Drug Monitoring of Antibiotics in Critical Care Patients

Sepsis Clinical Trial

— DRAK  

Official title:

Drug Monitoring of Antibiotics in Critical Care Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793012
• Other study ID #: MUC 428-12
• Secondary ID: DRKS00004426
• Status: Completed
• Start date: March 2013
• Est. completion date: January 2015

Study information

• Verified date: September 2020
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS
• Sepsis

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology of the University Hospital of Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variability of antibiotic serum concentrations in critically ill patients	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.	2 Years
Secondary	correlate these serum concentrations with clinical and laboratory outcome Correlate serum concentrations with clinical and laboratory outcome parameters	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.	2 Years