Treatment of Alcohol Withdrawal Syndrome With Alpha-2 Agonists and/or Anticonvulsants
- Conditions
- Alcohol Withdrawal Syndrome
- Interventions
- Drug: BZDP-Based ProtocolDrug: BZDP-Sparing Protocol
- Registration Number
- NCT05438641
- Lead Sponsor
- Stanford University
- Brief Summary
Complicated alcohol withdrawal syndrome (AWS) increases morbidity and mortality of hospitalized, medically ill patients. The Psychosomatic Medicine Service is commonly consulted to assist in the management of these patients when admitted to medical/surgical units. During the last 15 months, the investigators have implemented a benzodiazepine-sparing management approach with very positive clinical outcomes. The BZDP-sparing protocol consists of a combination of alpha-2 agonist and/or anticonvulsant agents; all currently being used for the management of other medical conditions. This project intends to collect and analyze the data of all subjects managed with this approach to better understand its effectiveness and assess for potential adverse effects.
- Detailed Description
Complicated alcohol withdrawal syndrome (C-AWS) increases morbidity and mortality of hospitalized, medically ill patients. The Psychosomatic Medicine Service is commonly consulted to assist in the management of these patients when admitted to medical/surgical units. During the last 15 months, the investigators have implemented a benzodiazepine-sparing management approach with very positive clinical outcomes. The BZDP-sparing protocol consists of a combination of alpha-2 agonist (e.g., clonidine, guanfacine, dexmedetomidine) and/or anticonvulsant agents (e.g., gabapentin, valproic acid, carbamazepine); all currently being used for the management of other medical conditions. The proposed study consists of an exhaustive chart review of these records to better understand the safety and effectiveness of alpha-2 agonists and anticonvulsants in the prophylaxis and treatment of AWS. Specifically the investigators want to understand the time to resolution of AWS symptoms, whether there are any limiting side effects to this regimen, and the need of for rescue with benzodiazepine agents. The information obtained from this study will be very helpful in assisting in the design of safer and more effective treatment of AWS.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- All the cases referred to the Psychosomatic Medicine Service for assistance with prophylactic or symptomatic management of AWS starting 8/1/2011 until 8/31/2014.
- Patients who through chart review were found to have been primarily suffering from delirium from causes other than AWS.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Conventional Benzodiazepine-based treatment group BZDP-Based Protocol Conventional Benzodiazepine-based group includes any subject primarily treated with BZDP agents (e.g., diazepam, lorazepam, chlordiazepoxide). Benzodiazepine-Sparing BZDP-Sparing Protocol BZDP-Sparing group includes subjects primarily treated with a non-BZDP agent (e.g., Alpha-2 agonists and/or anticonvulsants).
- Primary Outcome Measures
Name Time Method Change in Clinical Institute Withdrawal Assessment for Alcohol (CIWA) Score Baseline to month 6 The Clinical Institute Withdrawal Assessment for Alcohol (CIWA) measure is a ten item measure of alcohol withdrawal symptoms. The CIWA total score is the summation of 10 questions, with a range from 0 (little to no withdrawal) to 67 (worse alcohol withdrawal).
- Secondary Outcome Measures
Name Time Method Treatment Safety Up to 6 months Presence and nature of adverse reactions
Trial Locations
- Locations (1)
Stanford Hospital and Clinics
🇺🇸Stanford, California, United States