Authors' objectives: To test whether taking regular measurements with a bioimpedance device, which gives information about body composition, improves outcomes for people who have newly started haemodialysis treatment for their kidney failure. In particular we want to see if this helps maintain their remaining kidney function as this is associated with improved survival, fewer symptoms of kidney failure, fewer side effects of the dialysis treatment and a better quality of life. We also want to see if sharing the bioimpedance information with patients leads to greater involvement and participation in their treatment. Background to the research: Most patients who develop kidney failure choose unit-based haemodialysis treatment. One of the main functions of dialysis is to control the amount of fluid in the body; too much fluid can lead to harm such as a persistently raised blood pressure that damages the heart and increases the risk of stroke, and may cause fluid to collect in the lungs leading to breathing difficulties which if allowed to get out of control increases the risk of death. Too little fluid, often as a result of trying to avoid these problems, causes dehydration, cramps and low blood pressure on dialysis and more rapid or complete loss of any remaining kidney function along with its associated benefits. Bioimpedance is a simple, bedside measurement giving information about body composition, in particular how much excess fluid is present. Clinicians can use this to guide how much fluid should be removed by dialysis in conjunction with the normal clinical assessment of the amount of fluid in the body but it is not known if this results in better decisions and outcomes for patients. The bioimpedance information can be shared with patients to help them understand the objectives of their treatment, potentially improving confidence in how their dialysis care is managed. Design and methods used: We will invite people starting haemodialysis treatment as an outpatient who still have some remaining kidney function to participate in a clinical trial that compares current best practice with the same but additionally guided by regular bioimpedance measurements. We will randomly assign 516 patients from 30 dialysis units across the UK. This is a sufficient number for us to determine whether the additional use of bioimpedance reduces the risk of complete loss of kidney function in the first year of treatment from 3 in 10 patients to 2 in 10 patients. We will also compare between treatments how quickly kidney function is declining, the side effects of treatment, symptoms of kidney failure, blood pressure and heart function, patient reported measures including confidence in managing their health, as well as robust information to enable a cost benefit analysis of the intervention. Patient and public involvement: We have worked closely with the NIHRs Devices for Dignity (D4D) Healthcare Technology Co-operative Renal Theme to develop this study. D4D has a strong PPI focus on technology adoption with links to INVOLVE and a patient network group. Members of this network will be invited to become members of an advisory group advising on study design, patient recruitment and dissemination. We will publicise the findings of this study through conferences, peer reviewed publications, the D4D Media Centre, National Kidney Federation (KidneyLife) and British Kidney Patients Association, including articles written by patients for patients.

Project Status: Ongoing

URL for project: http://www.nets.nihr.ac.uk/projects/hta/1421601

Anticipated Publish Date: 2021

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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