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Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

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ClinicalTrials.gov Identifier: NCT01652326
Recruitment Status : Completed
First Posted : July 30, 2012
Last Update Posted : January 13, 2016
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Pittsburgh

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Alcohol Withdrawal Syndrome Drug: Diazepam

Study Design
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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 : July 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome [ Time Frame: up to 38 months ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01652326


Locations
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Hospira, now a wholly owned subsidiary of Pfizer
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01652326     History of Changes
Other Study ID Numbers: UPittsburgh 0031860
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

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