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CompletedNCT02866877Updated Apr 2, 2024

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

An observational study in Subarachnoid Hemorrhage, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-04-02.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

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Conditions studied

  • Subarachnoid Hemorrhage

Keywords

  • augmented renal clearance
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In context

Subarachnoid Hemorrhage

521 studies on the registry are indexed under Subarachnoid Hemorrhage; 126 are open to participants now.

This study's enrollment of 15 is below the median of 116 across 234 observational studies indexed under Subarachnoid Hemorrhage.

Browse Subarachnoid Hemorrhage studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 319 are open to participants now.

Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • Subarachnoid Hemorrhage

    Other: Pharmacokinetic modeling

Interventions

  • OtherPharmacokinetic modeling

    Timed blood draws and urine collections to model drug clearance

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What researchers measure

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

    Time frame: 0-20 days

Secondary outcomes

  1. Change in urinary clearance of levetiracetam and creatinine

    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

    Time frame: 0-20 days

07

Study locations

1 site
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2016 to primary completion in Jun 2019, 41 months.

Of 116 non-industry observational studies under Subarachnoid Hemorrhage, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 127. This study's 41 months is above that.

Counting every sponsor, half of 119 studies reached it within 37 months; a quarter within 17 and three quarters within 107.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 10, 2016
First posted
Aug 15, 2016
StartActual
Jan 2016
Primary completionActual
Jun 2019
CompletionActual
Mar 2021
Last update
Apr 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02866877
Responsible party
Sponsor
First posted
Aug 15, 2016
Start date
Jan 2016
Primary completion
Jun 2019
Completion
Mar 2021
Last update
Apr 2, 2024

Study contacts

Edward T Van Matre, PharmD
principal investigator · University of Colorado School of Pharmacy

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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