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

Completed

• Conditions: Subarachnoid Hemorrhage
• Interventions: Other: Pharmacokinetic modeling

• Registration Number: NCT02866877
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-15
• Primary Completion: 2019-06
• Study Completion: 2021-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subarachnoid Hemorrhage	Pharmacokinetic modeling	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States