Agents Intervening Against Delirium in Intensive Care Unit (AID-ICU)

Zealand University Hospital

Status and phase

Active, not recruiting

Phase 4

Conditions

Delirium

Treatments

Drug: Haloperidol Injection

Other: Saline (0,9%)

Study type

Interventional

Funder types

Other

Identifiers

NCT03392376

REG-169-2017

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)