Phenobarbital for Agitated Delirium

Duke University

Status and phase: Not yet enrolling; Phase 3

Conditions: Delirium Confusional State; Delirium in the Intensive Care Unit; Hyperactive Delirium; Agitated Delirium

Treatments: Drug: Phenobarbital; Drug: Conventional therapy group

Study type: Interventional

Funder types: Other

Identifiers

NCT07548489

Pro00119911

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Phenobarbital Therapy

Experimental group

Description:

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.

Treatment:

Drug: Phenobarbital

Conventional Therapy

Active Comparator group

Description:

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.

Treatment:

Drug: Conventional therapy group