Prevention of ischaemia-reperfusion injury in children undergoing surgery for tetralogy of Fallot or ventricular septal defect Circulatory System 1. Tetralogy of Fallot 2. Ventricular Septal Defect
Conditions
Interventions
On the day of surgery, participants will be randomised to either Remote Ischaemic Preconditioning (RIPC) or control in a 1:1 ratio using an online randomisation system. Patients will be stratified for
if vascular access is problematic and the femoral route is required by the anaesthetist, one cuff will be placed on the thigh and the other on the upper arm.
Control group: The cuffs will be placed b
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 24/03/2020: 1. Aged 3 months to 3 years at the time of surgery 2. Undergoing elective primary repair of Tetralogy of Fallot (TOF) or Ventricular Septal Defect (VSD), with or without a concomitant atrial septal defect (ASD) or pulmonary artery repair/augmentation, at Birmingham Children’s Hospital or Leeds Children’s Hospital. Previous participant inclusion criteria: 1. Aged 3 months to 3 years at the time of surgery 2. Undergoing elective primary repair of Tetralogy of Fallot (TOF) or Ventricular Septal Defect (VSD), with or without a concomitant atrial septal defect (ASD)
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 24/03/2020: 1. Those requiring an additional procedure (other than ASD closure) at the time of primary repair e.g. aortic arch repair 2. Those with significant airway or parenchymal lung disease, bleeding disorder or recent ischaemic event 3. Those who have undergone a previous cardiac surgical procedure with cardioplegic arrest. 4. Those presenting in a critical condition and requiring emergency cardiac surgery 5. Those for whom the parents are unwilling or unable to give informed consent Previous participant exclusion criteria: 1. Those requiring an additional procedure (other than ASD closure) at the time of primary repair e.g. aortic arch repair 2. Those with a known major chromosomal defect, significant airway or parenchymal lung disease, bleeding disorder or recent ischaemic event 3. Those presenting in a critical condition and requiring emergency cardiac surgery 4. Those for whom the parents are unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myocardial injury, determined by area under the time-concentration curve (AUC) for high-sensitivity troponin-T in the first 24 hours, measured at baseline, 3, 6, 12 and 24 hours after aortic cross-clamp release (reperfusion). | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/03/2020: 1. Myocardial injury, measured by peak hs-troponin-T in the first 12 hours, measured at baseline, 3, 6 and 12 hours after reperfusion 2. Inotropic support, determined by vasoactive inotrope score over the first 12 hours after reperfusion 3. Metabolic debt, measured by serum lactate concentration and mixed venous oxygen saturations over the first 12 hours after reperfusion 4. Length of stay, determined by the period of time required in the paediatric intensive care unit and the hospital following surgery 5. Exploratory outcome: myocardial function, measured by cardiac index using the ICON device over the first 12 hours after reperfusion Previous secondary outcome measures: 1. Myocardial injury, measured by peak hs-troponin-T in the first 12 hours, measured at baseline, 3, 6, 12 and 24 hours after reperfusion 2. Myocardial function, measured by cardiac index using the ICON device over the first 12 hours after reperfusion 3. Inotropic support, determined by inotrope score over the first 12 hours after reperfusion 4. Metabolic debt, measured by serum lactate concentration and mixed venous oxygen saturations over the first 12 hours after reperfusion 5. Length of stay, determined by the period of time required in the paediatric intensive care unit and the hospital following surgery | — |
Countries
England, United Kingdom
Contacts
Public ContactNigel Drury
Outcome results
None listed