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Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial: protocol for a two-centre, double-blind,
Nigel E Drury1,2, Rehana Bi3,4, Rebecca L Woolley5,6
1Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK n.e.drury@bham.ac.uk.
Insights
Remote ischaemic preconditioning may protect young children undergoing heart surgery from myocardial injury. The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial investigates this simple, low-risk technique to improve cardiac outcomes.
Area of Science:
- Cardiology
- Pediatric Cardiac Surgery
- Ischemia-Reperfusion Injury
Background:
- Myocardial injury is common in children post-cardiac surgery, impacting heart function.
- Current strategies do not fully prevent myocardial damage after aortic cross-clamping.
- Remote ischaemic preconditioning offers a potential low-risk method for myocardial protection.
Purpose of the Study:
- To evaluate the effectiveness of bilateral remote ischaemic preconditioning in reducing myocardial injury in young children undergoing cardiac surgery.
- To assess the impact of this intervention on cardiac biomarkers and clinical outcomes.
Main Methods:
- The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial is a two-centre, double-blind, randomized controlled trial.
- Recruiting up to 120 children (3 months to 3 years) undergoing specific cardiac repairs.
- Participants receive either remote ischaemic preconditioning or a sham procedure before surgery, with outcomes measured by troponin-T levels.
Main Results:
- Primary outcome: reduction in the area under the curve for high-sensitivity troponin-T release within 24 hours post-aortic cross-clamp release.
- Secondary outcomes: peak troponin-T, vasoactive-inotrope score, lactate levels, oxygen saturations, and lengths of stay.
- Follow-up until hospital discharge or 30 days.
Conclusions:
- The BRICC trial will provide crucial data on the efficacy of remote ischaemic preconditioning in pediatric cardiac surgery.
- Findings may lead to improved myocardial protection strategies for vulnerable young patients.
- Results will be disseminated through publications and presentations.
Introduction:
Myocardial protection against ischaemic-reperfusion injury is a key determinant of heart function and outcome following cardiac surgery in children. However, with current strategies, myocardial injury occurs routinely following aortic cross-clamping, as demonstrated by the ubiquitous rise in circulating troponin. Remote ischaemic preconditioning, the application of brief, non-lethal cycles of ischaemia and reperfusion to a distant organ or tissue, is a simple, low-risk and readily available technique which may improve myocardial protection. The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial will assess whether remote ischaemic preconditioning, applied to both lower limbs immediately prior to surgery, reduces myocardial injury in cyanotic and acyanotic young children.
Methods And Analysis:
The BRICC trial is a two-centre, double-blind, randomised controlled trial recruiting up to 120 young children (age 3 months to 3 years) undergoing primary repair of tetralogy of Fallot or surgical closure of an isolated ventricular septal defect. Participants will be randomised in a 1:1 ratio to either bilateral remote ischaemic preconditioning (3×5 min cycles) or sham immediately prior to surgery, with follow-up until discharge from hospital or 30 days, whichever is sooner. The primary outcome is reduction in area under the time-concentration curve for high-sensitivity (hs) troponin-T release in the first 24 hours after aortic cross-clamp release. Secondary outcome measures include peak hs-troponin-T, vasoactive inotrope score, arterial lactate and central venous oxygen saturations in the first 12 hours, and lengths of stay in the paediatric intensive care unit and the hospital.
Ethics And Dissemination:
The trial was approved by the West Midlands-Solihull National Health Service Research Ethics Committee (16/WM/0309) on 5 August 2016. Findings will be disseminated to the academic community through peer-reviewed publications and presentation at national and international meetings. Parents will be informed of the results through a newsletter in conjunction with a local charity.
Trial Registration Number:
ISRCTN12923441.
