Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.

Overview

Infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics (PK) compared to non-critically ill patients there is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU. To prevent the risk of inadequate dosing in ICU patients, it is important to fully understand the PK of antibiotics in this vulnerable group in order to optimize the dosing regimens.

With this study, the investigators will describe the pharmacokinetics of cefuroxime and amikacin in ICU patients. A heterogeneous population of ICU patients will be included to be able to find which factors might influence the pharmacokinetics of these drugs and to what extent. By using population modeling the investigators will simulate different dosing regimens and MIC values and compare probability of target attainment between each of these dose and MIC combinations. This will allow the investigators to optimize dosing regimens of cefuroxime and amikacin in critically ill patients.

Full Title of Study: “Population Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Septic Patients Admitted to the ICU”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 15, 2021

Interventions

  • Drug: Cefuroxime
    • Patients receive cefuroxime as part of standard care.
  • Drug: Amikacin
    • Patients receive amikacin as part of standard care.

Arms, Groups and Cohorts

  • Cefuroxime/Amikacin
    • 20 patients will be included in the cefuroxime cohort and 20 patients in the amikacin cohort.

Clinical Trial Outcome Measures

Primary Measures

  • To describe the population pharmacokinetics of amikacin in Intensive Care patients
    • Time Frame: 1 year
  • To describe the population pharmacokinetics of cefuroxime in Intensive Care patients
    • Time Frame: 1 year

Secondary Measures

  • To determine the influence of renal clearance and weight on the pharmacokinetics of amikacin and cefuroxime
    • Time Frame: 1 year
  • To determine the proportion of patients who attain adequate PK/PD targets in relation to the MIC of the suspected pathogen.
    • Time Frame: 1 year
  • To determine the toxicity of amikacin
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

1. The patient is admitted to the ICU-department;

2. The patient is at least 18 years of age on the day of inclusion;

3. Is managed with a central venous catheter or arterial line;

4. Is treated with amikacin and/or cefuroxime as standard care.

Exclusion Criteria

1. Has previously participated in this study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Radboud University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Roger Br├╝ggemann, Phd, Principal Investigator, Radboud University
  • Overall Contact(s)
    • Julian Machiels, MD, MSc, +31243614369, julian.machiels@radboudumc.nl

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