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NCT05080933 Clinical Trial

ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS

COVID-19 Clinical Trial

— InfluCOV_ECMO  

Official title:
Extracorporeal Membrane Oxygenation for COVID-19 and Influenza H1N1 Associated Acute Respiratory Distress Syndrome: a Multi-centre Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05080933
Other study ID # v1_12_2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 22, 2009
Est. completion date February 28, 2021

Study information
Verified date October 2021
Source University of Turin, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 308
Est. completion date February 28, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino Turin

Sponsors (1)
Lead Sponsor Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary All cause mortality on day 60 after ECMO initiation 60 days
Secondary Hospital length of stay 90 days
Secondary ICU length of stay 90 days
Secondary Hospital mortality on day 90 after ECMO initiation 90 days
Secondary ECMO duration 90 days
Secondary ECMO associated hemorrhagic complications 60 days
Secondary ECMO associated mechanical complications 60 days
Secondary Invasive mechanical ventilation duration 90 days
Secondary ECMO related haemorrhagic complications 90 days
Secondary ECMO related mechanical complications 90 days
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