Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation (IPANEMA-ECMO)
Primary Purpose
Catheter-Related Infections
Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Vancomycine
Sponsored by
About this trial
This is an interventional prevention trial for Catheter-Related Infections
Eligibility Criteria
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
Sites / Locations
- University Hospital of Saarland
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention: Prophylactic antibiotic treatment
Control Arm: No prophylactic antibiotic treatment
Arm Description
Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation
Control group - no intervention.
Outcomes
Primary Outcome Measures
Growth of pathogens in blood culture
Detection of pathogens / blood stream infection
Growth of pathogens in blood culture
Detection of pathogens / blood stream infection
Secondary Outcome Measures
Growth of pathogens on cannula tip
Detection of growth of pathogens on cannulas
laboratory parameters
leukocytes, procalcitonin, C-reactive protein
laboratory parameters
leukocytes, procalcitonin, C-reactive protein
laboratory parameters
leukocytes, procalcitonin, C-reactive protein
laboratory parameters
leukocytes, procalcitonin, C-reactive protein
Full Information
NCT ID
NCT05651464
First Posted
November 25, 2022
Last Updated
December 6, 2022
Sponsor
Universität des Saarlandes
1. Study Identification
Unique Protocol Identification Number
NCT05651464
Brief Title
Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation
Acronym
IPANEMA-ECMO
Official Title
Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität des Saarlandes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Related Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Prophylactic antibiotic treatment
Arm Type
Active Comparator
Arm Description
Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation
Arm Title
Control Arm: No prophylactic antibiotic treatment
Arm Type
No Intervention
Arm Description
Control group - no intervention.
Intervention Type
Drug
Intervention Name(s)
Vancomycine
Intervention Description
Application of 15-20 mg per kgKG Vancomycine I.V. prior to ECMO liberation
Primary Outcome Measure Information:
Title
Growth of pathogens in blood culture
Description
Detection of pathogens / blood stream infection
Time Frame
taken 72 hours after liberation of extracorporeal membrane oxygenation therapy
Title
Growth of pathogens in blood culture
Description
Detection of pathogens / blood stream infection
Time Frame
taken directly before removal of extracorporeal membrane oxygenation therapy
Secondary Outcome Measure Information:
Title
Growth of pathogens on cannula tip
Description
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
Title
laboratory parameters
Description
leukocytes, procalcitonin, C-reactive protein
Time Frame
6.00 am on the day of liberation of extracorporeal membrane oxygenation therapy
Title
laboratory parameters
Description
leukocytes, procalcitonin, C-reactive protein
Time Frame
24 hours after liberation of extracorporeal membrane oxygenation therapy
Title
laboratory parameters
Description
leukocytes, procalcitonin, C-reactive protein
Time Frame
48 hours after liberation of extracorporeal membrane oxygenation therapy
Title
laboratory parameters
Description
leukocytes, procalcitonin, C-reactive protein
Time Frame
72 hours after liberation of extracorporeal membrane oxygenation therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carsten Zeiner, MD
Phone
+49684116
Ext
21624
Email
carsten.zeiner@uks.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Philipp M Lepper, MD
Phone
+49684116
Ext
15055
Email
philipp.lepper@uks.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philipp M Lepper, MD
Organizational Affiliation
Saarland University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Saarland
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Prophylactic Antibiotics on Bloodstream Infections After Liberation From Extracorporeal Membrane Oxygenation
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