Clinical trial NCT04426383: Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal Fluid
Official title: Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventriculitis, Infectious
Keywords: therapeutic drug monitoring (TDM)
critically ill patients
cerebrospinal fluid
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: Freie Universität Berlin
First posted: 2020-06-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critically ill patients with an external ventricular drainage and the need of antibiotic therapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid
timeFrame: through study completion, on average 2 years
Secondary outcomes:
measure: 28-day mortality
timeFrame: through study completion, on average 2 years
measure: Correlation of antibiotic concentration in cerebrospinal fluid and C-reactive protein
timeFrame: through study completion, on average 2 years
measure: Correlation of antibiotic concentration in cerebrospinal fluid and interleucin 6
timeFrame: through study completion, on average 2 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Anaesthesiology of the University Hospital of Munich
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Michael Zoller
role: PRINCIPAL_INVESTIGATOR
References: