Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal Fluid

Study Overview
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Brief Summary
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Therapeutic drug monitoring of antibiotics in critically ill patients is a present research topic of the last ten years. Research results have shown subtherapeutic blood concentrations in those patients. However, the amount of antibiotics in the cerebrospinal fluid (CSF) in patients with ventriculitis or meningitis is still unclear. This study is a prospective study to evaluate the concentration of different antibiotics in the CSF in patients with an external ventricular drainage compared to antibiotic blood concentration.

Detailed Description
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Bacterial infections are still associated with a high mortality in intensive care unit patients. Especially patients diagnosed with ventriculitis caused by a bacterial infection have a bad outcome. Therefore, antibiotic therapy is the only causal opportunity to treat those infections. However, there are many chances in pharmacokinetic and -dynamic in critically ill patients with unpredictable antibiotic concentrations. Furthermore, it is important that the concentration in the blood as well as in the effect-compartment CSF is sufficient. Less data of the last years describe antibiotic concentrations in the CSF and show subtherapeutic levels, which is endangering for the therapeutic success. The introduced study is a prospective, observational study that analyses antibiotic concentrations in CSF in critically ill patients. The distribution between CSF and blood will be evaluated by comparing these two compartments.

Official Title
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Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal

Conditions
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Ventriculitis, Infectious

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written approval of the legal guardian external ventricular drainage antibiotic therapy Exclusion Criteria: no approval no antibiotic therapy or no external ventricular drainage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid | Percentage of subtherapeutic concentrations of different antibiotics in different subgroups like ventriculitis vs. no ventriculitis | through study completion, on average 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | evaluation of the 28-day mortality in patients with therapeutic and subtherapeutic antibiotic concentrations in cerebrospinal fluid | through study completion, on average 2 years | 
| Correlation of antibiotic concentration in cerebrospinal fluid and C-reactive protein | Correlation of different antibiotic concentrations in patients´ blood and cerebrospinal fluid and the C-reactive protein in the blood. Question of interest is, if therapeutic antibiotic concentration leads to a faster decrease of C-reactive protein | through study completion, on average 2 years | 
| Correlation of antibiotic concentration in cerebrospinal fluid and interleucin 6 | Correlation of different antibiotic concentrations in patients´ blood and cerebrospinal fluid and the interleucin 6 in the blood. Question of interest is, if therapeutic antibiotic concentration leads to a faster decrease of interleucin 6 | through study completion, on average 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic drug monitoring (TDM), critically ill patients, cerebrospinal fluid