NCT07377500

Brief Summary

When a person's kidneys are not working properly, they need a life-saving treatment called haemodialysis three times a week to filter the waste and extra fluids from the blood. 25 000 adults in the United Kingdom are currently having haemodialysis and unfortunately more than two-thirds of these people experience problems with thinking and memory, which may lead to dementia. These problems tend to worsen more rapidly than people who are not on haemodialysis. This decline in brain function can make it harder for people to do everyday tasks, increase their reliance on others, and lower their overall quality of life. It also raises the chances of needing hospital care and can shorten their lifespan. One reason for this decline in thinking and memory could be the dialysis treatment itself. Research has shown that blood flow to the brain can drop during dialysis. If this happens regularly, it can harm the brain over time. Earlier studies found that cooling the dialysis fluid slightly (to 0.5°C below body temperature) helped people tolerate dialysis better and showed less brain damage on magnetic imaging brain scans (MRI) after a year, compared to those who had haemodialysis without cooling the dialysis fluid. However, the investigators still don't know if this brain protection translates into better thinking and memory for people on haemodialysis. This study will see if cooling the dialysis fluid helps preserve thinking and memory function. The investigators will invite participants at three hospitals with haemodialysis centres to take part. Those who agree will be randomly assigned to either standard dialysis or cooled dialysis. The investigators will assess participants' thinking and memory functions using special tests at the start of the study and again after a year. By comparing the results from both groups, the investigators hope to see if the cooled dialysis really helps protect brain.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Jan 2028

First Submitted

Initial submission to the registry

January 2, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 2, 2026

Last Update Submit

January 30, 2026

Conditions

HaemodialysisKidney Failure

Keywords

DIALYSATE COOLINGKIDNEY FAILUREHAEMODIALYSISCOGNITIVE IMPAIRMENT

Outcome Measures

Primary Outcomes (1)

  • Change in working memory

    Change in working memory as measured by the Letter Number Sequencing (LNS) test after one year from randomisation.

    One year from randomisation

Study Arms (2)

Standard temperature dialysis

NO INTERVENTION

Dialysis with a dialysate temperature of 37 degrees

Cooled dialysis

ACTIVE COMPARATOR

Dialysis with a dialysate temperature of 0.5 degrees below body temperature.

Other: Dialysis cooling

Interventions

Dialysis coolingOTHER

dialysis with a dialysate temperature of 0.5 degrees below body temperature for a period of one year.

Cooled dialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The participant is receiving maintenance in-centre haemodialysis
  • Over 18 years of age at time of consent
  • The participant is able and willing to provide written informed consent.

You may not qualify if:

  • Participants with confirmed diagnosis of dementia.
  • Participants who lack capacity to consent.
  • Participants having dialysis less than three times a week.
  • Pregnant participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE223DT, United Kingdom

Location

Related Publications (26)

  • Selby NM, McIntyre CW. A systematic review of the clinical effects of reducing dialysate fluid temperature. Nephrol Dial Transplant. 2006;21(7):1883-98

    BACKGROUND

  • Sherman RA, Faustino EF, Bernholc AS, Eisinger RP. Effect of variations in dialysate temperature on blood pressure during hemodialysis. Am J Kidney Dis. 1984;4(1):66-8.

    BACKGROUND

  • Anazodo UC, Wong DY, Théberge J, Dacey M, Gomes J, Penny JD, et al. Hemodialysis-Related Acute Brain Injury Demonstrated by Application of Intradialytic Magnetic Resonance Imaging and Spectroscopy. J Am Soc Nephrol. 2023;34(6):1090-104

    BACKGROUND

  • Findlay MD, Dawson J, Dickie DA, Forbes KP, McGlynn D, Quinn T, et al. Investigating the Relationship between Cerebral Blood Flow and Cognitive Function in Hemodialysis Patients. J Am Soc Nephrol. 2019;30(1):147-58.

    BACKGROUND

  • Kanbay M, Ertuglu LA, Afsar B, Ozdogan E, Siriopol D, Covic A, Basile C, Ortiz A. An update review of intradialytic hypotension: concept, risk factors, clinical implications and management. Clin Kidney J. 2020 Jul 8;13(6):981-993. doi: 10.1093/ckj/sfaa078. eCollection 2020 Dec.

    PMID: 33391741BACKGROUND

  • Assa S, Hummel YM, Voors AA, Kuipers J, Westerhuis R, de Jong PE, et al. Hemodialysis-induced regional left ventricular systolic dysfunction: prevalence, patient and dialysis treatment-related factors, and prognostic significance. Clin J Am Soc Nephrol. 2012;7(10):1615-23.

    BACKGROUND

  • Burton JO, Jefferies HJ, Selby NM, McIntyre CW. Hemodialysis-induced cardiac injury: determinants and associated outcomes. Clin J Am Soc Nephrol. 2009;4(5):914-20.

