Pharmacokinetics and Pharmacodynamics of Extended-Infusion Cefepime in Continuous Renal Replacement Therapy

NCT02458261 | Completed

• 1 other identifier: 2014-6119
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective, multi-center study aims to determine the pharmacokinetics and pharmacodynamics of extended-infusion cefepime in continuous renal replacement therapy (CRRT).

Conditions

Drug Mechanism

Outcome Measures

Primary Outcomes (1)

• Composite pharmacokinetic and pharmacodynamic profile of extended-infusion cefepime in CRRT

  Each patient will have samples collected on both the first dose and another dose at presumed steady state (dose four, five, or six) to determine the pharmacokinetic and pharmacodynamic profile of extended-infusion cefepime in CRRT. Pharmacokinetic outcomes calculated include half life, volume of distribution, and area under the plasma concentration versus time curve. Sieving and saturation coefficients will also be calculated as appropriate. Time above the minimum inhibitory concentration will be the primary pharmacodynamic outcome studied.

  up to 12 months

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

Critically ill patients on continuous renal replacement therapy who are being initiated on cefepime 2000 mg IV every 8 hours with a four-hour infusion

You may qualify if:

• Age ≥ 18 years
• Admission to medical intensive care unit (MICU), surgical intensive care unit (SICU), neuroscience intensive care unit (NSICU), or cardiovascular intensive care unit (CVICU), at the University of Cincinnati Medical Center, or the mixed ICU at West Chester Hospital
• Patients receiving continuous venovenous hemofiltration or continuous venovenous hemodialysis
• Receiving empiric or definitive cefepime 2 g IV every 8 hours with a four-hour infusion

You may not qualify if:

• Prisoners
• Pregnant women
• Patients with cystic fibrosis
• Burns patients
• hour urine output \> 400 mL or unknown

Sponsors & Collaborators

• University of Cincinnati: lead
• Children's Hospital Medical Center, Cincinnati: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Samples that are being collected are as follows: serum, continuous renal replacement therapy effluent, and urine (if patient is making urine during sample collection). Drug assays will be performed for each sample and samples will be disposed of after the final analysis is complete. The assays are not interventional and patient care does not change as a result of study enrollment.

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist, UC Health, UCMC

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: June 1, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04