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RecruitingNCT06261164Updated Feb 15, 2024

Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients

An observational study in Sepsis, sponsored by University Clinical Centre of Republic of Srpska. Recruiting at 1 site in Bosnia and Herzegovina. Per ClinicalTrials.gov, last updated 2024-02-15.

Sponsored by University Clinical Centre of Republic of Srpska · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Sex
All
01

Study 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.

02

Conditions studied

  • Sepsis

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03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 20 is below the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

University Clinical Centre of Republic of Srpska is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • contraindication for hemodiafiltration with adsorbents,
  • patients under the age of 18,
  • terminal cancer patients.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients on hemodiafiltration with Cytosorb®

    Device: Cytosorb® and Oxiris® adsorbents

  • Patients on hemodiafiltration with Oxiris®

    Device: 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.

    Also known as: Drugs' concentrations measurements

06

What researchers measure

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.

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
  • Department of Medical Intensive Care Medicine
    Banja Luka, 78000, Bosnia and Herzegovina
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06261164
Lead sponsor
University Clinical Centre of Republic of Srpska
Responsible party
Nikolina Spiric (MPharm, University Clinical Centre of Republic of Srpska) — Principal investigator
First posted
Feb 15, 2024
Start date
Jan 31, 2024
Primary completion
Dec 31, 2024 (estimated)
Completion
Jan 31, 2025 (estimated)
Last update
Feb 15, 2024

Study contacts

Nikolina Spiric, MPharm
Contact
nikolina.spiric@kc-bl.com
+38751342295
Pedja Kovacevic, Prof.
Contact
pedja.kovacevic@kc-bl.com
+38751342507
Nikolina Spiric, MPharm
principal investigator · University Clinical Centre of Republic of Srpska

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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