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

Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866877
• Other study ID #: 15-1823
• Status: Completed
• Start date: January 2016
• Est. completion date: March 2021

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2021
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Other:
• Pharmacokinetic modeling
Timed blood draws and urine collections to model drug clearance

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0-20 days
Secondary	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	0-20 days