ICU sedation, delirium & recovery
Long-term outcomes after treatment of delirium during critical illness with antipsychotics (MIND-USA): a randomised, placebo-controlled, phase 3 trial
Authors' conclusion
In delirious, critically ill patients, neither haloperidol nor ziprasidone had a significant effect on cognitive, functional, psychological, or quality-of-life outcomes among survivors.
Study context
- Population
- Delirious adults (≥18 years) in ICU with respiratory failure or septic or cardiogenic shock, 16 US hospitals
- Participants
- 566 adults
- Comparison
- IV haloperidol or ziprasidone vs placebo for up to 14 days
- Placebon = 184reference
- Haloperidoln = 192
- Ziprasidonen = 190
- Primary endpoint
- Long-term cognitive outcomes (Telephone Interview for Cognitive Status T score)
- Follow-up
- 3 months and 12 months
Methodological detailsdouble-blind, placebo-controlled, phase 3, multicentre (16 hospitals), stratified permuted-block randomisation
- Double-blind
- Placebo-controlled
- Phase 3
- Multicentre (16 hospitals)
- Stratified permuted-block randomisation
Primary result
As reported in the abstract
Cognitive outcomes (Telephone Interview for Cognitive Status T score)
Each group vs placeboAdjusted odds ratio (95% CI)
Haloperidol3 months
1.22(0.73–2.04)
Haloperidol12 months
1.12(0.60–2.11)
Ziprasidone3 months
1.07(0.59–1.96)
Ziprasidone12 months
0.94(0.62–1.44)
Further findings
Functional, psychological, quality-of-life and employment outcomes · 3 months and 12 months
- No evidence of improvement with haloperidol or ziprasidone vs placebo
- More than half of surveyed survivors in each group had limitations precluding employment
1-year survival and follow-up rates
- Similar between groups
Original publication
Long-term outcomes after treatment of delirium during critical illness with antipsychotics (MIND-USA): a randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. Published 30 April 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →