Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome

Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Multicenter European Study

This study aims to investigate outcomes and predictors of outcome after extracorporeal membrane oxygenation (ECMO) therapy for severe acute respiratory syndrome (ARDS) in COVID-19 patients.

Study Overview

• Status: Completed
• Conditions: COVID-19; Acute Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation Complication
• Intervention / Treatment: Device: Extracorporeal membrane oxygenation

Detailed Description

We evaluated the outcome of adult patients with coronavirus disease 2019 (COVID-19)-related acute respiratory distress syndrome (ARDS) requiring the use of extracorporeal membrane oxygenation (ECMO).

• Study Type: Observational
• Enrollment (Actual): 132

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
• France
  • Besançon, France
    • University Hospital Jean Minjoz
  • Nancy, France
    • Nancy University Hospital
  • Paris, France
    • Henri Mondon Unoversity Hospital
  • Reims, France
    • Robert Debre University Hospital
• Germany
  • Hamburg, Germany
    • Hamburg University Heart Center
  • Münster, Germany
    • Münster University Hospital
• Italy
  • Bologna, Italy
    • S. Orsola Hospital
  • Lecco, Italy
    • Lecco Hospital
• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital
• United Kingdom
  • Leicester, United Kingdom
    • University Hospitals of Leicester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with PCR-confirmed or suspected COVID-19 infection with ARDS who require veno-venous or veno-arterial ECMO therapy

Description

Inclusion Criteria:

• PCR-confirmed or suspected COVID-19 infection with ARDS who require any ECMO therapy

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 positive patients	Device: Extracorporeal membrane oxygenation; Veno-venous or veno-arterial extracorporeal oxygenation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	All-cause mortality	Immediately after the intervention/procedure/surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death on ECMO	Death during ECMO therapy	During the intervention/procedure/surgery
Stroke	Stroke was defined as any focal or global neurological syndrome caused by ischemia and/or hemorrhage not resolving within 24 hours.	Immediately after the intervention/procedure/surgery
Blood stream infection	Blood stream infection detected on blood cultures	Immediately after the intervention/procedure/surgery
Lung complications requiring surgical treatment	Pneuthorax, pneumonia and/or abscess requiring surgical treatment	Immediately after the intervention/procedure/surgery
Blood transfusion	Transfusion of red blood cells	Immediately after the intervention/procedure/surgery
Acute kidney injury	Acute renal failure according to the Kidney Disease: Improving Global Outcomes classification (KDIGO) criteria	Immediately after the intervention/procedure/surgery
Duration of mechanical ventilation	Duration of mechanical ventilation	During index hospital stay follow-up until 1 year after ECMO initiation
Deep vein thrombosis	Thrombosis of lower limb deep venous system	Immediately after the intervention/procedure/surgery
Pulmonary embolism	Pulmonary embolism	Immediately after the intervention/procedure/surgery
Length of intensive care unit stay	Length of stay in the intensive care unit	Immediately after the intervention/procedure/surgery
Length of hospital stay	Length of hospital stay	Immediately after the intervention/procedure/surgery
Death after hospital discharge	All-cause death	Up to 6 months

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Fausto Biancari, Professor, Helsinki University Central Hospital

Publications and helpful links

General Publications

• Biancari F, Mariscalco G, Dalen M, Settembre N, Welp H, Perrotti A, Wiebe K, Leo E, Loforte A, Chocron S, Pacini D, Juvonen T, Broman LM, Perna DD, Yusuff H, Harvey C, Mongardon N, Maureira JP, Levy B, Falk L, Ruggieri VG, Zipfel S, Folliguet T, Fiore A. Six-Month Survival After Extracorporeal Membrane Oxygenation for Severe COVID-19. J Cardiothorac Vasc Anesth. 2021 Jul;35(7):1999-2006. doi: 10.1053/j.jvca.2021.01.027. Epub 2021 Jan 19.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2020
• Primary Completion (ACTUAL): April 1, 2021
• Study Completion (ACTUAL): April 1, 2021

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (ACTUAL): May 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 17, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: COVID-19 ECMO

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