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

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04383678
Collaborator
(none)
132
11
13
12
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
132 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Multicenter European Study
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Apr 1, 2021
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
COVID-19 positive patients

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

Outcome Measures

Primary Outcome Measures

  1. In-hospital mortality [Immediately after the intervention/procedure/surgery]

    All-cause mortality

Secondary Outcome Measures

  1. Death on ECMO [During the intervention/procedure/surgery]

    Death during ECMO therapy

  2. 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.

  3. Blood stream infection [Immediately after the intervention/procedure/surgery]

    Blood stream infection detected on blood cultures

  4. Lung complications requiring surgical treatment [Immediately after the intervention/procedure/surgery]

    Pneuthorax, pneumonia and/or abscess requiring surgical treatment

  5. Blood transfusion [Immediately after the intervention/procedure/surgery]

    Transfusion of red blood cells

  6. Acute kidney injury [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 [During index hospital stay follow-up until 1 year after ECMO initiation]

    Duration of mechanical ventilation

  8. Deep vein thrombosis [Immediately after the intervention/procedure/surgery]

    Thrombosis of lower limb deep venous system

  9. Pulmonary embolism [Immediately after the intervention/procedure/surgery]

    Pulmonary embolism

  10. Length of intensive care unit stay [Immediately after the intervention/procedure/surgery]

    Length of stay in the intensive care unit

  11. Length of hospital stay [Immediately after the intervention/procedure/surgery]

    Length of hospital stay

  12. Death after hospital discharge [Up to 6 months]

    All-cause death

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • PCR-confirmed or suspected COVID-19 infection with ARDS who require any ECMO therapy
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helsinki University Hospital Helsinki Finland
2 University Hospital Jean Minjoz Besançon France
3 Nancy University Hospital Nancy France
4 Henri Mondon Unoversity Hospital Paris France
5 Robert Debré University Hospital Reims France
6 Hamburg University Heart Center Hamburg Germany
7 Münster University Hospital Münster Germany
8 S. Orsola Hospital Bologna Italy
9 Lecco Hospital Lecco Italy
10 Karolinska University Hospital Stockholm Sweden
11 University Hospitals of Leicester Leicester United Kingdom

Sponsors and Collaborators

  • Helsinki University Central Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fausto Biancari, Professor, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT04383678
Other Study ID Numbers:
  • COVID-19 ECMO
First Posted:
May 12, 2020
Last Update Posted:
Apr 20, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2021