Phenobarbital til agiteret delirium
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27704
- Duke Regional Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Phenobarbital Therapy
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. |
Patients assigned to Phenobarbital Therapy will receive a validated regimen of this medication to manage their symptoms of agitation and impulsiveness. |
|
Aktiv komparator: Conventional Therapy
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. |
Patients assigned to Conventional Therapy will receive antipsychotics as the primary medication class used to manage their agitation and impulsiveness. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Provider Compliance
Tidsramme: 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. |
Six months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Hospital Length of Stay
Tidsramme: Six months
|
Hospital length of stay will be compared between patients receiving Phenobarbital and Conventional therapies. |
Six months
|
|
ICU Length of Stay
Tidsramme: Six months
|
ICU length of stay will be compared between patients receiving Phenobarbital and Conventional therapies. |
Six months
|
|
Need for rescue medications
Tidsramme: 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. |
Six months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Keith W. Van Dusen, M.D., Duke University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00119911
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Following completion of the study (Estimated late 2027), for 1 year.
IPD-delingsadgangskriterier
Only researchers who request IPD data and are approved by the DUH IRB to access will be permitted to review IPD data.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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