Wheat Beer for Prevention of Delirium in Intensive Care Patients

NCT04876742 | Recruiting DMC

• 1 other identifier: BASEC 2022-00779
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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 water following the same administration scheme.

Conditions

ICU Delirium

Outcome Measures

Primary Outcomes (1)

• Development of delirium

  Development of delirium until day 7 after enrolment

  7 days

Secondary Outcomes (3)

• Delirium-free days

  30 days

• Sedation-free days

  30 days

• Agitation-free days

  30 days

Study Arms (3)

0.5 liters of alcoholic beer

EXPERIMENTAL

Other: Beer

0.5 liters of water

PLACEBO COMPARATOR

Other: Water

non-interventional cohort control group

NO INTERVENTION

Interventions

Beer OTHER

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.

0.5 liters of alcoholic beer

Water OTHER

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

0.5 liters of water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Interventions

Beer; Water

Intervention Hierarchy (Ancestors)

Alcoholic Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Beverages; Fermented Foods; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: January 18, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: As soon as legally and ethically possible after trial publication.
• Access Criteria: Anyone interested can contact the study team and wherever legally and ethically possible data will be shared. Additional supporting information may as well be shared upon request.

Locations

CH (1)