Agents Intervening Against Delirium in Intensive Care Unit

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Delirium 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand University Hospital
• Collaborators: Centre for Research in Intensive Care (CRIC); Copenhagen Trial Unit, Center for Clinical Intervention Research; Scandinavian Critical Care Trials Group; The Danish Centre of Applied Social Science (VIVE)
• Treatments: Haloperidol; Haloperidol decanoate

Criteria

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)