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

NCT02866877 | Completed

• 1 other identifier: 15-1823
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage

Keywords

augmented renal clearance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in urinary clearance of levetiracetam and creatinine

  0-20 days

Study Arms (1)

Subarachnoid Hemorrhage

Other: Pharmacokinetic modeling

Interventions

Pharmacokinetic modeling OTHER

Timed blood draws and urine collections to model drug clearance

Subarachnoid Hemorrhage

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have suffered a non-traumatic subarachnoid hemorrhage requiring strict intake and output monitoring and admission to the neuro-intensive care unit

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Patients receiving renal replacement therapy
• Brain death or imminent brain death expected ≤48 hours
• Patient with history of nephrectomy or renal transplant

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward T Van Matre, PharmD

  University of Colorado School of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 15, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: March 1, 2021
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

US (1)