Development a Method to Extract Antibiotic Concentration From Interstitial Lung and Epithelial Lining Fluid.

Summary

Infections are critical factors for the survival of critically ill patients. A serious problem is the high variability of antibiotic concentrations in critically ill patients. This may result in the risk of underdosage with possible ineffective therapeutic levels as well as in the risk of overdosage with possible adverse and toxic effects. Essential for the effectiveness of antibiotic therapy is the antibiotic concentration at target site. The goal of this study is to establish a method to extract Interstitial Lung Fluid (ILF) and Epithelial Lining Fluid (ELF) for antibiotic concentration measurements in patients following lung Transplantation and to calculate a tissue/serum concentration ratio. Improved knowledge regarding tissue penetration of Antibiotics may help to optimize drug dosing and management.

Conditions

• Lung Transplantation

Interventions

DIAGNOSTIC_TEST

extraction of ELF and ILF from explanted lung tissue; meropenem concentration in ELF and ILF; ELF on postoperative day 1-5 when bronchoscopy is performed within clinical routine.

Interventions will only be performed on explanted lung tissue ex vivo and on supernatant of bronchoscopy and are therefore non-invasive

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich

  lead OTHER

Principal Investigators

• Michael Zoller, Dr.med. · Department of Anaesthesiology, University Hospital, LMU Munich

• Ines Schroeder, Dr.med. · Department of Anaesthesiology, University Hospital, LMU Munich

• Mathias Brügel, Dr.med. · Institute of Laboratory Medicine, University Hospital, LMU Munich

• Michael Vogeser, Prof.Dr.med. · Institute of Laboratory Medicine, University Hospital, LMU Munich

• Christina Scharf, Dr.med. · Department of Anaesthesiology, University Hospital, LMU Munich

• Uwe Liebchen, Dr.med. · Department of Anaesthesiology, University Hospital, LMU Munich

• Eike Speck, Dr.med. · Department of Anaesthesiology of the University Hospital of Munich

• Paal Michael, Dr.rer.nat. · Institute of Laboratory Medicine of the University Hospital of Munich

• Alexander Indrich, Dr.med. · Department of Anaesthesiology of the University Hospital of Munich

• Daniel Siegl, Dr.med. · Department of Anaesthesiology of the University Hospital of Munich

• Bernhard Zwissler, Prof.Dr.med · Department of Anaesthesiology of the University Hospital of Munich

• Daniel Teupser, Prof.Dr.med. · Institute of Laboratory Medicine of the University Hospital of Munich

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-15

Primary Completion

2020-07-15

Completion

2020-07-15

Countries

• Germany

Study Locations