Clinical trial NCT04470973: Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.
Official title: Population Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Septic Patients Admitted to the ICU or the ED
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Septic Shock
Infection, Bacterial
Critically Ill
Keywords: Sepsis
Septic Shock
Infection
Critically Ill
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to the ICU or ED.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To describe the population pharmacokinetics of amikacin in Intensive Care or Emergency Department patients
timeFrame: 1 year
measure: To describe the population pharmacokinetics of cefuroxime in Intensive Care or Emergency Department patients
timeFrame: 1 year
Secondary outcomes:
measure: To determine the influence of renal clearance and weight on the pharmacokinetics of amikacin and cefuroxime
timeFrame: 1 year
measure: To determine the proportion of patients who attain adequate PK/PD targets in relation to the MIC of the suspected pathogen.
timeFrame: 1 year
measure: To determine the toxicity of amikacin
timeFrame: 1 year
Other outcomes:
measure: To investigate to what extend renal replacement therapy affects the pharmacokinetics of amikacin and cefuroxime
timeFrame: 1 year
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc intensive care
Study officials:
affiliation: Radboud University Medical Center
name: Roger Brüggemann, Phd
role: PRINCIPAL_INVESTIGATOR
References: