Condition category
Urological and Genital Diseases
Date applied
09/07/2014
Date assigned
20/08/2014
Last edited
22/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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. We have shown that in patients requiring dialysis, heart muscle cells react in a different way even when they appear to be working well. We 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. We would like find out the relationship between blood pressure variation at the time of haemodialysis and changes in these biochemical parameters.

Who can participate?
All adult patients who are receiving haemodialysis can take part.

What does the study involve?
Participants will be randomly allocated to one to two groups: one group will undergo magnetic resonance scanning immediately before haemodialysis and when the blood is at the normal temperature (37C) and the other group will undergo 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?
The study starts in August 2014 and will run for a year.

Who is funding the study?
Academy of Medical Sciences, UK.

Who is the main contact?
Dr Rajan Patel
rajan.patel@glasgow.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rajan Patel

ORCID ID

Contact details

126 University Place
Glasgow
G12 8TA
United Kingdom
rajan.patel@glasgow.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Effect of cool temperature haemodialysis on myocardial metabolic function

Acronym

Study hypothesis

We wish to further evaluate the effects of cold intermittent haemodialysis on myocardial contractile and metabolic activity measured by MRI. We propose to perform a crossover interventional study investigating the effect cold dialysis on myocardial function and high-energy phosphate (HEP) levels. We will correlate these data with intradialytic blood pressure changes.

Ethics approval

West of Scotland REC, 16/07/2013, ref. 13/WS/0175

Study design

Crossover interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Our outcomes will include dialysis-induced:
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 trial start date

01/08/2014

Overall trial end date

01/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All patients aged over 18 years old receving maintenance haemodialysis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2014

Recruitment end date

01/08/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

126 University Place
Glasgow
G12 8TA
United Kingdom

Sponsor information

Organisation

Academy of Medical Sciences (UK)

Sponsor details

41 Portland Place
London
W1B 1QH
United Kingdom
info@acmedsci.ac.uk

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes