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Completed

NCT Number: NCT03970265

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

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.

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Key information

Conditions

Lung Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology of the University Hospital of Munich

Munich, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lung Transplantation at University Hospital of Munich
  • Administration of Meropenem as perioperative antibiotic prophylaxis
  • Valid informed consent subscribed by the patient prior to inclusion

Exclusion criteria

  • missing informed consent
  • subsequent withdrawal of the participation in the study by the patient or the guardian

Treatment and study plan

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.

Diagnostic Test

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

Primary outcomes

  1. Meropenem concentration in Interstitial Lung Fluid (ILF) and Epithelial Lining Fluid (ELF) in 30 explanted lungs

    Time frame: 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 outcomes

  1. Correlation of blood and tissue concentrations of Meropenem

    Time frame: 1 year

    Calculation of tissue/serum concentration ratio will be calculated

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

Development of a Method to Extract Interstitial Lung Fluid and Epithelial Lining Fluid for Antibiotic Concentration Measurement in Explanted Lung Tissue (Feasibility Study)

Acronym: ALF

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 31, 2019
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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