Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium
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Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium. / 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; Citerio, Guiseppe; Estrup, Stine; Egerod, Ingrid; Samuelson, Karin; Perner, Anders; Mathiesen, Ole.
I: Intensive Care Medicine, Bind 50, 2024, s. 103–113.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium
AU - Mortensen, Camilla Bekker
AU - Andersen-Ranberg, Nina Christine
AU - Poulsen, Lone Musaeus
AU - Granholm, Anders
AU - Rasmussen, Bodil Steen
AU - Kjær, Maj Brit Nørregaard
AU - Lange, Theis
AU - Ebdrup, Bjørn H.
AU - Collet, Marie Oxenbøll
AU - Andreasen, Anne Sofie
AU - Bestle, Morten Heiberg
AU - Uslu, Bülent
AU - Pedersen, Helle Scharling
AU - Nielsen, Louise Gramstrup
AU - Hästbacka, Johanna
AU - Jensen, Troels Bek
AU - Damgaard, Kjeld
AU - Sommer, Trine
AU - Morgen, Matthew
AU - Dey, Nilanjan
AU - Citerio, Guiseppe
AU - Estrup, Stine
AU - Egerod, Ingrid
AU - Samuelson, Karin
AU - Perner, Anders
AU - Mathiesen, Ole
N1 - Publisher Copyright: © 2023, The Author(s).
PY - 2024
Y1 - 2024
N2 - 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.
AB - 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.
KW - Delirium
KW - Health-related quality of life
KW - ICU
KW - Long-term outcomes
KW - Mortality
KW - Treatment
U2 - 10.1007/s00134-023-07282-7
DO - 10.1007/s00134-023-07282-7
M3 - Journal article
C2 - 38170227
AN - SCOPUS:85181235598
VL - 50
SP - 103
EP - 113
JO - European Journal of Intensive Care Medicine
JF - European Journal of Intensive Care Medicine
SN - 0935-1701
ER -
ID: 380197116