Intraoperative High-Dose Dexamethasone for Cardiac Surgery A Randomized Controlled Trial
Intraoperative High-Dose Dexamethasone for Cardiac Surgery A Randomized Controlled Trial
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DOI：
10.1001/jama.2012.14144
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发表时间：
2012-11-07
影响因子：
120.7
通讯作者：
van Dijk, Diederik
中科院分区：
文献类型：
--
作者：
Dieleman, Jan M.;Nierich, Arno P.;van Dijk, Diederik
背景在心脏手术中经常使用预防性皮质类固醇来减轻心肺转流术和手术创伤的炎症反应;然而，常规使用皮质类固醇可以预防主要不良事件的证据是缺乏的。目的量化术中大剂量地塞米松对心脏手术患者主要不良事件发生率的影响。设计，设置和参与者是一个多中心，随机，一项双盲、安慰剂对照试验，纳入了2006年4月13日至11月23日期间在荷兰8家心脏外科中心接受体外循环心脏手术的4494例18岁或以上患者，2011.干预患者被随机分配接受单次术中剂量1 mg/kg地塞米松（n=2239）或安慰剂（n=2255）主要结局指标：随机分组后30天内死亡、心肌梗死、中风、肾功能衰竭或呼吸衰竭的复合指标。结果在4494例随机分组的患者中，4482例（99.7%）可评价主要结局。地塞米松组共有157例患者（7.0%）和安慰剂组共有191例患者（8.5%）达到主要研究终点（相对风险，0.83; 95%CI，0.67-1.01;绝对风险降低，-1.5%; 95%CI，-3.0%至0.1%; P= 0.07）。地塞米松与术后感染、术后机械通气时间、重症监护室和住院时间的减少相关。相比之下，地塞米松与较高的术后血糖levels.Conclusion在我们的试验中接受心脏手术的成年人，术中使用地塞米松并没有减少30天的主要不良事件的发生率相比，安慰剂。
Context Prophylactic corticosteroids are often administered during cardiac surgery to attenuate the inflammatory response to cardiopulmonary bypass and surgical trauma; however, evidence that routine corticosteroid use can prevent major adverse events is lacking.Objective To quantify the effect of intraoperative high-dose dexamethasone on the incidence of major adverse events in patients undergoing cardiac surgery.Design, Setting, and Participants A multicenter, randomized, double-blind, placebo-controlled trial of 4494 patients aged 18 years or older undergoing cardiac surgery with cardiopulmonary bypass at 8 cardiac surgical centers in the Netherlands enrolled between April 13, 2006, and November 23, 2011.Intervention Patients were randomly assigned to receive a single intraoperative dose of 1 mg/kg dexamethasone (n=2239) or placebo (n=2255).Main Outcome Measures A composite of death, myocardial infarction, stroke, renal failure, or respiratory failure, within 30 days of randomization.Results Of the 4494 patients who underwent randomization, 4482 (99.7%) could be evaluated for the primary outcome. A total of 157 patients (7.0%) in the dexamethasone group and 191 patients (8.5%) in the placebo group reached the primary study end point (relative risk, 0.83; 95% CI, 0.67-1.01; absolute risk reduction, -1.5%; 95% CI, -3.0% to 0.1%; P=.07). Dexamethasone was associated with reductions in postoperative infection, duration of postoperative mechanical ventilation, and lengths of intensive care unit and hospital stays. In contrast, dexamethasone was associated with higher postoperative glucose levels.Conclusion In our trial of adults undergoing cardiac surgery, the use of intraoperative dexamethasone did not reduce the 30-day incidence of major adverse events compared with placebo.