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Pharmacological Management of Delirium in the Intensive Care Unit: A Randomized Pragmatic Clinical Trial.

Abstract：

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.

journal_name

J Am Geriatr Soc

journal_title

Journal of the American Geriatrics Society

authors

Khan BA,Perkins AJ,Campbell NL,Gao S,Farber MO,Wang S,Khan SH,Zarzaur BL,Boustani MA

doi

10.1111/jgs.15781

subject

Has Abstract

pub_date

2019-05-01 00:00:00

pages

1057-1065

issue

eissn

0002-8614

issn

1532-5415

journal_volume

pub_type

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Pharmacological Management of Delirium in the Intensive Care Unit: A Randomized Pragmatic Clinical Trial.