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

Completed

• Conditions: Ventriculitis, Infectious

• Registration Number: NCT04426383
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-11
• Primary Completion: 2022-01-31
• Status Verified: 2022-05
• Study Completion: 2022-05-01
• Last Update Submitted: 2022-05-30
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anaesthesiology of the University Hospital of Munich; 🇩🇪 Munich, Germany