Optimizing Drug Doses in Critically Ill

NCT02437838 | Completed

• 1 other identifier: 15-0455
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Traumatic Brain Injury; Kidney Functional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

No Intervention OTHER

No Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40 patients with traumatic brain injury requiring levetiracetam admitted to the University of North Carolina Intensive Care Unit and University of Kentucky Chandler Medical Center Intensive Care Unit

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Kentucky: collaborator

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• Cook AM, Hall K, Kolpek JH, Morbitzer KA, Jordan JD, Rhoney DH. Enhanced renal clearance impacts levetiracetam concentrations in patients with traumatic brain injury with and without augmented renal clearance. BMC Neurol. 2024 Jan 2;24(1):12. doi: 10.1186/s12883-023-03515-w.

  PMID: 38166710 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Kathryn Morbitzer, PharmD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: May 8, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

US (2)