ALF: Development a Method to Extract Antibiotic Concentration From Interstitial Lung and Epithelial Lining Fluid.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Informed consent will be obtained prior to inclusion. 30 patients following lung Transplantation at the University Hospital of Munich will be included in this study. Intravenous Meropenem will be administered as perioperative antibiotic prophylaxis for lung transplantation. Interstitial Lung Fluid and Epithelial Lining Fluid will be extracted immediately after explantation of the lung from explanted lung tissue. Concentrations of antibiotics will be determined by liquid chromatography-mass spectrometry (LC-MS/MS) in ILF and ELF. Serum samples will be collected according to our in clinical routine established therapeutic drug monitoring. Tissue/Serum concentration ratio will be calculated. ELF will be collected on postoperative day 1-5 when bronchoscopy is performed during clinical routine. Numerous clinical and laboratory parameters will be determined. The investigators expect that correlations between antibiotic target site and blood concentrations and clinical and laboratory parameters will be found.
Study Design
Outcome Measures
Primary Outcome Measures
- Meropenem concentration in Interstitial Lung Fluid (ILF) and Epithelial Lining Fluid (ELF) in 30 explanted lungs [1 year]
The primary goal of this study is to measure Meropenem concentration by LC-MS/MS in ELF and ILF from 30 explanted lung tissue.
Secondary Outcome Measures
- Correlation of blood and tissue concentrations of Meropenem [1 year]
Calculation of tissue/serum concentration ratio will be calculated
Eligibility Criteria
Criteria
Inclusion Criteria:
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Lung Transplantation at University Hospital of Munich
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Administration of Meropenem as perioperative antibiotic prophylaxis
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Valid informed consent subscribed by the patient prior to inclusion
Exclusion Criteria:
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missing informed consent
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subsequent withdrawal of the participation in the study by the patient or the guardian
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anaesthesiology of the University Hospital of Munich | Munich | Germany | 81377 |
Sponsors and Collaborators
- Ludwig-Maximilians - University of Munich
Investigators
- Principal Investigator: Michael Zoller, Dr.med., Department of Anaesthesiology, University Hospital, LMU Munich
- Principal Investigator: Ines Schroeder, Dr.med., Department of Anaesthesiology, University Hospital, LMU Munich
- Principal Investigator: Mathias Brügel, Dr.med., Institute of Laboratory Medicine, University Hospital, LMU Munich
- Study Chair: Michael Vogeser, Prof.Dr.med., Institute of Laboratory Medicine, University Hospital, LMU Munich
- Study Chair: Christina Scharf, Dr.med., Department of Anaesthesiology, University Hospital, LMU Munich
- Study Chair: Uwe Liebchen, Dr.med., Department of Anaesthesiology, University Hospital, LMU Munich
- Study Chair: Eike Speck, Dr.med., Department of Anaesthesiology of the University Hospital of Munich
- Study Chair: Paal Michael, Dr.rer.nat., Institute of Laboratory Medicine of the University Hospital of Munich
- Study Chair: Alexander Indrich, Dr.med., Department of Anaesthesiology of the University Hospital of Munich
- Study Chair: Daniel Siegl, Dr.med., Department of Anaesthesiology of the University Hospital of Munich
- Study Director: Bernhard Zwissler, Prof.Dr.med, Department of Anaesthesiology of the University Hospital of Munich
- Study Director: Daniel Teupser, Prof.Dr.med., Institute of Laboratory Medicine of the University Hospital of Munich
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LMU 18-928