Ventriculitis, Infectious
Conditions
Keywords
therapeutic drug monitoring (TDM), critically ill patients, cerebrospinal fluid
Brief summary
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
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.
Interventions
None listed
Sponsors
Freie Universität Berlin
Ludwig-Maximilians - University of Munich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid | through study completion, on average 2 years | Percentage of subtherapeutic concentrations of different antibiotics in different subgroups like ventriculitis vs. no ventriculitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | through study completion, on average 2 years | evaluation of the 28-day mortality in patients with therapeutic and subtherapeutic antibiotic concentrations in cerebrospinal fluid |
| Correlation of antibiotic concentration in cerebrospinal fluid and C-reactive protein | through study completion, on average 2 years | 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 |
| Correlation of antibiotic concentration in cerebrospinal fluid and interleucin 6 | through study completion, on average 2 years | 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 |
Countries
Germany
Outcome results
None listed