Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
NCT01652326
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Adult Trials: 18+ Years
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
- if < 18 years of age or had evidence of use of other illicit substances as determined
by urine toxicology screen
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- Pittsburgh, Pennsylvania
| 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 | 792 | ||
| Original Estimated Enrollment | 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
Exclusion Criteria:
| ||
| Sex/Gender |
| ||
| 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 | ||