AID-ICU

In adult patients admitted to the ICU that develop hyperactive or hypoactive delirium, does scheduled and as needed intravenous haloperidol as compared to placebo affect the number of days alive and out of the hospital?

Study design

Multicenter, double-blind, randomized, placebo-controlled trial

Population

Number of patients studied: 1000
Inclusion criteria: ≥18 years old with unplanned admission to an ICU for an acute condition, screened positive for delirium with CAM-ICU or ICDSC
Exclusion criteria: Haloperidol contraindication, non-pharmacologic coma, regular anti-psychotic therapy, permanently incompetent patient, withdrawal from active therapy, brain death, pregnancy, involuntary hospitalization, alcohol withdrawal

Interventions

Experimental group: Haloperidol at 2.5mg IV three times daily, plus as needed doses of 2.5mg up to a daily maximum of 20mg
Control group: Matched placebo of both scheduled and as needed doses

Primary outcome

Significant difference? No (P = 0.22)

Secondary outcomes

All-cause mortality at 90 days: 36.3% in the haloperidol group vs. 43.3% in the placebo group (adjusted RR 0.84; 95% CI 0.72 to 0.98)

Safety outcomes or Adverse Events

Serious adverse reactions in ICU: 2.2% in the haloperidol group vs. 1.9% in the placebo group

Therapy stopped due to QTc prolongation: 2.4% in the haloperidol group vs. 1.4% in the placebo group

Physical restraints utilized: 1.9% in the haloperidol group vs. 2.1% in the placebo group

Andersen-Ranberg NC, et al. "Haloperidol for the Treatment of Delirium in ICU Patients". The New England Journal of Medicine. 2022. Online ahead of print(2022-10-26):1-11.