Phenobarbital for Acute Alcohol Withdrawal

NCT01184417 | Completed Results DMC

• 1 other identifier: AlamedaCountyMC
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Withdrawal

Outcome Measures

Primary Outcomes (3)

• 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

• Percentage of Patients Requiring ICU Admission

  admission to intensive care unit

  1 year

• 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

Secondary Outcomes (5)

• Length of Stay

  1 year

• Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability

  1 year

• Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability

  1 year

• Number of Study Patients With Seizure as a Measure of Safety and Tolerability

  1 year

• Number of Study Patients With Mortality as a Measure of Safety and Tolerability

  1 year

Study Arms (2)

Phenobarbital group

ACTIVE COMPARATOR

10 mg/kg IV phenobarbital in 100 ml saline

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

Placebo group

PLACEBO COMPARATOR

100 ml saline

Drug: placebo

Interventions

10 mg/kg IV phenobarbital in 100 ml saline DRUG

10 mg/kg IV phenobarbital in 100 ml saline

Phenobarbital group

placebo DRUG

100 m l saline

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Need for admission to hospital for acute alcohol withdrawal

You may not qualify if:

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

Sponsors & Collaborators

• Jonathan Rosenson: lead
• Alameda County Medical Center: collaborator

Study Sites (1)

Alameda County Medical Center

Oakland, California, 94608, United States

Location

MeSH Terms

Interventions

Phenobarbital; Sodium Chloride

Intervention Hierarchy (Ancestors)

Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Jonathan Rosenson MD
• Organization: Alameda County Medical Center

jonrosenson@yahoo.com

510-407-6743

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Jonathan Rosenson MD

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 19, 2010
• Study Start: January 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 9, 2012
• Results First Posted: March 9, 2012

Record last verified: 2012-03

Locations

US (1)