Fenobarbital ved agitert delirium
Fenobarbital ved agitert delir
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27704
- Duke Regional Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Keith W. Van Dusen, M.D., Duke University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00119911
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
Only researchers who request IPD data and are approved by the DUH IRB to access will be permitted to review IPD data.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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