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

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ClinicalTrials.gov Identifier: NCT02866877
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Subarachnoid Hemorrhage Other: Pharmacokinetic modeling

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Study Type : Observational
Estimated 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 : January 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
Subarachnoid Hemorrhage Other: Pharmacokinetic modeling
Timed blood draws and urine collections to model drug clearance




Primary Outcome Measures :
  1. Change in systemic levetiracetam clearance over time [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866877


Contacts
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Contact: Edward T Van matre, PharmD edward.vanmatre@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Gerard Barber    720-848-6964    gerard.barber@uchealth.org   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Edward T Van Matre, PharmD University of Colorado School of Pharmacy

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02866877     History of Changes
Other Study ID Numbers: 15-1823
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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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:
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Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents