Subarachnoid HemorrhageNCT02866877
Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Pharmacokinetic modeling
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Patients receiving renal replacement therapy
- Brain death or imminent brain death expected ≤48 hours
- Patient with history of nephrectomy or renal transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Pharmacokinetic modeling
- Keywords
- augmented renal clearance
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic modelingOther
Timed blood draws and urine collections to model drug clearance
| Study group | Role | What they receive |
|---|---|---|
| Subarachnoid Hemorrhage | Not described Receives: Other: Pharmacokinetic modeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 0-20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2019
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward T Van Matre, PharmD, Principal investigator, University of Colorado School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866877
- Sponsor's protocol ID
- 15-1823
- Status last verified
- Apr 2024
- First submitted
- 10 Aug 2016
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02866877
- Acronym / sponsor ID
- 15-1823
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- augmented renal clearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 15 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subarachnoid Hemorrhage | – | Other: Pharmacokinetic modeling |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- Patients receiving renal replacement therapy
- Brain death or imminent brain death expected ≤48 hours
- Patient with history of nephrectomy or renal transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacokinetic modelingTimed blood draws and urine collections to model drug clearance | Other | Subarachnoid Hemorrhage |
Primary outcome
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
1 secondary outcome
Change in urinary clearance of levetiracetam and creatinine
Time frame: 0-20 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward T Van Matre, PharmD principal investigator
University of Colorado School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systemic levetiracetam clearance over time (time frame: 0-20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.