Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05438641 |
| Other study ID # |
25510 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2013 |
| Est. completion date |
August 2017 |
Study information
| Verified date |
June 2022 |
| Source |
Stanford University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
