Mortality and HRQoL in ICU patients with delirium: Protocol for 1-year follow-up of AID-ICU trial

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Background: Intensive care unit (ICU)-acquired delirium is frequent and associated with poor short- and long-term outcomes for patients in ICUs. It therefore constitutes a major healthcare problem. Despite limited evidence, haloperidol is the most frequently used pharmacological intervention against ICU-acquired delirium. Agents intervening against Delirium in the ICU (AID-ICU) is an international, multicentre, randomised, blinded, placebo-controlled trial investigates benefits and harms of treatment with haloperidol in patients with ICU-acquired delirium. The current pre-planned one-year follow-up study of the AID-ICU trial population aims to explore the effects of haloperidol on one-year mortality and health related quality of life (HRQoL). Methods : The AID-ICU trial will include 1000 participants. One-year mortality will be obtained from the trial sites; we will validate the vital status of Danish participants using the Danish National Health Data Registers. Mortality will be analysed by Cox-regression and visualized by Kaplan-Meier curves tested for significance using the log-rank test. We will obtain HRQoL data using the EQ-5D instrument. HRQoL analysis will be performed using a general linear model adjusted for stratification variables. Deceased participants will be designated the worst possible value. Results: We expect to publish results of this study in 2022. Conclusion: We expect that this one-year follow-up study of participants with ICU-acquired delirium allocated to haloperidol vs. placebo will provide important information on the long-term consequences of delirium including the effects of haloperidol. We expect that our results will improve the care of this vulnerable patient group.


  • Camilla B. Mortensen
  • Lone M. Poulsen
  • Nina C. Andersen-Ranberg
  • Anders Perner
  • Theis Lange
  • Stine Estrup S
  • Bjørn H. Ebdrup
  • Ingrid Egerod
  • Bodil S. Rasmussen
  • Johanna Hästbacka
  • Jesús Caballero
  • Giuseppe Citerio
  • Matthew P.G. Morgan
  • Karin Samuelson
  • Ole Mathiesen
Enheter & grupper
Externa organisationer
  • Region Hospital Køge
  • University of Copenhagen
  • Aalborg University Hospital
  • Helsinki University Central Hospital
  • Hospital Arnau de Vilanova
  • University of Wales
  • University of Milano-Bicocca
  • CRIC - Collaboration for Research in Intensive Care
  • Copenhagen University Hospital
  • Autonomous University of Barcelona

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Anestesi och intensivvård
Sidor (från-till)1519-1525
Antal sidor7
TidskriftActa Anaesthesiologica Scandinavica
Utgåva nummer10
Tidigt onlinedatum2020 jul 22
StatusPublished - 2020 nov
Peer review utfördJa