ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS

Completed

• Conditions: COVID-19; ARDS; H1N1 Influenza

• Registration Number: NCT05080933
• Lead Sponsor: University of Turin, Italy

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-22
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28
• Status Verified: 2021-10
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Last Update Submitted: 2021-10-15
• Study First Posted: 2021-10-18
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality on day 60 after ECMO initiation	60 days

Secondary Outcome Measures

Name	Time	Method
ECMO related haemorrhagic complications	90 days
ECMO related mechanical complications	90 days
Hospital length of stay	90 days
ICU length of stay	90 days
Hospital mortality on day 90 after ECMO initiation	90 days
ECMO duration	90 days
ECMO associated hemorrhagic complications	60 days
ECMO associated mechanical complications	60 days
Invasive mechanical ventilation duration	90 days

Trial Locations

Locations (1)

University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino; 🇮🇹 Turin, Italy