ICU sedation, delirium & recovery
Antipsychotics and the QTc Interval During Delirium in the Intensive Care Unit: A Secondary Analysis of a Randomized Clinical Trial
Authors' conclusion
The findings of this trial suggest that daily QTc interval monitoring during antipsychotic use may have limited value in patients in the ICU with normal baseline QTc and few risk factors for QTc prolongation.
Study context
- Population
- Adults with delirium in the ICU with baseline QTc <550 ms, medical/surgical intensive care units (ICUs) in 16 US centres
- Participants
- 566 adults
- Comparison
- IV haloperidol or ziprasidone vs saline placebo
- Haloperidoln = 192
- Ziprasidonen = 190
- Placebon = 184reference
- Primary endpoint
- Next-day maximum QTc interval (proportional odds regression, antipsychotics vs placebo)
Methodological detailsa priori analysis, multicentre, placebo-controlled, intention-to-treat, December 2011 to August 2017
- A priori analysis
- Multicentre
- Placebo-controlled
- Intention-to-treat
- December 2011 to August 2017
Primary result
As reported in the abstract
Next-day QTc interval
Each group vs placeboOdds ratio (95% CI)P value
Haloperidol
0.95(0.66–1.37)
P = 0.78Ziprasidone
1.09(0.75–1.57)
P = 0.78Further findings
Median, ms
| Outcome | Haloperidol | Ziprasidone | Placebo |
|---|---|---|---|
| Change in QTc from day 1 to day 2 | −1.0 (IQR −28.0–15.0) | 0 (IQR −23.0–20.0) | −3.5 (IQR −24.8–17.0) |
Safety
Events
| Outcome | Haloperidol | Ziprasidone | Placebo |
|---|---|---|---|
| Nonfatal torsade de pointes | 2 | 0 | 0 |
Nonfatal torsade de pointes
- Neither occurrence associated with study drug administration
Original publication
Antipsychotics and the QTc Interval During Delirium in the Intensive Care Unit: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. Published 2 January 2024. doi:10. 1001/ jamanetworkopen. 2023. 52034
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