Drug Monitoring of Antibiotics in Critical Care Patients

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.

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Key information

Conditions

ARDS Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology of the University Hospital of Munich

Munich, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
Presence of infection by clinical assessment
Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
Bolus administration of selected antibiotics
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

Prophylactic antibiotics without clinical assessment for the presence of infection
Planned shorter hospital stay than 4 days
Administration of the selected antibiotic 14 days to 48 hours before the begin of the study
Only a single dose of an antibiotic per day
Subsequent withdrawal of the participation in the study by the patient or the guardian

Treatment and study plan

Primary outcomes

Variability of antibiotic serum concentrations in critically ill patients

Time frame: 2 Years

The primary goal of this study is to evaluate the variability of antibiotic serum concentrations in critically ill patients. 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.

Secondary outcomes

correlate these serum concentrations with clinical and laboratory outcome Correlate serum concentrations with clinical and laboratory outcome parameters

Time frame: 2 Years

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 (liver,lung) patients with and without renal replacement therapy).

Correlation between antibiotics serum concentrations and Apache II score / SOFA score. Correlation between antibiotics serum concentrations and CRP, procalcitonin, interleukin-6.

Finally minimal inhibitory concentrations (MIC) of antibiotics will be documented in case of detection of pathogens.

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Acronym: DRAK

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Feb 15, 2013
Registry last updated: Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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