Drug Monitoring of Antibiotics in Critical Care Patients
Information source: Ludwig-Maximilians - University of Munich
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: ARDS; Sepsis
Phase: N/A
Status: Completed
Sponsored by: Ludwig-Maximilians - University of Munich Official(s) and/or principal investigator(s):
Bernhard Zwissler, Prof.Dr.med., Study Director, Affiliation: Department of Anaesthesiology of the University Hospital of Munich
Daniel Teupser, Prof.Dr.med., Study Director, Affiliation: Institute of Laboratory Medicine of the University Hospital of Munich
Johannes Zander, Dr. med., Principal Investigator, Affiliation: Institute of Laboratory Medicine of the University Hospital of Munich
Michael Zoller, Dr. med., Principal Investigator, Affiliation: Department of Anaesthesiology of the University Hospital of Munich
Lorenz Frey, Dr. med., Study Chair, Affiliation: Department of Anaesthesiology of the University Hospital of Munich
Michael Vogeser, Prof.Dr.med., Study Chair, Affiliation: Institute of Laboratory Medicine of the University Hospital of Munich
Mathias Bruegel, Dr. med., Study Chair, Affiliation: Institute of Laboratory Medicine of the University Hospital of Munich
Lesca Holdt, Dr.rer.nat., Study Chair, Affiliation: Institute of Laboratory Medicine of the University Hospital of Munich
Summary
Infections are critical factors for the survival of critically ill patients. A broad,
high-dose and early initial therapy of antibiotics is of particular relevance.
A serious problem is the high variability of antibiotic serum concentrations after
administration of antibiotics in patients of the critical care units. This may result in the
risk of underdosage with possible ineffective therapeutic levels as well as in the risk of
overdosage with possible adverse and toxic effects. The goal of this study is to determine
antibiotic concentrations in blood and to evaluate concentrations with the course of the
therapy. The measurement of antibiotic concentrations in blood may allow an individual
adaption of the dose in future.
100 - 200 patients will be included in this study. Only critically ill patients of the ICU
of the Department of Anaesthesiology will be included that receive one or more of the
following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin,
linezolid, and colistin.
Clinical Details
Official title: Drug Monitoring of Antibiotics in Critical Care Patients
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Variability of antibiotic serum concentrations in critically ill patients
Secondary outcome: correlate these serum concentrations with clinical and laboratory outcome Correlate serum concentrations with clinical and laboratory outcome parameters
Detailed description:
Substantial variations of serum concentrations of different antibiotics with partly
insufficient levels have been observed in critically ill patients. The high variabilities
between the pharmacokinetic parameters in different patients argue for a therapeutic drug
monitoring (TDM) in intensive care units. TDM may lower the risk of overdosage with possible
adverse and toxic effects as well as the risk of underdosage with possible insufficient
therapeutic effects and development of antibiotic resistance. The aim of this study is to
evaluate variabilities of pharmacokinetic parameters of different widely used antibiotics
and to correlate them with clinical and laboratory parameters. Therefore, numerous clinical
and laboratory parameters including serum, urine and dialysate concentrations of 6 different
antibiotics will be determined in 100 - 200 critically ill patients of the Department of
Anaesthesiology, University Hospital of Munich. Laboratory parameters (e. g. inflammatory
parameters) will be quantified by facilities of the Institute of Laboratory Medicine,
University Hospital of Munich. Concentrations of antibiotics will be determined by liquid
chromatography-mass spectrometry (LC-MS/MS). We expect that correlations between antibiotic
serum concentrations and clinical and laboratory outcome parameters will be found.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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:
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
Locations and Contacts
Department of Anaesthesiology of the University Hospital of Munich, Munich 81377, Germany
Additional Information
Starting date: March 2013
Last updated: March 30, 2015
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