Alcohol Withdrawal
Conditions
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.
Interventions
DRUG10 mg/kg IV phenobarbital in 100 ml saline
10 mg/kg IV phenobarbital in 100 ml saline
DRUGplacebo
100 m l saline
Sponsors
Alameda County Medical Center
Jonathan Rosenson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Need for admission to hospital for acute alcohol withdrawal
Exclusion criteria
* allergy to phenobarbital, lorazepam, age\<18 or \>65
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Length of Stay | 1 year | hospital LOS, per patient, in hours from admission to discharge |
| Number of Study Patients With Mortality as a Measure of Safety and Tolerability | 1 year | mortality in study patients |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phenobarbital Group 10 mg/kg IV phenobarbital in 100 ml saline | 51 |
| Placebo Group 100 ml saline | 51 |
| Total | 102 |
Baseline characteristics
| Characteristic | Placebo Group | Phenobarbital Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 51 Participants | 102 Participants |
| Age Continuous | 48 years STANDARD_DEVIATION 17 | 46 years STANDARD_DEVIATION 12 | 47 years STANDARD_DEVIATION 14 |
| Region of Enrollment United States | 51 participants | 51 participants | 102 participants |
| Sex: Female, Male Female | 45 Participants | 46 Participants | 91 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
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).
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenobarbital Group | Number of Patients Requiring Continuous Lorazepam Infusion | 2 participants |
| Placebo Group | Number of Patients Requiring Continuous Lorazepam Infusion | 16 participants |
Primary
Percentage of Patients Requiring ICU Admission
admission to intensive care unit
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenobarbital Group | Percentage of Patients Requiring ICU Admission | 8 percentage of participants |
| Placebo Group | Percentage of Patients Requiring ICU Admission | 25 percentage of participants |
95% CI: [4, 32]
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.
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenobarbital Group | Total Lorazepam Required Per Patient Per Admission | 26 milligrams | Standard Deviation 45 |
| Placebo Group | Total Lorazepam Required Per Patient Per Admission | 49 milligrams | Standard Deviation 37 |
95% CI: [4, 49]
Secondary
Length of Stay
hospital LOS, per patient, in hours from admission to discharge
Time frame: 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phenobarbital Group | Length of Stay | 76 hours |
| Placebo Group | Length of Stay | 118 hours |
95% CI: [-4, 82]
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenobarbital Group | Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability | 0 participants |
| Placebo Group | Number of Patients Requiring Endotracheal Intubation as a Measure of Safety and Tolerability | 0 participants |
Secondary
Number of Study Patients With Mortality as a Measure of Safety and Tolerability
mortality in study patients
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenobarbital Group | Number of Study Patients With Mortality as a Measure of Safety and Tolerability | 0 participants |
| Placebo Group | Number of Study Patients With Mortality as a Measure of Safety and Tolerability | 0 participants |
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).
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenobarbital Group | Number of Study Patients With Seizure as a Measure of Safety and Tolerability | 1 participants |
| Placebo Group | Number of Study Patients With Seizure as a Measure of Safety and Tolerability | 2 participants |
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phenobarbital Group | Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability | 28 percentage of participants |
| Placebo Group | Percentage of Patients Requiring a Bedside Sitter as a Measure of Safety and Tolerability | 22 percentage of participants |
95% CI: [-11, 23]