EUCTR2017-003829-15-ES
Active, not recruiting
Phase 1
Agents Intervening against Delirium in the Intensive Care Unit (AID-ICU) - AID-IC
ConditionsTreatment of delirium in critically ill adult patients in intensive care unit.MedDRA version: 21.1 Level: LLT Classification code 10000702 Term: Acute delirium System Organ Class: 100000004873MedDRA version: 21.1 Level: LLT Classification code 10013758 Term: Drug-induced delirium System Organ Class: 100000004873MedDRA version: 21.1 Level: LLT Classification code 10042275 Term: Subacute delirium System Organ Class: 100000004873MedDRA version: 21.0 Level: LLT Classification code 10012220 Term: Delirium due to a general medical condition System Organ Class: 100000004873MedDRA version: 21.0 Level: LLT Classification code 10012226 Term: Delirium, cause unknown System Organ Class: 100000004873MedDRA version: 20.0 Level: LLT Classification code 10050233 Term: Delirium on emergence System Organ Class: 100000004863MedDRA version: 21.0 Level: LLT Classification code 10071313 Term: Hypoactive delirium System Organ Class: 100000004873MedDRA version: 21.0 Level: LLT Classification code 10071314 Term: Hyperactive delirium System Organ Class: 100000004873MedDRA version: 21.0 Level: LLT Classification code 10071315 Term: Mixed deliriumTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsHaloperidol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Treatment of delirium in critically ill adult patients in intensive care unit.
- Sponsor
- Zealand University Hospital
- Enrollment
- 1000
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Acute admission to the ICU AND
- •\- Age \= 18 years AND
- •\- Diagnosed delirium with a validated screening tool as either CAM\-ICU or ICDSC.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 200
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 800
Exclusion Criteria
- •\- Contraindications to haloperidol
- •\- Habitual treatment with any antipsychotic medication
- •\- Permanently incompetent (e.g. dementia, mental retardation)
- •\- Delirium assessment non\-applicable (coma or language barriers)
- •\- Withdrawal from active therapy or brain death
- •\- Fertile women (women \< 50 years) 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)
Outcomes
Primary Outcomes
Not specified
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