Understanding how amikacin and vancomycin behave in critically ill patients with sepsis
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
This study looks at how the antibiotics amikacin and vancomycin work in critically ill patients with sepsis to see if we can improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | University Clinical Centre of Republic of Srpska Academic / other |
| Locations | 1 site (Banja Luka) |
| Trial ID | NCT06261164 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the pharmacokinetic profiles of amikacin and vancomycin in critically ill patients diagnosed with sepsis or septic shock. It investigates the variability in drug behavior among patients undergoing treatment with specific extracorporeal therapy using Cytosorb® and Oxiris® adsorbents. By analyzing how these medications are processed in the body, the study seeks to improve treatment strategies for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with SIRS, sepsis, or septic shock who are being treated with amikacin and/or vancomycin.
Not a fit: Patients under 18 years old or those with contraindications for hemodiafiltration with adsorbents, as well as terminal cancer patients, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective dosing strategies for antibiotics in critically ill patients, potentially improving their outcomes.
How similar studies have performed: While this approach is focused on a specific patient population and treatment method, similar studies have shown promise in understanding pharmacokinetics in critically ill patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Banja Luka
- Department of Medical Intensive Care Medicine — Banja Luka, Bosnia and Herzegovina (Recruiting)
Study contacts
- Principal investigator: Nikolina Spiric, MPharm — University Clinical Centre of Republic of Srpska
- Study coordinator: Nikolina Spiric, MPharm
- Email: nikolina.spiric@kc-bl.com
- Phone: +38751342295
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.