Subarachnoid Hemorrhage
Conditions
Keywords
augmented renal clearance
Brief summary
This study evaluates the pharmacokinetic profile of levetiracetam in critically ill patients who have suffered a subarachnoid hemorrhage. The patients will be evaluated for development of augmented renal clearance and the effects and duration of effects this may have on levetiracetam clearance.
Interventions
OTHERPharmacokinetic modeling
Timed blood draws and urine collections to model drug clearance
Sponsors
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with non-traumatic subarachnoid hemorrhage requiring levetiracetam for seizure prophylaxis or treatment * Presentation to University of Colorado Hospital within 48 hours of subarachnoid hemorrhage * Adults ages 18 to 89 years * Anticipated length of stay ≥ 48 hours * Informed consent provided by the patient or patient's designated medical proxy
Exclusion criteria
* Pregnancy * Patients receiving renal replacement therapy * Brain death or imminent brain death expected ≤48 hours * Patient with history of nephrectomy or renal transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systemic levetiracetam clearance over time | 0-20 days | calculated systemic levetiracetam clearance (based on plasma concentrations) within 48 hours of initial presentation to the neurointensive care unit and every 5 days thereafter up to 20 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in urinary clearance of levetiracetam and creatinine | 0-20 days | 12-hour urine collections on day 0, 5, 10, 15, and 20, calculated creatinine based on 12-hour urine collections daily for 7 days following diagnosis of vasospasm, and calculation of direct renal clearance of levetiracitam based on urine collection |
Countries
United States
Outcome results
None listed