Phenobarbital for Acute Alcohol Withdrawal

Not Applicable

Completed

• Conditions: Alcohol Withdrawal
• Interventions: Drug: placebo; Drug: 10 mg/kg IV phenobarbital in 100 ml saline

• Registration Number: NCT01184417
• Lead Sponsor: Jonathan Rosenson

Brief Summary

Intravenous phenobarbital in combination with a symptom-guided standardized lorazepam-based alcohol withdrawal protocol will be associated with decreased need for ICU admission, continuous lorazepam infusion and will not be associated with increased adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Results First Submitted: 2012-02-18
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-07
• Last Update Submitted: 2012-03-07
• Results First Posted: 2012-03-09
• Last Update Posted: 2012-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Need for admission to hospital for acute alcohol withdrawal

Exclusion Criteria

• allergy to phenobarbital, lorazepam, age<18 or >65

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	placebo	100 ml saline
Phenobarbital group	10 mg/kg IV phenobarbital in 100 ml saline	10 mg/kg IV phenobarbital in 100 ml saline

Primary Outcome Measures

Name	Time	Method
Number of Patients Requiring Continuous Lorazepam Infusion	1 year	All study patients are placed on the standardized institutional alcohol withdrawal protocol and receive boluses of lorazepam (1, 2 or 4 mg IV) based on their acute alcohol withdrawal score (AAWS), adminstered serially up to every 15 minutes. Patients who are refractory to the maximum dose of lorazepam allowed by the protocol (up to 4mg lorazepam IV q 15 mins)are placed on a continuous IV lorazepam infusion (or "lorazepam drip"). Thus, continuous lorazepam infusion is a "yes or no" variable (i.e. continuous infusion, or not).
Percentage of Patients Requiring ICU Admission	1 year	admission to intensive care unit
Total Lorazepam Required Per Patient Per Admission	1 year	How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams.

Secondary Outcome Measures

Name	Time	Method
Length of Stay	1 year	hospital LOS, per patient, in hours from admission to discharge
Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability	1 year	The outome answeres the question "Did the study patient require endotracheal intubation, or not". This outcome investigates if the phenobarbital intervention is associted with increased incidence of respiratory depression and subsequent increased need for intubation.
Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability	1 year	Did the study patient require a Licensed Vocational Nurse (LVN) or other hospital staff to serve as a "bedside sitter" to observe the patient and provide additional safety supervision during any portion of their hospitalization.
Number of Study Patients With Seizure as a Measure of Safety and Tolerability	1 year	Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).
Number of Study Patients With Mortality as a Measure of Safety and Tolerability	1 year	mortality in study patients

Trial Locations

Locations (1)

Alameda County Medical Center; 🇺🇸 Oakland, California, United States