Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT01652326
• Collaborator: Hospira, now a wholly owned subsidiary of Pfizer (Industry)
• Enrollment: 792
• Location: 1
• Duration (Months): 38
• Patients Per Site Per Month: 20.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Alcohol Withdrawal Syndrome	Drug: Diazepam

Study Design

• Study Type: Observational
• Actual Enrollment: 792 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Benzodiazepine-resistant 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	Drug: Diazepam

Outcome Measures

Primary Outcome Measures

1. Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome [up to 38 months]

Secondary Outcome Measures

1. 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

2. Effectiveness of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal [Up to 38 months]

   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

3. Tolerability of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal [Up to 38 months]

   Comparative markers will include: Rikers Sedation Scale Assessments Hypotension Hypertriglyceridemia/Pancreatitis Drug induced hallucinosis or seizures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• Hospira, now a wholly owned subsidiary of Pfizer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01652326
• Other Study ID Numbers: UPittsburgh 0031860
• First Posted: Jul 30, 2012
• Last Update Posted: Jan 13, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Syndrome; Substance Withdrawal Syndrome; Diazepam

Study Results

No Results Posted as of Jan 13, 2016