The Impact of Multi-drug Resistant Gram-negative Bacteria on Outcomes in Patients Requiring Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiratory Distress Syndrome, Adult
- Sponsor
- University of Padova
- Enrollment
- 279
- Locations
- 1
- Primary Endpoint
- Incidence of MDR Gram negative bacteria acquired
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Veno-venous extracorporeal membrane oxygenation (VV-ECMO) is a life-support technique used in patients with most severe acute respiratory distress syndrome (ARDS). ARDS is a life-threatening form of respiratory failure associated with a mortality rate of approximately 40-45%.Despite several studies confirming a real benefit of the use of ECMO in patients with ARDS who are unresponsive to conventional management, ECMO is still a complex and costly treatment that can be exposed to potential complications, such as nosocomial infections (NI).
Detailed Description
Noteworthy, the most frequent NIs occurring during VV-ECMO are pneumonia (\>40%) and, secondly, blood-stream infections (3-18%). The situation is more challenging for Gram-negative bacilli: more than one-half of the Escherichia coli and more than one-third of the Klebsiella pneumoniae isolates were resistant to at least one antimicrobial group. Of note, an alarming increase in carbapenem resistance has been reported in several species, including K. pneumoniae (7.9% of isolates), P.aeruginosa (16.5% of isolates) and A. baumannii (\>30% of isolates). In fact, the isolation of MDROs has been shown to be an independent risk of death and of subsequent infections not only in critically ill patients but also in those patients requiring VV-ECMO (mortality rate between 56-68%). However, data are still conflicting about the exact incidence of multidrug resistant organisms (MDRO) during VV-ECMO and the impact on short- and mid-term outcomes.
Investigators
Annalisa Boscolo
Co-investigator
University of Padova
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •pregnancy
- •age \< 18
- •uncompleted records
- •survival \< 24h after ECMO connection
Outcomes
Primary Outcomes
Incidence of MDR Gram negative bacteria acquired
Time Frame: From ECMO connection up to 48 hours after ECMO de-connection
Incidence of MDR Gram negative bacteria acquired after ECMO connection (n° events/1.000 person-days of ECMO)
Overall incidence of MDR Gram negative bacteria isolations
Time Frame: From ECMO connection up to 48 hours after ECMO de-connection
Overall incidence of MDR Gram negative bacteria isolations during ECMO (n° events/1.000 person-days of ECMO)
Incidence of MDR Gram negative bacteria isolated prior to ECMO connection
Time Frame: At study enrollment
Incidence of patients requiring VV-ECMO with a previous MDR Gram negative bacteria
Secondary Outcomes
- Incidence of MDR-related colonizations (plus descriptive analysis)(From ECMO connection up to 48 hours after ECMO de-connection)
- Incidence of MDR-related infections (plus descriptive analysis)(From ECMO connection up to 48 hours after ECMO de-connection)
- Risk factors-mortality(At ECMO connection (baseline))