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Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06261164
Enrollment
20
Registered
2024-02-15
Start date
2024-01-31
Completion date
2025-01-31
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Interventions

DEVICECytosorb® 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.

Sponsors

University Clinical Centre of Republic of Srpska
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Development of population pharmacokinetic modelOne yearMeasurement 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.

Countries

Bosnia and Herzegovina

Contacts

Primary ContactNikolina Spiric, MPharm
nikolina.spiric@kc-bl.com+38751342295
Backup ContactPedja Kovacevic, Prof.
pedja.kovacevic@kc-bl.com+38751342507

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026