HOPE-ICU
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
58.0% male
N = 141
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
5 days
6 days
6.0 days
4.5 days
3.0 days
1.5 days
0.0 days
Haloperidol
Placebo
No significant
difference ↔
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.
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