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

The effects of cooling the dialysate on systolic dysfunction in chronic haemodialysis patients: a multicentre randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN00206012

Enrollment

102

Registered

2009-10-15

Start date

2009-09-17

Completion date

Unknown

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease Urological and Genital Diseases

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Resting left ventricular ejection fraction on cardiac magnetic resonance imaging at 12 months.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026