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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02458261

Enrollment

Registered

2015-06-01

Start date

2015-03-31

Completion date

2019-02-28

Last updated

2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Mechanism

Brief summary

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

Detailed description

This prospective, multi-center study aims to determine the pharmacokinetics and pharmacodynamics of extended-infusion cefepime in CRRT. Patients on CRRT who are being initiated on cefepime 2000 mg IV every eight hours with a four-hour infusion will be considered for enrollment. Pre- and post-membrane serum levels will be drawn at scheduled intervals for both the first dose and again during another dose at steady state. Concomitant effluent and urine levels will also be obtained. A pharmacokinetic analysis will be performed and Monte Carlo simulations will be used to determine the probability of target attainment for various pharmacodynamic endpoints. Documented organism MICs will be used to determine the cumulative fraction of response.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Prisoners * Pregnant women * Patients with cystic fibrosis * Burns patients * 24-hour urine output \> 400 mL or unknown

Design outcomes

Primary

Measure	Time frame	Description
Composite pharmacokinetic and pharmacodynamic profile of extended-infusion cefepime in CRRT	up to 12 months	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.

Outcome results