Title
Agents Intervening Against Delirium in Intensive Care Unit
Agents Intervening Against Delirium in Intensive Care Unit (AID-ICU) A Randomized, Blinded, Placebo-controlled Trial
Phase
Phase 4Lead Sponsor
University of CopenhagenStudy Type
InterventionalStatus
Active, not recruitingIndication/Condition
DeliriumIntervention/Treatment
Haloperidol Injection ...Study Participants
1000Delirium is a frequent condition in the Intensive Care Unit (ICU) with no existing evidence-based treatment. The aim of the AID-ICU study is to assess the benefits and harms of haloperidol treatment for the management of ICU acquired delirium.
Delirium among critically ill patients in the intensive care unit (ICU) is a common condition associated with increased morbidity and mortality. No evidence-based treatment exist of this condition. Haloperidol is the most frequently used agent to treat ICU-related delirium, but according to the available literature there is no firm evidence of efficacy and safety of this intervention. AID-ICU aims to assess the benefits and harms of haloperidol in adult, critically ill patients with delirium in the ICU.
ICU patients with diagnosed delirium are treated with 2,5mg haloperidol x 3 daily intravenously with additional as needed doses to a maximum of 20mg/daily.
ICU patients with diagnosed delirium are treated with 0,5ml isotonic saline x 3 daily and as needed doses to a maximum of 4ml/daily, corresponding to the algorithm in the experimental arm.
Haloperidol 2,5mg x 3 daily, with additional as needed doses to a maximum of 20mg/daily. Other name: Serenase
Inclusion Criteria: Acute admission to the ICU AND Age ≥ 18 years AND Diagnosed delirium with validated screening Tool as either CAM-ICU or ICDSC Exclusion Criteria: Contraindications to haloperidol Habitual treatment with any antipsychotic medication or treatment with antipsychotics in the ICU prior to inclusion Permanently incompetent (e.g. dementia, mental retardation) Delirium assessment non-applicable (coma or language barriers) Withdrawal from active therapy Fertile women (women < 50) with positive urine human chorionic gonadotropin (hCG) or plasma hCG. Consent according to national regulations not obtainable Patients under coercive measures by regulatory authorities Patients with alcohol-induced delirium (Delirium Tremens)
