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NCT Number: NCT04426383

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

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.

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Key information

Conditions

Ventriculitis, Infectious Brain Diseases Central Nervous System Diseases Central Nervous System Infections Central Nervous System Viral Diseases Cerebral Ventriculitis Encephalitis Infections Nervous System Diseases Neuroinflammatory Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anaesthesiology of the University Hospital of Munich

Munich, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid

    Time frame: through study completion, on average 2 years

    Percentage of subtherapeutic concentrations of different antibiotics in different subgroups like ventriculitis vs. no ventriculitis

Secondary outcomes

  1. 28-day mortality

    Time frame: through study completion, on average 2 years

    evaluation of the 28-day mortality in patients with therapeutic and subtherapeutic antibiotic concentrations in cerebrospinal fluid

  2. Correlation of antibiotic concentration in cerebrospinal fluid and C-reactive protein

    Time frame: 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

  3. Correlation of antibiotic concentration in cerebrospinal fluid and interleucin 6

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • Freie Universität Berlin

Registry information

Official study title

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

Acronym: EMIL

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2020
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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