Haloperidol vs. placebo for the treatment of delirium in ICU patients: a pre-planned, secondary Bayesian analysis of the AID–ICU trial

Nina C. Andersen-Ranberg*, Lone Musaeus Poulsen, Anders Perner, Johanna Hästbacka, Matthew Morgan, Giuseppe Citerio, Marie Oxenbøll Collet, Sven Olaf Weber, Anne Sofie Andreasen, Morten Bestle, Bülent Uslu, Helle Scharling Pedersen, Louise Gramstrup Nielsen, Kjeld Damgaard, Troels Bek Jensen, Trine Sommer, Nilanjan Dey, Ole Mathiesen, Anders Granholm

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review


Purpose: The AID–ICU trial was a randomised, blinded, placebo-controlled trial investigating effects of haloperidol versus placebo in acutely admitted, adult patients admitted in intensive care unit (ICU) with delirium. This pre-planned Bayesian analysis facilitates probabilistic interpretation of the AID–ICU trial results. Methods: We used adjusted Bayesian linear and logistic regression models with weakly informative priors to analyse all primary and secondary outcomes reported up to day 90, and with sensitivity analyses using other priors. The probabilities for any benefit/harm, clinically important benefit/harm, and no clinically important differences with haloperidol treatment according to pre-defined thresholds are presented for all outcomes. Results: The mean difference for days alive and out of hospital to day 90 (primary outcome) was 2.9 days (95% credible interval (CrI) − 1.1 to 6.9) with probabilities of 92% for any benefit and 82% for clinically important benefit. The risk difference for mortality was − 6.8 percentage points (95% CrI − 12.8 to − 0.8) with probabilities of 99% for any benefit and 94% for clinically important benefit. The adjusted risk difference for serious adverse reactions was 0.3 percentage points (95% CrI − 1.3 to 1.9) with 98% probability of no clinically important difference. Results were consistent across sensitivity analyses using different priors, with more than 83% probability of benefit and less than 17% probability of harm with haloperidol treatment. Conclusions: We found high probabilities of benefits and low probabilities of harm with haloperidol treatment compared with placebo in acutely admitted, adult ICU patients with delirium for the primary and most secondary outcomes.

Original languageEnglish
JournalIntensive Care Medicine
Issue number4
Pages (from-to)411-420
Publication statusPublished - Apr 2023


  • Bayesian analysis
  • Delirium
  • Haloperidol
  • Delirium/drug therapy
  • Intensive Care Units
  • Humans
  • Bayes Theorem
  • Adult
  • Antipsychotic Agents/therapeutic use
  • Haloperidol/therapeutic use


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