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
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2024
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2024
CompletedStudy Start
First participant enrolled
January 31, 2024
CompletedFirst Posted
Study publicly available on registry
February 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedFebruary 15, 2024
February 1, 2024
11 months
January 30, 2024
February 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Patients on hemodiafiltration with Cytosorb®
Patients on hemodiafiltration with Oxiris®
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- contraindication for hemodiafiltration with adsorbents,
- patients under the age of 18,
- terminal cancer patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medical Intensive Care Medicine
Banja Luka, 78000, Bosnia and Herzegovina
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nikolina Spiric, MPharm
University Clinical Centre of Republic of Srpska
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MPharm
Study Record Dates
First Submitted
January 30, 2024
First Posted
February 15, 2024
Study Start
January 31, 2024
Primary Completion
December 31, 2024
Study Completion
January 31, 2025
Last Updated
February 15, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share