Agents intervening against delirium in the intensive care unit (AID-ICU) - Protocol for a randomised placebo-controlled trial of haloperidol in patients with delirium in the ICU

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperJournal articleResearchpeer-review

DOI

  • Nina C Andersen-Ranberg, Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark., University of Copenhagen
  • ,
  • Lone M Poulsen, Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark., University of Copenhagen
  • ,
  • Anders Perner, Centre for Research in Intensive Care (CRIC), University of Copenhagen
  • ,
  • Jørn Wetterslev, Centre for Research in Intensive Care (CRIC), University of Copenhagen
  • ,
  • Stine Estrup, Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark., University of Copenhagen
  • ,
  • Theis Lange, Centre for Research in Intensive Care (CRIC), University of Copenhagen
  • ,
  • Bjørn H Ebdrup, University of Copenhagen
  • ,
  • Johanna Hästbacka, University of Helsinki
  • ,
  • Matthew P G Morgan, University of Wales
  • ,
  • Giuseppe Citerio, Universitá Milano Bicocca, Monza, Italy.
  • ,
  • Lara Zafrani, Intensive Care Unit, AP HP, Saint Louis University Hospital, Paris, France.
  • ,
  • Jesús Caballero, Universitat Autonoma de Barcelona
  • ,
  • Marie Oxenbøll-Collet, University of Copenhagen
  • ,
  • Sven-Olaf Weber, Aalborg University
  • ,
  • Anne S Andreasen, University of Copenhagen
  • ,
  • Morten Bestle, University of Copenhagen
  • ,
  • Helle B S Pedersen, Department of Anaesthesiology and Intensive Care, Nykøbing Falster Hospital, Nykobing, Denmark.
  • ,
  • Thomas Hildebrandt, University of Copenhagen
  • ,
  • Carsten Thee, Hospital Sønderjylland
  • ,
  • Troels B Jensen
  • Nilanjan Dey
  • ,
  • Louise G Nielsen, University of Southern Denmark
  • ,
  • Ole Mathiesen, University of Copenhagen, Centre for Research in Intensive Care (CRIC)

BACKGROUND: Delirium among patients in the intensive care unit (ICU) is a common condition associated with increased morbidity and mortality. Haloperidol is the most frequently used pharmacologic intervention, but its use is not supported by firm evidence. Therefore, we are conducting Agents Intervening against Delirium in the Intensive Care Unit (AID-ICU) trial to assess the benefits and harms of haloperidol for the treatment of ICU-acquired delirium.

METHODS: AID-ICU is an investigator-initiated, pragmatic, international, randomised, blinded, parallel-group, trial allocating adult ICU patients with manifest delirium 1:1 to haloperidol or placebo. Trial participants will receive intravenous 2.5 mg haloperidol three times daily or matching placebo (isotonic saline 0.9%) if they are delirious. If needed, a maximum of 20 mg/daily haloperidol/placebo is given. An escape protocol, not including haloperidol, is part of the trial protocol. The primary outcome is days alive out of the hospital within 90 days post-randomisation. Secondary outcomes are number of days without delirium or coma, serious adverse reactions to haloperidol, usage of escape medication, number of days alive without mechanical ventilation; mortality, health-related quality-of-life and cognitive function at 1-year follow-up. A sample size of 1000 patients is required to detect a 7-day improvement or worsening of the mean days alive out of the hospital, type 1 error risk of 5% and power 90%.

PERSPECTIVE: The AID-ICU trial is based on gold standard methodology applied to a large sample of clinically representative patients and will provide pivotal high-quality data on the benefits and harms of haloperidol for the treatment ICU-acquired delirium.

Original languageEnglish
JournalActa Anaesthesiologica Scandinavica
Volume63
Issue10
Pages (from-to)1426-1433
Number of pages8
ISSN0001-5172
DOIs
Publication statusPublished - Nov 2019

    Research areas

  • ICU, antipsychotics, delirium, delirium treatment, haloperidol, intensive care unit

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