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

Study Overview
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Brief Summary
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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.

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

Conditions
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Catheter-Related Infections

Intervention / Treatment
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* Drug: Vancomycine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention: Prophylactic antibiotic treatment<br>Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation | Drug: Vancomycine<br>* Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation<br>|
| No Intervention: Control Arm: No prophylactic antibiotic treatment<br>Control group - no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth of pathogens in blood culture | Detection of pathogens / blood stream infection | taken 72 hours after liberation of extracorporeal membrane oxygenation therapy | 
| Growth of pathogens in blood culture | Detection of pathogens / blood stream infection | taken directly before removal of extracorporeal membrane oxygenation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth of pathogens on cannula tip | Detection of growth of pathogens on cannulas | on the day of liberation, cannula tip will be send to institute of microbiology directly after liberation from ECMO | 
| laboratory parameters | leukocytes, procalcitonin, C-reactive protein | 6.00 am on the day of liberation of extracorporeal membrane oxygenation therapy | 
| laboratory parameters | leukocytes, procalcitonin, C-reactive protein | 24 hours after liberation of extracorporeal membrane oxygenation therapy | 
| laboratory parameters | leukocytes, procalcitonin, C-reactive protein | 48 hours after liberation of extracorporeal membrane oxygenation therapy | 
| laboratory parameters | leukocytes, procalcitonin, C-reactive protein | 72 hours after liberation of extracorporeal membrane oxygenation therapy |