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The Agents Intervening against Delirium in the Intensive Care Unit-Trial (AID-ICU trial):- a detailed statistical analysis plan

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Harvard

Andersen-Ranberg, N, Poulsen, LM, Perner, A, Wetterslev, J, Mathiesen, O, Mortensen, CB, Estrup, S, Ebdrup, BH, Hästbacka, J, Citerio, G, Caballero, J, Morgan, MPG, Oxenbøll-Collet, M, Weber, S-O, Andreasen, AS, Bestle, MH, Pedersen, HBS, Nielsen, LG, Uslu, B, Jensen, TB, Thee, C, Dey, N & Lange, T 2020, 'The Agents Intervening against Delirium in the Intensive Care Unit-Trial (AID-ICU trial):- a detailed statistical analysis plan', Acta Anaesthesiologica Scandinavica, bind 64, nr. 9, s. 1357-1364. https://doi.org/10.1111/aas.13661

APA

Andersen-Ranberg, N., Poulsen, L. M., Perner, A., Wetterslev, J., Mathiesen, O., Mortensen, C. B., Estrup, S., Ebdrup, B. H., Hästbacka, J., Citerio, G., Caballero, J., Morgan, M. P. G., Oxenbøll-Collet, M., Weber, S-O., Andreasen, A. S., Bestle, M. H., Pedersen, H. B. S., Nielsen, L. G., Uslu, B., ... Lange, T. (2020). The Agents Intervening against Delirium in the Intensive Care Unit-Trial (AID-ICU trial):- a detailed statistical analysis plan. Acta Anaesthesiologica Scandinavica, 64(9), 1357-1364. https://doi.org/10.1111/aas.13661

CBE

MLA

Vancouver

Author

Andersen-Ranberg, Nina ; Poulsen, Lone M ; Perner, Anders ; Wetterslev, Jørn ; Mathiesen, Ole ; Mortensen, Camilla B ; Estrup, Stine ; Ebdrup, Bjørn H ; Hästbacka, Johanna ; Citerio, Giuseppe ; Caballero, Jesus ; Morgan, Matthew P G ; Oxenbøll-Collet, Marie ; Weber, Sven-Olaf ; Andreasen, Anne Sofie ; Bestle, Morten H ; Pedersen, Helle B S ; Nielsen, Louise G ; Uslu, Bülent ; Jensen, Troels B ; Thee, Carsten ; Dey, Nilanjan ; Lange, Theis. / The Agents Intervening against Delirium in the Intensive Care Unit-Trial (AID-ICU trial):- a detailed statistical analysis plan. I: Acta Anaesthesiologica Scandinavica. 2020 ; Bind 64, Nr. 9. s. 1357-1364.

Bibtex

@article{94ecd3b7619342ce81636f867dd60b2c,
title = "The Agents Intervening against Delirium in the Intensive Care Unit-Trial (AID-ICU trial):- a detailed statistical analysis plan",
abstract = "BACKGROUND: The AID-ICU trial aims to assess the benefits and harms of haloperidol for the treatment of delirium in acutely admitted, adult intensive care unit (ICU) patients. This paper describes the detailed statistical analysis plan for the primary publication of results from the AID-ICU trial.METHODS: The AID-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomized, blinded, parallel-group trial allocating 1000 adult ICU patients with manifest delirium 1:1 to haloperidol or placebo. The primary outcome measure is days alive and out of hospital within 90 days post-randomization. Secondary outcome measures are days alive without delirium or coma, serious adverse reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomization. Statistical analysis will be conducted in accordance with the current pre-specified statistical analysis plan. One formal interim analysis will be performed. The primary outcome will be adjusted for stratification variables (site and delirium motor subtype) and compared between treatment groups using a likelihood ratio test described by Jensen et al A secondary analysis will be conducted with additional adjustment of the primary outcome for prognostic variables at baseline. The primary conclusion of the trial will be based on the intention-to-treat analysis of the primary outcome adjusted for stratification variables.CONCLUSION: The AID-ICU trial will provide important, high-quality data on the benefits and harms of treatment with haloperidol in acutely admitted, adult patients with manifest delirium in the ICU.",
author = "Nina Andersen-Ranberg and Poulsen, {Lone M} and Anders Perner and J{\o}rn Wetterslev and Ole Mathiesen and Mortensen, {Camilla B} and Stine Estrup and Ebdrup, {Bj{\o}rn H} and Johanna H{\"a}stbacka and Giuseppe Citerio and Jesus Caballero and Morgan, {Matthew P G} and Marie Oxenb{\o}ll-Collet and Sven-Olaf Weber and Andreasen, {Anne Sofie} and Bestle, {Morten H} and Pedersen, {Helle B S} and Nielsen, {Louise G} and B{\"u}lent Uslu and Jensen, {Troels B} and Carsten Thee and Nilanjan Dey and Theis Lange",
note = "{\textcopyright} 2020 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.",
year = "2020",
month = oct,
day = "1",
doi = "10.1111/aas.13661",
language = "English",
volume = "64",
pages = "1357--1364",
journal = "Acta Anaesthesiologica Scandinavica",
issn = "0001-5172",
publisher = "Wiley-Blackwell Munksgaard",
number = "9",

