Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation (IPANEMA-ECMO)

Universität des Saarlandes

Status: Not yet enrolling

Conditions: Catheter-Related Infections

Treatments: Drug: Vancomycine

Study type: Interventional

Funder types: Other

Identifiers

NCT05651464

PL002

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Intervention: Prophylactic antibiotic treatment

Active Comparator group

Description:

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

Treatment:

Drug: Vancomycine

Control Arm: No prophylactic antibiotic treatment

No Intervention group

Description:

Control group - no intervention.