Clinical Quality Improvement of Benzodiazepine-Resistant Alcohol Withdrawal Syndrome

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01652326

Enrollment

792

Registered

2012-07-30

Start date

2012-07-31

Completion date

2015-09-30

Last updated

2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGDiazepam

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Identify those risk factors predictive of benzodiazepine-resistant alcohol withdrawal syndrome	up to 38 months

Secondary

Measure	Time frame	Description
Drug utilization of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal syndrome	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	Up to 38 months	Comparative markers will include: 1. Presence or absence of the following: delirium tremens, hallucinosis, seizures, or arrhythmias 2. Indication and duration of mechanical intubation 3. Nosocomial infection rates 4. ICU length of stay
Tolerability of phenobarbital, propofol, dexmedetomidine, and ketamine in benzodiazepine-resistant alcohol withdrawal	Up to 38 months	Comparative markers will include: 1. Rikers Sedation Scale Assessments 2. Hypotension 3. Hypertriglyceridemia/Pancreatitis 4. Drug induced hallucinosis or seizures

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026