Agents Intervening Against Delirium in Intensive Care Unit (AID-ICU) A Randomized, Blinded, Placebo-controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Saline (0,9%)
- Conditions
- Delirium
- Sponsor
- Zealand University Hospital
- Enrollment
- 1000
- Locations
- 16
- Primary Endpoint
- Days alive out of the hospital within 90 days post-randomization
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility 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)
Arms & Interventions
Normal Saline
Saline (0,9%)
Intervention: Saline (0,9%)
Haloperidol injection
Haloperidol 2,5mg x 3 daily, with additional as needed doses to a maximum of 20mg/daily. Other name: Serenase
Intervention: Haloperidol Injection
Outcomes
Primary Outcomes
Days alive out of the hospital within 90 days post-randomization
Time Frame: 90 days
Number of days alive and out of hospital
90-day mortality
Time Frame: 90 days
Death from any cause within 90 days post-randomization
Hospital Length of Stay
Time Frame: 90 days
Total number of days the patient is admitted to any hospital within the 90-day intervention period
Secondary Outcomes
- Mortality(1 year)
- Number of days alive without mechanical ventilation within 90 days postrandomisation(Measured every day from inclusion until ICU discharge, maximum 90 days)
- Quality of life (five level)(1 year)
- Quality of life (overall self assessment)(1 year)
- Cognitive function at admission(At inclusion (within the first week))
- Number of patients with one or more serious adverse reactions to haloperidol and the total number of serious adverse reactions to haloperidol compared with placebo(Measured every day from inclusion until ICU discharge, maximum 90 days)
- Usage of escape medicine(Measured every day from inclusion until ICU discharge, maximum 90 days)
- Number of days alive without delirium or coma in the ICU(Until ICU discharge, maximum 90 days)
- Executive function 1 year after randomisation at selected sites(1 year)
- Cognitive function 1 year after randomisation at selected sites(1 year)
- A health economic analysis(90 days)