NCT03628391.

Trial name or title	Efficacy of halopeRIdol to decrease the burden of Delirium In adult Critically ill patiEnts: a prospective randomized multi‐center double‐blind placebo‐controlled clinical trial (EuRIDICE)
Methods	Multi‐site (6), quadruple‐blind, randomized placebo‐controlled trial taking place in the Netherlands. Target enrolment: 742 participants
Participants	Adult (≥ 18 years) participants admitted to 1 of 6 participating ICUs and diagnosed with delirium by the CAM‐ICU or ICDSC ≥ 4
Interventions	Participants randomized to receive haloperidol, starting with 2.5 mg IV q8h and titrated to a maximum of 5 mg IV q8h, or placebo
Outcomes	Primary Numbers of delirium‐free and coma‐free days in the ICU Secondary Time to delirium resolution 28‐day and 1‐year mortality Time to readiness of ICU discharge Adverse drug reaction (e.g. QTc prolongation, arrhythmias, extrapyramidal symptoms) Patient and family well‐being (ICU Memory Tool) Delirium Experience Questionnaire (DEQ) Caregiver Strain Index at discharge and 3 months after randomization Incidence of post‐traumatic stress disorder in participants and family 3 months after randomization Maximum ICU mobility scale Quality of sleep (Richards‐Campbell Sleep Questionnaire) 3‐ and 12‐month cognitive function (Montreal Cognitive Assessment) Rey Auditory Verbal Learning Test Semantic Fluency Digit Span Trailmaking Tests A and B Boston Naming Test Hospital Anxiety and Depression Scale 3‐ and 12‐month functional outcomes and quality of life (Short Form‐36) Workload experienced by ICU nurses while caring for delirious patients (based on Delirium Experience Questionnaire)
Starting date	February 2018
Contact information	Mathieu van der Jagt (m.vanderjagt@erasmusmc.nl)
Notes	Study is currently recruiting Study sponsor: Erasmus Medical Center Rotterdam Study funded by: ZonMw Study registered: at https://www.clinicaltrialsregister.eu/ctr‐search/trial/2017‐003115‐20/NL

APACHE: Acute Physiology and Chronic Healh Evaluation.

CAM‐ICU: Confusion Assessment Method for the ICU.

DRS‐R‐98: Delirium Rating Scale ‐ Revised ‐ 98.

DSM: Diagnostic and Statistical Manual.

EEG: electroencephalography.

EQ‐5D‐5L: EuroQoL Group Quality of Life Based on 5 Dimensions ‐ 5‐Level Scale.

ICDSC: Intensive Care Delirium Screening Checklist.

ICU: intensive care unit.

QTc: measure of time between start of the Q wave and end of the T wave in the heart's electrical cycle corrected for heart rate.

RASS: Richmond Agitation‐Sedation Scale.