Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage

University of Colorado, Denver15 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Subarachnoid Hemorrhage

Interventions

Pharmacokinetic modelingOTHER

Timed blood draws and urine collections to model drug clearance

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado Hospital

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Change in systemic levetiracetam clearance over time

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

Time frame: 0-20 days

Secondary Outcomes

Change in urinary clearance of levetiracetam and creatinine

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

Time frame: 0-20 days

Data from ClinicalTrials.gov

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