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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06199141
Other study ID # MDR GN bacteria in VV-ECMO
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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)
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