Alcohol Use Disorder Clinical Trial
Official title:
Prospective Assessment of Valproate on Ethanol Withdrawal
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.
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 patient population. Current treatment and/or prevention of AWS includes
the administration of sedatives (benzodiazepines [BZD]) in response to the manifestation AWS
symptoms. This manifestation is indicated by monitoring patients using the Clinical Institute
Withdrawal Assessment (CIWA) tool. Benzodiazepines elicit an effect on AWS via mediation of
the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). Benzodiazepines, however,
have the potential to promote multiple negative effects in the acute care setting, including
increased incidence of delirium, hospital stay, mortality, and the potential for decreased
long-term cognitive function. The antiepileptic medication valproate (VPA) also has GABA
activity in the brain, but may be less likely to promote the negative effects associated with
BZDs. Currently, previous experience with this agent for the prevention of AWS is limited to
two small studies. In these studies VPA was shown to decrease symptoms of AWS as indicated by
patients' CIWA scores. Therefore, VPA could serve as an efficacious adjuvant therapy for the
prevention of AWS. The aim of this study is to determine whether VPA will decrease the use of
BZD in patients who are receiving symptom-based preventative therapy via CIWA monitoring. The
hypothesis is that VPA will decrease the utilization of symptom-based lorazepam
administration in patients who are determined to be at risk of alcohol withdrawal due to
routine consumption of alcohol.
The purpose of this study is to determine if prophylactic VPA for the prevention of alcohol
withdrawal syndrome can decrease symptom-triggered use of benzodiazepines in patients
monitored for alcohol withdrawal syndrome with the CIWA.
The Primary objective of this study is to determine if prophylactic VPA acid is associated
with decreased lorazepam use in patients monitored for alcohol withdrawal syndrome with the
CIWA.
Secondary objectives are:
To evaluate the difference between comparator arms with respect to:
- CIWA scores between patients with and without VPA prophylaxis
- Hospital and Intensive Care Unit (ICU) length of stay
- In-hospital mortality
- VPA acid associated side effects (e.g. thrombocytopenia, transaminitis, pancreatitis)
This will be single-center prospective, randomized study, enrolling trauma patients with a
history of alcohol consumption admitted to a Level 1 trauma center. Patients included in this
study will receive standard therapies for AWS practiced at study institution which include
monitoring of withdrawal symptoms and the administration of BZDs (lorazepam) based on CIWA
monitoring.
Following informed consent, patients will be randomized to receive CIWA protocol
monitoring/BZD or CIWA protocol monitoring/BZD and VPA. Therefore, patients that meet the
inclusion criteria will be separated into two study groups to compare outcomes:
1. Treatment Group: Patients treated with CIWA protocol/BZD and VPA
2. Control Group: Patients treated with CIWA protocol/BZD only.
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