Effect of reduced temperature haemodialysis on myocardial function

ISRCTN	ISRCTN63390185
DOI	https://doi.org/10.1186/ISRCTN63390185
IRAS number	126372
Secondary identifying numbers	1.0, IRAS 126372

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Rajan Patel
Scientific

126 University Place
Glasgow
G12 8TA
United Kingdom

Email	rajan.patel@glasgow.ac.uk

Study information

Study design	Crossover interventional study
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient 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	1. Changes in PCr: ATP and correlation of these changes with intradialytic blood pressure variation 2. Effect of cold dialysis on these measurements These will be measured at 3, 6 and 12 months
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2014
Completion date	01/08/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Scotland
United Kingdom

Study participating centre

University of Glasgow

Glasgow
G12 8TA
United Kingdom

Sponsor information

Academy of Medical Sciences (UK)
Research organisation

41 Portland Place
London
W1B 1QH
United Kingdom

Email	info@acmedsci.ac.uk
"ROR"	https://ror.org/00c489v88

Funders

Funder type

Research organisation

Academy of Medical Sciences (UK) - Starter Grants for Clinical Lecturers

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

Editorial Notes

02/09/2020: IRAS Project ID added. No publications found.
14/09/2017: No publications found, verifying study status with principal investigator.