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NCT04383678 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04383678
Other study ID # COVID-19 ECMO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date April 1, 2021

Study information
Verified date April 2021
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date April 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - PCR-confirmed or suspected COVID-19 infection with ARDS who require any ECMO therapy Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
  • COVID-19
  • Extracorporeal Membrane Oxygenation Complication
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Syndrome

Intervention

Device:
• Extracorporeal membrane oxygenation
Veno-venous or veno-arterial extracorporeal oxygenation

Locations
Country Name City State
Finland Helsinki University Hospital Helsinki
France University Hospital Jean Minjoz Besançon
France Nancy University Hospital Nancy
France Henri Mondon Unoversity Hospital Paris
France Robert Debré University Hospital Reims
Germany Hamburg University Heart Center Hamburg
Germany Münster University Hospital Münster
Italy S. Orsola Hospital Bologna
Italy Lecco Hospital Lecco
Sweden Karolinska University Hospital Stockholm
United Kingdom University Hospitals of Leicester Leicester

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Countries where clinical trial is conducted

Finland,  France,  Germany,  Italy,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary In-hospital mortality All-cause mortality Immediately after the intervention/procedure/surgery
Secondary Death on ECMO Death during ECMO therapy During the intervention/procedure/surgery
Secondary 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
Secondary Blood stream infection Blood stream infection detected on blood cultures Immediately after the intervention/procedure/surgery
Secondary Lung complications requiring surgical treatment Pneuthorax, pneumonia and/or abscess requiring surgical treatment Immediately after the intervention/procedure/surgery
Secondary Blood transfusion Transfusion of red blood cells Immediately after the intervention/procedure/surgery
Secondary Acute kidney injury Acute renal failure according to the Kidney Disease: Improving Global Outcomes classification (KDIGO) criteria Immediately after the intervention/procedure/surgery
Secondary Duration of mechanical ventilation Duration of mechanical ventilation During index hospital stay follow-up until 1 year after ECMO initiation
Secondary Deep vein thrombosis Thrombosis of lower limb deep venous system Immediately after the intervention/procedure/surgery
Secondary Pulmonary embolism Pulmonary embolism Immediately after the intervention/procedure/surgery
Secondary Length of intensive care unit stay Length of stay in the intensive care unit Immediately after the intervention/procedure/surgery
Secondary Length of hospital stay Length of hospital stay Immediately after the intervention/procedure/surgery
Secondary Death after hospital discharge All-cause death Up to 6 months
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