Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients

NCT ID: NCT06261164

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-31

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients on hemodiafiltration with Cytosorb®

Cytosorb® and Oxiris® adsorbents

Intervention Type DEVICE

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.

Patients on hemodiafiltration with Oxiris®

Cytosorb® and Oxiris® adsorbents

Intervention Type DEVICE

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

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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.

Intervention Type DEVICE

Other Intervention Names

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Drugs' concentrations measurements

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Clinical Centre of Republic of Srpska

OTHER

Sponsor Role lead

Responsible Party

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Nikolina Spiric

MPharm

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nikolina Spiric, MPharm

Role: PRINCIPAL_INVESTIGATOR

University Clinical Centre of Republic of Srpska

Locations

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Department of Medical Intensive Care Medicine

Banja Luka, , Bosnia and Herzegovina

Site Status RECRUITING

Countries

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Bosnia and Herzegovina

Central Contacts

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Nikolina Spiric, MPharm

Role: CONTACT

+38751342295

Pedja Kovacevic, Prof.

Role: CONTACT

+38751342507

Facility Contacts

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Nikolina Spiric, MPharm

Role: primary

+38751342295

Other Identifiers

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01-19-373- 2/23

Identifier Type: -

Identifier Source: org_study_id

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