Optimizing Drug Doses in Critically Ill

Completed

Conditions studied: Traumatic Brain Injury, Kidney Functional

In brief

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.

Key facts

Study ID

NCT02437838

Run by

University of North Carolina, Chapel Hill

People needed

20

Starts

2015-08-01

Expected to finish

2016-08-01

Last updated by the study team

2017-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults ≥ 18 years
• Patients with TBI requiring levetiracetam for seizure prophylaxis
• Anticipated length of stay in the SICU or NSICU > 48 hours
• Informed consent provided by the patient's designated medical proxy

You may not qualify if…

• Pregnancy
• Patients with renal dysfunction (CKD stages 3 - 5 and/or SCr > 1.4 mg/dL)
• Patients receiving renal replacement therapy
• Brain death or suspected imminent brain death within the next 48 hours
• Patients with history of nephrectomy or renal transplant

Where it is running

• University of Kentucky — Lexington, Kentucky, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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