Randomised controlled trial of remote ischaemic pre-conditioning to reduce dialysis induced myocardial stunning in haemodialysis patients

ISRCTN	ISRCTN22392984
DOI	https://doi.org/10.1186/ISRCTN22392984
Protocol serial number	10327
Sponsor	Derby Hospital NHS Foundation Trust (United Kingdom)
Funder	British Heart Foundation (United Kingdom)

Submission date: 21/06/2011
Registration date: 21/06/2011
Last edited: 16/11/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Aghogho Odudu
Scientific

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Scientific title	Randomised controlled trial of remote ischaemic pre-conditioning to reduce dialysis induced myocardial stunning in haemodialysis patients
Study acronym	RIPC
Study objectives	Patients with kidney disease who require dialysis have an increased rate of death due to heart disease. This is partly due to the stress which dialysis places on the heart. This stress known as 'stunning' eventually leads to heart failure. This research explores using a simple blood pressure cuff to restrict blood flow to the leg for a few minutes. This may boosts the body's protective responsive to condition the heart in a way which may protect it from stunning during dialysis. The hope is that this simple and cheap technique could be used to reduce the development of heart disease in dialysis patients. This study lasts 4 to 6 weeks per participant and requires 80 participants.
Ethics approval(s)	11/EM/0037
Health condition(s) or problem(s) studied	Cardiovascular, Renal and Urogenital
Intervention	1. Remote pre-conditioning 2. 3 cycles of cuff inflations to 200mmHg for 5 mins 3. Follow Up Length: 1 month
Intervention type	Other
Primary outcome measure(s)	1. Regional wall motion abnormalities on 2D-echo 2. Timepoint(s): Within 4 hours of the stimulus or sham-stimulus
Key secondary outcome measure(s)	1. Change in haemodynamic variables after: 1.1. Intervention visit 1.2. First follow-up visit 1.3. Final visit 2. Frequency of intradialytic hypotension after: 2.1. Intervention visit 2.2. First follow-up visit 2.3. Final visit 3. Regional wall motion abnormalities on 2D-echo after: 3.1. First follow-up visit 3.2. Final visit 4. Troponin-T, Plasma IL-6 and N-Type proBNP after: 4.1. Intervention visit 4.2. First follow-up visit 4.3. Final visit
Completion date	16/10/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Patients having haemodialysis treatment at least 3 times per week at the Royal Derby Hospital 2. Male or female 3. Lower Age Limit 16 years
Key exclusion criteria	1. Not meeting inclusion criteria 2. Exposure to haemodialysis for <90 days prior to recruitment 3. Severe heart failure (New York Heart Association grade IV) 4. Cardiac transplant recipients 5. Mental incapacity to consent 6. Declined to participate 7. Taking cyclosporin 8. Taking ATP-sensitive potassium channel opening or blocking drugs
Date of first enrolment	16/05/2011
Date of final enrolment	16/10/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Derby Hospital

Derby
DE22 3NE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

16/11/2017: No publications found in PubMed, verifying study status with principal investigator.