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

Catheter-Related Infections Clinical Trial

— IPANEMA-ECMO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05651464
• Other study ID #: PL002
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Universität des Saarlandes
• Contact: Carsten Zeiner, MD
• Phone: +49684116
• Email: carsten.zeiner[@]uks.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter-Related Infections
• Communicable Diseases
• Infections
• Sepsis

Intervention

Drug:
• Vancomycine
Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation

Locations

Country	Name	City	State
Germany	University Hospital of Saarland	Homburg	Saarland

Sponsors (1)

Lead Sponsor	Collaborator
Universität des Saarlandes

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth of pathogens in blood culture	Detection of pathogens / blood stream infection	taken 72 hours after liberation of extracorporeal membrane oxygenation therapy
Primary	Growth of pathogens in blood culture	Detection of pathogens / blood stream infection	taken directly before removal of extracorporeal membrane oxygenation therapy
Secondary	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
Secondary	laboratory parameters	leukocytes, procalcitonin, C-reactive protein	6.00 am on the day of liberation of extracorporeal membrane oxygenation therapy
Secondary	laboratory parameters	leukocytes, procalcitonin, C-reactive protein	24 hours after liberation of extracorporeal membrane oxygenation therapy
Secondary	laboratory parameters	leukocytes, procalcitonin, C-reactive protein	48 hours after liberation of extracorporeal membrane oxygenation therapy
Secondary	laboratory parameters	leukocytes, procalcitonin, C-reactive protein	72 hours after liberation of extracorporeal membrane oxygenation therapy