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Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

This study has been completed.
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01652326
First received: July 20, 2012
Last updated: January 12, 2016
Last verified: January 2016
History of Changes
  Purpose
The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome.

Condition Intervention
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:

Drug Information available for: Diazepam
U.S. FDA Resources

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
Enrollment: 792
Study Start Date: July 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (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   (Adult, Senior)
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

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: January 12, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Syndrome
Substance Withdrawal Syndrome
Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Diazepam
Adjuvants, Anesthesia
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016