Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients
- Conditions
- Sepsis
- Interventions
- Device: Cytosorb® and Oxiris® adsorbents
- Registration Number
- NCT06261164
- Lead Sponsor
- University Clinical Centre of Republic of Srpska
- Brief Summary
The object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- diagnosis of SIRS, sepsis and/or septic shock,
- older than 18 years, who are being treated with amikacin and/or vancomycin,
- length of use of adsorbent at least 12 hours.
- contraindication for hemodiafiltration with adsorbents,
- patients under the age of 18,
- terminal cancer patients.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients on hemodiafiltration with Cytosorb® Cytosorb® and Oxiris® adsorbents - Patients on hemodiafiltration with Oxiris® Cytosorb® and Oxiris® adsorbents -
- Primary Outcome Measures
Name Time Method Development of population pharmacokinetic model One year Measurement of amikacin and vancomycine serum concentrations in several time points in order to gain pharmacokinetic profiles of previously mentioned drugs and to develop population pharmacokinetic model of amikacin and vancomycin by nonlinear modeling of combined effects in critically ill patients on veno-venous hemodiafiltration with two types of adsorbents.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Medical Intensive Care Medicine
🇧🇦Banja Luka, Bosnia and Herzegovina