Clinical Trials Directory

Trials / Completed

CompletedNCT05438641

Treatment of Alcohol Withdrawal Syndrome With Alpha-2 Agonists and/or Anticonvulsants

Retrospective Chart Review of Treatment of Alcohol Withdrawal Syndrome With Alpha-2 Agonists and/or Anticonvulsants

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGBZDP-Sparing ProtocolBZDP-Sparing group includes subjects primarily treated with a non-BZDP agent (e.g., Alpha-2 agonists and/or anticonvulsants). Rescue with BZDP-based treatment allowed if there is symptomatic breakthrough- as measured by CIWA \> 15.
DRUGBZDP-Based ProtocolPatients in this arm will received active treatment based on conventional BZDP-based protocol; additional BZDP are permitted for patients who are still symptomatic, based on CIWA-Protocol.

Timeline

Start date
2013-08-01
Primary completion
2017-08-01
Completion
2017-08-01
First posted
2022-06-30
Last updated
2022-06-30

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05438641. Inclusion in this directory is not an endorsement.