| Registry | NCT07548489 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, sequential, masking: none, treatment |
| Enrollment | 150 (Estimated) |
| Sponsor | Duke University (Other) |
| Conditions | Agitated Delirium, Delirium Confusional State, Delirium in the Intensive Care Unit, Hyperactive Delirium |
| Interventions | Phenobarbital, Conventional therapy group (Drug) |
| Dates | start 2026-06-01 (estimated), primary completion 2027-01-01 (estimated), completion 2027-07-01 (estimated), first posted 2026-04-23, last updated 2026-04-23 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Agitated Delirium All trials for Delirium Confusional State All trials of Phenobarbital All trials of Conventional therapy group
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Phenobarbital Therapy | Experimental | Drug: Phenobarbital | 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 | Drug: Conventional therapy group | 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. |
Sex: All, ages: 21 Years to any
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Duke Regional Hospital | Durham, North Carolina | United States |