A Phase 3 interventional study of Phenobarbital and Conventional therapy group in Agitated Delirium, Delirium Confusional State and Delirium in the Intensive Care Unit, sponsored by Duke University. Withdrawn at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Duke University · Phase 3, Interventional, and Treatment
Not approved by IRB
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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Exclusion Criteria:
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.
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 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.
Drug: Conventional therapy group
Patients assigned to Phenobarbital Therapy will receive a validated regimen of this medication to manage their symptoms of agitation and impulsiveness.
Patients assigned to Conventional Therapy will receive antipsychotics as the primary medication class used to manage their agitation and impulsiveness.
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
Hospital Length of Stay
Hospital length of stay will be compared between patients receiving Phenobarbital and Conventional therapies.
Time frame: Six months
ICU Length of Stay
ICU length of stay will be compared between patients receiving Phenobarbital and Conventional therapies.
Time frame: 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.
Time frame: Six months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Following completion of the study (Estimated late 2027), for 1 year.
Access criteria: Only researchers who request IPD data and are approved by the DUH IRB to access will be permitted to review IPD data.
Data sharing details ↗ · myresearchpath.duke.edu
Not approved by IRB
Not approved by IRB
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is withdrawn, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Phenobarbital