Using wheat beer to prevent delirium in ICU patients
A Randomised Placebo-controlled Double-blind Exploratory Trial Within Cohort Using Wheat Beer for Prevention of Delirium in Intensive Care Patients
This study is testing if giving ICU patients at risk of delirium daily wheat beer instead of water can help prevent them from developing delirium.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT04876742 on ClinicalTrials.gov |
What this trial studies
This study investigates whether the daily administration of 0.5L of alcohol-containing wheat beer can reduce the prevalence of delirium in intensive care unit (ICU) patients compared to water. The intervention is administered at 8 pm for six consecutive days to patients at risk of developing delirium, particularly those with an expected ICU stay of 24 hours or more. Delirium is a common and serious complication in ICU settings, and this study aims to explore a novel, non-pharmacological approach to its prevention.
Who should consider this trial
Good fit: Ideal candidates include ICU patients aged 18 years and older, weighing at least 50 kg, who are expected to stay in the ICU for 24 hours or more and have a naso-gastric tube in place.
Not a fit: Patients with pre-existing liver conditions, active psychosis, or a history of alcohol abuse are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of delirium in ICU patients, leading to improved patient outcomes and reduced healthcare costs.
How similar studies have performed: While there are various pharmacological approaches to prevent delirium, this study's non-pharmacological method using wheat beer is novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.