Trial Outcomes & Findings for Phenobarbital for Acute Alcohol Withdrawal (NCT NCT01184417)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

1 year

Results posted on

2012-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	Phenobarbital Group 10 mg/kg IV phenobarbital in 100 ml saline	Placebo Group 100 ml saline
Overall Study STARTED	51	51
Overall Study COMPLETED	51	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phenobarbital for Acute Alcohol Withdrawal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phenobarbital Group n=51 Participants 10 mg/kg IV phenobarbital in 100 ml saline	Placebo Group n=51 Participants 100 ml saline	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	51 Participants n=7 Participants	102 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	46 years STANDARD_DEVIATION 12 • n=5 Participants	48 years STANDARD_DEVIATION 17 • n=7 Participants	47 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	45 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	51 participants n=7 Participants	102 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Phenobarbital Group n=51 Participants 10 mg/kg IV phenobarbital in 100 ml saline	Placebo Group n=51 Participants 100 ml saline
Number of Patients Requiring Continuous Lorazepam Infusion	2 participants	16 participants

PRIMARY outcome

Timeframe: 1 year

admission to intensive care unit

Outcome measures

Outcome measures
Measure	Phenobarbital Group n=51 Participants 10 mg/kg IV phenobarbital in 100 ml saline	Placebo Group n=51 Participants 100 ml saline
Percentage of Patients Requiring ICU Admission	8 percentage of participants Interval 4.0 to 32.0	25 percentage of participants Interval 4.0 to 32.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phenobarbital Group n=51 Participants 10 mg/kg IV phenobarbital in 100 ml saline	Placebo Group n=51 Participants 100 ml saline
Total Lorazepam Required Per Patient Per Admission	26 milligrams Standard Deviation 45 • Interval 7.0 to 49.0	49 milligrams Standard Deviation 37 • Interval 7.0 to 49.0

SECONDARY outcome

Timeframe: 1 year

hospital LOS, per patient, in hours from admission to discharge

Outcome measures

Outcome measures
Measure	Phenobarbital Group n=51 Participants 10 mg/kg IV phenobarbital in 100 ml saline	Placebo Group n=51 Participants 100 ml saline
Length of Stay	76 hours Interval 54.0 to 114.0	118 hours Interval 47.0 to 190.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phenobarbital Group n=51 Participants 10 mg/kg IV phenobarbital in 100 ml saline	Placebo Group n=51 Participants 100 ml saline
Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phenobarbital Group n=51 Participants 10 mg/kg IV phenobarbital in 100 ml saline	Placebo Group n=51 Participants 100 ml saline
Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability	28 percentage of participants Interval -11.0 to 23.0	22 percentage of participants Interval -11.0 to 23.0

SECONDARY outcome

Timeframe: 1 year

Did the study patient have a witnessed seizure during their hospitaliztion (yes/no).

Outcome measures

Outcome measures
Measure	Phenobarbital Group n=51 Participants 10 mg/kg IV phenobarbital in 100 ml saline	Placebo Group n=51 Participants 100 ml saline
Number of Study Patients With Seizure as a Measure of Safety and Tolerability	1 participants	2 participants

SECONDARY outcome

Timeframe: 1 year

mortality in study patients

Outcome measures

Outcome measures
Measure	Phenobarbital Group n=51 Participants 10 mg/kg IV phenobarbital in 100 ml saline	Placebo Group n=51 Participants 100 ml saline
Number of Study Patients With Mortality as a Measure of Safety and Tolerability	0 participants	0 participants

Adverse Events

Phenobarbital Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Rosenson MD

Alameda County Medical Center

Phone: 510-407-6743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place