Optimizing Drug Doses in Critically Ill



Status:Completed
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:6/21/2017
Start Date:August 2015
End Date:August 2016

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Optimizing Drug Doses to Improve Outcomes of Critically Ill Patients

The primary objectives of this study are to examine whether augmented renal clearance (ARC)
compromises renally eliminated drug therapeutic serum concentrations in patients with
traumatic brain injury (TBI) and to estimate the optimal dose needed to achieve therapeutic
serum concentrations of the probe medication levetiracetam in patients with TBI.

Purpose: The primary objectives of this study are to examine whether augmented renal
clearance compromises renally eliminated drug therapeutic serum concentrations in patients
with traumatic brain injury (TBI) and to estimate the optimal dose needed to achieve
therapeutic serum concentrations of the probe medication levetiracetam in patients with TBI.

Participants: The population will be comprised of patients with traumatic brain injury
requiring levetiracetam for seizure prophylaxis admitted to the neurosciences intensive care
unit

Procedures (methods): This is a multi-center, prospective, non-randomized pharmacokinetic
study in patients with TBI. In patients who meet the inclusion criteria, a 12-hour urine
collection for measuring creatinine clearance levetiracetam urine concentrations will be
performed daily for 7 days. Serum levetiracetam concentrations will be obtained twice daily
for 7 days.

Inclusion Criteria:

1. Adults ≥ 18 years

2. Patients with TBI requiring levetiracetam for seizure prophylaxis

3. Anticipated length of stay in the SICU or NSICU > 48 hours

4. Informed consent provided by the patient's designated medical proxy

Exclusion Criteria:

1. Pregnancy

2. Patients with renal dysfunction (CKD stages 3 - 5 and/or SCr > 1.4 mg/dL)

3. Patients receiving renal replacement therapy

4. Brain death or suspected imminent brain death within the next 48 hours

5. Patients with history of nephrectomy or renal transplant
We found this trial at
2
sites
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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