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

Respiratory Distress Syndrome, Adult Clinical Trial

— MDR-ECMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06199141
• Other study ID #: MDR GN bacteria in VV-ECMO
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ARDS

• VV-ECMO

Exclusion Criteria:

• pregnancy

• age < 18

• uncompleted records

• survival < 24h after ECMO connection

Related Conditions & MeSH terms

• Acute Lung Injury
• Multi-antibiotic Resistance
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Università Padova	Padova

Sponsors (5)

Lead Sponsor	Collaborator
University of Padova	Azienda Ospedaliera Mater Domini di Catanzaro, Azienda Ospedaliera Universitaria Integrata Verona, Fondazione IRCCS San Gerardo di Monza, Policlinico di Bari Giovanni XXIII

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall incidence of MDR Gram negative bacteria isolations	Overall incidence of MDR Gram negative bacteria isolations during ECMO (n° events/1.000 person-days of ECMO)	From ECMO connection up to 48 hours after ECMO de-connection
Primary	Incidence of MDR Gram negative bacteria acquired	Incidence of MDR Gram negative bacteria acquired after ECMO connection (n° events/1.000 person-days of ECMO)	From ECMO connection up to 48 hours after ECMO de-connection
Primary	Incidence of MDR Gram negative bacteria isolated prior to ECMO connection	Incidence of patients requiring VV-ECMO with a previous MDR Gram negative bacteria	At study enrollment
Secondary	Incidence of MDR-related infections (plus descriptive analysis)	Incidence of patients acquiring MDR-related infections	From ECMO connection up to 48 hours after ECMO de-connection
Secondary	Incidence of MDR-related colonizations (plus descriptive analysis)	Incidence of patients acquiring MDR-related colonizations	From ECMO connection up to 48 hours after ECMO de-connection
Secondary	Risk factors-mortality	Risk factors for mortality	At ECMO connection (baseline)