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dc.contributor.authorSchlapbach, LJ
dc.contributor.authorHorton, SB
dc.contributor.authorLong, DA
dc.contributor.authorBeca, J
dc.contributor.authorErickson, S
dc.contributor.authorFesta, M
dc.contributor.authorD'Udekem, Y
dc.contributor.authorAlphonso, N
dc.contributor.authorWinlaw, D
dc.contributor.authorJohnson, K
dc.contributor.authorDelzoppo, C
dc.contributor.authorVan Loon, K
dc.contributor.authorGannon, B
dc.contributor.authorFooken, J
dc.contributor.authorBlumenthal, A
dc.contributor.authorYoung, P
dc.contributor.authorJones, M
dc.contributor.authorButt, W
dc.contributor.authorSchibler, A
dc.date.accessioned2019-09-05T23:19:23Z
dc.date.available2019-09-05T23:19:23Z
dc.date.issued2019
dc.identifier.issn2044-6055
dc.identifier.doi10.1136/bmjopen-2018-026664
dc.identifier.urihttp://hdl.handle.net/10072/386977
dc.description.abstractIntroduction: 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 standard care. Here, we describe the NITRIC trial protocol. Methods and analysis: The 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 <2 years of age undergoing cardiac surgery with CPB will be randomly assigned to NO at 20 ppm administered into the CPB oxygenator for the duration of CPB or standard care (no NO) in a 1:1 ratio with stratification by age (<6 and ≥6 weeks), single ventricle physiology (Y/N) and study centre. The primary outcome will be VFD to day 28. Secondary outcomes include a composite of LCOS, need for extracorporeal membrane oxygenation or death within 28 days of surgery; length of stay in intensive care and in hospital; and, healthcare costs. Analyses will be conducted on an intention-to-treat basis. Preplanned secondary analyses will investigate the impact of NO on host inflammatory profiles postsurgery. Ethics and dissemination: The study has ethical approval (HREC/17/QRCH/43, dated 26 April 2017), is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12617000821392) and commenced recruitment in July 2017. The primary manuscript will be submitted for publication in a peer-reviewed journal. Trial registration number: ACTRN12617000821392
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherBMJ Group
dc.publisher.placeUnited Kingdom
dc.relation.ispartofpagefrome026664:1
dc.relation.ispartofpagetoe026664:8
dc.relation.ispartofissue8
dc.relation.ispartofjournalBMJ Open
dc.relation.ispartofvolume9
dc.subject.fieldofresearchClinical sciences
dc.subject.fieldofresearchHealth services and systems
dc.subject.fieldofresearchPublic health
dc.subject.fieldofresearchOther health sciences
dc.subject.fieldofresearchcode3202
dc.subject.fieldofresearchcode4203
dc.subject.fieldofresearchcode4206
dc.subject.fieldofresearchcode4299
dc.titleStudy protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC trial): A randomised controlled trial
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationSchlapbach, LJ; Horton, SB; Long, DA; Beca, J; Erickson, S; Festa, M; D'Udekem, Y; Alphonso, N; Winlaw, D; Johnson, K; Delzoppo, C; Van Loon, K; Gannon, B; Fooken, J; Blumenthal, A; Young, P; Jones, M; Butt, W; Schibler, A, Study protocol: NITric oxide during cardiopulmonary bypass to improve Recovery in Infants with Congenital heart defects (NITRIC trial): A randomised controlled trial, BMJ Open, 2019, 9 (8), pp. e026664:1-e026664:8
dcterms.licensehttp://creativecommons.org/licenses/by-nc/4.0/
dc.date.updated2019-09-05T22:59:13Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© The Author(s). Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial.
gro.hasfulltextFull Text
gro.griffith.authorLong, Debbie A.


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