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Open Access 03-01-2024 | Haloperidol | Original

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

Authors: 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 Dey, Guiseppe Citerio, Stine Estrup, Ingrid Egerod, Karin Samuelson, Anders Perner, Ole Mathiesen

Published in: Intensive Care Medicine | Issue 1/2024

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Abstract

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.
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Metadata
Title
Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium
Authors
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 Dey
Guiseppe Citerio
Stine Estrup
Ingrid Egerod
Karin Samuelson
Anders Perner
Ole Mathiesen
Publication date
03-01-2024
Publisher
Springer Berlin Heidelberg
Published in
Intensive Care Medicine / Issue 1/2024
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-023-07282-7