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

October 15, 2021 updated by: Vito Fanelli MD, PhD, University of Turin, Italy

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

308

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who required VV ECMO for COVID-19 and influenza A H1N1 associated ARDS

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
COVID-19
H1N1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality on day 60 after ECMO initiation
Time Frame: 60 days
60 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2009

Primary Completion (Actual)

February 28, 2021

Study Completion (Actual)

February 28, 2021

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

October 15, 2021

First Posted (Actual)

October 18, 2021

Study Record Updates

Last Update Posted (Actual)

October 18, 2021

Last Update Submitted That Met QC Criteria

October 15, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • v1_12_2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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