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 Dey; Guiseppe Citerio; Stine Estrup; Ingrid Egerod; Karin Samuelson; Anders Perner; Ole Mathiesen

doi:10.1007/s00134-023-07282-7

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 af dette arbejde

8 Citationer (Scopus)

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.

Originalsprog	Engelsk
Tidsskrift	Intensive Care Medicine
Vol/bind	50
Udgave nummer	1
Sider (fra-til)	103-113
Antal sider	11
ISSN	0342-4642
DOI	https://doi.org/10.1007/s00134-023-07282-7
Status	Udgivet - jan. 2024

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10.1007/s00134-023-07282-7Licens: CC BY-NC

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Mortensen, C. B., Andersen-Ranberg, N. C., Poulsen, L. M., Granholm, A., Rasmussen, B. S., Kjær, M.-B. N., Lange, T., Ebdrup, B. H., Collet, M. O., Andreasen, A. S., Bestle, M. H., Uslu, B., Pedersen, H. S., Nielsen, L. G., Hästbacka, J., Jensen, T. B., Damgaard, K., Sommer, T., Morgen, M., ... Mathiesen, O. (2024). Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium. Intensive Care Medicine, 50(1), 103-113. https://doi.org/10.1007/s00134-023-07282-7

Mortensen, CB, Andersen-Ranberg, NC, Poulsen, LM, Granholm, A, Rasmussen, BS, Kjær, M-BN, Lange, T, Ebdrup, BH , Collet, MO, Andreasen, AS, Bestle, MH, Uslu, B, Pedersen, HS, Nielsen, LG, Hästbacka, J, Jensen, TB, Damgaard, K, Sommer, T, Morgen, M, Dey, N, Citerio, G, Estrup, S, Egerod, I, Samuelson, K, Perner, A & Mathiesen, O 2024, 'Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium', Intensive Care Medicine, bind 50, nr. 1, s. 103-113. https://doi.org/10.1007/s00134-023-07282-7

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title = "Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium",

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.",

keywords = "Delirium, Health-related quality of life, ICU, Long-term outcomes, Mortality, Treatment",

author = "Mortensen, {Camilla Bekker} and Andersen-Ranberg, {Nina Christine} and Poulsen, {Lone Musaeus} and Anders Granholm and Rasmussen, {Bodil Steen} and Kj{\ae}r, {Maj-Brit N{\o}rregaard} and Theis Lange and Ebdrup, {Bj{\o}rn H} and Collet, {Marie Oxenb{\o}ll} and Andreasen, {Anne Sofie} and Bestle, {Morten Heiberg} and B{\"u}lent Uslu and Pedersen, {Helle Scharling} and Nielsen, {Louise Gramstrup} and Johanna H{\"a}stbacka and Jensen, {Troels Bek} and Kjeld Damgaard and Trine Sommer and Matthew Morgen and Nilanjan Dey and Guiseppe Citerio and Stine Estrup and Ingrid Egerod and Karin Samuelson and Anders Perner and Ole Mathiesen",

note = "{\textcopyright} 2023. The Author(s).",

year = "2024",

month = jan,

doi = "10.1007/s00134-023-07282-7",

language = "English",

volume = "50",

pages = "103--113",

journal = "Intensive Care Medicine",

issn = "0342-4642",

publisher = "Springer",

number = "1",

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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

PY - 2024/1

Y1 - 2024/1

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

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U2 - 10.1007/s00134-023-07282-7

DO - 10.1007/s00134-023-07282-7

M3 - Journal article

C2 - 38170227

SN - 0342-4642

VL - 50

SP - 103

EP - 113

JO - Intensive Care Medicine

JF - Intensive Care Medicine

IS - 1

ER -

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

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