secondary measures. There were no significant adverse events reported. Discussion: The trial was significantly affected by the COVID-19 pandemic contributing to an attrition rate of 27%. The non-dialysis day research visits were mainly responsible for low recruitment and consent withdrawal. There are several learning points, described in the article, which will inform design of definitive trials in this area in the future. Trial registration: ClinicalTrials.gov Identifier NCT03645733. Registration date 24/08/2018.
published_date 2024-12-19T14:39:18Z
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