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NCT Number: NCT04383678

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

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.

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Key information

Conditions

COVID-19 Acute Respiratory Distress Syndrome Coronaviridae Infections Coronavirus Infections Extracorporeal Membrane Oxygenation Complication Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Hospital, Helsinki, Finland

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Extracorporeal membrane oxygenation

Device

Veno-venous or veno-arterial extracorporeal oxygenation

Primary outcomes

  1. In-hospital mortality

    Time frame: Immediately after the intervention/procedure/surgery

    All-cause mortality

Secondary outcomes

  1. Death on ECMO

    Time frame: During the intervention/procedure/surgery

    Death during ECMO therapy

  2. Stroke

    Time frame: 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.

  3. Blood stream infection

    Time frame: Immediately after the intervention/procedure/surgery

    Blood stream infection detected on blood cultures

  4. Lung complications requiring surgical treatment

    Time frame: Immediately after the intervention/procedure/surgery

    Pneuthorax, pneumonia and/or abscess requiring surgical treatment

  5. Blood transfusion

    Time frame: Immediately after the intervention/procedure/surgery

    Transfusion of red blood cells

  6. Acute kidney injury

    Time frame: Immediately after the intervention/procedure/surgery

    Acute renal failure according to the Kidney Disease: Improving Global Outcomes classification (KDIGO) criteria

  7. Duration of mechanical ventilation

    Time frame: During index hospital stay follow-up until 1 year after ECMO initiation

    Duration of mechanical ventilation

  8. Deep vein thrombosis

    Time frame: Immediately after the intervention/procedure/surgery

    Thrombosis of lower limb deep venous system

  9. Pulmonary embolism

    Time frame: Immediately after the intervention/procedure/surgery

    Pulmonary embolism

  10. Length of intensive care unit stay

    Time frame: Immediately after the intervention/procedure/surgery

    Length of stay in the intensive care unit

  11. Length of hospital stay

    Time frame: Immediately after the intervention/procedure/surgery

    Length of hospital stay

  12. Death after hospital discharge

    Time frame: Up to 6 months

    All-cause death

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 12, 2020
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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