Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

NCT01652326

Last updated date
Study Location
UPMC
Pittsburgh, Pennsylvania, 15213, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alcohol Withdrawal Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- if < 18 years of age or had evidence of use of other illicit substances as determined
by urine toxicology screen

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Alcohol Withdrawal SyndromeClinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
NCT01652326
  1. Pittsburgh, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
Official Title Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
Brief Summary The overarching goal of this project is to improve the clinical quality of patients with Benzodiazepine-resistant alcohol withdrawal syndrome.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population hospitalized inpatients
Condition Alcohol Withdrawal Syndrome
Intervention Drug: Diazepam
Study Groups/Cohorts 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
Intervention: Drug: Diazepam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 12, 2016)
792
Original Estimated Enrollment
 (submitted: July 25, 2012)
1000
Actual Study Completion Date September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01652326
Other Study ID Numbers UPittsburgh 0031860
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pittsburgh
Study Sponsor University of Pittsburgh
Collaborators Hospira, now a wholly owned subsidiary of Pfizer
Investigators Not Provided
PRS Account University of Pittsburgh
Verification Date January 2016