Study protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC trial): a randomised controlled trial
Luregn J Schlapbach, Stephen Brian Horton, Debbie Amanda Long, John Beca, Simon Erickson, Marino Festa, Yves d'Udekem, Nelson Alphonso, David Winlaw, Kerry Johnson, Carmel Delzoppo, Kim van Loon, B Gannon, Jonas Fooken, Antje Blumenthal, Paul Young, Mark Jones, Warwick Butt, Andreas Schibler, Johnny Millar Show all
BMJ Open | BMJ PUBLISHING GROUP | Published : 2019
INTRODUCTION: Congenital heart disease (CHD) is a major cause of infant mortality. Many infants with CHD require corrective surgery with most operations requiring cardiopulmonary bypass (CPB). CPB triggers a systemic inflammatory response which is associated with low cardiac output syndrome (LCOS), postoperative morbidity and mortality. Delivery of nitric oxide (NO) into CPB circuits can provide myocardial protection and reduce bypass-induced inflammation, leading to less LCOS and improved recovery. We hypothesised that using NO during CPB increases ventilator-free days (VFD) (the number of days patients spend alive and free from invasive mechanical ventilation up until day 28) compared with..View full abstract
Awarded by Australian National Health and Medical Research Council
This work was supported by grants from the Heart Kids Foundation, Australia; the Children's Health Foundation, Brisbane, Australia; and by a grant from the Australian National Health and Medical Research Council (1140322). LJS, YdU and AS hold a NHMRC Clinical Practitioner Fellowship. The Victorian Government's Operational Infrastructure Support Program supported this research project. PY holds a Clinical Practitioner Fellowship from the Health Research Council of New Zealand. Mallinckrodt Pharmaceuticals will provide nitric oxide delivery devices to study centres but has no involvement in study design, conduct, nor analyses.