Pharmacological treatment of organic psychosis in critically ill adults

Phase 1

• Conditions: Treatment 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: 100000004873; MedDRA version: 21.1 Level: LLT Classification code 10013758 Term: Drug-induced delirium System Organ Class: 100000004873; MedDRA version: 21.1 Level: LLT Classification code 10042275 Term: Subacute delirium System Organ Class: 100000004873; MedDRA version: 21.0 Level: LLT Classification code 10012220 Term: Delirium due to a general medical condition System Organ Class: 100000004873; MedDRA version: 21.0 Level: LLT Classification code 10012226 Term: Delirium, cause unknown System Organ Class: 100000004873; MedDRA version: 20.0 Level: LLT Classification code 10050233 Term: Delirium on emergence System Organ Class: 100000004863; MedDRA version: 21.0 Level: LLT Classification code 10071313 Term: Hypoactive delirium System Organ Class: 100000004873; MedDRA version: 21.0 Level: LLT Classification code 10071314 Term: Hyperactive delirium System Organ Class: 100000004873; MedDRA version: 21.0 Level: LLT Classification code 10071315 Term: Mixed delirium

• Registration Number: EUCTR2017-003829-15-ES
• Lead Sponsor: Zealand University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-02
• Last Update Posted: 11 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 1000

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified