Phenobarbital for Agitated Delirium

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult Patients identified by providers to have agitated or hyperactive delirium

Disqualifiers

Pregnancy

Incarceration

Severe liver disease

Allergy or prior adverse reaction to phenobarbital or antipsychotic drugs (depending on the month of therapy initiation)

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Phenobarbital TherapyExperimental treatment 1 intervention
Group B: Conventional TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Hospital Length of Stay

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

Time frame
Six months
2

ICU Length of Stay

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

Time frame
Six months
3

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: