An observational study in Sepsis, Septic Shock and Infection, Bacterial, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-10.
Sponsored by Radboud University Medical Center · Observational
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.
862 studies on the registry are indexed under Shock, Septic; 206 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 298 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Critically ill patients admitted to the ICU or ED.
Exclusion Criteria:
20 patients will be included in the cefuroxime cohort and 20 patients in the amikacin cohort.
Drug: Cefuroxime · Drug: Amikacin
Patients receive cefuroxime as part of standard care.
Patients receive amikacin as part of standard care.
To describe the population pharmacokinetics of amikacin in Intensive Care or Emergency Department patients
Time frame: 1 year
To describe the population pharmacokinetics of cefuroxime in Intensive Care or Emergency Department patients
Time frame: 1 year
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
To investigate to what extend renal replacement therapy affects the pharmacokinetics of amikacin and cefuroxime
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center