Study to compare the effects of cooled dialysis fluid with a normal temperature of dialysis fluid on the pumping function of the heart

ISRCTN ISRCTN00206012
DOI https://doi.org/10.1186/ISRCTN00206012
Secondary identifying numbers DHRD/2009/031
Submission date
12/09/2009
Registration date
15/10/2009
Last edited
26/10/2018
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

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chris McIntyre
Scientific

Royal Derby Hospital
Uttoxeter Road
DERBY
DE22 3NE
United Kingdom

Email chris.mcintyre@nottingham.ac.uk

Study information

Study designMulticentre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleThe effects of cooling the dialysate on systolic dysfunction in chronic haemodialysis patients: a multicentre randomised controlled trial
Study objectivesThis 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(s)Nottingham Research Ethics Committee, approved on 30/6/2009 (ref: 09/H0408/71)
Health condition(s) or problem(s) studiedChronic kidney disease
InterventionCurrent 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 typeOther
Primary outcome measureResting left ventricular ejection fraction on cardiac magnetic resonance imaging at 12 months.
Secondary outcome measuresCurrent 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 study start date17/09/2009
Completion date17/12/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants102 (198 at time of registration)
Key inclusion criteria1. 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
Key exclusion criteriaCurrent 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)
Date of first enrolment17/09/2009
Date of final enrolment17/12/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Derby Hospital
DERBY
DE22 3NE
United Kingdom

Sponsor information

Derby Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Research and Development Department
Derby Hospitals NHS Foundation Trust
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3DT
England
United Kingdom

Website http://www.derbyhospitals.nhs.uk

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0408-16195)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article study protocol 21/06/2012 Yes No
Results article results 07/08/2015 Yes No

Editorial Notes

26/10/2018: Publication reference added.