Preventing ICU Subsyndromal Delirium Conversion to Delirium With Low-Dose IV Haloperidol: A Double-Blind, Placebo-Controlled Pilot Study.
Preventing ICU Subsyndromal Delirium Conversion to Delirium With Low-Dose IV Haloperidol: A Double-Blind, Placebo-Controlled Pilot Study.
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DOI：
10.1097/ccm.0000000000001411
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发表时间：
2016-03
影响因子：
8.8
通讯作者：
Devlin JW
中科院分区：
文献类型：
--
作者：
Al-Qadheeb NS;Skrobik Y;Schumaker G;Pacheco MN;Roberts RJ;Ruthazer RR;Devlin JW
目的：比较常规小剂量氟哌啶醇与安慰剂预防妄想的有效性和安全性[重症监护妄想筛查量表(ICDSC)≥4]对患有亚综合征妄想的危重成人(ICDSC=1-3)的预防效果和安全性。随机、双盲、安慰剂对照试验。美国一家学术医疗中心的三个10个床位的ICU(2个内科；1个外科)。68名亚综合征神志不清的机械通气患者，无需复杂的神经疾病、心脏手术或需要深度镇静。患者被随机分配到静脉注射氟哌啶醇1 mg或安慰剂，每6小时一次，直到出现精神错乱(ICDSC≥4，经精神检查证实)、治疗≥10天或ICU出院。氟哌啶醇组(n=34)和安慰剂组(n=34)的基线特征相似。服用氟哌啶醇[12/34(35%)]和安慰剂[8/34(23%)]的患者出现妄想的患者数量相似(p=0.29)。使用氟哌啶醇减少了患者每天焦虑不安的时间(sas≥5)(p=0.008)，但不影响患者在没有昏迷(sas≤2)或精神错乱(p=0.36)、首次出现精神错乱的时间(p=0.22)或精神错乱持续时间(p=0.26)的情况下12小时轮班的比例。两组的机械通气天数(p=0.80)、ICU病死率(p=0.55)和ICU病人处理情况(p=0.22)相似。两组患者出现QTC间期延长(p=0.16)、锥体外系症状(p=0.31)、过度镇静(p=0.31)或新发低血压(p=1.0)导致停药的比例相似。在ICU逗留的早期开始使用小剂量的预定氟哌啶醇，不能预防神志不清，而且对机械通气的危重成人亚综合征神志不清几乎没有治疗优势。
To compare the efficacy and safety of scheduled low-dose, haloperidol vs. placebo for the prevention of delirium [Intensive Care Delirium Screening Checklist (ICDSC) ≥ 4)] administered to critically ill adults with subsyndromal delirium (ICDSC = 1-3). Randomized, double-blind, placebo-controlled trial. Three 10-bed ICUs (2 medical; 1 surgical) at an academic medical center in the U.S. Sixty-eight mechanically ventilated patients with subsyndromal delirium without complicating neurologic conditions, cardiac surgery or requiring deep sedation. Patients were randomly assigned to receive intravenous haloperidol 1 mg or placebo every six hours until either delirium (ICDSC ≥ 4 with psychiatric confirmation), therapy ≥ 10 days or ICU discharge occurred. Baseline characteristics were similar between the haloperidol (n=34) and placebo (n=34) groups. A similar number of patients given haloperidol [12/34 (35%)] and placebo [8/34 (23%)] patients developed delirium (p=0.29). Haloperidol use reduced the hours per study day spent agitated (SAS ≥ 5) (p=0.008), but did not influence the proportion of 12-hour ICU shifts patients’ spent alive without coma (SAS ≤ 2) or delirium (p=0.36), the time to first delirium occurrence (p=0.22) nor delirium duration (p=0.26). Days of mechanical ventilation (p=0.80), ICU mortality (p=0.55) and ICU patient disposition (p=0.22) were similar in the two groups. The proportion of patients who developed QTc-interval prolongation (p=0.16), extrapyramidal symptoms (p=0.31), excessive sedation (p=0.31) or new-onset hypotension (p=1.0) that resulted in study drug discontinuation was comparable between the two groups. Low-dose scheduled haloperidol, initiated early in the ICU stay, does not prevent delirium and has little therapeutic advantage in mechanically ventilated, critically ill adults with subsyndromal delirium.