Status:
COMPLETED
A Pharmacokinetic Analysis of Levetiracetam Prophylaxis in Critically Ill Patients With Severe Traumatic Brain Injury
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
American College of Clinical Pharmacy
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-75 years
Brief Summary
This study aims is to describe the pharmacokinetic properties of levetiracetam through measurement of serum concentrations in critically ill, severe traumatic brain injury patients.
Detailed Description
Levetiracetam (LEV) is widely used for the prevention and treatment of seizures given its favorable pharmacokinetic profile. A strong correlation between serum concentrations and clinical efficacy has...
Eligibility Criteria
Inclusion
- Admitted to the neurosurgical intensive care unit or surgical intensive care unit following severe traumatic brain injury (post-resuscitation GCS 3-8 with or without CT abnormalities)
- Receiving intravenous levetiracetam for seizure prophylaxis at a dose of 1000 mg every 12 hours or 1000 mg every 8 hours at time of enrollment
Exclusion
- Known history of epilepsy or seizure disorder
- Taking antiseizure medication prior to admission
- Taking medication with known effect on levetiracetam pharmacokinetics including carbamazepine, phenytoin, oxcarbazepine, mefloquine, methotrexate, mianserin, or orlistat
- Weight \< 50 kg
- Anticipated survival \<72 hours from injury, as deemed by the primary neurosurgical provider
- Acute Kidney Injury (Scr rise \> 0.3 mg/dL from baseline) or creatinine clearance \<50 mL/min at time of enrollment
- Prisoners
- Pregnant
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04836481
Start Date
January 1 2021
End Date
October 1 2023
Last Update
February 29 2024
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219