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Randomised controlled trial of dialysate cooling for preservation of cognitive function in haemodialysis

Randomised controlled trial of dialysate cooling for the preservation of cognitive function in haemodialysis patients (COOL HD)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67955356
Enrollment
356
Registered
2026-05-07
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive function in haemodialysis patients Mental and Behavioural Disorders

Interventions

This is a randomised study, meaning participants are assigned by chance to one of two groups for 1 year: 1. Dialysis fluid is set at 37°C (normal body temperature) 2. Dialysis fluid is set at 0.5°C be
blood results, hospital admissions, and heart-related events will be reviewed every 3 months. Safety will be monitored throughout the study.

Sponsors

University Hospitals of Derby and Burton NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. The participant is receiving maintenance in-centre haemodialysis 2. Over 18 years of age at time of consent 3. The participant is able and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Participants with confirmed diagnosis of dementia 2. Participants who lack capacity to consent 3. Participants having dialysis less than three times a week 4. Pregnant participants

Design outcomes

Secondary

MeasureTime frame
1. Other cognitive domains: processing speed, inhibition, attention, perception and general cognition and memory measured using Digit symbol matching task, Flanker Test and Letter Number Sequence Task at baseline and 12 months 2. Clinical outcomes, namely, number and length of hospitalisation episodes and frailty score measured by the clinical frailty score at baseline and 12 months 3. Quality of life measured by the Short Form Health Survey Questionnaire (SF-36) at baseline and 12 months 4. Adverse events and serious adverse events related to intervention, cardiovascular events and cerebral ischaemic events recorded at baseline, 3, 6, 9 and 12 months

Countries

England, United Kingdom

Contacts

Public ContactDerby Clinical Trials Support Unit
uhdb.coolhdstudy@nhs.net+44 (0)1332340131

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 22, 2026