UnknownPhase 4

Assessment of Valproate on Ethanol Withdrawal

United States210 participantsStarted 2017-07-11

Plain-language 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 that can range from anxiety and restlessness to seizures, delirium and even death. The Clinical Institute Withdrawal Assessment (CIWA) tool is routinely used to assess alcohol withdrawal symptoms. Benzodiazepines (BZD) are commonly administered to trauma patients who exhibit symptoms of AWS based on the CIWA scoring system. Although these medications have proven efficacy, they can also have negative side effects which may affect recovery. Valprate (VPA) is a medication which may have efficacy in management of AWS symptoms, thus ameliorating or preventing the need for BZD administration. This trial will study the effectiveness of VPA in the prevention of AWS symptoms by comparing the amount of BZD use in trauma patients who receive BZD treatment as indicated by CIWA scores with patients who receive prophylactic VPA therapy in addition to BZD as indicated by CIWA scores.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Lorazepam use in patient monitored with CIWA

Timeframe: Time between CIWA initiation and discontinuation for up to 3 weeks

Trial details

NCT IDNCT03235531

SponsorCAMC Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-11

Contact for this trial

Audis Bethea, PharmD, BCPS

304-388-6260 audis.bethea@camc.org