Haloperidol for the Treatment of Delirium in ICU Patients
Haloperidol for the Treatment of Delirium in ICU Patients
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DOI：
10.1056/nejmoa2211868
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发表时间：
2022-10-26
影响因子：
158.5
通讯作者：
AID ICU Trial Grp
中科院分区：
文献类型：
--
作者：
Andersen-Ranberg, Nina C.;Poulsen, Lone M.;AID ICU Trial Grp
氟哌啶醇常用于治疗重症监护室（ICU）患者的谵妄，但其疗效的证据有限。方法：在这项多中心、盲法、安慰剂对照试验中，我们将因急性疾病而入住ICU的成人谵妄患者随机分配接受静脉氟哌啶醇（2.5 mg，每日3次，根据需要加2.5 mg，每日最大总剂量为20 mg）或安慰剂。只要谵妄持续和复发需要，就在ICU给予氟哌啶醇或安慰剂。主要结局是随机分组后90天的存活天数和出院天数。结果：共有1000例患者接受随机分组; 510例被分配到氟哌啶醇组，490例被分配到安慰剂组。在这些患者中，987例（98.7%）被纳入最终分析（氟哌啶醇组501例，安慰剂组486例）。963例患者（97.6%）的主要结局数据可用。90天时，氟哌啶醇组和安慰剂组的平均存活和出院天数分别为35.8（95%置信区间[CI]，32.9 - 38.6）和32.9（95% CI，29.9 - 35.8），校正后的平均差异为2.9天（95% CI，-1.2至7.0）（P=0.22）。氟哌啶醇组90天时的死亡率为36.3%，安慰剂组为43.3%（校正的绝对差异，-6.9个百分点[95% CI，-13.0至-0.6]）。氟哌啶醇组11例患者和安慰剂组9例患者发生严重不良反应。结论：在ICU谵妄患者中，与安慰剂相比，氟哌啶醇治疗并没有显著增加患者的存活天数和90天出院天数。
BACKGROUND Haloperidol is frequently used to treat delirium in patients in the intensive care unit (ICU), but evidence of its effect is limited. METHODS In this multicenter, blinded, placebo-controlled trial, we randomly assigned adult patients with delirium who had been admitted to the ICU for an acute condition to receive intravenous haloperidol (2.5 mg 3 times daily plus 2.5 mg as needed up to a total maximum daily dose of 20 mg) or placebo. Haloperidol or placebo was administered in the ICU for as long as delirium continued and as needed for recurrences. The primary outcome was the number of days alive and out of the hospital at 90 days after randomization. RESULTS A total of 1000 patients underwent randomization; 510 were assigned to the haloperidol group and 490 to the placebo group. Among these patients, 987 (98.7%) were included in the final analyses (501 in the haloperidol group and 486 in the placebo group). Primary outcome data were available for 963 patients (97.6%). At 90 days, the mean number of days alive and out of the hospital was 35.8 (95% confidence interval [CI], 32.9 to 38.6) in the haloperidol group and 32.9 (95% CI, 29.9 to 35.8) in the placebo group, with an adjusted mean difference of 2.9 days (95% CI, -1.2 to 7.0) (P=0.22). Mortality at 90 days was 36.3% in the haloperidol group and 43.3% in the placebo group (adjusted absolute difference, -6.9 percentage points [95% CI, -13.0 to -0.6]). Serious adverse reactions occurred in 11 patients in the haloperidol group and in 9 patients in the placebo group. CONCLUSIONS Among patients in the ICU with delirium, treatment with haloperidol did not lead to a significantly greater number of days alive and out of the hospital at 90 days than placebo.