地塞米松、轻度麻醉和严格血糖控制（DeLiT）试验的设计和组织：一项评估皮质类固醇、血糖控制和麻醉深度对大型非心脏手术围手术期炎症和发病率影响的析因试验。
Design and Organization of the Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT) Trial: a factorial trial evaluating the effects of corticosteroids, glucose control, and depth-of-anesthesia on perioperative inflammation and morbidity from major non-cardiac surgery.
机构信息
Department of OUTCOMES RESEARCH, Cleveland Clinic, Cleveland, Ohio, USA.
出版信息
BMC Anesthesiol. 2010 Jun 30;10:11. doi: 10.1186/1471-2253-10-11.
BACKGROUND
The perioperative period is characterized by an intense inflammatory response. Perioperative inflammation promotes postoperative morbidity and increases mortality. Blunting the inflammatory response to surgical trauma might thus improve perioperative outcomes. We are studying three interventions that potentially modulate perioperative inflammation: corticosteroids, tight glucose control, and light anesthesia.
METHODS/DESIGN: The DeLiT Trial is a factorial randomized single-center trial of dexamethasone vs placebo, intraoperative tight vs. conventional glucose control, and light vs deep anesthesia in patients undergoing major non-cardiac surgery. Anesthetic depth will be estimated with Bispectral Index (BIS) monitoring (Aspect medical, Newton, MA). The primary outcome is a composite of major postoperative morbidity including myocardial infarction, stroke, sepsis, and 30-day mortality. C-reactive protein, a measure of the inflammatory response, will be evaluated as a secondary outcome. One-year all-cause mortality as well as post-operative delirium will be additional secondary outcomes. We will enroll up to 970 patients which will provide 90% power to detect a 40% reduction in the primary outcome, including interim analyses for efficacy and futility at 25%, 50% and 75% enrollment.
DISCUSSION
The DeLiT trial started in February 2007. We expect to reach our second interim analysis point in 2010. This large randomized controlled trial will provide a reliable assessment of the effects of corticosteroids, glucose control, and depth-of-anesthesia on perioperative inflammation and morbidity from major non-cardiac surgery. The factorial design will enable us to simultaneously study the effects of the three interventions in the same population, both individually and in different combinations. Such a design is an economically efficient way to study the three interventions in one clinical trial vs three.
TRIAL REGISTRATION
This trial is registered at Clinicaltrials.gov #: NTC00433251.
背景
围手术期的特点是强烈的炎症反应。围手术期炎症会促进术后发病率增加和死亡率上升。因此，减轻手术创伤引起的炎症反应可能会改善围手术期的结果。我们正在研究三种可能调节围手术期炎症的干预措施：皮质类固醇、严格的血糖控制和浅麻醉。
方法/设计：DeLiT 试验是一项在接受非心脏大手术的患者中进行的地塞米松与安慰剂、术中严格与常规血糖控制以及浅与深麻醉的三因素随机单中心试验。麻醉深度将使用双谱指数（BIS）监测（Aspect medical，Newton，MA）进行估计。主要结局是包括心肌梗死、中风、脓毒症和 30 天死亡率在内的主要术后发病率的复合指标。C 反应蛋白，炎症反应的一种衡量标准，将作为次要结局进行评估。一年全因死亡率和术后谵妄将是额外的次要结局。我们将招募多达 970 名患者，这将提供 90%的效能来检测主要结局降低 40%，包括在 25%、50%和 75%入组时进行疗效和无效性的中期分析。
讨论
DeLiT 试验于 2007 年 2 月开始。我们预计将在 2010 年达到第二次中期分析点。这项大型随机对照试验将可靠地评估皮质类固醇、血糖控制和麻醉深度对非心脏大手术围手术期炎症和发病率的影响。这种设计将使我们能够同时在同一人群中研究三种干预措施的效果，包括单独研究和不同组合研究。与三项临床试验相比，这种设计是在一项临床试验中研究这三种干预措施的一种经济有效的方法。
试验注册
这项试验在 Clinicaltrials.gov 注册：NTC00433251。
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