Determination of antibiotic concentrations in interstitial space fluid of muscle and subcutis in septic patients including a pilot phase

Not Applicable

• Conditions: A41.8; Other specified sepsis

• Registration Number: DRKS00012985
• Lead Sponsor: Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Universitätsklinikum Knappschaftskrankenhaus Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-04-29
• Study Start: 2018-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Age >= 18 years, severe sepsis or septic shock as diagnosed according to the criteria of ACCP/SCCM within 24 hours

Exclusion Criteria

Age < 18 years

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the concentration time curve (AUC), maximum concentration (Cmax), half-life (t1/2) in the microdialysate and plasma after single dose and at steady state on day 1, 3 and 5

Secondary Outcome Measures

Name	Time	Method
1) Relationship subject condition and therapeutic measures and pharmacokinetic parameters<br>2) Protein binding throughout the study<br>3) AUCtissue/AUCplasma ratio<br>4) PK/PD parameters: ratio of area under the concentration vs. time curve from 0 to 24 hours (AUC0-24)/MIC; Cmax/MIC<br>5) Survival<br>(also on days 1, 3 and 5)