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

NCT ID: NCT04426383

Last Updated: 2022-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-05-01

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.

Conditions

Ventriculitis, Infectious

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Freie Universität Berlin

OTHER

Sponsor Role: collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Michael Zoller MD

senior physician, Department of Anaesthesiology, university hospital munich

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Zoller

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

Department of Anaesthesiology of the University Hospital of Munich

Munich, , Germany

Countries

Germany

References

Wicha SG, Kinast C, Munchow M, Wittova S, Greppmair S, Kunzelmann AK, Zoller M, Paal M, Vogeser M, Habler K, Weig T, Terpolilli N, Heck S, Dimitriadis K, Scharf C, Liebchen U. Meropenem pharmacokinetics in cerebrospinal fluid: comparing intermittent and continuous infusion strategies in critically ill patients-a prospective cohort study. Antimicrob Agents Chemother. 2024 Sep 4;68(9):e0045124. doi: 10.1128/aac.00451-24. Epub 2024 Jul 31.

Reference Type: DERIVED

PMID: 39082803 (View on PubMed)

Chen Z, Taubert M, Chen C, Dokos C, Fuhr U, Weig T, Zoller M, Heck S, Dimitriadis K, Terpolilli N, Kinast C, Scharf C, Lier C, Dorn C, Liebchen U. Plasma and Cerebrospinal Fluid Population Pharmacokinetics of Vancomycin in Patients with External Ventricular Drain. Antimicrob Agents Chemother. 2023 Jun 15;67(6):e0024123. doi: 10.1128/aac.00241-23. Epub 2023 May 10.

Reference Type: DERIVED

PMID: 37162349 (View on PubMed)

Other Identifiers

LMU 20-169

Identifier Type: -

Identifier Source: org_study_id