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

IF 9.1 1区 医学 Q1 ANESTHESIOLOGY Anesthesiology Pub Date : 2024-11-01 DOI:10.1097/ALN.0000000000005127
Paul S Myles, Jan M Dieleman, Karin E Munting, Andrew Forbes, Catherine A Martin, Julian A Smith, David McGiffin, Lieke P J Verheijen, Sophie Wallace
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Abstract

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.

Editor’s perspective:

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地塞米松用于心脏手术:实践偏好-随机同意比较效果试验》。
背景:大剂量皮质类固醇已被用于减轻心脏手术和心肺旁路术的炎症反应,但对患者疗效的益处仍不明确。我们的主要目的是确定使用地塞米松是否比不使用地塞米松更能增加心脏手术后前 30 天的居家天数。我们的次要目标是评估新试验设计的效率、价值和影响:这项务实的国际试验采用了有利于当地实践的预随机同意设计,在澳大利亚和荷兰的 7 家医院招募了接受心脏手术的患者。患者被随机分配使用地塞米松(1 毫克/千克)或不使用(对照组)。主要结果是术后 30 天内存活和在家的天数("在家天数")。次要结果包括机械通气时间延长(超过48小时)、败血症、肾功能衰竭、心肌梗死、中风和死亡:在接受资格评估的 2093 名患者中,1951 人接受了随机治疗(中位年龄为 63 岁,80% 为男性)。地塞米松组居家天数中位数为 23.0 天(IQR,20.1 至 24.1 天),无地塞米松组为 23.1 天(IQR,20.1 至 24.6 天);中位数差异为 0.1(95% CI,-0.3 至 0.5),P=0.66。延长机械通气率 RR 0.72(95% CI,0.48 至 1.08)、败血症率 RR 1.02(95% CI,0.57 至 1.82)、肾功能衰竭率 RR 0.94(95% CI,0.80 至 1.12)、心肌梗死率 RR 0.72(95% CI,0.48 至 1.08)、肾功能衰竭率 RR 1.02(95% CI,0.57 至 1.82)。12)、心肌梗死 RR1.20(95% CI,0.30 至 4.82)、中风 RR1.06(95% CI,0.54 至 2.08)和死亡 RR0.72(95% CI,0.22 至 2.35)。地塞米松缩短了重症监护室的住院时间,中位数为29(IQR,22至50)小时,而地塞米松为43(24至72)小时,P=0.004。我们新颖的试验设计效率很高(89.3%的入选率):结论:在接受心脏手术的患者中,大剂量地塞米松可缩短重症监护室的住院时间,但不会增加术后居家天数。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Anesthesiology
Anesthesiology 医学-麻醉学
CiteScore
10.40
自引率
5.70%
发文量
542
审稿时长
3-6 weeks
期刊介绍: With its establishment in 1940, Anesthesiology has emerged as a prominent leader in the field of anesthesiology, encompassing perioperative, critical care, and pain medicine. As the esteemed journal of the American Society of Anesthesiologists, Anesthesiology operates independently with full editorial freedom. Its distinguished Editorial Board, comprising renowned professionals from across the globe, drives the advancement of the specialty by presenting innovative research through immediate open access to select articles and granting free access to all published articles after a six-month period. Furthermore, Anesthesiology actively promotes groundbreaking studies through an influential press release program. The journal's unwavering commitment lies in the dissemination of exemplary work that enhances clinical practice and revolutionizes the practice of medicine within our discipline.
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