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

Camilla B. Mortensen, Lone M. Poulsen, Nina C. Andersen-Ranberg, Anders Perner, Theis Lange, S Stine Estrup, Bjørn H. Ebdrup, Ingrid Egerod, Bodil S Rasmussen, Johanna Hästbacka, Jesús Caballero, Giuseppe Citerio, Matthew P.G. Morgan, Karin Samuelson, Ole Mathiesen

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Abstract

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.

Original languageEnglish
JournalActa Anaesthesiologica Scandinavica
Volume64
Issue number10
Pages (from-to)1519-1525
Number of pages7
ISSN0001-5172
DOIs
Publication statusPublished - 1 Nov 2020

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