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 volunteersQualifiers
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
Sequential
Treatments tested in this trial
Phenobarbital
DrugPatients assigned to Phenobarbital Therapy will receive a validated regimen of this medication to manage their symptoms of agitation and impulsiveness.
Conventional therapy group
DrugPatients assigned to Conventional Therapy will receive antipsychotics as the primary medication class used to manage their agitation and impulsiveness.
Treatment groups
Trial 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.
Secondary outcomes
Hospital Length of Stay
Hospital length of stay will be compared between patients receiving Phenobarbital and Conventional therapies.
ICU Length of Stay
ICU length of stay will be compared between patients receiving Phenobarbital and Conventional therapies.
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.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: