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

Completed

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

• Registration Number: NCT06199141
• Lead Sponsor: University of Padova

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2023-12-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Study First Submitted QC: 2024-01-09
• Study First Posted: 2024-01-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

Inclusion Criteria

• ARDS
• VV-ECMO

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of MDR Gram negative bacteria acquired	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)
Overall incidence of MDR Gram negative bacteria isolations	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)
Incidence of MDR Gram negative bacteria isolated prior to ECMO connection	At study enrollment	Incidence of patients requiring VV-ECMO with a previous MDR Gram negative bacteria

Secondary Outcome Measures

Name	Time	Method
Incidence of MDR-related colonizations (plus descriptive analysis)	From ECMO connection up to 48 hours after ECMO de-connection	Incidence of patients acquiring MDR-related colonizations
Incidence of MDR-related infections (plus descriptive analysis)	From ECMO connection up to 48 hours after ECMO de-connection	Incidence of patients acquiring MDR-related infections
Risk factors-mortality	At ECMO connection (baseline)	Risk factors for mortality

Trial Locations

Locations (1)

Azienda Ospedaliera Università Padova; 🇮🇹 Padova, Italy