Optimizing Drug Doses in Critically Ill

Traumatic Brain Injury Clinical Trial

Official title:

Optimizing Drug Doses to Improve Outcomes of Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437838
• Other study ID #: 15-0455
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: June 19, 2017
• Start date: August 2015
• Est. completion date: August 2016

Study information

• Verified date: June 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Critical Illness
• Kidney Functional
• Traumatic Brain Injury

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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