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

NCT ID: NCT06199141

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 279 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Respiratory Distress Syndrome, Adult; Multi-antibiotic Resistance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

VV-ECMO patients

Patients requiring VV-ECMO for acute respiratory distress syndrome (ARDS)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• ARDS
• VV-ECMO

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Mater Domini di Catanzaro

UNKNOWN

Sponsor Role: collaborator

Policlinico di Bari Giovanni XXIII

UNKNOWN

Sponsor Role: collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: collaborator

Fondazione IRCCS San Gerardo di Monza

UNKNOWN

Sponsor Role: collaborator

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Annalisa Boscolo

Co-investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Bruni, Prof

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Mater Domini di Catanzaro

Locations

Azienda Ospedaliera Università Padova

Padua, , Italy

Countries

Italy

References

Boscolo A, Bruni A, Giani M, Garofalo E, Sella N, Pettenuzzo T, Bombino M, Palcani M, Rezoagli E, Pozzi M, Falcioni E, Pistollato E, Biamonte E, Murgolo F, D'Arrigo G, Gori M, Tripepi GL, Gottin L, Longhini F, Grasso S, Navalesi P, Foti G. Retrospective ANalysis of multi-drug resistant Gram-nEgative bacteRia on veno-venous extracorporeal membrane oxygenation. The multicenter RANGER STUDY. Crit Care. 2024 Aug 27;28(1):279. doi: 10.1186/s13054-024-05068-x.

Reference Type: DERIVED

PMID: 39192287 (View on PubMed)

Other Identifiers

MDR GN bacteria in VV-ECMO

Identifier Type: -

Identifier Source: org_study_id