Optimizing Drug Doses in Critically Ill

University of North Carolina, Chapel Hill20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Traumatic Brain Injury Kidney Functional

Interventions

No InterventionOTHER

No Intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Kentucky

Lexington, Kentucky, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

To examine whether ARC compromises renally eliminated drug therapeutic serum concentrations in patients with TBI (urine collections/ two levetiracetam serum concentrations, to measure creatinine clearance and therapeutic drug concentrations)

Time frame: Daily 12-hour urine collections and two levetiracetam serum concentrations will be performed to directly measure creatinine clearance and therapeutic drug concentrations up to day 7 of ICU stay

Secondary Outcomes

To estimate the optimal dose needed to achieve therapeutic serum concentrations of the probe medication levetiracetam in patients with TBI

Time frame: Data will be obtained during study period of up to 7 days

Data from ClinicalTrials.gov

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