Clinical Trials Directory

Trials / Completed

CompletedNCT06199141

Multi-drug Resistant Gram-negative Bacteria and Veno-venous Extracorporeal Membrane Oxygenation (ECMO)

The Impact of Multi-drug Resistant Gram-negative Bacteria on Outcomes in Patients Requiring Veno-venous Extracorporeal Membrane Oxygenation (ECMO)

Status
Completed
Phase
Study type
Observational
Enrollment
279 (actual)
Sponsor
University of Padova · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2017-01-01
Primary completion
2023-12-31
Completion
2023-12-31
First posted
2024-01-10
Last updated
2024-02-28

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06199141. Inclusion in this directory is not an endorsement.