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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01184417
Other study ID # AlamedaCountyMC
Secondary ID
Status Completed
Phase N/A
First received August 17, 2010
Last updated March 7, 2012
Start date January 2009
Est. completion date March 2010

Study information

Verified date March 2012
Source Alameda County Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board ACMC (for Oversight Authority)**Note: This study was approved by the ACMC Ethics committee in conjunction with the ACMC IRB.
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Need for admission to hospital for acute alcohol withdrawal

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
10 mg/kg IV phenobarbital in 100 ml saline
10 mg/kg IV phenobarbital in 100 ml saline
placebo
100 m l saline

Locations

Country Name City State
United States Alameda County Medical Center Oakland California

Sponsors (2)

Lead Sponsor Collaborator
Jonathan Rosenson Alameda County Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients Requiring Continuous Lorazepam Infusion 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). 1 year No
Primary Percentage of Patients Requiring ICU Admission admission to intensive care unit 1 year No
Primary Total Lorazepam Required Per Patient Per Admission How much total lorazepam did each study patient receive from inital presentation in the Emergency Department through their discharge from the hospital, in milligrams. 1 year No
Secondary Length of Stay hospital LOS, per patient, in hours from admission to discharge 1 year No
Secondary Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability 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. 1 year Yes
Secondary Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability 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. 1 year Yes
Secondary Number of Study Patients With Seizure as a Measure of Safety and Tolerability Did the study patient have a witnessed seizure during their hospitaliztion (yes/no). 1 year Yes
Secondary Number of Study Patients With Mortality as a Measure of Safety and Tolerability mortality in study patients 1 year Yes
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