Dexamethasone for Cardiac Surgery: A Practice Preference–Randomized Consent Comparative Effectiveness Trial

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dc.contributor.authorMyles, P.S.
dc.contributor.authorDieleman, J.M.
dc.contributor.authorMunting, K.E.
dc.contributor.authorForbes, A.
dc.contributor.authorMartin, C.A.
dc.contributor.authorSmith, J.A.
dc.contributor.authorMcGiffin, D.
dc.contributor.authorVerheijen, L.P.J.
dc.contributor.authorWallace, S.
dc.contributor.authorMyles, P.S.
dc.contributor.authorWallace, S.
dc.contributor.authorUeoka, M.
dc.contributor.authorDutton, M.
dc.contributor.authorRobertshaw, S.
dc.contributor.authorClarris, M.
dc.contributor.authorNeylan, A.
dc.contributor.authorSmith, J.
dc.contributor.authorHulley, A.
dc.contributor.authorWarwarek, S.
dc.contributor.authorPainter, T.
dc.contributor.authoret al.
dc.date.issued2024
dc.description.abstractBackground: High-dose corticosteroids have been used to attenuate the inflammatory response to cardiac surgery and cardiopulmonary bypass, but patient outcome benefits remain unclear. The primary aim was to determine whether using dexamethasone was superior to not using dexamethasone to increase the number of home days in the first 30 days after cardiac surgery. The secondary aim was to evaluate efficiency, value, and impact of the novel trial design. Methods: This pragmatic, international trial incorporating a prerandomized consent design favoring local practice enrolled patients undergoing cardiac surgery across seven hospitals in Australia and The Netherlands. Patients were randomly assigned to dexamethasone 1 mg/kg or not (control). The primary outcome was the number of days alive and at home up to 30 days after surgery (“home days”). Secondary outcomes included prolonged mechanical ventilation (more than 48 h), sepsis, renal failure, myocardial infarction, stroke, and death. Results: Of 2,562 patients assessed for eligibility, 1,951 were randomized (median age, 63 yr; 80% male). The median number of home days was 23.0 (interquartile range, 20.1 to 24.1) in the no dexamethasone group and 23.1 (interquartile range, 20.1 to 24.6) in the dexamethasone group (median difference, 0.1; 95% CI, –0.3 to 0.5; P = 0.66). The rates of prolonged mechanical ventilation (risk ratio, 0.72; 95% CI, 0.48 to 1.08), sepsis (risk ratio, 1.02; 95% CI, 0.57 to 1.82), renal failure (risk ratio, 0.94; 95% CI, 0.80 to 1.12), myocardial infarction (risk ratio, 1.20; 95% CI, 0.30 to 4.82), stroke (risk ratio, 1.06; 95% CI, 0.54 to 2.08), and death (risk ratio, 0.72; 95% CI, 0.22 to 2.35) were comparable between groups (all P > 0.10). Dexamethasone reduced intensive care unit stay (median, 29 h; interquartile range, 22 to 50 h vs. median, 43 h; interquartile range, 24 to 72 h; P = 0.004). The authors’ novel trial design was highly efficient (89.3% enrollment). Conclusions: Among patients undergoing cardiac surgery, high-dose dexamethasone decreased intensive care unit stay but did not increase the number of home days after surgery.
dc.description.statementofresponsibilityPaul S. Myles, Jan M. Dieleman, Karin E. Munting, Andrew Forbes, Catherine A. Martin, Julian A. Smith, David McGiffin, Lieke P. J. Verheijen, Sophie Wallace, for the DECS-II Investigators and the ANZCA Clinical Trials Network
dc.identifier.citationAnesthesiology, 2024; 141(5):859-869
dc.identifier.doi10.1097/ALN.0000000000005127
dc.identifier.issn0003-3022
dc.identifier.issn1528-1175
dc.identifier.orcidPainter, T. [0000-0003-2216-2046]
dc.identifier.urihttps://hdl.handle.net/2440/147908
dc.language.isoen
dc.publisherLippincott, Williams & Wilkins
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/ID2008079
dc.rights© 2024 American Society of Anesthesiologists. All Rights Reserved.
dc.source.urihttps://doi.org/10.1097/aln.0000000000005127
dc.subjectCardiac Surgery; Preference–Randomized Consent Comparative Effectiveness Trial
dc.subject.meshHumans
dc.subject.meshPostoperative Complications
dc.subject.meshDexamethasone
dc.subject.meshAnti-Inflammatory Agents
dc.subject.meshTreatment Outcome
dc.subject.meshCardiac Surgical Procedures
dc.subject.meshInformed Consent
dc.subject.meshAged
dc.subject.meshMiddle Aged
dc.subject.meshAustralia
dc.subject.meshNetherlands
dc.subject.meshFemale
dc.subject.meshMale
dc.subject.meshComparative Effectiveness Research
dc.titleDexamethasone for Cardiac Surgery: A Practice Preference–Randomized Consent Comparative Effectiveness Trial
dc.typeJournal article
pubs.publication-statusPublished

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