Recipient organisationUniversity Hospitals of Derby and Burton NHS FoundationTrust
Funding£500K
PeriodAug 2025 — Mar 2028
In plain English
AI plain-English summary
A simple cooling of the dialysis fluid by half a degree Celsius could determine whether a patient on kidney dialysis keeps their memory and thinking skills or loses them over time. People with end-stage kidney disease who receive haemodialysis suffer cognitive impairment at far higher rates than the general population. This erodes quality of life and worsens clinical outcomes. The researchers previously showed that cooling the dialysate to 0.5°C below the patient’s body temperature preserves the brain’s white matter structure on MRI scans. What remains unknown is whether that structural preservation translates into preserved cognitive function—the ability to think, remember, and reason. This multicentre randomised controlled trial will recruit 356 participants across three dialysis centres. Half will receive dialysis with cooled fluid (0.5°C below body temperature) for one year; the other half will receive standard fluid at 37°C. The primary outcome is change in working memory, measured by a letter-number sequencing task. Secondary outcomes include perception, processing speed, attention, general cognition, quality of life, frailty, and cardiovascular events. If the trial shows that cooling preserves cognitive function, it would provide the first intervention for this high-risk group. The results could immediately change clinical guidelines and standard practice for haemodialysis, directly improving the daily lives of thousands of patients.
View original technical description
Research question Does receiving haemodialysis with a cooled dialysate temperature of 0.5?C below the person s body temperature preserves cognitive function in people with end stage kidney disease on haemodialysis? Background Cognitive impairment is prevalent among adults receiving haemodialysis, the severity and progression of cognitive impairment in this group is much higher compared to the general population. This significantly impacts on the quality of life and clinical outcomes of people on haemodialysis. We previously demonstrated that reducing the dialysate temperature by 0.5?C below body temperature led to preservation on the brain white matter structure on diffusion tensor magnetic resonance imaging. However, it remains unclear as to whether this preservation in brain white matter structure translates into preservation in cognitive function. Aims and Objectives In this multicentre randomised controlled trial, we aim to examine whether having haemodialysis with a cooled dialysate by 0.5?C below the person s body temperature leads to preservation of cognitive function. Methods This is an open label multicentre randomised controlled trial across three haemodialysis centres. We aim to recruit 356 participants from the haemodialysis centres. Participants will be randomised into receiving haemodialysis with a dialysate temperature of 0.5?C below their body temperature versus haemodialysis with a dialysate temperature of 37?C for one year. The primary outcome is change in working memory assessed by the Letter Number Sequencing (LNS) task between the two groups. Secondary outcomes include cognitive function assessments across various domains such as perception, processing speed, inhibition, attention and general cognition, quality of life assessment, clinical frailty and stroke and cardiovascular events. These assessments will be conducted in two visits the first is on enrolment and the second at one year. Timelines for delivery We anticipate obtaining approvals and trial setup by 31/12/2025, Recruitment of first patient by January 2026, and end of recruitment by July 2026. We aim to complete the one year follow up of the last patients by end of July 2027 and performing data quality assessment, data analysis and report writing by end of January 2028. Anticipated Impact and Dissemination A positive anticipated results of this study would provide the first intervention in this high-risk group that preserve their cognitive function and could have a major impact on quality of life and functionality. The impact of such results will add to the available evidence related to dialysate cooling in haemodialysis and could have an immediate impact and translation into changing clinical guidelines and practice related to dialysate cooling in people on haemodialysis.
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