Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Correlation of meropenem concentration in serum to the concentration in brain fluid
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •routines TDM of antiinfectives
Exclusion Criteria
- •TDM is not available
Outcomes
Primary Outcomes
Correlation of meropenem concentration in serum to the concentration in brain fluid
Time Frame: 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
Incidence of subtherapeutic antiinfective concentrations
Time Frame: four years
Number of subtherapeutic concentrations from different antiinfectives in critically ill patients
Subtherapeutic antiinfective concentrations during hemoadsorption
Time Frame: during hemoadsorption treatment
Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment
Secondary Outcomes
- 28-day mortality of patients with therapeutic drug monitoring of antiinfectives(during intensive care treatment)
- ICU-free days of patients with therapeutic drug monitoring of antiinfectives(during intensive care treatment)
- Sofa-score course of patients with therapeutic drug monitoring of antiinfectives(during the treatment with the antiinfectives)
- Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives(during the treatment with the antiinfectives)
- Time course of CRP in patients with therapeutic drug monitoring of antiinfectives(during the treatment with the antiinfectives)
Investigators
Michael Zoller MD
Principal Investigator
Ludwig-Maximilians - University of Munich