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Not yet recruiting Phase 3 NCT07548489

Phenobarbital for Agitated Delirium

Phase 3 – large-scale trial before approval
Conditions: Agitated Delirium Delirium Confusional State Delirium in the Intensive Care Unit Hyperactive Delirium

Sponsor: Duke University

trial.available_in: БГ
Overview
The goal of this clinical trial is to test whether the medication phenobarbital is as effective for treating agitated delirium among adult patients admitted to the intensive care unit. Agitated delirium is a condition involving confusion and impulsiveness which is dangerous to both patients and healthcare providers. The main questions this trial aims to answer include: * Can phenobarbital decrease the amount of time patients with agitated delirium spend in the intensive care unit and the hospital? * Does phenobarbital decrease the amount of additional calming medications patients with agitated delirium need? Researchers in this study will compare phenobarbital to other medications commonly used to treat agitated delirium. Participants will be monitored closely to make sure they remain safe and to measure how well their agitation and confusion are managed while they are in the ICU.
Who can participate
Inclusion Criteria: * Adult Patients identified by providers to have agitated or hyperactive delirium Exclusion Criteria: * Pregnancy * Incarceration * Severe liver disease * Allergy or prior adverse reaction to phenobarbital or antipsychotic drugs (depending on the month of therapy initiation)
Interventions
Phenobarbital
DRUG
Conventional therapy group
DRUG
Locations 1
United States (1)
Duke Regional Hospital
Durham , North Carolina
Keith W Van Dusen, M.D.
Technical details
Status
Not yet recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
21 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
01.07.2027
Registry ID
NCT07548489
Source
clinicaltrials.gov
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