Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: the MIND randomized, placebo-controlled trial.
Feasibility, efficacy, and safety of antipsychotics for intensive care unit delirium: the MIND randomized, placebo-controlled trial.
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DOI：
10.1097/ccm.0b013e3181c58715
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发表时间：
2010-02
影响因子：
8.8
通讯作者：
MIND Trial Investigators
中科院分区：
文献类型：
--
作者：
Girard TD;Pandharipande PP;Carson SS;Schmidt GA;Wright PE;Canonico AE;Pun BT;Thompson JL;Shintani AK;Meltzer HY;Bernard GR;Dittus RS;Ely EW;MIND Trial Investigators
证明抗精神病药治疗重症监护室（ICU）谵妄的安慰剂对照试验的可行性，并检验抗精神病药可改善无谵妄或昏迷生存天数的假设。随机、双盲、安慰剂对照试验。美国的六个三级医疗中心。101名机械通气的内科和外科ICU患者。患者被随机分配接受氟哌啶醇或齐拉西酮或安慰剂，每6小时一次，持续14天。根据谵妄状态、镇静水平和副作用调整给药频率，每日两次。主要终点是患者无谵妄或昏迷存活的天数。在为期21天的研究期间，氟哌啶醇组患者无谵妄或昏迷的存活天数（中位数[IQR]，14.0 [6.0-18.0]天）与齐拉西酮组（15.0 [9.1-18.0]天）和安慰剂组（12.5 [1.2-17.2]天）相似（p = 0.66）。次要临床结局无差异，包括无呼吸机天数（p = 0.25）、住院时间（p = 0.68）和死亡率（p = 0.81）。氟哌啶醇组有10例（29%）患者报告了与静坐不能一致的症状，齐拉西酮组有6例（20%）患者，安慰剂组有7例（19%）患者（p = 0.60），治疗组之间锥体外系症状的总体测量结果相似（p = 0.46）。抗精神病药物治疗机械通气ICU患者谵妄的随机、安慰剂对照试验是可行的。在这项有限的初步试验中，抗精神病药物治疗没有改善无谵妄或昏迷的生存天数，也没有增加不良结局。因此，需要一个大的试验来确定是否使用抗精神病药ICU谵妄是适当的。
To demonstrate the feasibility of a placebo-controlled trial of antipsychotics for delirium in the intensive care unit (ICU) and to test the hypothesis that antipsychotics would improve days alive without delirium or coma. Randomized, double-blind, placebo-controlled trial. Six tertiary care medical centers in the United States. 101 mechanically ventilated medical and surgical ICU patients. Patients were randomly assigned to receive haloperidol or ziprasidone or placebo every 6 hours for up to 14 days. Frequency of administration was adjusted twice daily according to delirium status, level of sedation, and side effects. The primary end point was the number of days patients were alive without delirium or coma. During the 21-day study period, patients in the haloperidol group spent a similar number days alive without delirium or coma (median [IQR], 14.0 [6.0–18.0] days) as did patients in the ziprasidone (15.0 [9.1–18.0] days) and placebo groups (12.5 [1.2–17.2] days) (p = 0.66). No differences were found in secondary clinical outcomes, including ventilator-free days (p = 0.25), hospital length of stay (p = 0.68), and mortality (p = 0.81). Ten (29%) patients in the haloperidol group reported symptoms consistent with akathisia, compared with 6 (20%) patients in the ziprasidone group and 7 (19%) patients in the placebo group (p = 0.60), and a global measure of extrapyramidal symptoms was similar between treatment groups (p = 0.46). A randomized, placebo-controlled trial of antipsychotics for delirium in mechanically ventilated ICU patients is feasible. Treatment with antipsychotics in this limited pilot trial did not improve the number of days alive without delirium or coma nor did it increase adverse outcomes. Thus, a large trial is needed to determine whether use of antipsychotics for ICU delirium is appropriate.
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影响因子：
158.5
作者：
Inouye, SK;Bogardus, ST;Cooney, LW
通讯作者：
Cooney, LW
影响因子：
8.8
作者：
Pandharipande, P;Shintani, A;Ely, EW
通讯作者：
Ely, EW
影响因子：
17.7
作者：
Devanand, DP;Marder, K;Mayeux, R
通讯作者：
Mayeux, R
影响因子：
8.8
作者：
Ely, EW;Margolin, R;Inouye, SK
通讯作者：
Inouye, SK
影响因子：
8.8
作者：
Micek, ST;Anand, NJ;Kollef, MH
通讯作者：
Kollef, MH