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.

OriginalsprogEngelsk
TidsskriftActa Anaesthesiologica Scandinavica
Vol/bind64
Udgave nummer10
Sider (fra-til)1519-1525
Antal sider7
ISSN0001-5172
DOI
StatusUdgivet - 1 nov. 2020

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