InfluCOV_ECMO: ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS

Sponsor
University of Turin, Italy (Other)
Overall Status
Completed
CT.gov ID
NCT05080933
Collaborator
(none)
308
Enrollment
1
Location
138.3
Actual Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective: Veno-venous ECMO has been used as a rescue therapy for patients with severe ARDS associated to influenza A H1N1 and COVID19 viral pneumonia. Little is known about outcome of these patients who required extracorporeal support.

Research question: To compare outcome of patients who required VV ECMO for Covid19 and H1N1 associated ARDS

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    308 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Extracorporeal Membrane Oxygenation for COVID-19 and Influenza H1N1 Associated Acute Respiratory Distress Syndrome: a Multi-centre Retrospective Cohort Study
    Actual Study Start Date :
    Aug 22, 2009
    Actual Primary Completion Date :
    Feb 28, 2021
    Actual Study Completion Date :
    Feb 28, 2021

    Arms and Interventions

    ArmIntervention/Treatment
    COVID-19

    H1N1

    Outcome Measures

    Primary Outcome Measures

    1. All cause mortality on day 60 after ECMO initiation [60 days]

    Secondary Outcome Measures

    1. Hospital length of stay [90 days]

    2. ICU length of stay [90 days]

    3. Hospital mortality on day 90 after ECMO initiation [90 days]

    4. ECMO duration [90 days]

    5. ECMO associated hemorrhagic complications [60 days]

    6. ECMO associated mechanical complications [60 days]

    7. Invasive mechanical ventilation duration [90 days]

    8. ECMO related haemorrhagic complications [90 days]

    9. ECMO related mechanical complications [90 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • COVID-19 or influenza A H1N1 (suspected or confirmed) diagnosis

    • Severe ARDS (according to Berlin Definition)

    • VV ECMO

    • Invasive mechanical ventilation through endotracheal tube or tracheostomy

    Exclusion Criteria:

    • Age<18 years

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di TorinoTurinItaly10126

    Sponsors and Collaborators

    • University of Turin, Italy

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vito Fanelli MD, PhD, MD, PhD, University of Turin, Italy
    ClinicalTrials.gov Identifier:
    NCT05080933
    Other Study ID Numbers:
    • v1_12_2020
    First Posted:
    Oct 18, 2021
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 18, 2021