Status:
RECRUITING
Wheat Beer for Prevention of Delirium in Intensive Care Patients
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
ICU Delirium
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators hypothesise that the daily administration of 0.5L alcohol-containing wheat beer at 8 pm over a study period of 6 days in a row leads to a lower prevalence of delirium compared to wat...
Detailed Description
Delirium Delirium is a complex state of confusion that can be seen as an acute failure of brain function. It is characterised by fluctuating deficits in cognition and attention, dysregulation of emot...
Eligibility Criteria
Inclusion
- Inclusion criteria
- All Patients meeting the following criteria are eligible for the study:
- Risk of delirium: ICU patients with expected length of stay (LOS) ≥ 24 hours
- Naso-gastric tube in situ
- ICU stay ≤ 72h until first study intervention
- Women: negative pregnancy test, age ≥50 years or status post hysterectomy/bilateral ovariectomy
- Adult patients (age ≥ 18 years)
- ≥ 50 kg body weight or BMI ≥18.5
- Exclusion Criteria
- Patients fulfilling the following criteria are excluded from the study:
- Pre-existing liver pathologies
- Patients after bone marrow transplantation
- Women: breastfeeding
- Pre-existing delirium (ICDSC ≥ 4)
- Terminal state
- Active psychosis
- Anamnestic complete alcohol abstinence or status post alcohol abuse
- Especially vulnerable patients
- Allergy to any ingredient(s) of beer
Exclusion
Key Trial Info
Start Date :
January 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT04876742
Start Date
January 18 2023
End Date
December 31 2029
Last Update
February 11 2025
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland, 4031