Status:
RECRUITING
The Basel BOMP-AID Randomized Trial
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Hypoactive Delirium
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
Delirium is a neurobehavioural syndrome that frequently develops in the postoperative and/or ICU setting. The incidence of elderly patients who develop delirium during hospital stay ranges from 11-82%...
Detailed Description
Delirium is a neurobehavioural syndrome that frequently develops in the postoperative and/or ICU setting. The incidence of elderly patients who develop delirium during hospital stay ranges from 10-80%...
Eligibility Criteria
Inclusion
- Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Adult patients (aged 55 years or older)
- Current delirium (hypoactive type) detected by a specialised assessment method: ICDSC score \>2 and RASS score \< 0
Exclusion
- Participants meeting the following criteria are excluded from the study:
- Delirium prior to ICU admission
- Sleep disorder not caused by hypoactive delirium
- Sedation in the ICU
- Hypersensitivity to the studied substances (i.e., melatonin, placebo content)
- Age \<55 years
- Terminal state
- Status epilepticus or postictal states following seizures on electroencephalogram (EEG)
- Active psychosis
- Substance abuse in current medical history
- Dementia
- Pregnancy
Key Trial Info
Start Date :
January 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT03438526
Start Date
January 3 2022
End Date
December 1 2027
Last Update
December 11 2024
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland, 4031