Z94.2 Z94.4 A41 J80
Conditions
Interventions
Group 1: Within the routine blood drawing processes additionally monovettes will be used for determination of blood concentrations of antibiotics. In contrast, routine blood monovettes will be used to
Sponsors
Klinikum der Universität München
Klinik für Anaesthesiologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich 2. Presence of infection by clinical assessment 3. Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin 4. Bolus administration of selected antibiotics 5. Valid informed consent subscribed by the patient or by his or her legal guardian or - if only a provisional guardian is defined - by the provisional guardian.
Exclusion criteria
Exclusion criteria: 1. Prophylactic antibiotics without clinical assessment for the presence of infection 2. Planned shorter hospital stay than 4 days 3. Administration of the selected antibiotic 14 days to 48 hours before the begin of the study 4. Only a single dose of an antibiotic per day 5. Subsequent withdrawal of the participation in the study by the patient or the guardian
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary goal of this study is to evaluate the variability of antibiotic serum concentrations in critically ill patients. Therefore, patients of the ICU will be monitored within a period of 4 days. In total, serum concentrations of 6 different antibiotics (piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, and colistin) in 100-200 patients of the ICU will be determined by liquid chromatography mass spectrometry. The first blood sampling for determination of antibiotics will be performed directly before the administration of antibiotics. During and after the end of the antibiotic infusion further blood sampling will be performed. Before the next administration of antibiotics a trough level will also be determined. Blood sampling for determination of antibiotic concentrations will be performed after each antibiotic administration on day 1, but only after single antibiotic administrations on day 2-4. Other laboratory parameters of serum and EDTA blood will be determined once a day. The antibiotic levels of the 24-h urine are also determined once a day. If the patient is treated by a renal replacement therapy, laboratory parameters will be determined from the dialysate. For determination of antibiotic concentrations dialysate will be used from the time points 30 min, 60 min and 3-3.5 h. | — |
Secondary
| Measure | Time frame |
|---|---|
| Moreover, numerous clinical and laboratory parameters will be determined from the study patients in order to correlate these serum concentrations with clinical and laboratory outcome parameters such as temperature, scores, inflammation parameters and pathogen detection. Moreover, we will evaluate if antibiotic serum concentrations differ between the different diseases (e.g. ARDS, sepsis) and the different therapies (e.g. different transplantation types, patients with and without renal replacement therapy). As clinical data vital signs and different scores (Glasgow Coma Scale, Apache II score, and SOFA score) are determined daily. As laboratory parameters different parameters such as different inflammatory parameters (e.g. CRP, procalcitonin, interleukin-6), liver parameters (e.g. alanine-aminotransferase) and retention values (e.g. creatinine) are determined in an immediate analysis process within the Institute of Laboratory Medicine. Finally minimal inhibitory concentrations (MIC) of antibiotics will be documented in case of detection of pathogens. | — |
Countries
Germany
Contacts
Public ContactMichael Zoller
Klinik für Anaesthesiologie
Outcome results
None listed