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OpenTrials
Completed

NCT Number: NCT06199141

Multi-drug Resistant Gram-negative Bacteria and 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).

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Key information

Conditions

Respiratory Distress Syndrome, Adult Lung Diseases Multi-antibiotic Resistance Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Università Padova

Padova, 35126, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ARDS
  • VV-ECMO

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  1. Incidence of MDR-related infections (plus descriptive analysis)

    Time frame: From ECMO connection up to 48 hours after ECMO de-connection

    Incidence of patients acquiring MDR-related infections

  2. Incidence of MDR-related colonizations (plus descriptive analysis)

    Time frame: From ECMO connection up to 48 hours after ECMO de-connection

    Incidence of patients acquiring MDR-related colonizations

  3. Risk factors-mortality

    Time frame: At ECMO connection (baseline)

    Risk factors for mortality

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Collaborators

  • Azienda Ospedaliera Mater Domini di Catanzaro
  • Azienda Ospedaliera Universitaria Integrata Verona
  • Fondazione IRCCS San Gerardo di Monza
  • Policlinico di Bari Giovanni XXIII

Registry information

Official study title

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

Acronym: MDR-ECMO

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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