ICU sedation, delirium & recovery

Antipsychotics and the QTc Interval During Delirium in the Intensive Care Unit: A Secondary Analysis of a Randomized Clinical Trial

JAMA Netw OpenPublished Secondary analysis of a randomised 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 = 0.78
Ziprasidone
1.09(0.75–1.57)
P = 0.78

Further findings

Median, ms

OutcomeHaloperidolZiprasidonePlacebo
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

OutcomeHaloperidolZiprasidonePlacebo
Nonfatal torsade de pointes200

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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