Optimizing Drug Doses in Critically Ill

Completed

• Conditions: Kidney Functional; Traumatic Brain Injury

• Registration Number: NCT02437838
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Study Start: 2015-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	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 Outcome Measures

Name	Time	Method
To estimate the optimal dose needed to achieve therapeutic serum concentrations of the probe medication levetiracetam in patients with TBI	Data will be obtained during study period of up to 7 days

Trial Locations

Locations (2)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States