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Completed

NCT Number: NCT02866877

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

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.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacokinetic modeling

Other

Timed blood draws and urine collections to model drug clearance

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Aug 15, 2016
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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