Assessment of Valproate on Ethanol Withdrawal (PAVE)
Alcohol Dependence, Alcohol Withdrawal Syndrome, Trauma
About this trial
This is an interventional prevention trial for Alcohol Dependence focused on measuring alcohol withdrawal syndrome, trauma, alcohol use disorder, alcohol, lorazepam, benzodiazepine, valproate
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Charleston Area Medical Center, General Hospital, Level 1 Trauma CenterRecruiting
- Charleston Area Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
CIWA Protocol/BZD and Valproate
CIWA Protocol Only
Interventions to decrease symptoms of AWS will be made based on the CIWA tool. CIWA Score 9-14: 1 mg IV push lorazepam CIWA Score >15: 2 mg IV push lorazepam Patients who have a known history of alcohol withdrawal seizures or who have received greater than 4 mg IV lorazepam per CIWA protocol will be placed on a scheduled lorazepam regimen, 1 mg every 6 hours. The primary managing service may increase the scheduled lorazepam regimen above 1mg every 6 hours if needed to control withdrawal symptoms. Scheduled lorazepam will be discontinued or de-escalated following a 24-hour period in which no additional lorazepam was received per CIWA protocol. The treatment group will also receive scheduled valproate (VPA), 15 mg/kg divided over 4 doses, rounded up to the nearest increment of 50mg (i.e. a 70 kg person would be administered 300 mg IV VPA every 6 hours) for 96 hours.
Interventions to decrease symptoms of AWS will be made based on the CIWA tool CIWA Score 9-14: 1 mg IV push lorazepam CIWA Score >15: 2 mg IV push lorazepam Patients who have a known history of alcohol withdrawal seizures or who have received greater than 4 mg IV lorazepam per CIWA protocol will be placed on a scheduled lorazepam regimen, 1 mg every 6 hours. The primary managing service may increase the scheduled lorazepam regimen above 1mg every 6 hours if needed to control withdrawal symptoms. Scheduled lorazepam will be discontinued or de-escalated following a 24-hour period in which no additional lorazepam was received per CIWA protocol.