ClinicalTrials.gg
Status unknownNCT05651464IPANEMA-ECMOUpdated Dec 15, 2022

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

An interventional study of Vancomycine in Catheter-Related Infections, sponsored by Universität des Saarlandes. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-15.

Sponsored by Universität des Saarlandes · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Catheter-Related Infections
03

In context

Catheter-Related Infections

108 studies on the registry are indexed under Catheter-Related Infections; 17 are open to participants now.

This study's planned enrollment of 42 is below the median of 150 across 77 interventional studies indexed under Catheter-Related Infections.

Browse Catheter-Related Infections studies →

Lead sponsor

Universität des Saarlandes is the lead sponsor of 68 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adult patients older than 18 years
  • ECMO-Therapy

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Active comparator
    Intervention: Prophylactic antibiotic treatment

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

    Drug: Vancomycine

  • No intervention
    Control Arm: No prophylactic antibiotic treatment

    Control group - no intervention.

Interventions

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

06

What researchers measure

Primary outcomes

  1. Growth of pathogens in blood culture

    Detection of pathogens / blood stream infection

    Time frame: taken 72 hours after liberation of extracorporeal membrane oxygenation therapy

  2. Growth of pathogens in blood culture

    Detection of pathogens / blood stream infection

    Time frame: taken directly before removal of extracorporeal membrane oxygenation therapy

Secondary outcomes

  1. Growth of pathogens on cannula tip

    Detection of growth of pathogens on cannulas

    Time frame: on the day of liberation, cannula tip will be send to institute of microbiology directly after liberation from ECMO

  2. laboratory parameters

    leukocytes, procalcitonin, C-reactive protein

    Time frame: 6.00 am on the day of liberation of extracorporeal membrane oxygenation therapy

  3. laboratory parameters

    leukocytes, procalcitonin, C-reactive protein

    Time frame: 24 hours after liberation of extracorporeal membrane oxygenation therapy

  4. laboratory parameters

    leukocytes, procalcitonin, C-reactive protein

    Time frame: 48 hours after liberation of extracorporeal membrane oxygenation therapy

  5. laboratory parameters

    leukocytes, procalcitonin, C-reactive protein

    Time frame: 72 hours after liberation of extracorporeal membrane oxygenation therapy

07

Study locations

1 site
  • University Hospital of Saarland
    Homburg, Saarland 66421, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05651464
Lead sponsor
Universität des Saarlandes
Responsible party
Philipp Lepper (Deputy Director, Universität des Saarlandes) — Principal investigator
First posted
Dec 15, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Dec 15, 2022

Study contacts

Carsten Zeiner, MD
Contact
carsten.zeiner@uks.eu
+49684116 ext. 21624
Philipp M Lepper, MD
Contact
philipp.lepper@uks.eu
+49684116 ext. 15055
Philipp M Lepper, MD
principal investigator · Saarland University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Vancomycin

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