Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.
Indiana University Center for Aging Research, Indianapolis, Indiana.
J Am Geriatr Soc. 2019 May;67(5):1057-1065. doi: 10.1111/jgs.15781. Epub 2019 Jan 25.
BACKGROUND/OBJECTIVE: Delirium in the intensive care units (ICUs) is prevalent, with both delirium duration and delirium severity associated with adverse outcomes. We designed a pragmatic trial to test the efficacy of a pharmacological management of delirium (PMD) bundle in improving delirium/coma-free days and reducing delirium severity among ICU patients. DESIGN: A randomized pragmatic clinical trial. SETTING: Medical, surgical, and progressive ICUs of three tertiary care hospitals. PARTICIPANTS: A total of 351 critically ill patients. INTERVENTION: A multicomponent PMD bundle consisting of reducing the exposure to 20 definite anticholinergic medications and benzodiazepines and prescribing low-dose haloperidol. MEASUREMENTS: The primary outcomes were delirium/coma-free days, measured through the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the ICU (CAM-ICU), and delirium severity, measured through Delirium Rating Scale-Revised-98 and the CAM-ICU-7. Secondary outcomes were in-hospital and posthospital discharge 30-day mortality, ICU and hospital lengths of stay, and delirium-related hospital complications. RESULTS: We randomized 351 critically ill delirious patients (mean age = 59.3 years [SD = 16.9 years]; 52% female, 42% African Americans) to receive the PMD bundle or usual care. There were no significant differences in median delirium/coma-free days at day 8 (PMD vs usual care = 4 [interquartile range {IQR} = 2-7] days vs 5 [IQR = 1-7] days; P = .888) or at day 30 (PMD vs usual care = 26 [IQR 19-29] days vs 26 [IQR, 14-29] days; P = .991). There were no significant differences for decrease in delirium severity at day 8, but at hospital discharge, the intervention group showed a greater reduction in delirium severity (mean decrease in CAM-ICU-7 score for PMD vs usual care = 3.2 [SD = 3.3] vs 2.5 [SD = 3.2]; P = .046). No differences were observed between groups for ICU and hospital lengths of stay, mortality, and delirium-related hospital complications. Similar results were observed when analyses were limited to patients 65 years or older and 75 years or older. CONCLUSION AND RELEVANCE: Implementing the PMD bundle in the ICU did not reduce delirium duration or severity among critically ill patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00842608. J Am Geriatr Soc 67:1057-1065, 2019.
背景/目的：重症监护病房（ICU）中谵妄很常见，谵妄持续时间和严重程度均与不良结局相关。我们设计了一项实用临床试验，以测试药物管理谵妄（PMD）方案包改善 ICU 患者谵妄/昏迷无天数和降低谵妄严重程度的疗效。 设计：一项随机实用临床试验。 地点：三家三级护理医院的内科、外科和渐进式 ICU。 参与者：共 351 名危重症患者。 干预措施：由减少接触 20 种明确的抗胆碱能药物和苯二氮䓬类药物以及开低剂量氟哌啶醇组成的多成分 PMD 方案包。 测量：主要结果是通过 Richmond 激越镇静量表和 ICU 意识模糊评估法（CAM-ICU）测量的谵妄/昏迷无天数，以及通过谵妄评定量表修订版-98（DRS-R-98）和 ICU 意识模糊评估法-7（CAM-ICU-7）测量的谵妄严重程度。次要结果为院内和出院后 30 天死亡率、ICU 和住院时间以及与谵妄相关的医院并发症。 结果：我们将 351 名患有谵妄的危重症患者（平均年龄=59.3 岁[SD=16.9 岁]；52%为女性，42%为非裔美国人）随机分为接受 PMD 方案包或常规护理组。第 8 天的谵妄/昏迷无天数中位数（PMD 组 vs 常规护理组=4[四分位距 {IQR} = 2-7]天 vs 5[IQR = 1-7]天；P=.888）和第 30 天的谵妄/昏迷无天数中位数（PMD 组 vs 常规护理组=26[IQR 19-29]天 vs 26[IQR，14-29]天；P=.991）无显著差异。第 8 天的谵妄严重程度下降无显著差异，但在出院时，干预组的谵妄严重程度降低更为明显（PMD 组 vs 常规护理组的 CAM-ICU-7 评分平均降低=3.2[SD=3.3] vs 2.5[SD=3.2]；P=.046）。两组间 ICU 和住院时间、死亡率和与谵妄相关的医院并发症无差异。当分析仅限于 65 岁或以上和 75 岁或以上的患者时，观察到了相似的结果。 结论和相关性：在 ICU 中实施 PMD 方案包并未降低危重症患者的谵妄持续时间或严重程度。 试验注册：clinicaltrials.gov 标识符：NCT00842608。J Am Geriatr Soc 67:1057-1065, 2019.
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