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Wheat Beer for Prevention of Delirium in Intensive Care Patients

ConditionICU Delirium
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pre-existing liver pathologies

Patients after bone marrow transplantation

Women: breastfeeding

Pre-existing delirium (ICDSC ≥ 4)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Beer

    Other intervention

    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.

  • Water

    Other intervention

    For the interventional control group 0.5L water is administered once a day at 8pm for 6 consecutive days after enrolment.

Treatment groups

380 Participants
are divided into 3 treatment groups
Group A: 0.5 liters of alcoholic beerExperimental treatment 1 intervention
Group B: 0.5 liters of waterPlacebo comparator 1 intervention
Group C: non-interventional cohort control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Development of delirium

Development of delirium until day 7 after enrolment

Time frame
7 days

Secondary outcomes

1

Delirium-free days

Delirium-free days alive

Time frame
30 days
2

Sedation-free days

Sedation-free days alive

Time frame
30 days
3

Agitation-free days

Agitation-free days alive

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Source ClinicalTrials.gov
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