Your browser doesn't support javascript.
loading
Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial: protocol for a two-centre, double-blind, randomised controlled trial in young children undergoing cardiac surgery.
Drury, Nigel E; Bi, Rehana; Woolley, Rebecca L; Stickley, John; Morris, Kevin P; Montgomerie, James; van Doorn, Carin; Dunn, Warwick B; Madhani, Melanie; Ives, Natalie J; Kirchhof, Paulus; Jones, Timothy J.
Afiliação
  • Drury NE; Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK n.e.drury@bham.ac.uk.
  • Bi R; Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, West Midlands, UK.
  • Woolley RL; Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK.
  • Stickley J; Paediatric Intensive Care, Birmingham Children's Hospital, Birmingham, West Midlands, UK.
  • Morris KP; Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, West Midlands, UK.
  • Montgomerie J; Institute of Applied Health Research, University of Birmingham, Birmingham, West Midlands, UK.
  • van Doorn C; Paediatric Cardiac Surgery, Birmingham Children's Hospital, Birmingham, West Midlands, UK.
  • Dunn WB; Paediatric Intensive Care, Birmingham Children's Hospital, Birmingham, West Midlands, UK.
  • Madhani M; Institute of Applied Health Research, University of Birmingham, Birmingham, West Midlands, UK.
  • Ives NJ; Paediatric Cardiac Anaesthesia, Birmingham Children's Hospital, Birmingham, West Midlands, UK.
  • Kirchhof P; Congenital Cardiac Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire, UK.
  • Jones TJ; School of Biosciences, University of Birmingham, Birmingham, West Midlands, UK.
BMJ Open ; 10(10): e042176, 2020 10 07.
Article em En | MEDLINE | ID: mdl-33033035
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.
Assuntos
Palavras-chave

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Precondicionamento Isquêmico / Procedimentos Cirúrgicos Cardíacos Tipo de estudo: Clinical_trials Aspecto: Ethics Limite: Child / Humans Idioma: En Revista: BMJ Open Ano de publicação: 2020 Tipo de documento: Article País de publicação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Precondicionamento Isquêmico / Procedimentos Cirúrgicos Cardíacos Tipo de estudo: Clinical_trials Aspecto: Ethics Limite: Child / Humans Idioma: En Revista: BMJ Open Ano de publicação: 2020 Tipo de documento: Article País de publicação: Reino Unido