Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alameda County Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenobarbital group | Active Comparator | 10 mg/kg IV phenobarbital in 100 ml saline |
|
| Placebo group | Placebo Comparator | 100 ml saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 mg/kg IV phenobarbital in 100 ml saline | Drug | 10 mg/kg IV phenobarbital in 100 ml saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | hospital LOS, per patient, in hours from admission to discharge | 1 year |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alameda County Medical Center | Oakland | California | 94608 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phenobarbital Group | 10 mg/kg IV phenobarbital in 100 ml saline |
| FG001 | Placebo Group | 100 ml saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phenobarbital Group | 10 mg/kg IV phenobarbital in 100 ml saline |
| BG001 | Placebo Group | 100 ml saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | participants | 1 year |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phenobarbital Group | 10 mg/kg IV phenobarbital in 100 ml saline |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Rosenson MD | Alameda County Medical Center | 510-407-6743 | jonrosenson@yahoo.com |
Not provided
| ID | Term |
|---|---|
| D010634 | Phenobarbital |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo | Drug | 100 m l saline |
|
| 1 year |
| 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 |
| 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 |
| Number of Study Patients With Mortality as a Measure of Safety and Tolerability | mortality in study patients | 1 year |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
100 ml saline
|
|
| Primary | Percentage of Patients Requiring ICU Admission | admission to intensive care unit | Posted | Number | percentage of participants | 1 year |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | milligrams | 1 year |
|
|
|
|
| Secondary | Length of Stay | hospital LOS, per patient, in hours from admission to discharge | Posted | Median | Inter-Quartile Range | hours | 1 year |
|
|
|
|
| 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. | Posted | Number | participants | 1 year |
|
|
|
| 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. | Posted | Number | percentage of participants | 1 year |
|
|
|
|
| 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). | Posted | Number | participants | 1 year |
|
|
|
| Secondary | Number of Study Patients With Mortality as a Measure of Safety and Tolerability | mortality in study patients | Posted | Number | participants | 1 year |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Placebo Group | 100 ml saline | 0 | 51 | 0 | 51 |
Not provided
Not provided
Not provided
| D006571 |
| Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |