Clinical trial NCT06199141: Multi-drug Resistant Gram-negative Bacteria and Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
Official title: The Impact of Multi-drug Resistant Gram-negative Bacteria on Outcomes in Patients Requiring Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Adult
Multi-antibiotic Resistance
Keywords: ARDS
Multi-antibiotic Resistance
extracorporeal membrane oxygenation
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Mater Domini di Catanzaro
name: Policlinico di Bari Giovanni XXIII
name: Azienda Ospedaliera Universitaria Integrata Verona
name: Fondazione IRCCS San Gerardo di Monza
First posted: 2024-01-10
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by ARDS (according to Berlon criteria) undergoing VV-ECMO.

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.

Eligibility criteria: Inclusion Criteria:

* ARDS
* VV-ECMO

Exclusion Criteria:

* pregnancy
* age \< 18
* uncompleted records
* survival \< 24h after ECMO connection

Primary outcomes:
measure: Overall incidence of MDR Gram negative bacteria isolations
timeFrame: From ECMO connection up to 48 hours after ECMO de-connection
measure: Incidence of MDR Gram negative bacteria acquired
timeFrame: From ECMO connection up to 48 hours after ECMO de-connection
measure: Incidence of MDR Gram negative bacteria isolated prior to ECMO connection
timeFrame: At study enrollment
Secondary outcomes:
measure: Incidence of MDR-related infections (plus descriptive analysis)
timeFrame: From ECMO connection up to 48 hours after ECMO de-connection
measure: Incidence of MDR-related colonizations (plus descriptive analysis)
timeFrame: From ECMO connection up to 48 hours after ECMO de-connection
measure: Risk factors-mortality
timeFrame: At ECMO connection (baseline)
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Azienda Ospedaliera Università Padova
Study officials:
affiliation: Azienda Ospedaliera Mater Domini di Catanzaro
name: Andrea Bruni, Prof
role: PRINCIPAL_INVESTIGATOR
References: