Caffeine, Postoperative Delirium And Change In Outcomes after Surgery (CAPACHINOS)-2: protocol for a randomised controlled trial.
Caffeine, Postoperative Delirium And Change In Outcomes after Surgery (CAPACHINOS)-2: protocol for a randomised controlled trial.
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DOI：
10.1136/bmjopen-2023-073945
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发表时间：
2023-05-15
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
--
作者：
谵妄是手术患者及其家属的一个主要公共卫生问题，因为它与死亡率增加、认知和功能下降、住院时间延长和医疗费用增加有关。根据初步数据，本试验检验了术后静脉注射咖啡因将降低老年人在重大非心脏手术后谵妄发生率的假设。咖啡因，术后谵妄和手术后结局变化-2（CAPACHINOS-2）试验是一项单中心，安慰剂对照，随机临床试验，将在密歇根医学进行。该试验将是四盲的，临床医生，研究人员，参与者和分析师都对干预措施保持沉默。目标是以1：1：1的分配比例入组250例患者：5%葡萄糖水安慰剂、1.5 mg/kg咖啡因和3 mg/kg咖啡因作为柠檬酸咖啡因输注液。研究药物将在手术闭合期间和术后前两个早晨静脉给药。主要结局将是谵妄，通过长式意识模糊评估方法进行评估。次要结局将包括谵妄严重程度、谵妄持续时间、患者报告的结局和阿片类药物消耗模式。还将使用高密度脑电图（72通道系统）进行子研究分析，以确定术前基线时与谵妄和轻度认知障碍相关的神经异常。本研究已获得密歇根大学医学院机构审查委员会（HUM00218290）的批准。还成立了一个独立的数据和安全监测委员会，并批准了临床试验方案和相关文件。试验方法和结果将通过临床和科学期刊以及社会和新闻媒体沿着传播。NCT 05574400。
Delirium is a major public health issue for surgical patients and their families because it is associated with increased mortality, cognitive and functional decline, prolonged hospital admission and increased healthcare expenditures. Based on preliminary data, this trial tests the hypothesis that intravenous caffeine, given postoperatively, will reduce the incidence of delirium in older adults after major non-cardiac surgery. The CAffeine, Postoperative Delirium And CHange In Outcomes after Surgery-2 (CAPACHINOS-2) Trial is a single-centre, placebo-controlled, randomised clinical trial that will be conducted at Michigan Medicine. The trial will be quadruple-blinded, with clinicians, researchers, participants and analysts all masked to the intervention. The goal is to enrol 250 patients with a 1:1:1: allocation ratio: dextrose 5% in water placebo, caffeine 1.5 mg/kg and caffeine 3 mg/kg as a caffeine citrate infusion. The study drug will be administered intravenously during surgical closure and on the first two postoperative mornings. The primary outcome will be delirium, assessed via long-form Confusion Assessment Method. Secondary outcomes will include delirium severity, delirium duration, patient-reported outcomes and opioid consumption patterns. A substudy analysis will also be conducted with high-density electroencephalography (72-channel system) to identify neural abnormalities associated with delirium and Mild Cognitive Impairment at preoperative baseline. This study was approved by the University of Michigan Medical School Institutional Review Board (HUM00218290). An independent data and safety monitoring board has also been empanelled and has approved the clinical trial protocol and related documents. Trial methodology and results will be disseminated via clinical and scientific journals along with social and news media. NCT05574400.
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影响因子：
39.2
作者：
Inouye SK;Kosar CM;Tommet D;Schmitt EM;Puelle MR;Saczynski JS;Marcantonio ER;Jones RN
通讯作者：
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影响因子：
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作者：
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3
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影响因子：
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作者：
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通讯作者：
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