Phenobarbital for Agitated Delirium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Phenobarbital, Conventional therapy group.
- Who it may be relevant to
- Registry conditions: Agitated Delirium, Delirium Confusional State, Delirium in the Intensive Care Unit, Hyperactive Delirium. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Phenobarbital
Patients assigned to Phenobarbital Therapy will receive a validated regimen of this medication to manage their symptoms of agitation and impulsiveness. - Drug Conventional therapy group
Patients assigned to Conventional Therapy will receive antipsychotics as the primary medication class used to manage their agitation and impulsiveness.
Primary outcome measures
- Provider Compliance [Time frame: Six months]
Secondary outcome measures (3)
- Hospital Length of Stay [Time frame: Six months]
- ICU Length of Stay [Time frame: Six months]
- Need for rescue medications [Time frame: Six months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke Regional Hospital — Durham
Publications
- 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. PMID 37368937
Identifiers
NCT: NCT07548489 · Pro00119911