E-CHECKED
Research type
Research Study
Full title
Evaluation of the Effect of Cooled Haemodialysis on cognitive Function in Patients suffering with End-stage Kidney Disease: Feasibility Study (E-CHECKED)
IRAS ID
234107
Contact name
George Tadros
Contact email
Sponsor organisation
Heart of England NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Patients with kidneys that do not work properly need a kidney machine to remove excess fluid and waste products from the body; a process called haemodialysis. In the UK, 26000 patients receive haemodialysis three times weekly for 4 hours with yearly costs of £636 million. The numbers needing haemodialysis are rising, particularly in older people. Average survival in UK haemodialysis patients in five years is worse than for most cancers. Haemodialysis is a huge burden for patients and their family or carers. Most patients endure unpleasant symptoms and poor quality-of-life with high rates of depression, thinking difficulties and memory problems (known as cognitive impairment). This reduces the ability to cope with taking many medicines, eating and drinking restrictions. Dialysis patients value quality-of-life over life expectancy, but no treatments have been shown to help. During haemodialysis, fluids are removed that cause sudden drops in blood pressure, with dizziness and muscle cramps. These drops in blood pressure damage the heart and brain and may cause the high levels of cognitive impairment in haemodialysis patients (30-70%). Several, small, short-term studies suggest using cooler fluid during haemodialysis reduces blood pressure drops. A recent small trial showed cooler dialysis fluid might prevent brain injury by reducing these drops in blood pressure. Few studies report how well tolerated cooler dialysis fluid is, but effects on cognitive impairment and quality-of-life are not known. As all patients can use cooler dialysis fluid at no added cost, a trial to test the health benefits to prevent cognitive impairment and preserve quality-of-life is urgently needed. This feasibility study will randomly give 90 haemodialysis patients either standard or cooled fluid for one year.
This study is a useful way to let us test the possible issues with how to run the next study that will be big enough to determine this.REC name
London - Surrey Research Ethics Committee
REC reference
17/LO/1608
Date of REC Opinion
1 Dec 2017
REC opinion
Further Information Favourable Opinion