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

Sponsor
Universität des Saarlandes (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05651464
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention: Prophylactic antibiotic treatment

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

Drug: Vancomycine
Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation
No Intervention: Control Arm: No prophylactic antibiotic treatment

Control group - no intervention.

Outcome Measures

Primary Outcome Measures

  1. Growth of pathogens in blood culture [taken 72 hours after liberation of extracorporeal membrane oxygenation therapy]

    Detection of pathogens / blood stream infection

  2. Growth of pathogens in blood culture [taken directly before removal of extracorporeal membrane oxygenation therapy]

    Detection of pathogens / blood stream infection

Secondary Outcome Measures

  1. 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

  2. laboratory parameters [6.00 am on the day of liberation of extracorporeal membrane oxygenation therapy]

    leukocytes, procalcitonin, C-reactive protein

  3. laboratory parameters [24 hours after liberation of extracorporeal membrane oxygenation therapy]

    leukocytes, procalcitonin, C-reactive protein

  4. laboratory parameters [48 hours after liberation of extracorporeal membrane oxygenation therapy]

    leukocytes, procalcitonin, C-reactive protein

  5. laboratory parameters [72 hours after liberation of extracorporeal membrane oxygenation therapy]

    leukocytes, procalcitonin, C-reactive protein

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Saarland Homburg Saarland Germany 66421

Sponsors and Collaborators

  • Universität des Saarlandes

Investigators

  • Principal Investigator: Philipp M Lepper, MD, Saarland University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Philipp Lepper, Deputy Director, Universität des Saarlandes
ClinicalTrials.gov Identifier:
NCT05651464
Other Study ID Numbers:
  • PL002
First Posted:
Dec 15, 2022
Last Update Posted:
Dec 15, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Communicable Diseases
Sepsis
Catheter-Related Infections
Vancomycin

Study Results

No Results Posted as of Dec 15, 2022