Status:
UNKNOWN
Assessment of Valproate on Ethanol Withdrawal
Lead Sponsor:
CAMC Health System
Conditions:
Alcohol Dependence
Alcohol Withdrawal Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Alcohol use disorder, or heavy drinking, is commonly seen in patients who present to trauma centers. These patients are at risk for Alcohol Withdrawal Syndrome (AWS), which is collection of symptoms t...
Detailed Description
Alcohol use disorder is a common comorbidity among trauma patients. This pre-existing condition is associated with Alcohol Withdrawal Syndrome (AWS) and frequently complicates the management of this p...
Eligibility Criteria
Inclusion
- Admission to Trauma Services
- Heavy drinkers based on social history
- Men \<65 years: \> 4 drinks per day or 14 per week
- Women: \> 3 drinks per day or 7 drinks per week
- All adults \>65 years: \> 3 drinks per day or 7 drinks per week
- Moderate or severe alcohol use disorder based on social history and DSM-5 criteria
- Moderate: Presence of 4-5 symptoms based on social history
- Severe: Presence of 6 symptoms based on social history
Exclusion
- Intubated patients
- Glasgow Coma Score \<8
- Grade IV liver laceration or greater
- Child-Pugh Class B or greater, history of cirrhosis, or cirrhosis identified by radiographic imaging upon admission
- Transaminase (AST/ALT) elevation of ≥ 2x normal
- Anticipated admission less than 72 hours
- Levetiracetam administration for seizure prophylaxis secondary to a traumatic brain injury
- Patient with VPA as home medication
- Known allergy to VPA
- Patients with pre-existing blood dyscrasias, i.e. thrombocytopenia (platelet count \< 50,000, etc)
- Inability to obtain social history from patient, surrogate, family member or an individual deemed to be knowledgeable about the patient's social history
- Pregnancy
Key Trial Info
Start Date :
July 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT03235531
Start Date
July 11 2017
End Date
January 1 2020
Last Update
August 1 2017
Active Locations (2)
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1
Charleston Area Medical Center, General Hospital, Level 1 Trauma Center
Charleston, West Virginia, United States, 25301
2
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304