Condition category
Urological and Genital Diseases
Date applied
12/09/2009
Date assigned
15/10/2009
Last edited
14/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.derbyhospitals.nhs.uk

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

Results - basic reporting

Publication summary

1. 2012 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/22720738

Publication citations

  1. 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.

Additional files

Editorial Notes