    BACKGROUND

  • McIntyre CW. Recurrent circulatory stress: the dark side of dialysis. Semin Dial. 2010;23(5):449-51

    BACKGROUND

  • Sánchez-Fernández MDM, Reyes Del Paso GA, Gil-Cunquero JM, Fernández-Serrano MJ. Executive function in end-stage renal disease: Acute effects of hemodialysis and associations with clinical factors. PLoS One. 2018;13(9):e0203424.

    BACKGROUND

  • Berger I, Wu S, Masson P, Kelly PJ, Duthie FA, Whiteley W, et al. Cognition in chronic kidney disease: a systematic review and meta-analysis. BMC Med. 2016;14(1):206.

    BACKGROUND

  • Brodski J, Rossell SL, Castle DJ, Tan EJ. A Systematic Review of Cognitive Impairments Associated With Kidney Failure in Adults Before Natural Age-Related Changes. J Int Neuropsychol Soc. 2019;25(1):101-14

    BACKGROUND

  • Gaubert F, Borg C, Chainay H. Decision-Making in Alzheimer's Disease: The Role of Working Memory and Executive Functions in the Iowa Gambling Task and in Tasks Inspired by Everyday Situations. Journal of Alzheimer's Disease. 2022;90:1793-815.

    BACKGROUND

  • McDougall GJ, Han A, Staggs VS, Johnson DK, McDowd JM. Predictors of instrumental activities of daily living in community-dwelling older adults. Archives of Psychiatric Nursing. 2019;33(5):43-50

    BACKGROUND

  • Baddeley A. Working memory. Science. 1992;255(5044):556-9.

    BACKGROUND

  • Joshi U, Subedi R, Poudel P, Ghimire PR, Panta S, Sigdel MR. Assessment of quality of life in patients undergoing hemodialysis using WHOQOL-BREF questionnaire: a multicenter study. Int J Nephrol Renovasc Dis. 2017;10:195-203.

    BACKGROUND

  • UK Renal Regisstry 23rd Annual Report, Chapter 5 - Adults on in-centre haemodialysis (ICHD) in the UK at the end of 2019 [Available from: https://ukkidney.org/sites/renal.org/files/23rd_UKRR_ANNUAL_REPORT_ICHD_Ch5_0.pdf

    BACKGROUND

  • Hain DJ. Cognitive function and adherence of older adults undergoing hemodialysis. Nephrol Nurs J. 2008;35(1):23-9.

    BACKGROUND

  • Kim EY, Lee YN. Coexisting with the Life of Patients with Hemodialysis: Qualitative Meta-Synthesis Study of Life of Caregivers of Patients with Hemodialysis. Int J Environ Res Public Health. 2022;19(4)

    BACKGROUND

  • Eldehni MT. Frailty, multimorbidity and sarcopaenia in haemodialysis patients. Curr Opin Nephrol Hypertens. 2022;31(6):560-5.

    BACKGROUND

  • Young HML, Ruddock N, Harrison M, Goodliffe S, Lightfoot CJ, Mayes J, et al. Living with frailty and haemodialysis: a qualitative study. BMC Nephrol. 2022;23(1):260.

    BACKGROUND

  • Eldehni MT, Odudu A, McIntyre CW. Brain white matter microstructure in end-stage kidney disease, cognitive impairment, and circulatory stress. Hemodial Int. 2019;23(3):356-65

    BACKGROUND

  • Fazekas G, Fazekas F, Schmidt R, Kapeller P, Offenbacher H, Krejs GJ. Brain MRI findings and cognitive impairment in patients undergoing chronic hemodialysis treatment. J Neurol Sci. 1995;134(1-2):83-8.

    BACKGROUND

  • Fukunishi I, Kitaoka T, Shirai T, Kino K, Kanematsu E, Sato Y. Psychiatric disorders among patients undergoing hemodialysis therapy. Nephron. 2002;91(2):344-7.

    BACKGROUND

  • O'Lone E, Connors M, Masson P, Wu S, Kelly PJ, Gillespie D, et al. Cognition in People With End-Stage Kidney Disease Treated With Hemodialysis: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2016;67(6):925-35.

    BACKGROUND

  • Kavanagh NT, Schiller B, Saxena AB, Thomas IC, Kurella Tamura M. Prevalence and correlates of functional dependence among maintenance dialysis patients. Hemodial Int. 2015;19(4):593-600.

    BACKGROUND

  • Kurella Tamura M, Covinsky KE, Chertow GM, Yaffe K, Landefeld CS, McCulloch CE. Functional status of elderly adults before and after initiation of dialysis. N Engl J Med. 2009;361(16):1539-47

    BACKGROUND

MeSH Terms

Conditions

Renal InsufficiencyCognitive Dysfunction

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Tarek Eldehni

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Davis

CONTACT

07472910392daniel.davis6@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessor of outcomes will be blinded to mitigate introduction of any potential bias.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2026

First Posted

January 30, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)