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- Title
Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium.
- Authors
Mortensen, Camilla Bekker; Andersen-Ranberg, Nina Christine; Poulsen, Lone Musaeus; Granholm, Anders; Rasmussen, Bodil Steen; Kjær, Maj-Brit Nørregaard; Lange, Theis; Ebdrup, Bjørn H.; Collet, Marie Oxenbøll; Andreasen, Anne Sofie; Bestle, Morten Heiberg; Uslu, Bülent; Pedersen, Helle Scharling; Nielsen, Louise Gramstrup; Hästbacka, Johanna; Jensen, Troels Bek; Damgaard, Kjeld; Sommer, Trine; Morgen, Matthew; Dey, Nilanjan
- 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.
- Subjects
DELIRIUM; QUALITY of life; HALOPERIDOL; INTENSIVE care units; PLACEBOS
- Publication
Intensive Care Medicine, 2024, Vol 50, Issue 1, p103
- ISSN
0342-4642
- Publication type
Article
- DOI
10.1007/s00134-023-07282-7