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

NCT ID: NCT02866877

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2021-03-31

Brief Summary

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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

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Conditions

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Subarachnoid Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subarachnoid Hemorrhage

Pharmacokinetic modeling

Intervention Type OTHER

Timed blood draws and urine collections to model drug clearance

Interventions

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Pharmacokinetic modeling

Timed blood draws and urine collections to model drug clearance

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward T Van Matre, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Pharmacy

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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15-1823

Identifier Type: -

Identifier Source: org_study_id

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