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 |
| Secondary identifying numbers | 10327 |
- 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
Scientific
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 16/05/2011 |
| Completion date | 16/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 80; UK Sample Size: 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
- England
- United Kingdom
Study participating centre
Royal Derby Hospital
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Sponsor information
Derby Hospital NHS Foundation Trust (United Kingdom)
Hospital/treatment centre
Hospital/treatment centre
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
England
United Kingdom
| Website | http://www.derbyhospitals.nhs.uk/ |
|---|
Funders
Funder type
Charity
British Heart Foundation (United Kingdom)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
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 |
Editorial Notes
16/11/2017: No publications found in PubMed, verifying study status with principal investigator.
