Clinical Trials Directory

Trials / Completed

CompletedNCT02458261

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

Status
Completed
Phase
Study type
Observational
Enrollment
10 (actual)
Sponsor
University of Cincinnati · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2015-03-01
Primary completion
2018-12-01
Completion
2019-02-01
First posted
2015-06-01
Last updated
2019-04-16

Source: ClinicalTrials.gov record NCT02458261. Inclusion in this directory is not an endorsement.