Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium

Camilla Bekker Mortensen*, Nina Christine Andersen-Ranberg, Lone Musaeus Poulsen, Anders Granholm, Bodil Steen Rasmussen, Maj-Brit Nørregaard Kjær, Theis Lange, Bjørn H Ebdrup, Marie Oxenbøll Collet, Anne Sofie Andreasen, Morten Heiberg Bestle, Bülent Uslu, Helle Scharling Pedersen, Louise Gramstrup Nielsen, Johanna Hästbacka, Troels Bek Jensen, Kjeld Damgaard, Trine Sommer, Matthew Morgen, Nilanjan DeyGuiseppe Citerio, Stine Estrup, Ingrid Egerod, Karin Samuelson, Anders Perner, Ole Mathiesen

*Corresponding author for this work
2 Citations (Scopus)


PURPOSE: We assessed long-term outcomes in acutely admitted adult patients with delirium treated in intensive care unit (ICU) with haloperidol versus placebo.

METHODS: We conducted pre-planned analyses of 1-year outcomes in the Agents Intervening against Delirium in the ICU (AID-ICU) trial, including mortality and health-related quality of life (HRQoL) assessed by Euroqol (EQ) 5-dimension 5-level questionnaire (EQ-5D-5L) index values and EQ visual analogue scale (EQ VAS) (deceased patients were assigned the numeric value zero). Outcomes were analysed using logistic and linear regressions with bootstrapping and G-computation, all with adjustment for the stratification variables (site and delirium motor subtype) and multiple imputations for missing HRQoL values.

RESULTS: At 1-year follow-up, we obtained vital status for 96.2% and HRQoL data for 83.3% of the 1000 randomised patients. One-year mortality was 224/501 (44.7%) in the haloperidol group versus 251/486 (51.6%) in the placebo group, with an adjusted absolute risk difference of - 6.4%-points (95% confidence interval [CI] - 12.8%-points to - 0.2%-points; P = 0.045). These results were largely consistent across the secondary analyses. For HRQoL, the adjusted mean differences were 0.04 (95% CI - 0.03 to 0.11; P = 0.091) for EQ-5D-5L-5L index values, and 3.3 (95% CI - 9.3 to 17.5; P = 0.142) for EQ VAS.

CONCLUSIONS: In acutely admitted adult ICU patients with delirium, haloperidol treatment reduced mortality at 1-year follow-up, but did not statistically significantly improve HRQoL.

Original languageEnglish
JournalIntensive Care Medicine
Issue number1
Pages (from-to)103-113
Number of pages11
Publication statusPublished - Jan 2024


  • Delirium
  • Health-related quality of life
  • ICU
  • Long-term outcomes
  • Mortality
  • Treatment


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