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

NCT ID: NCT05651464

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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Catheter-Related Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention: Prophylactic antibiotic treatment

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

Group Type ACTIVE_COMPARATOR

Vancomycine

Intervention Type DRUG

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

Control Arm: No prophylactic antibiotic treatment

Control group - no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vancomycine

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität des Saarlandes

OTHER

Sponsor Role lead

Responsible Party

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Philipp Lepper

Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philipp M Lepper, MD

Role: PRINCIPAL_INVESTIGATOR

Saarland University Medical Center

Locations

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University Hospital of Saarland

Homburg, Saarland, Germany

Site Status

Countries

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Germany

Central Contacts

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Carsten Zeiner, MD

Role: CONTACT

Phone: +49684116

Email: [email protected]

Philipp M Lepper, MD

Role: CONTACT

Phone: +49684116

Email: [email protected]

Other Identifiers

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PL002

Identifier Type: -

Identifier Source: org_study_id