6/28/23, 11:05 PM HOPE-ICU Pathway Feedback Search Clinical Topics Home Studies HOPE ICU HOPE ICU Disease ICU delirium Trial question What is the effect of IV haloperidol in critically ill patients? Study design Single center Double blinded RCT Population Characteristics of study participants 42.0% female N = 141 58.0% male 141 patients (59 female, 82 male) Inclusion criteria: critically ill adult patients needing mechanical ventilation within 72 hours of admission Key exclusion criteria: allergy to haloperidol, moderate to severe dementia, Parkinson's disease, structural brain damage, chronic antipsychotic use, moribund state Interventions N=71 haloperidol (at a dose of 2.5 mg IV every 8 hours) N=70 placebo (an equal volume of 0.9% saline IV every 8 hours) Primary outcome Days alive without delirium and without coma in first 14 days 6.0 days 6 5 4.5 days https://web.pathway.md/studies/recAajrQLj9AatYDD 1/2 6/28/23, 11:05 PM HOPE-ICU Pathway 3.0 days 1.5 days No significant difference 0.0 days Haloperidol Placebo No significant difference in days alive without delirium and without coma in the first 14 days (5 days vs. 6 days; AD -0.48 days, 95% CI -2.08 to 1.21) Secondary outcomes No significant difference in ventilator-free days in the first 28 days (21 days vs. 17 days; AD 0.25 days, 95% CI -3.26 to 4.16) No significant difference in death at 28 days (28.2% vs. 27.1%; RR 1.04, 95% CI 0.61 to 1.77) No significant difference in length of critical care stay (9.5 days vs. 9 days; AD -1.45 days, 95% CI -5.42 to 2.52) Safety outcomes No significant differences in use of individual sedative or opioid drugs, QTc prolongation > 500 ms. Significant difference in risk of needing additional antipsychotics (11% vs. 26%). Conclusion In critically ill adult patients needing mechanical ventilation within 72 hours of admission, haloperidol was not superior to placebo with respect to days alive without delirium and without coma in the first 14 days. Reference Valerie J Page, E Wesley Ely, Simon Gates et al. Effect of intravenous haloperidol on the duration of delirium and coma in critically ill patients (Hope-ICU): a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2013 Sep;1(7):515-23. Open reference URL https://web.pathway.md/studies/recAajrQLj9AatYDD 2/2