Agitated Delirium, Delirium Confusional State, Delirium in the Intensive Care Unit, Hyperactive Delirium
Conditions
Brief summary
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.
Interventions
DRUGPhenobarbital
Patients assigned to Phenobarbital Therapy will receive a validated regimen of this medication to manage their symptoms of agitation and impulsiveness.
DRUGConventional therapy group
Patients assigned to Conventional Therapy will receive antipsychotics as the primary medication class used to manage their agitation and impulsiveness.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Provider Compliance | Six months | 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
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | Six months | Hospital length of stay will be compared between patients receiving Phenobarbital and Conventional therapies. |
| ICU Length of Stay | Six months | ICU length of stay will be compared between patients receiving Phenobarbital and Conventional therapies. |
| Need for rescue medications | Six months | 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. |
Countries
United States
Contacts
CONTACTKeith W Van Dusen, M.D.
PRINCIPAL_INVESTIGATORKeith W. Van Dusen, M.D.
Duke University
Outcome results
None listed