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
Scientific
Royal Derby Hospital
Uttoxeter Road
DERBY
DE22 3NE
United Kingdom
| chris.mcintyre@nottingham.ac.uk |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effects of cooling the dialysate on systolic dysfunction in chronic haemodialysis patients: a multicentre randomised controlled trial |
| Study objectives | 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(s) | Nottingham Research Ethics Committee, approved on 30/6/2009 (ref: 09/H0408/71) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 17/09/2009 |
| Completion date | 17/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 102 (198 at time of registration) |
| Key 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 |
| Key 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) |
| Date of first enrolment | 17/09/2009 |
| Date of final enrolment | 17/12/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Derby Hospital
DERBY
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Sponsor information
Derby Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
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 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? |
|---|---|---|---|---|---|
| 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.
