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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients on hemodiafiltration with Cytosorb® |
| ||
| Patients on hemodiafiltration with Oxiris® |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytosorb® and Oxiris® adsorbents | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Development of population pharmacokinetic model | 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. | One year |
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Inclusion Criteria:
Exclusion Criteria:
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Adult critically ill patients with a diagnosis of SIRS, sepsis and/or septic shock who are hospitalized in the Department of Medical Intensive Care Medicine
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolina Spiric, MPharm | Contact | +38751342295 | nikolina.spiric@kc-bl.com | |
| Pedja Kovacevic, Prof. | Contact | +38751342507 | pedja.kovacevic@kc-bl.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikolina Spiric, MPharm | University Clinical Centre of Republic of Srpska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Intensive Care Medicine | Recruiting | Banja Luka | 78000 | Bosnia and Herzegovina |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |