Clinical trial NCT03985605: Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness = TAPSI
Official title: Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection, Bacterial
Keywords: TDM
Routine
intensive care patients
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill intensive care patients who were included in the routines TDM-program since January 2018.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* routines TDM of antiinfectives

Exclusion Criteria:

* TDM is not available

Primary outcomes:
measure: Incidence of subtherapeutic antiinfective concentrations
timeFrame: four years
measure: Correlation of meropenem concentration in serum to the concentration in brain fluid
timeFrame: during the treatment with an external ventricular drainage
measure: Subtherapeutic antiinfective concentrations during hemoadsorption
timeFrame: during hemoadsorption treatment
Secondary outcomes:
measure: 28-day mortality of patients with therapeutic drug monitoring of antiinfectives
timeFrame: during intensive care treatment
measure: ICU-free days of patients with therapeutic drug monitoring of antiinfectives
timeFrame: during intensive care treatment
measure: Sofa-score course of patients with therapeutic drug monitoring of antiinfectives
timeFrame: during the treatment with the antiinfectives
measure: Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives
timeFrame: during the treatment with the antiinfectives
measure: Time course of CRP in patients with therapeutic drug monitoring of antiinfectives
timeFrame: during the treatment with the antiinfectives
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Anaesthesiology of the University Hospital of Munich
Study officials:
affiliation: Institute of Laboratory Medicine of the University Hospital of Munich
name: Bruegel Mathias, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anaesthesiology of the University Hospital of Munich
name: Liebchen Uwe, Dr.med.
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology of the University Hospital of Munich
name: Ines Schroeder, Dr.med.
role: STUDY_CHAIR
affiliation: Institute of Laboratory Medicine of the University Hospital of Munich
name: Paal Michael, Dr.rer.nat.
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology of the University Hospital of Munich
name: Bernhard Zwissler, Prof.Dr.med.
role: STUDY_DIRECTOR
affiliation: Institute of Laboratory Medicine of the University Hospital of Munich
name: Daniel Teupser, Prof.Dr.med.
role: STUDY_DIRECTOR
affiliation: Institute of Laboratory Medicine of the University Hospital of Munich
name: Lesca Holdt, Prof.Dr.med.
role: STUDY_CHAIR
affiliation: Institute of Laboratory Medicine of the University Hospital of Munich
name: Michael Vogeser, Prof.Dr.med.
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology of the University Hospital of Munich
name: Eike Speck
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology of the University Hospital of Munich
name: Michael Irlbeck, PD.Dr.med.
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology of the University Hospital of Munich
name: Thomas Weig, PD.Dr.med.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.