Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01652326 |
Recruitment Status
:
Completed
First Posted
: July 30, 2012
Last Update Posted
: January 13, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Alcohol Withdrawal Syndrome | Drug: Diazepam |
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 |

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 |
- Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome [ Time Frame: up to 38 months ]
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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
United States, Pennsylvania | |
UPMC | |
Pittsburgh, Pennsylvania, United States, 15213 |
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 |