Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2015-08-31
2016-08-31
Brief Summary
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Detailed Description
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Participants: The population will be comprised of patients with traumatic brain injury requiring levetiracetam for seizure prophylaxis admitted to the neurosciences intensive care unit
Procedures (methods): This is a multi-center, prospective, non-randomized pharmacokinetic study in patients with TBI. In patients who meet the inclusion criteria, a 12-hour urine collection for measuring creatinine clearance levetiracetam urine concentrations will be performed daily for 7 days. Serum levetiracetam concentrations will be obtained twice daily for 7 days.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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No Intervention
No Intervention
Eligibility Criteria
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Inclusion Criteria
2. Patients with TBI requiring levetiracetam for seizure prophylaxis
3. Anticipated length of stay in the SICU or NSICU \> 48 hours
4. Informed consent provided by the patient's designated medical proxy
Exclusion Criteria
2. Patients with renal dysfunction (CKD stages 3 - 5 and/or SCr \> 1.4 mg/dL)
3. Patients receiving renal replacement therapy
4. Brain death or suspected imminent brain death within the next 48 hours
5. Patients with history of nephrectomy or renal transplant
18 Years
ALL
No
Sponsors
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University of Kentucky
OTHER
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Kathryn Morbitzer, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of Kentucky
Lexington, Kentucky, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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References
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Cook AM, Hall K, Kolpek JH, Morbitzer KA, Jordan JD, Rhoney DH. Enhanced renal clearance impacts levetiracetam concentrations in patients with traumatic brain injury with and without augmented renal clearance. BMC Neurol. 2024 Jan 2;24(1):12. doi: 10.1186/s12883-023-03515-w.
Other Identifiers
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15-0455
Identifier Type: -
Identifier Source: org_study_id
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