Randomised trial of haloperidol for delirium in critically ill patients
Completed
- Conditions
- Delirium, delier
- Registration Number
- NL-OMON26510
- Lead Sponsor
- Erasmus Medical Center, Rotterdam, The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 742
Inclusion Criteria
Inclusion criteria for eligibility
1.Age ≥ 18 years
Exclusion Criteria
Exclusion criteria for eligibility
1.Admitted to ICU with a neurological diagnosis (such as acute stroke, traumatic brain injury, intracranial malignancy, anoxic coma). Previous non-acute stroke or other previous neurological condition without cognitive deterioration is not an exclusion criterion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delirium- and coma free days at ICU (up to 14 days after randomisation).
- Secondary Outcome Measures
Name Time Method 1) To study the efficacy of haloperidol to reduce ICU-delirium associated short- and long-term burdens (up to one-year), consisting of: 1) mortality; 2) cognitive and functional impairment; 3) patient- and family experiences and psychological sequelae during and after ICU stay.<br /><br>2) Safety concerns associated with haloperidol use.