Phenobarbital for Agitated Delirium

Phase 3Not Yet RecruitingNCT07548489

Duke University150 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Agitated Delirium Delirium Confusional State Delirium in the Intensive Care Unit

Interventions

PhenobarbitalDRUG

Patients assigned to Phenobarbital Therapy will receive a validated regimen of this medication to manage their symptoms of agitation and impulsiveness.

Conventional therapy groupDRUG

Patients assigned to Conventional Therapy will receive antipsychotics as the primary medication class used to manage their agitation and impulsiveness.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Provider Compliance

The primary outcome of this study will be provider compliance with the study protocol assessed by selection of Conventional or Phenobarbital Therapy according to the designated month.

Time frame: Six months

Secondary Outcomes

Hospital Length of Stay

Hospital length of stay will be compared between patients receiving Phenobarbital and Conventional therapies.

Time frame: Six months

ICU Length of Stay

ICU length of stay will be compared between patients receiving Phenobarbital and Conventional therapies.

Time frame: Six months

Need for rescue medications

Need for additional medications above the Phenobarbital or Conventional therapy regimens will be assessed to determine if patients receiving phenobarbital require fewer doses of additional medications.

Time frame: Six months

Phenobarbital for Agitated Delirium

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts