Kidney Functional, Traumatic Brain Injury
Conditions
Brief summary
The primary objectives of this study are to examine whether augmented renal clearance (ARC) compromises renally eliminated drug therapeutic serum concentrations in patients with traumatic brain injury (TBI) and to estimate the optimal dose needed to achieve therapeutic serum concentrations of the probe medication levetiracetam in patients with TBI.
Detailed description
Purpose: The primary objectives of this study are to examine whether augmented renal clearance compromises renally eliminated drug therapeutic serum concentrations in patients with traumatic brain injury (TBI) and to estimate the optimal dose needed to achieve therapeutic serum concentrations of the probe medication levetiracetam in patients with TBI. 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.
Interventions
OTHERNo Intervention
No Intervention
Sponsors
University of Kentucky
University of North Carolina, Chapel Hill
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults ≥ 18 years 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
1. Pregnancy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To examine whether ARC compromises renally eliminated drug therapeutic serum concentrations in patients with TBI (urine collections/ two levetiracetam serum concentrations, to measure creatinine clearance and therapeutic drug concentrations) | Daily 12-hour urine collections and two levetiracetam serum concentrations will be performed to directly measure creatinine clearance and therapeutic drug concentrations up to day 7 of ICU stay |
Secondary
| Measure | Time frame |
|---|---|
| To estimate the optimal dose needed to achieve therapeutic serum concentrations of the probe medication levetiracetam in patients with TBI | Data will be obtained during study period of up to 7 days |
Countries
United States
Outcome results
None listed