Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

January 12, 2016 updated by: University of Pittsburgh
The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

792

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hospitalized inpatients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome
Time Frame: up to 38 months
up to 38 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug utilization of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal syndrome
Time Frame: Up to 38 months
Will compare the frequency, duration and dosages of the above agents when used for benzodiazepine-resistant alcohol withdrawal
Up to 38 months
Effectiveness of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal
Time Frame: 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
Up to 38 months
Tolerability of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal
Time Frame: Up to 38 months

Comparative markers will include:

  1. Rikers Sedation Scale Assessments
  2. Hypotension
  3. Hypertriglyceridemia/Pancreatitis
  4. Drug induced hallucinosis or seizures
Up to 38 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Hospira, now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

July 20, 2012

First Submitted That Met QC Criteria

July 25, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPittsburgh 0031860

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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