Study protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC trial): a randomised controlled trial

Autor: Yves d’Udekem, Simon Erickson, Marino Festa, Stephen Brian Horton, Debbie Amanda Long, John Beca, Nelson Alphonso, Kerry Johnson, Carmel Delzoppo, Kim van Loon, B Gannon, Jonas Fooken, Antje Blumenthal, Warwick Butt, Steve Horton, Johnny Millar, David Buckley, Taryn Evans, Claire Sherring, John Artrip, Killian O’Shaughnessy, Rebecca Fletcher, Simon Byrne, Sam Barr, Rae Kelly, Deborah Long, Kerry Johnston, Carla Zuzak, Benjamin Anderson, Nicole J C W van Belle-van Haaren, Bram van Wijk, Erik Koomen
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: BMJ Open, Vol 9, Iss 8 (2019)
Druh dokumentu: article
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2018-026664
Popis: IntroductionCongenital 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 standard care. Here, we describe the NITRIC trial protocol.Methods and analysisThe NITRIC trial is a randomised, double-blind, controlled, parallel-group, two-sided superiority trial to be conducted in six paediatric cardiac surgical centres. One thousand three-hundred and twenty infants
Databáze: Directory of Open Access Journals