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NCT06261164 Clinical Trial

Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients

Sepsis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06261164
Other study ID # 01-19-373- 2/23
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 31, 2024
Est. completion date January 31, 2025

Study information
Verified date February 2024
Source University Clinical Centre of Republic of Srpska
Contact Nikolina Spiric, MPharm
Phone +38751342295
Email nikolina.spiric@kc-bl.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date January 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cytosorb® and Oxiris® adsorbents
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.

Locations
Country Name City State
Bosnia and Herzegovina Department of Medical Intensive Care Medicine Banja Luka

Sponsors (1)
Lead Sponsor Collaborator
University Clinical Centre of Republic of Srpska

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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