Department of Pharmacy Practice, Purdue University School of Pharmacy, West Lafayette, IN, USA.
Trials. 2011 Jun 6;12:139. doi: 10.1186/1745-6215-12-139.
Delirium prevalence in the intensive care unit (ICU) is high. Numerous psychotropic agents are used to manage delirium in the ICU with limited data regarding their efficacy or harms.
METHODS/DESIGN: This is a randomized controlled trial of 428 patients aged 18 and older suffering from delirium and admitted to the ICU of Wishard Memorial Hospital in Indianapolis. Subjects assigned to the intervention group will receive a multicomponent pharmacological management protocol for delirium (PMD) and those assigned to the control group will receive no change in their usual ICU care. The primary outcomes of the trial are (1) delirium severity as measured by the Delirium Rating Scale revised-98 (DRS-R-98) and (2) delirium duration as determined by the Confusion Assessment Method for the ICU (CAM-ICU). The PMD protocol targets the three neurotransmitter systems thought to be compromised in delirious patients: dopamine, acetylcholine, and gamma-aminobutyric acid. The PMD protocol will target the reduction of anticholinergic medications and benzodiazepines, and introduce a low-dose of haloperidol at 0.5-1 mg for 7 days. The protocol will be delivered by a combination of computer (artificial intelligence) and pharmacist (human intelligence) decision support system to increase adherence to the PMD protocol.
The proposed study will evaluate the content and the delivery process of a multicomponent pharmacological management program for delirium in the ICU.
ClinicalTrials.gov: NCT00842608.
重症监护病房（ICU）中谵妄的发病率很高。有许多精神药物被用于治疗 ICU 中的谵妄，但关于它们的疗效或危害的数据有限。
方法/设计：这是一项在印第安纳波利斯威赛德纪念医院 ICU 住院的年龄在 18 岁及以上患有谵妄的 428 名患者的随机对照试验。分配到干预组的患者将接受多组分药物管理方案治疗谵妄（PMD），而分配到对照组的患者将不会改变其常规 ICU 护理。试验的主要结果是（1）使用修订后的 98 项谵妄评定量表（DRS-R-98）测量的谵妄严重程度，以及（2）使用 ICU 意识模糊评估法（CAM-ICU）确定的谵妄持续时间。PMD 方案针对三种被认为在谵妄患者中受损的神经递质系统：多巴胺、乙酰胆碱和γ-氨基丁酸。PMD 方案的目标是减少抗胆碱能药物和苯二氮䓬类药物，并在 7 天内使用低剂量的氟哌啶醇（0.5-1mg）。该方案将通过计算机（人工智能）和药剂师（人类智能）决策支持系统的组合来提供，以提高对 PMD 方案的依从性。
拟议的研究将评估 ICU 中多组分药物管理方案治疗谵妄的内容和实施过程。
ClinicalTrials.gov：NCT00842608。
