Infection, Bacterial
Conditions
Keywords
TDM, Routine, intensive care patients
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.
Interventions
None listed
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* routines TDM of antiinfectives
Exclusion criteria
* TDM is not available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of subtherapeutic antiinfective concentrations | four years | Number of subtherapeutic concentrations from different antiinfectives in critically ill patients |
| Correlation of meropenem concentration in serum to the concentration in brain fluid | during the treatment with an external ventricular drainage | The concentration of meropenem in the brain fluid of 30 patients with an external ventricular drainage will be correlated to their serum concentration |
| Subtherapeutic antiinfective concentrations during hemoadsorption | during hemoadsorption treatment | Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives | during the treatment with the antiinfectives | Correlation of antiinfective concentrations to Interleukin-6 in critically ill patients |
| 28-day mortality of patients with therapeutic drug monitoring of antiinfectives | during intensive care treatment | Correlation of antiinfective concentrations in serum to 28-day mortality |
| Time course of CRP in patients with therapeutic drug monitoring of antiinfectives | during the treatment with the antiinfectives | Correlation of antiinfective concentrations to CRP in critically ill patients |
| ICU-free days of patients with therapeutic drug monitoring of antiinfectives | during intensive care treatment | Correlation of antiinfective concentrations in serum to ICU-free days to day 28 |
| Sofa-score course of patients with therapeutic drug monitoring of antiinfectives | during the treatment with the antiinfectives | Correlation of antiinfective concentrations in serum to sofa-score |
Countries
Germany
Outcome results
None listed