TY - JOUR

T1 - Mortality and HRQoL in ICU patients with delirium

T2 - Protocol for 1-year follow-up of AID-ICU trial

AU - Mortensen, Camilla B.

AU - Poulsen, Lone M.

AU - Andersen-Ranberg, Nina C.

AU - Perner, Anders

AU - Lange, Theis

AU - Estrup, Stine S.

AU - Ebdrup, Bjørn H.

AU - Egerod, Ingrid

AU - Rasmussen, Bodil S.

AU - Hastbacka, Johanna

AU - Caballero, Jesus

AU - Citerio, Giuseppe

AU - Morgan, Matthew P. G.

AU - Samuelson, Karin

AU - Mathiesen, Ole

PY - 2020

Y1 - 2020

N2 - 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.

AB - 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.

KW - QUALITY-OF-LIFE

KW - MECHANICALLY VENTILATED PATIENTS

KW - SURVIVAL

KW - HALOPERIDOL

KW - PREDICTOR

KW - RISK

U2 - 10.1111/aas.13679

DO - 10.1111/aas.13679

M3 - Journal article

C2 - 33460045

VL - 64

SP - 1519

EP - 1525

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

SN - 0001-5172

IS - 10

ER -