Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

Completed

• Conditions: Alcohol Withdrawal Syndrome
• Interventions: Drug: Diazepam

• Registration Number: NCT01652326
• Lead Sponsor: University of Pittsburgh

Brief Summary

The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-20
• Study First Submitted QC: 2012-07-25
• Study First Posted: 2012-07-30
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 792

Inclusion Criteria

either

1. a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs;
2. > 40mg of diazepam (or diazepam equivalents) in 1 hr; or
3. an individual dose of 40 mg or greater of intravenous diazepam for control of agitation

Exclusion Criteria

• if < 18 years of age or had evidence of use of other illicit substances as determined by urine toxicology screen

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Benzodiazepine-resistant	Diazepam	those patients with either 1) a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs; 2) \>40mg of diazepam (or diazepam equivalents) in 1 hr; or 3) an individual dose of 40 mg or greater of intravenous diazepam for control of agitation

Primary Outcome Measures

Name	Time	Method
Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome	up to 38 months

Secondary Outcome Measures

Name	Time	Method
Drug utilization of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal syndrome	Up to 38 months	Will compare the frequency, duration and dosages of the above agents when used for benzodiazepine-resistant alcohol withdrawal
Effectiveness of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal	Up to 38 months	Comparative markers will include: 1. Presence or absence of the following: delirium tremens, hallucinosis, seizures, or arrhythmias; 2. Indication and duration of mechanical intubation; 3. Nosocomial infection rates; 4. ICU length of stay
Tolerability of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal	Up to 38 months	Comparative markers will include: 1. Rikers Sedation Scale Assessments; 2. Hypotension; 3. Hypertriglyceridemia/Pancreatitis; 4. Drug induced hallucinosis or seizures

Trial Locations

Locations (1)

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States