Respiratory Distress Syndrome, AdultMDR-ECMONCT06199141
Multi-drug Resistant Gram-negative Bacteria and Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
An observational study of Respiratory Distress Syndrome, Adult and Multi-antibiotic Resistance, run by University of Padova at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Multi-antibiotic Resistance
- How many people
- 279 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients affected by ARDS (according to Berlon criteria) undergoing VV-ECMO.
Who may be able to join
- ARDS
- VV-ECMO
Who cannot join
- pregnancy
- age < 18
- uncompleted records
- survival < 24h after ECMO connection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Keywords
- ARDS, Multi-antibiotic Resistance, extracorporeal membrane oxygenation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VV-ECMO patients | Patients requiring VV-ECMO for acute respiratory distress syndrome (ARDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: At study enrollment
Secondary outcomes (3)
Incidence of MDR-related infections (plus descriptive analysis)
Incidence of patients acquiring MDR-related infections
Measured: 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
Measured: From ECMO connection up to 48 hours after ECMO de-connection
Risk factors-mortality
Risk factors for mortality
Measured: At ECMO connection (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Jan 2017
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Mater Domini di Catanzaro, Policlinico di Bari Giovanni XXIII, Azienda Ospedaliera Universitaria Integrata Verona, Fondazione IRCCS San Gerardo di Monza
- Responsible party
- Principal investigator, Annalisa Boscolo, University of Padova
- Investigators
- Andrea Bruni, Prof, Principal investigator, Azienda Ospedaliera Mater Domini di Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199141
- Sponsor's protocol ID
- MDR GN bacteria in VV-ECMO
- Acronym
- MDR-ECMO
- Status last verified
- Feb 2024
- First submitted
- 26 Dec 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39192287
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Multi-drug Resistant Gram-negative Bacteria on Outcomes in Patients Requiring Veno-venous Extracorporeal Membrane Oxygenation (ECMO)
- ClinicalTrials.gov ID
- NCT06199141
- Acronym / sponsor ID
- MDR-ECMO / MDR GN bacteria in VV-ECMO
- Keywords
- ARDS, Multi-antibiotic Resistance, extracorporeal membrane oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Mater Domini di Catanzaro, Policlinico di Bari Giovanni XXIII, Azienda Ospedaliera Universitaria Integrata Verona, Fondazione IRCCS San Gerardo di Monza
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VV-ECMO patients | – | –Patients requiring VV-ECMO for acute respiratory distress syndrome (ARDS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients affected by ARDS (according to Berlon criteria) undergoing VV-ECMO.
Key inclusion criteria (2 listed)
- ARDS
- VV-ECMO
Key exclusion criteria (4 listed)
- pregnancy
- age < 18
- uncompleted records
- survival < 24h after ECMO connection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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
3 secondary outcomes
Incidence of MDR-related infections (plus descriptive analysis)
Time frame: From ECMO connection up to 48 hours after ECMO de-connection
Incidence of MDR-related colonizations (plus descriptive analysis)
Time frame: From ECMO connection up to 48 hours after ECMO de-connection
Risk factors-mortality
Time frame: At ECMO connection (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 39192287Boscolo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Bruni, Prof principal investigator
Azienda Ospedaliera Mater Domini di Catanzaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult and Multi-antibiotic Resistance, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of MDR Gram negative bacteria isolations (time frame: From ECMO connection up to 48 hours after ECMO de-connection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06199141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.