Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10327
Study information
Scientific title
Randomised controlled trial of remote ischaemic pre-conditioning to reduce dialysis induced myocardial stunning in haemodialysis patients
Acronym
RIPC
Study hypothesis
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
11/EM/0037
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
1. Regional wall motion abnormalities on 2D-echo
2. Timepoint(s): Within 4 hours of the stimulus or sham-stimulus
Secondary outcome measures
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
Overall trial start date
16/05/2011
Overall trial end date
16/10/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 80; UK Sample Size: 80
Participant 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
Recruitment start date
16/05/2011
Recruitment end date
16/10/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
Sponsor information
Organisation
Derby Hospital NHS Foundation Trust (United Kingdom)
Sponsor details
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (United Kingdom)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
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