}

RIS

TY - JOUR

T1 - The Agents Intervening against Delirium in the Intensive Care Unit-Trial (AID-ICU trial):- a detailed statistical analysis plan

AU - Andersen-Ranberg, Nina

AU - Poulsen, Lone M

AU - Perner, Anders

AU - Wetterslev, Jørn

AU - Mathiesen, Ole

AU - Mortensen, Camilla B

AU - Estrup, Stine

AU - Ebdrup, Bjørn H

AU - Hästbacka, Johanna

AU - Citerio, Giuseppe

AU - Caballero, Jesus

AU - Morgan, Matthew P G

AU - Oxenbøll-Collet, Marie

AU - Weber, Sven-Olaf

AU - Andreasen, Anne Sofie

AU - Bestle, Morten H

AU - Pedersen, Helle B S

AU - Nielsen, Louise G

AU - Uslu, Bülent

AU - Jensen, Troels B

AU - Thee, Carsten

AU - Dey, Nilanjan

AU - Lange, Theis

N1 - © 2020 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

PY - 2020/10/1

Y1 - 2020/10/1

N2 - BACKGROUND: The AID-ICU trial aims to assess the benefits and harms of haloperidol for the treatment of delirium in acutely admitted, adult intensive care unit (ICU) patients. This paper describes the detailed statistical analysis plan for the primary publication of results from the AID-ICU trial.METHODS: The AID-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomized, blinded, parallel-group trial allocating 1000 adult ICU patients with manifest delirium 1:1 to haloperidol or placebo. The primary outcome measure is days alive and out of hospital within 90 days post-randomization. Secondary outcome measures are days alive without delirium or coma, serious adverse reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomization. Statistical analysis will be conducted in accordance with the current pre-specified statistical analysis plan. One formal interim analysis will be performed. The primary outcome will be adjusted for stratification variables (site and delirium motor subtype) and compared between treatment groups using a likelihood ratio test described by Jensen et al A secondary analysis will be conducted with additional adjustment of the primary outcome for prognostic variables at baseline. The primary conclusion of the trial will be based on the intention-to-treat analysis of the primary outcome adjusted for stratification variables.CONCLUSION: The AID-ICU trial will provide important, high-quality data on the benefits and harms of treatment with haloperidol in acutely admitted, adult patients with manifest delirium in the ICU.

AB - BACKGROUND: The AID-ICU trial aims to assess the benefits and harms of haloperidol for the treatment of delirium in acutely admitted, adult intensive care unit (ICU) patients. This paper describes the detailed statistical analysis plan for the primary publication of results from the AID-ICU trial.METHODS: The AID-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomized, blinded, parallel-group trial allocating 1000 adult ICU patients with manifest delirium 1:1 to haloperidol or placebo. The primary outcome measure is days alive and out of hospital within 90 days post-randomization. Secondary outcome measures are days alive without delirium or coma, serious adverse reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomization. Statistical analysis will be conducted in accordance with the current pre-specified statistical analysis plan. One formal interim analysis will be performed. The primary outcome will be adjusted for stratification variables (site and delirium motor subtype) and compared between treatment groups using a likelihood ratio test described by Jensen et al A secondary analysis will be conducted with additional adjustment of the primary outcome for prognostic variables at baseline. The primary conclusion of the trial will be based on the intention-to-treat analysis of the primary outcome adjusted for stratification variables.CONCLUSION: The AID-ICU trial will provide important, high-quality data on the benefits and harms of treatment with haloperidol in acutely admitted, adult patients with manifest delirium in the ICU.

U2 - 10.1111/aas.13661

DO - 10.1111/aas.13661

M3 - Journal article

C2 - 32592589

VL - 64

SP - 1357

EP - 1364

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

IS - 9

ER -

ID: 60260918