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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenobarbital Therapy | Experimental | 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. |
|
| Conventional Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenobarbital | Drug | Patients assigned to Phenobarbital Therapy will receive a validated regimen of this medication to manage their symptoms of agitation and impulsiveness. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Hospital length of stay will be compared between patients receiving Phenobarbital and Conventional therapies. | Six months |
| ICU Length of Stay | ICU length of stay will be compared between patients receiving Phenobarbital and Conventional therapies. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keith W Van Dusen, M.D. | Contact | (919) 684-8111 | kwv@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Keith W. Van Dusen, M.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Regional Hospital | Durham | North Carolina | 27704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37368937 | Background | Malone D, Costin BN, MacElroy D, Al-Hegelan M, Thompson J, Bronshteyn Y. Phenobarbital versus benzodiazepines in alcohol withdrawal syndrome. Neuropsychopharmacol Rep. 2023 Dec;43(4):532-541. doi: 10.1002/npr2.12347. Epub 2023 Jun 27. |
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Only data pertaining to the primary and secondary objectives (e.g., hospital length of stay, doses of specific medications given, RASS assessments) will be shared. All data will be anonymized.
Following completion of the study (Estimated late 2027), for 1 year.
Only researchers who request IPD data and are approved by the DUH IRB to access will be permitted to review IPD data.
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| ID | Term |
|---|---|
| D003221 | Confusion |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D010634 | Phenobarbital |
| ID | Term |
|---|---|
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Conventional therapy group | Drug | Patients assigned to Conventional Therapy will receive antipsychotics as the primary medication class used to manage their agitation and impulsiveness. |
|
| 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. | Six months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |