Contact information
Type
Scientific
Primary contact
Dr Chris McIntyre
ORCID ID
Contact details
Royal Derby Hospital
Uttoxeter Road
DERBY
DE22 3NE
United Kingdom
chris.mcintyre@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DHRD/2009/031
Study information
Scientific title
The effects of cooling the dialysate on systolic dysfunction in chronic haemodialysis patients: a multicentre randomised controlled trial
Acronym
Study hypothesis
This study will examine whether cooling the dialysate retards the development of cardiac systolic dysfunction in haemodialysis patients. This study will also examine whether cooling the dialysate will have an abrogating effect on a wide range of haemodynamic functional measures and microvascular function.
Primary objective: To observe the effects of cooling the dialysate on cardiac systolic function after 12 months using magnetic resonance imaging.
The secondary aims of the study are to observe the effects of cooling the dialysate on:
1. Left ventricular ejection fraction measured with intra-dialytic echocardiography
2. Frequency and severity of myocardial stunning measured with intra-dialytic echocardiography
3. A range of measures of haemodynamic variables, including cardiac output, pulse rate, heart rate, arrhythmias and frequency of intradialytic hypotension
4. Microvascular function using myography
5. Cross-sectional correlants of cardiovascular outcomes to biomarkers
Please note, as of 26/04/2011 the anticipated end date for this trial has been extended from 17/09/2012 to 17/12/2012 and the target number of participants reduced from 198 to 106.
As of 02/02/2012, the target number of participants have been reduced from 106 to 102.
Ethics approval
Nottingham Research Ethics Committee, approved on 30/6/2009 (ref: 09/H0408/71)
Study design
Multicentre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Chronic kidney disease
Intervention
Current interventions as of 26/04/2012
Individualised cooled dialysate vs dialysate at 37 degrees centigrade (control).
Duration of interventions: 12 months
Previous interventions
Individualised cooled dialysate vs dialysate at 37 degrees centigrade (control).
Duration of interventions: 18 months (Note: primary endpoint is measured at 12 months).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Resting left ventricular ejection fraction on cardiac magnetic resonance imaging at 12 months.
Secondary outcome measures
Current secondary outcome measure(s) as of 26/04/2012
1. Left ventricular ejection fraction measured by intra-dialytic echocardiography
2. Frequency and severity of myocardial stunning measured with intra-dialytic echocardiography
3. A range of haemodynamic variables, including cardiac output, pulse rate, heart rate, arrhythmias and frequency of intra-dialytic hypotension
4. Endothelial function using myography
5. A range of biochemical markers of cardiac and endothelial function
All secondary outcomes will be assessed at baseline and 12 months
Previous secondary outcome measure(s)
1. Left ventricular ejection fraction measured by intra-dialytic echocardiography
2. Frequency and severity of myocardial stunning measured with intra-dialytic echocardiography
3. A range of haemodynamic variables, including cardiac output, pulse rate, heart rate, arrhythmias and frequency of intra-dialytic hypotension
4. Endothelial function using myography
5. A range of biochemical markers of cardiac and endothelial function
All secondary outcomes will be assessed at 6, 12 and 18 months
Overall trial start date
17/09/2009
Overall trial end date
17/12/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female, age >=16 years old
2. Patients having haemodialysis treatment at least 3 times per week
3. Willing and able to provide consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
102 (198 at time of registration)
Participant exclusion criteria
Current exclusion criteria as of 26/04/2012
1. Exposure to haemodialysis >180 days
2. Contraindications for using magnetic resonance imaging (MRI) (e.g. patients with pacemakers and metal implants)
3. Inability to tolerate MRI due to claustrophobia
4. New York Heart Association grade IV heart failure
5. Mental incapacity to consent
6. Pregnancy or lactating patients
Previous exclusion criteria as of 02/02/2012
1. Exposure to haemodialysis >180 days
2. Contraindications for using magnetic resonance imaging (MRI) (e.g. patients with pacemakers and metal implants)
3. Inability to tolerate MRI due to claustrophobia
4. New York Heart Association grade IV heart failure
5. Mental incapacity to consent
Previous exclusion criteria as of 26/04/2011:
1. Exposure to haemodialysis >180 days
2. Contraindications for using magnetic resonance imaging (MRI) (e.g. patients with pacemakers and metal implants)
3. Inability to tolerate MRI due to claustrophobia
4. New York Heart Association grade IV heart failure
5. Cardiac transplant recipients
6. Mental incapacity to consent
Previous exclusion criteria:
1. Exposure to haemodialysis for >90 days
(criteria 2 - 6 remained unchanged)
Recruitment start date
17/09/2009
Recruitment end date
17/12/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Derby Hospital
DERBY
DE22 3NE
United Kingdom
Sponsor information
Organisation
Derby Hospitals NHS Foundation Trust (UK)
Sponsor details
Research and Development Department
Derby Hospitals NHS Foundation Trust
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3DT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0408-16195)
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
Basic results (scientific)
Publication list
1. 2012 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/22720738
Publication citations
-
Study protocol
Odudu A, Eldehni MT, Fakis A, McIntyre CW, Rationale and design of a multi-centre randomised controlled trial of individualised cooled dialysate to prevent left ventricular systolic dysfunction in haemodialysis patients., BMC Nephrol, 2012, 13, 45, doi: 10.1186/1471-2369-13-45.