Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01652326
First received: July 20, 2012
Last updated: December 4, 2014
Last verified: December 2014
  Purpose

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


Condition Intervention
Benzodiazepine-resistant Alcohol Withdrawal Syndrome
Drug: Diazepam

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome [ Time Frame: up to 38 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug utilization of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal syndrome [ Time Frame: Up to 38 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 38 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: Up to 38 months ] [ Designated as safety issue: Yes ]

    Comparative markers will include:

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


Estimated Enrollment: 1000
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

hospitalized inpatients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652326

Locations
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Hospira, Inc.
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01652326     History of Changes
Other Study ID Numbers: UPittsburgh 0031860
Study First Received: July 20, 2012
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders

ClinicalTrials.gov processed this record on March 03, 2015