Evaluation of the Effect of Cooled Haemodialysis on Cognitive Function in Patients Suffering With… (NCT03645733) | Clinical Trial Compass
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Evaluation of the Effect of Cooled Haemodialysis on Cognitive Function in Patients Suffering With End-stage KD
United Kingdom90 participantsStarted 2017-12-20
Plain-language summary
The Investigators aim to perform a feasibility study that will inform the development of a definitive, fully powered, randomised, controlled clinical trial in the future. 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 one 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient is aged \>18 years.
. Receiving haemodialysis three (3) times per week for ESKD, for at least 3 months
. Having proven mental capacity to understand the study and give informed consent
Exclusion criteria
. Established diagnosis of dementia in a memory clinic or specialised service.
. Receiving Acetylcholine Esterase Inhibitors
. Receiving antipsychotic or antidepressants unless stable on treatment for at least 6 weeks
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Investigation of lower temperatures of dialysis and cognitive decline