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Completed

NCT Number: NCT01652326

Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

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

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Key information

Conditions

Alcohol Withdrawal Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

either

  • a requirement of either 200 mg of diazepam (or diazepam equivalents) in 4 hrs;
  • > 40mg of diazepam (or diazepam equivalents) in 1 hr; or
  • 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

Treatment and study plan

Diazepam

Drug

Primary outcomes

  1. Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome

    Time frame: up to 38 months

Secondary outcomes

  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:

    • 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

    Time frame: Up to 38 months

    Comparative markers will include:

    • Rikers Sedation Scale Assessments
    • Hypotension
    • Hypertriglyceridemia/Pancreatitis
    • Drug induced hallucinosis or seizures

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Hospira, now a wholly owned subsidiary of Pfizer

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2012
Registry last updated
Jan 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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