Phenobarbital for Agitated Delirium

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07548489
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Agitated Delirium
  • Delirium Confusional State
  • Delirium in the Intensive Care Unit
  • Hyperactive Delirium

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Phenobarbital — DRUG
    Patients assigned to Phenobarbital Therapy will receive a validated regimen of this medication to manage their symptoms of agitation and impulsiveness.
  • Conventional therapy group — DRUG
    Patients assigned to Conventional Therapy will receive antipsychotics as the primary medication class used to manage their agitation and impulsiveness.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phenobarbital Therapy
    In alternating months, patients starting therapy for agitated delirium will be assigned to either a phenobarbital regimen or a conventional antipsychotic-based regimen. Patients assigned to Phenobarbital Therapy will receive this drug according to a validated protocol similar to that in use for patients with alcohol withdrawal. Additional "rescue" medications including dexmedetomidine will be available as needed.
  • Active Comparator: Conventional Therapy
    In alternating months, patients starting therapy for agitated delirium will be assigned to either a phenobarbital regimen or a conventional antipsychotic-based regimen. Patients assigned to Conventional Therapy will receive antipsychotics as the primary medications for managing their agitation. Additional "rescue" medications including antipsychotics and dexmedetomidine will be available as needed.

Primary Outcome Measure

Provider Compliance [ Time Frame: Six months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Regional HospitalDurhamNorth Carolina27704
Keith W Van Dusen, M.D.
(919) 684-8111

Find similar trials in Durham, NC

By research site
Duke Regional Hospital· Durham, NC

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