Alcohol Withdrawal Clinical Trial
— PARTIOfficial title:
Phenobarbital Versus Ativan for Refractory Alcohol Withdrawal Treatment in the Intensive Care Unit
NCT number | NCT04156464 |
Other study ID # | 1499413 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 6, 2020 |
Est. completion date | March 1, 2022 |
Our aim is to compare outcomes of patients with benzodiazepine-refractory alcohol withdrawal syndrome who are treated with either a phenobarbital-based or a lorazepam based protocol.
Status | Recruiting |
Enrollment | 142 |
Est. completion date | March 1, 2022 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients will be eligible for randomization if he/she has met one of the following three conditions: 1. has required more than 10 mg of lorazepam within a one hour time period, 2. has required more than 30 mg of lorazepam within a four hour time period, or 3. requires admission/transfer to the intensive care unit for primarily uncontrolled alcohol withdrawal symptoms Exclusion Criteria: - Patients will be excluded from the study if he/she: 1. has a traumatic brain injury or other neurological condition requiring frequent neurological assessment (stroke, intracranial hemorrhage, active seizures on admission) 2. has severe hypotension requiring vasopressor support 3. is less than 18 years of age 4. is actively pregnant 5. has an allergy to either of the drugs being studied (phenobarbital or lorazepam) 6. is already intubated at the time of randomization |
Country | Name | City | State |
---|---|---|---|
United States | OSF Saint Francis Medical Center | Peoria | Illinois |
Lead Sponsor | Collaborator |
---|---|
OSF Healthcare System |
United States,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ICU length of stay | number of days in the intensive care unit | study completion, up to 18 months | |
Secondary | Hospital length of stay | number of days in the hospital | Study completion, up to 18 months | |
Secondary | 30-day readmission | rate of readmission of patients within 30 days for any cause | study complettion, up to 18 months | |
Secondary | mortality | number of deaths | Study completion, up to 18 months | |
Secondary | Intubation | rate of endotracheal intubation | study completion, up to 18 months | |
Secondary | Hospitalization cost | Cost of index hospital stay | Study completion, up to 18 months | |
Secondary | Lorazepam use | total lorazepam use in mg during the entire hospital stay | Study completion, up to 18 months | |
Secondary | dexmedetomidine use | total dexmedetomidine used in mcg during the entire hospital stay | Study completion, up to 18 months | |
Secondary | propofol use | total propofol used in mg during the entire hospital stay | Study completion, up to 18 months |
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