Condition category
Circulatory System
Date applied
21/06/2011
Date assigned
21/06/2011
Last edited
24/06/2015
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 Aghogho Odudu

ORCID ID

Contact details

Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

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

http://www.derbyhospitals.nhs.uk/

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

Publication citations

Additional files

Editorial Notes