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

Completed

• Conditions: Extracorporeal Membrane Oxygenation Complication; COVID-19; Acute Respiratory Distress Syndrome
• Interventions: Device: Extracorporeal membrane oxygenation

• Registration Number: NCT04383678
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-12
• Status Verified: 2021-04
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Last Update Submitted: 2021-04-17
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 positive patients	Extracorporeal membrane oxygenation	-

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	Immediately after the intervention/procedure/surgery	All-cause mortality

Secondary Outcome Measures

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

Trial Locations

Locations (11)

Henri Mondon Unoversity Hospital; 🇫🇷 Paris, France

University Hospital Jean Minjoz; 🇫🇷 Besançon, France

Nancy University Hospital; 🇫🇷 Nancy, France

Münster University Hospital; 🇩🇪 Münster, Germany

Robert Debré University Hospital; 🇫🇷 Reims, France

Hamburg University Heart Center; 🇩🇪 Hamburg, Germany

S. Orsola Hospital; 🇮🇹 Bologna, Italy

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

University Hospitals of Leicester; 🇬🇧 Leicester, United Kingdom

Lecco Hospital; 🇮🇹 Lecco, Italy

Helsinki University Hospital; 🇫🇮 Helsinki, Finland