Wheat Beer for Prevention of Delirium in Intensive Care Patients
A Randomised Placebo-controlled Double-blind Exploratory Trial Within Cohort Using Wheat Beer for Prevention of Delirium in Intensive Care Patients
University Hospital, Basel, Switzerland
380 participants
Jan 18, 2023
INTERVENTIONAL
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 water following the same administration scheme.
Eligibility
Inclusion Criteria7
- 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 Criteria10
- 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
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Interventions
As interventive agent 0.5 L organic alcohol-containing wheat beer produced by the brewery "Unser Bier" in Basel, Switzerland, is administered once a day at 8pm for 6 consecutive days after enrolment.
For the interventional control group 0.5L water is administered once a day at 8pm for 6 consecutive days after enrolment.
Locations(1)
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NCT04876742