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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00007145
Enrollment
25
Registered
2014-11-06
Start date
2015-09-10
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 tigecycline therapy blood samples will be drawn in steady state once before application of tigecycline (T0) as well as approximately 0.5 h (T1), 1.5 h (T2), 3h (T3), 6h (T4)

Sponsors

Universitätsklinikum Jena - Klinik für Anästhesiologie und Intensivtherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - antibiotic treatment with tigecyclin 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

MeasureTime frame
course of tigecyclin serum levels in steady state (after 4th, 5th, 6th or 7th application) dependent on liver function

Secondary

MeasureTime frame
-course of tigecyclin 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 tigecyclin

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