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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02866877
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 67
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subarachnoid Hemorrhage	Other: Pharmacokinetic modeling

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage
• Actual Study Start Date: Jan 1, 2016
• Anticipated Primary Completion Date: Aug 1, 2021
• Anticipated Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Subarachnoid Hemorrhage	Other: Pharmacokinetic modeling; Timed blood draws and urine collections to model drug clearance

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Hospital	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver

Investigators

• Principal Investigator: Edward T Van Matre, PharmD, University of Colorado School of Pharmacy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02866877
• Other Study ID Numbers: 15-1823
• First Posted: Aug 15, 2016
• Last Update Posted: Feb 18, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by University of Colorado, Denver: augmented renal clearance
• Additional relevant MeSH terms: Subarachnoid Hemorrhage; Hemorrhage

Study Results

No Results Posted as of Feb 18, 2021