Effect of reduced temperature haemodialysis on myocardial function
| ISRCTN | ISRCTN63390185 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63390185 |
| Integrated Research Application System (IRAS) | 126372 |
| Protocol serial number | 1.0, IRAS 126372 |
| Sponsor | Academy of Medical Sciences (UK) |
| Funder | Academy of Medical Sciences (UK) - Starter Grants for Clinical Lecturers |
- Submission date
- 09/07/2014
- Registration date
- 20/08/2014
- Last edited
- 02/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Patients with kidney failure who need haemodialysis (filtering the blood to get rid of waste products) three a week are at higher risk of death due to heart attacks or abnormal heart rhythms. This can alter the size and shape of their hearts. In addition, changes that occur during the haemodialysis therapy, such as fall in blood pressure, are associated with a poorer outcome. This could be due to a poor blood supply to the heart. These falls in blood pressure can be improved by reducing the temperature of the blood during dialysis. The trialists have shown that in patients requiring dialysis, heart muscle cells react in a different way even when they appear to be working well. They would like to further explain the short term effects of dialysis on heart function by studying the changes in biochemical parameters (high-energy phosphates) which can be measured using magnetic resonance imaging. They would like find out the relationship between blood pressure variation at the time of haemodialysis and changes in these biochemical parameters.
Who can participate?
Adult patients who are receiving haemodialysis
What does the study involve?
Participants are randomly allocated to one to two groups: one group undergoes magnetic resonance scanning immediately before haemodialysis and when the blood is at the normal temperature (37C) and the other group undergoes the scanning at a reduced temperature (35C).
What are the possible benefits and risks of participating?
Patients may experience a reduction in HEPs and thereby benefit from better control of blood pressure during dialysis and cold dialysis. There are no risks associated with reduced temperature dialysis or MRI scanning.
Where is the study run from?
NHS Greater Glasgow and Clyde (UK)
When is the study starting and how long is it expected to run for?
August 2014 to August 2015
Who is funding the study?
Academy of Medical Sciences (UK)
Who is the main contact?
Dr Rajan Patel
rajan.patel@glasgow.ac.uk
Contact information
Scientific
126 University Place
Glasgow
G12 8TA
United Kingdom
| rajan.patel@glasgow.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Crossover interventional study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Effect of cool temperature haemodialysis on myocardial metabolic function |
| Study objectives | The trialists wish to further evaluate the effects of cold intermittent haemodialysis on myocardial contractile and metabolic activity measured by MRI. They propose to perform a crossover interventional study investigating the effect cold dialysis on myocardial function and high-energy phosphate (HEP) levels. They will correlate these data with intradialytic blood pressure changes. |
| Ethics approval(s) | West of Scotland REC, 16/07/2013, ref. 13/WS/0175 |
| Health condition(s) or problem(s) studied | End stage renal failure |
| Intervention | Cardiac magnetic resonance (CMR) and magnetic resonance scanning (MRS) on two different groups (randomly allocated) of maintenance haemodialysis patients: Group 1: Immediately before and after normal temperature (37°C) haemodialysis. Group 2: Reduced temperature (35C) haemodialysis. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Changes in PCr: ATP and correlation of these changes with intradialytic blood pressure variation |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | All patients aged over 18 years old receving maintenance haemodialysis |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2014 |
| Date of final enrolment | 01/08/2015 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
G12 8TA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/09/2020: IRAS Project ID added. No publications found.
14/09/2017: No publications found, verifying study status with principal investigator.
