Critically Ill, Infection, Bacterial, Sepsis, Septic Shock
Conditions
Keywords
Sepsis, Septic Shock, Infection, Critically Ill
Brief summary
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 or the ED. 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 and ED patients. A heterogeneous population of ICU and ED 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.
Interventions
DRUGCefuroxime
Patients receive cefuroxime as part of standard care.
DRUGAmikacin
Patients receive amikacin as part of standard care.
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient is admitted to the ICU or ED; 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the population pharmacokinetics of amikacin in Intensive Care or Emergency Department patients | 1 year |
| To describe the population pharmacokinetics of cefuroxime in Intensive Care or Emergency Department patients | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To determine the influence of renal clearance and weight on the pharmacokinetics of amikacin and cefuroxime | 1 year |
| To determine the proportion of patients who attain adequate PK/PD targets in relation to the MIC of the suspected pathogen. | 1 year |
| To determine the toxicity of amikacin | 1 year |
Other
| Measure | Time frame |
|---|---|
| To investigate to what extend renal replacement therapy affects the pharmacokinetics of amikacin and cefuroxime | 1 year |
Countries
Netherlands
Contacts
Primary ContactJulian Machiels, MD, MSc
Outcome results
None listed