Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04876742

A Randomised Placebo-controlled Double-blind Exploratory Trial Using Wheat Beer for Prevention of Delirium in Intensive Care Patients

Led by University Hospital, Basel, Switzerland · Updated on 2025-02-11

380

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether daily intake of 0.5 liters of alcoholic wheat beer at 8 pm for six consecutive days can reduce the occurrence of delirium in intensive care unit (ICU) patients compared to water. Delirium is a sudden, fluctuating state of confusion common among ICU patients, especially those on mechanical ventilation or after cardiac surgery, and is linked to longer hospital stays, higher morbidity and mortality, and lasting cognitive issues. Current prevention and treatment options are limited, making new strategies important to improve patient outcomes. The trial compares two groups: one receiving 0.5 liters of organic alcoholic wheat beer and the other receiving 0.5 liters of water, both administered once daily at 8 pm for six days after enrollment. The wheat beer contains ingredients such as hop and alcohol, which are hypothesized to have calming effects that may influence delirium development. Standard delirium prevention care is provided to all patients, including pain management, sleep support, orientation, and mobilization. Treatment for different delirium types follows established protocols at the University Hospital Basel. Participants will be monitored for delirium development over seven days using standardized assessment tools like the Intensive Care Delirium Screening Checklist and Richmond Agitation Sedation Scale. Researchers will also track delirium-free, sedation-free, and agitation-free days over 30 days. The study involves regular assessments, including cognitive evaluations and observation of symptoms, to understand the impact of the intervention. Participation is expected to last for at least seven days with follow-up assessments extending to 30 days to capture longer-term effects.

CONDITIONS

Brief Title

Wheat Beer for Prevention of Delirium in Intensive Care Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ICU patients at risk of delirium with expected stay of 24 hours or more
  • Presence of a naso-gastric tube
  • ICU stay of 72 hours or less before first study intervention
  • Women aged 50 years or older or women who had hysterectomy or both ovaries removed with negative pregnancy test
  • Adults aged 18 years or older
  • Body weight of at least 50 kg or BMI of 18.5 or higher
Not Eligible

You will not qualify if you...

  • Pre-existing liver diseases
  • Patients after bone marrow transplantation
  • Breastfeeding women
  • Patients with pre-existing delirium (ICDSC score 4 or higher)
  • Patients in a terminal state
  • Patients with active psychosis
  • Patients with history of complete alcohol abstinence or alcohol abuse
  • Especially vulnerable patients
  • Allergy to any ingredient of beer

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 days

Participants receive either 0.5 liters of organic alcoholic wheat beer or 0.5 liters of water once daily at 8 pm for 6 consecutive days after enrollment.

Daily administration for 6 days

Follow-up

Duration - Up to 30 days

Participants are monitored for delirium development and other clinical outcomes over a period of up to 30 days following treatment.

Assessments up to 30 days post-treatment

Trial Site Locations

Total: 1 location

1

University Hospital Basel

Basel, Switzerland, 4031

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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