MIND-USA (haloperidol)
Trial question
What is the effect of haloperidol on delirium in critically ill patients?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 376
376 patients (161 female, 215 male).
Inclusion criteria: patients with acute respiratory failure or shock and hypoactive or hyperactive delirium.
Key exclusion criteria: pregnancy or lactation; severe dementia or neurodegenerative disease; history of torsades de pointes; documented baseline QT prolongation; ongoing maintenance therapy with typical or atypical antipsychotics; neuroleptic malignant syndrome; hypersensitivity to haloperidol.
Interventions
N=192 haloperidol (maximum dose of 20 mg daily).
N=184 placebo (matching placebo).
Primary outcome
Median number of days alive without delirium or coma
7.9 days
8.5 days
8.5 days
6.4 days
4.3 days
2.1 days
0.0 days
Haloperidol
Placebo
No significant
difference ↔
No significant difference in median number of days alive without delirium or coma (7.9 days vs. 8.5 days; OR 0.88, 95% CI 0.64 to 1.21).
Conclusion
In patients with acute respiratory failure or shock and hypoactive or hyperactive delirium, haloperidol was not superior to placebo with respect to median number of days alive without delirium or coma.
Reference
Girard TD, Exline MC, Carson SS et al. Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness. N Engl J Med. 2018 Dec 27;379(26):2506-2516.
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