MIND-USA (ziprasidone)
Trial question
What is the effect of ziprasidone 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 = 374
374 patients (159 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 ziprasidone.
Interventions
N=190 ziprasidone (maximum dose of 40 mg daily).
N=184 placebo (matching placebo).
Primary outcome
Median number of days alive without delirium or coma
8.7 days
8.5 days
8.7 days
6.5 days
4.3 days
2.2 days
0.0 days
Ziprasidone
Placebo
No significant
difference ↔
No significant difference in median number of days alive without delirium or coma (8.7 days vs. 8.5 days; OR 1.04, 95% CI 0.73 to 1.48).
Conclusion
In patients with acute respiratory failure or shock and hypoactive or hyperactive delirium, ziprasidone 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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