Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation

Not Applicable

Not yet recruiting

• Conditions: Catheter-Related Infections
• Interventions: Drug: Vancomycine

• Registration Number: NCT05651464
• Lead Sponsor: Universität des Saarlandes

Brief Summary

The goal of this prospective interventional study is to evaluate the impact of antibiotic prophylaxis on bloodstream infections after liberation of extracorporeal membrane oxygenation therapy. The main questions aims to answer are:

• does application of vancomycine prior to ECMO liberation have an impact of bloodstream infections?

Participants will get 1 dose of vancomycine I.V. (15-20 mg per kgKG) prior to liberation of ECMO.

Researchers will compare this interventional group to a group without antibiotic prophylaxis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-25
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-06
• Last Update Submitted: 2022-12-06
• Study First Posted: 2022-12-15
• Last Update Posted: 2022-12-15
• Study Start: 2023-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• adult patients older than 18 years
• ECMO-Therapy

Exclusion Criteria

• patients younger than 18 years
• fever >38,5°C
• pregnancy
• antibiotic treatment with Vancomycine, Linezolid, Daptomycin or Tygacil on the day of liberation
• prior adverse events after application of Vancomycine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention: Prophylactic antibiotic treatment	Vancomycine	Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation

Primary Outcome Measures

Name	Time	Method
Growth of pathogens in blood culture	taken directly before removal of extracorporeal membrane oxygenation therapy	Detection of pathogens / blood stream infection

Secondary Outcome Measures

Name	Time	Method
Growth of pathogens on cannula tip	on the day of liberation, cannula tip will be send to institute of microbiology directly after liberation from ECMO	Detection of growth of pathogens on cannulas
laboratory parameters	72 hours after liberation of extracorporeal membrane oxygenation therapy	leukocytes, procalcitonin, C-reactive protein

Trial Locations

Locations (1)

University Hospital of Saarland; 🇩🇪 Homburg, Saarland, Germany