Prospective study on plasma levels of linezolid in septic patients dependent on liver funtion measured by plasma disappearance rate of indocyanine gree

• Conditions: A41.9; Sepsis, unspecified

• Registration Number: DRKS00007479
• Lead Sponsor: niversitätsklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-12
• Study Completion: 2019-02-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

antibiotic treatment with linezolid indicated by physician in charge
- severe sepsis and/or septic shock
- intensive care therapy

Exclusion Criteria

-renal failure with renal replacement therapy
-pregnancy, lactation period
-participation in an interventional study
-restriction of therapeutic measures (e.g. DNR (do-not-resuscitate) order)
-staff and their relatives
-Hyperthyreosis
-allergy against iodine

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
course of linezolid serum levels (before appl., approx. 0.5 h, 1.5 h, 3h, 6h and 12h after appl.) in steady state (after 4th, 5th, 6th or 7th application) dependent on liver function, assessed by plasma disappearance rate of indocyanine green up to 6h before application.<br>

Secondary Outcome Measures

Name	Time	Method
-course of linezolid serum levels in steady state in severe sepsis and/or septic shock,<br>-AUC0-24/MIC<br>-clinical cure<br>course of organ failure (SoFA score and subscores)<br>-laboratory parameters of infection on day 7 (PCT, CRP, WBC)<br>-Hospital and ICU mortality and stay<br>-subgroup: bile concentration of linezolid