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Completed

NCT Number: NCT02458261

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

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

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Key information

Conditions

Drug Mechanism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 1, 2015
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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