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Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
This study has been completed.
Sponsor:
University of Pittsburgh
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
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
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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:
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 ]
Secondary Outcome Measures:
- 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
- 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
- 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
| 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) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
hospitalized inpatients
Criteria
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
Contacts and Locations
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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
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, now a wholly owned subsidiary of Pfizer
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 |
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 June 28, 2017