NCT03392376.

Trial name or title	Agents intervening against delirium in intensive care unit (AID‐ICU)
Methods	Multi‐site (23), quadruple‐blind, randomized placebo‐controlled trial taking place in Denmark, Finland, Germany, Italy, Norway, and Spain. Target enrolment: 1000 patients
Participants	Acutely admitted adult (> 18 years) patients diagnosed with delirium via the CAM‐ICU or ICDSC
Interventions	Participants randomized to receive haloperidol (2.5 mg IV thrice daily with additional, as needed doses up to a maximum of 20 mg/d) or placebo (0.5 mL IV isotonic saline thrice daily, with additional, as needed doses up to a maximum of 4 mL/d)
Outcomes	Primary Days alive out of the hospital within 90 days post randomization Secondary Number of days alive without delirium or coma in the ICU Number of patients with 1 or more serious adverse reactions or the total number of serious adverse reactions to haloperidol compared with placebo, or both Usage of escape medicine and dosage of escape medicine per patient Number of days alive without mechanical ventilation within 90 days post randomization Mortality Quality of life (EQ‐5D‐5L total score 1 year post randomization) Quality of life (EQ‐Visual Analogue Scale 1 year post randomization) Cognitive function 1 year after randomization (at selected sites) Executive function 1 year after randomization (at selected sites) Health economics analysis Cognitive function at admission
Starting date	12 June 2018
Contact information	Lone Musaeus Poulsen, MD (lmp@regionsjaelland.dk) Nina Christine Andersen‐Ranberg, MD (ncan@regionsjaelland.dk)
Notes	Subset of sites currently recruiting Study sponsor: Zealand University Hospital Study registered: at https://clinicaltrials.gov/ct2/show/NCT03392376