Status:
UNKNOWN
Agents Intervening Against Delirium in Intensive Care Unit
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
Centre for Research in Intensive Care (CRIC)
Copenhagen Trial Unit, Center for Clinical Intervention Research
Conditions:
Delirium
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 f...
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. Ha...
Eligibility Criteria
Inclusion
- Acute admission to the ICU AND
- Age ≥ 18 years AND
- Diagnosed delirium with validated screening Tool as either CAM-ICU or ICDSC
Exclusion
- 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)
Key Trial Info
Start Date :
June 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03392376
Start Date
June 13 2018
End Date
July 1 2023
Last Update
January 18 2023
Active Locations (16)
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1
Dept. Intensive Care, Aabenraa Hospital
Aabenraa, Denmark, 6200
2
Dept. of Intensive Care, Aalborg University Hospital
Aalborg, Denmark, 9000
3
Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
4
Dept. of Intensive Care, Herlev Hospital
Herlev, Denmark, 2730