Development and Use of a Population Pharmacokinetic Model of Amikacin and Vancomycin for the Optimization of Dosing Regimens in Critically Ill Patients on Different Modalities of Extracorporeal Hemoadsorption
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sepsis
- Sponsor
- University Clinical Centre of Republic of Srpska
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Development of population pharmacokinetic model
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Nikolina Spiric
MPharm
University Clinical Centre of Republic of Srpska
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •contraindication for hemodiafiltration with adsorbents,
- •patients under the age of 18,
- •terminal cancer patients.
Outcomes
Primary Outcomes
Development of population pharmacokinetic model
Time Frame: 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.