Pharmacological treatment of organic psychosis in critically ill adults

Phase 1

• Conditions: Treatment of delirium in critically ill adult patients in intensive care unit.; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-12
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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