Assessment of Valproate on Ethanol Withdrawal (NCT03235531) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lorazepam use in patient monitored with CIWA
Timeframe: Time between CIWA initiation and discontinuation for up to 3 weeks