NCT06199141

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
279

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

7 years

First QC Date

December 26, 2023

Last Update Submit

February 26, 2024

Conditions

Respiratory Distress Syndrome, AdultMulti-antibiotic Resistance

Keywords

ARDSMulti-antibiotic Resistanceextracorporeal membrane oxygenation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • Incidence of MDR-related infections (plus descriptive analysis)

    From ECMO connection up to 48 hours after ECMO de-connection

  • Incidence of MDR-related colonizations (plus descriptive analysis)

    From ECMO connection up to 48 hours after ECMO de-connection

  • Risk factors-mortality

    At ECMO connection (baseline)

Study Arms (1)

VV-ECMO patients

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients affected by ARDS (according to Berlon criteria) undergoing VV-ECMO.

You may qualify if:

  • ARDS
  • VV-ECMO

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Università Padova

Padua, 35126, Italy

Location

Related Publications (1)

  • 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.

    PMID: 39192287DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Andrea Bruni, Prof

    Azienda Ospedaliera Mater Domini di Catanzaro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-investigator

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

January 1, 2017

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)