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Therapeutic drug monitoring of antiinfectives in intensive care patients is an usual research topic of the last years. Based on research result, which have shown subtherapeutic plasma concentrations of antibiotics, a routines therapeutic drug monitoring for β-lactam-antibiotics was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany. This study is an prospective evaluation of these TDM-program.
Bacterial infections are associated with high mortality in intensive care patients. Antibiotic therapy is the only causal opportunity to treat those infections. Pharmacokinetic and -dynamic changes in critically ill patients lead to unpredictable plasma concentrations of the applied drugs. Research results of the last years with many quantified plasma concentrations in subtherapeutic levels yield to the recommendation of the Paul-Ehrlich-Society for an routines therapeutic drug monitoring of antibiotics in intensive care patients. These was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany for all intensive care patients as a routines procedure. The introduced study is a prospective evaluation of the TDM-program with regard to improvement opportunity, influencing factors and parallels to other studies.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of subtherapeutic antiinfective concentrations | Number of subtherapeutic concentrations from different antiinfectives in critically ill patients | four years |
| Correlation of meropenem concentration in serum to the concentration in brain fluid | The concentration of meropenem in the brain fluid of 30 patients with an external ventricular drainage will be correlated to their serum concentration | during the treatment with an external ventricular drainage |
| Subtherapeutic antiinfective concentrations during hemoadsorption | Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment | during hemoadsorption treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality of patients with therapeutic drug monitoring of antiinfectives | Correlation of antiinfective concentrations in serum to 28-day mortality | during intensive care treatment |
| ICU-free days of patients with therapeutic drug monitoring of antiinfectives |
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Inclusion Criteria:
Exclusion Criteria:
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Critically ill intensive care patients who were included in the routines TDM-program since January 2018.
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| Name | Affiliation | Role |
|---|---|---|
| Bruegel Mathias, Dr. med. | Institute of Laboratory Medicine of the University Hospital of Munich | Principal Investigator |
| Liebchen Uwe, Dr.med. | Department of Anaesthesiology of the University Hospital of Munich | Study Chair |
| Ines Schroeder, 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 |
| 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 Director |
| Lesca Holdt, Prof.Dr.med. | Institute of Laboratory Medicine of the University Hospital of Munich | Study Chair |
| Michael Vogeser, Prof.Dr.med. | Institute of Laboratory Medicine of the University Hospital of Munich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology of the University Hospital of Munich | Munich | 81377 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40279026 | Derived | Weber F, Scharf C, Aulin LBS, Weinelt F, Paal M, Mikus G, Vogeser M, Habler K, Huisinga W, Zoller M, Michelet R, Kloft C, Liebchen U. Model-informed identification of optimised dosing strategies for meropenem in critically ill patients receiving SLEDD: an observational study. Infection. 2025 Oct;53(5):1819-1831. doi: 10.1007/s15010-025-02504-0. Epub 2025 Apr 25. | |
| 35599248 |
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sharing individual participant data is restricted by EU General Data Protection Regulation (GDPR)
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Correlation of antiinfective concentrations in serum to ICU-free days to day 28 |
| during intensive care treatment |
| Sofa-score course of patients with therapeutic drug monitoring of antiinfectives | Correlation of antiinfective concentrations in serum to sofa-score | during the treatment with the antiinfectives |
| Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives | Correlation of antiinfective concentrations to Interleukin-6 in critically ill patients | during the treatment with the antiinfectives |
| Time course of CRP in patients with therapeutic drug monitoring of antiinfectives | Correlation of antiinfective concentrations to CRP in critically ill patients | during the treatment with the antiinfectives |
| Eike Speck |
| Department of Anaesthesiology of the University Hospital of Munich |
| Study Chair |
| Michael Irlbeck, PD.Dr.med. | Department of Anaesthesiology of the University Hospital of Munich | Study Chair |
| Thomas Weig, PD.Dr.med. | Department of Anaesthesiology of the University Hospital of Munich | Study Chair |
| Scharf C, Weinelt F, Schroeder I, Paal M, Weigand M, Zoller M, Irlbeck M, Kloft C, Briegel J, Liebchen U. Does the cytokine adsorber CytoSorb(R) reduce vancomycin exposure in critically ill patients with sepsis or septic shock? a prospective observational study. Ann Intensive Care. 2022 May 23;12(1):44. doi: 10.1186/s13613-022-01017-5. |
| 33292582 | Derived | Scharf C, Liebchen U, Paal M, Taubert M, Vogeser M, Irlbeck M, Zoller M, Schroeder I. The higher the better? Defining the optimal beta-lactam target for critically ill patients to reach infection resolution and improve outcome. J Intensive Care. 2020 Nov 23;8(1):86. doi: 10.1186/s40560-020-00504-w. |