Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

Alcohol Withdrawal Syndrome Clinical Trial

Official title:

Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652326
• Other study ID #: UPittsburgh 0031860
• Status: Completed
• Phase: N/A
• First received: July 20, 2012
• Last updated: January 12, 2016
• Start date: July 2012
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 792
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Alcohol Withdrawal Syndrome
• Substance Withdrawal Syndrome
• Syndrome

Intervention

Drug:
• Diazepam

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Hospira, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome		up to 38 months	No
Secondary	Drug utilization of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal syndrome	Will compare the frequency, duration and dosages of the above agents when used for benzodiazepine-resistant alcohol withdrawal	Up to 38 months	No
Secondary	Effectiveness of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal	Comparative markers will include: Presence or absence of the following: delirium tremens, hallucinosis, seizures, or arrhythmias; Indication and duration of mechanical intubation; Nosocomial infection rates; ICU length of stay	Up to 38 months	No
Secondary	Tolerability of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal	Comparative markers will include: Rikers Sedation Scale Assessments; Hypotension; Hypertriglyceridemia/Pancreatitis; Drug induced hallucinosis or seizures	Up to 38 months	Yes