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

Autor:	Myles PS; Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia., Dieleman JM; Department of Anaesthesia, Westmead Hospital, Western Sydney University, Penrith, Australia., Munting KE; Department of Anaesthesia, University Medical Center, Utrecht, The Netherlands., Forbes A; Biostatistics Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia., Martin CA; Biostatistics Unit, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia., Smith JA; Department of Cardiothoracic Surgery, and Department of Surgery, School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia., McGiffin D; Department of Cardiothoracic Surgery, Alfred Hospital, Melbourne, Australia., Verheijen LPJ; Department of Anaesthesia, University Medical Center, Utrecht, The Netherlands., Wallace S; Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Australia.
Jazyk:	angličtina
Zdroj:	Anesthesiology [Anesthesiology] 2024 Nov 01; Vol. 141 (5), pp. 859-869.
DOI:	10.1097/ALN.0000000000005127
Abstrakt:	Background: 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. (Copyright © 2024 American Society of Anesthesiologists. All Rights Reserved.)
Databáze:	MEDLINE
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