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

Prospective study on plasma levels of linezolid in septic patients dependent on liver funtion measured by plasma disappearance rate of indocyanine green - LINESEP-Liver

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00007479

Enrollment

Registered

2014-12-12

Start date

2015-01-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A41.9

Interventions

Group 1: In patients with linezolid therapy blood samples will be drawn in steady state once before application of linezolid (T0) as well as approximately 0.5 h (T1), 1.5 h (T2), 3h (T3), 6h (T4) and

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

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

Countries

Germany

Contacts

Public ContactAndreas Kortgen

Universitätsklinikum Jena - Klinik für Anästhesiologie und Intensivtherapie

andreas.kortgen at med.uni-jena.de036419323101

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026