Feasibility of melatonin for prevention of delirium in critically ill patients: a protocol for a multicentre, randomised, placebo-controlled study
Feasibility of melatonin for prevention of delirium in critically ill patients: a protocol for a multicentre, randomised, placebo-controlled study
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DOI：
10.1136/bmjopen-2016-015420
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发表时间：
2017-03-01
期刊：
影响因子：
2.9
通讯作者：
Rose, Louise
中科院分区：
文献类型：
--
作者：
Burry, Lisa;Scales, Damon;Rose, Louise
谵妄在重症监护病房（ICU）非常普遍，并与不良临床结果相关。在这个时候，没有药物可以有效地预防危重病人的谵妄。褪黑素分泌和代谢的改变可能导致谵妄的发生。外源性褪黑素的管理已被证明可以防止谵妄在非危重症外科和内科病人。该试验将证明计划中的多中心随机对照试验的可行性，以验证与安慰剂相比，褪黑素可以预防危重患者谵妄的假设。方法和分析：这项可行性试验是一项随机、三组、安慰剂对照的研究，研究褪黑素（2 mg vs 0.5 mg vs安慰剂，服用最多14天）预防危重患者谵妄。从3个加拿大ICU共招募69名18岁及以上患者，预计ICU住院时间为48小时。主要结果是方案依从性（即在规定给药窗口内给予研究药物剂量的总体比例）。次要结局包括药代动力学参数、发病率、发病时间、谵妄持续时间、无谵妄天数、不良事件、自我报告的睡眠质量、手腕活动记录仪测量的休息-活动周期、机械通气持续时间、ICU住院时间和死亡率。数据将采用意向治疗方法进行分析。伦理和传播：该研究已得到加拿大卫生部和每个研究地点的研究伦理委员会的批准。试验结果将在国际会议上发表，并发表在同行评议的期刊上。
Introduction: Delirium is highly prevalent in the intensive care unit (ICU) and is associated with adverse clinical outcomes. At this time, there is no drug that effectively prevents delirium in critically ill patients. Alterations in melatonin secretion and metabolism may contribute to the development of delirium. Administration of exogenous melatonin has been shown to prevent delirium in non-critically ill surgical and medical patients. This trial will demonstrate the feasibility of a planned multicentre, randomised controlled trial to test the hypothesis that melatonin can prevent delirium in critically ill patients compared with placebo.Methods and analysis: This feasibility trial is a randomised, 3-arm, placebo-controlled study of melatonin (2 vs 0.5 mg vs placebo, administered for a maximum of 14 days) for the prevention of delirium in critically ill patients. A total of 69 patients aged 18 years and older with an expected ICU length of stay >48 hours will be recruited from 3 Canadian ICUs. The primary outcome is protocol adherence (ie, overall proportion of study drug doses administered in the prescribed administration window). Secondary outcomes include pharmacokinetic parameters, incidence, time to onset, duration of delirium, number of delirium-free days, adverse events, self-reported sleep quality, rest-activity cycles measured by wrist actigraphy, duration of mechanical ventilation, ICU length of stay and mortality. Data will be analysed using an intention-to-treat approach.Ethics and dissemination: The study has been approved by Health Canada and the research ethics board of each study site. Trial results will be presented at international conferences and published in a peerreviewed journal.