Alcohol Withdrawal Syndrome
Conditions
Keywords
Lorazepam, Ketamine, Phenobarbital
Brief summary
The goal of this study will aim to determine if adding phenobarbital or ketamine to a symptom-triggered benzodiazepine regimen decreases the rate of intensive care unit admissions during the treatment of alcohol withdrawal syndrome when compared to symptom-triggered benzodiazepine therapy alone.
Detailed description
The primary objective of this study is to compare phenobarbital and ketamine adjunctive therapies to lorazepam-based therapy in the treatment of acute alcohol withdrawal syndrome. It is hypothesized that the use of an alternative agent, either phenobarbital or ketamine, when used as an adjunct to symptom-triggered lorazepam therapy will significantly reduce the rate of intensive care unit admissions and thereby reduce the total cost associated with hospital admission for treatment of alcohol withdrawal syndrome. Enrolled patients will be admitted to Santa Barbara Cottage Hospital where they will be monitored with continuous pulse oximetry and cardiac telemetry. They will remain hospitalized while undergoing study-guided therapy in addition to supportive care for acute alcohol withdrawal syndrome. Patients will undergo standard of care therapy with lorazepam symptom-triggered therapy regardless of study participation.
Interventions
Sponsors
Santa Barbara Cottage Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Each participant will be randomized according to a web-based randomization program employed by a research pharmacist once the Emergency Department provider deems the patient appropriate for inpatient treatment of alcohol withdrawal syndrome. Each medication will be packaged by Santa Barbara Cottage Hospital pharmacy. In order to blind both the clinicians and the participants, the pharmacy will provide medication bags that are identical. Therefore, Emergency Department nursing staff and physicians will be unaware of which study drug is being provided to the patient. Normal saline will be used as a placebo to mimic study drugs (phenobarbital and ketamine). Pharmacy will remain unblinded and maintain records of which treatment assignment is prepared for each patient. Treatment will be provided for the duration of the patient's hospitalization; therefore, treatment compliance will be documented in the electronic health record using the medication bag identifier.
Intervention model description
prospective, randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary admitting diagnosis of acute alcohol withdrawal syndrome based on International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10), code F10.3, F10.4.
Exclusion criteria
* Significant comorbid medical illness requiring Intensive Care Unit admission; * Pregnancy; * Inability to obtain intravenous access; * Child Pugh Class C; and * Allergy to study medications (phenobarbital, ketamine, lorazepam).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care Unit admission rate | Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years | Number of admissions to the intensive care unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) scores | Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years | CIWA-Ar scores (initial, maximum, discharge); Total score is cumulative of subscale measures: Minimum score is 0 (no evidence of alcohol withdrawal), Maximum score is 67 (severe alcohol withdrawal) Subscale measures: A) Nausea and vomiting (score 0-7); B) Tremor (score 0-7); C) Paroxysmal sweats (score 0-7); D) Anxiety (score 0-7); E) Tactile disturbances (score 0-7); F) Auditory disturbances (score 0-7); G) Visual disturbances (score 0-7); H) Headache, fullness in head (score 0-7); I) Agitation (score 0-7); J) Orientation and clouding of sensorium (score 0-4) |
| Cumulative dose of medication/s administered | Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years | Cumulative dose of Lorazepam, Ketamine, and Phenobarbital |
| Incidence of withdrawal seizures | Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years | Number of patients with documented seizures while treated for alcohol withdrawal syndrome |
| Rate of mechanical ventilation | Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years | Rate of intubation |
| Incidence of alcohol withdrawal hallucinations | Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years | Number of patients with documented auditory or visual hallucinations |
| Incidence of refractory alcohol withdrawal requiring alternative sedation with dexmedetomidine, propofol or midazolam infusions | Presentation to Emergency Department through hospital stay, data will be utilized through study completion, anticipated 2 years | Number of patients who require Dexmedetomidine, Propofol or Benzodiazepine continuous infusions and average dose while being treated for alcohol withdrawal syndrome |
Outcome results
None listed