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

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

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).

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome, Adult; Multi-antibiotic Resistance

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.

• Study Type: Observational
• Enrollment (Actual): 279

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35126
    • Azienda Ospedaliera Universita Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients affected by ARDS (according to Berlon criteria) undergoing VV-ECMO.

Description

Inclusion Criteria:

• ARDS
• VV-ECMO

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
VV-ECMO patients; Patients requiring VV-ECMO for acute respiratory distress syndrome (ARDS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk factors-mortality	Risk factors for mortality	At ECMO connection (baseline)
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
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

Collaborators and Investigators

• Sponsor: University of Padova
• Collaborators: Azienda Ospedaliera Universitaria Integrata Verona; Azienda Ospedaliera Mater Domini di Catanzaro; Policlinico di Bari Giovanni XXIII; Fondazione IRCCS San Gerardo di Monza
• Investigators: Principal Investigator: Andrea Bruni, Prof, Azienda Ospedaliera Mater Domini Di Catanzaro

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 10, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ARDS; extracorporeal membrane oxygenation; Multi-antibiotic Resistance
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: MDR GN bacteria in VV-ECMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No