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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

Tracking Information
First Submitted Date August 10, 2016
First Posted Date August 15, 2016
Last Update Posted Date January 29, 2019
Actual Study Start Date January 2016
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 12, 2016)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02866877 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 12, 2016)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage
Official Title Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Subarachnoid Hemorrhage
Intervention Other: Pharmacokinetic modeling
Timed blood draws and urine collections to model drug clearance
Study Groups/Cohorts Subarachnoid Hemorrhage
Intervention: Other: Pharmacokinetic modeling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 12, 2016)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2019
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Edward T Van matre, PharmD edward.vanmatre@ucdenver.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02866877
Other Study ID Numbers 15-1823
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Not Provided
Investigators
Principal Investigator: Edward T Van Matre, PharmD University of Colorado School of Pharmacy
PRS Account University of Colorado, Denver
Verification Date January 2019