Respiratory Trials·org

Sedation, analgesia & delirium · Treating delirium

AID-ICU randomised trial

Haloperidol for the Treatment of Delirium in ICU Patients

AID-ICU trial design and results
Design Multicentre, blinded, placebo-controlled randomised trial
Treatment Haloperidol
Control Placebo
Population 987 analysed ICU patients with delirium
Follow-up 90 days
Primary endpoint Days alive and out of hospital at 90 days
Result Haloperidol did not lead to significantly more days alive and out of hospital at 90 days than placebo, among 501 and 486 patients respectively. Mortality at 90 days was 36.3% with haloperidol and 43.3% with placebo — adjusted absolute difference -6.9 percentage points (95% CI -13.0 to -0.6), a secondary outcome not adjusted for multiplicity.
Secondary endpoints Mortality, serious adverse reactions, days with delirium or coma

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.

The trial authors, in the published abstract

How it has aged

Concordant with MIND-USA, and between them they removed the pharmacological treatment of ICU delirium from evidence-based practice. Haloperidol still has a role in managing dangerous agitation; it does not treat the delirium.

Publications

Haloperidol for the Treatment of Delirium in ICU Patients

Andersen-Ranberg NC, Poulsen LM, Perner A, et al. Haloperidol for the Treatment of Delirium in ICU Patients. N Engl J Med 2022 Dec 29;387(26):2425-2435.

  • No increase in days alive and out of hospital at 90 days