European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO

Last updated: September 3, 2021
Sponsor: Maastricht University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sars-cov-2

Covid-19

Corona Virus

Treatment

N/A

Clinical Study ID

NCT04366921
METC 2020-1343
  • All Genders

Study Summary

In the last 10 years, severe acute respiratory infection (SARI) was responsible of multiple outbreaks putting a strain on the public health worldwide. Indeed, SARI had a relevant role in the development of pandemic and epidemic with terrible consequences such as the 2009 H1N1 pandemic which led to more than 200.000 respiratory deaths globally.

In late December 2019, in Wuhan, Hubei, China, a new respiratory syndrome emerged with clinical signs of viral pneumonia and person-to-person transmission. Tests showed the appearance of a novel coronavirus, namely the 2019 novel coronavirus (COVID-19). Two other strains, the severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV) have caused severe respiratory illnesses, sometimes fatal. In particular, the mortality rate associated with SARS-CoV and MERS-CoV, was of 10% and 37% respectively.

Even though COVID-19 appeared from the first time in China, quickly it spread worldwide and cases have been described in other countries such as Thailand, Japan, South Korea, Germany, Italy, France, Iran, USA and many other countries. An early paper reported 41 patients with laboratory-confirmed COVID-19 infection in Wuhan. The median age of the patients was 49 years and mostly men (73%). Among those, 32% were admitted to the ICU because of the severe hypoxemia. The most associated comorbidities were diabetes (20%), hypertension (15%), and cardiovascular diseases (15%). On admission, 98% of the patients had bilateral multiple lobular and sub-segmental areas of consolidation. Importantly, acute respiratory distress syndrome (ARDS) developed in 29% of the patients, while acute cardiac injury in 12%, and secondary infection in 10%. Invasive mechanical ventilation was required in 10% of those patients, and two of these patients (5%) had refractory hypoxemia and received extracorporeal membrane oxygenation (ECMO). In a later retrospective report by Wang and collaborators, clinical characteristics of 138 patients with COVID-19 infection were described. ICU admission was required in 26.1% of the patients for acute respiratory distress syndrome (61.1%), arrhythmia (44.4%), and shock (30.6%). ECMO support was needed in 11% of the patients admitted to the ICU. During the period of follow-up, overall mortality was 4.3%.

The use of ECMO in COVID-19 infection is increasing due to the high transmission rate of the infection and the respiratory-related mortality.

Therefore, the investigators believe that ECMO in case of severe interstitial pneumonia caused by COVID could represent a valid solution in order to avoid lung injuries related to prolonged treatment with non-invasive and invasive mechanical ventilation. In addition, ECMO could have a role for the systemic complications such as septic and cardiogenic shock as well myocarditis scenarios. Potential clinical effects and outcomes of the ECMO support in the novel coronavirus pandemic will be recorded and analyzed in our project.

The researchers hypothesize that a significant percentage of patients with COVID-19 infection will require the utilize of ECMO for refactory hypoxemia, cardiogenic shock or septic shock. This study seeks to prove this hypothesis by conducting an observational retrospective/prospective study of patients in the ICU who underwent ECMO support and describe clinical features, severity of pulmonary dysfunction and risk factors of COVID-patients who need ECMO support, the incidence of ECMO use, ECMO technical characteristics, duration of ECMO, complications and outcomes of COVID-patients requiring ECMO support.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Laboratory-confirmed COVID-19 infection by real-time PCR (polymerase chain reaction)
  • ECMO for treatment severe lung disease COVID-19 related

Exclusion

Exclusion Criteria:

  • Patients treated with ECMO for other concomitant causes.

Study Design

Total Participants: 150
Study Start date:
April 10, 2020
Estimated Completion Date:
April 30, 2022

Connect with a study center

  • Universitätskliniken Innsbruck

    Innsbruck,
    Austria

    Active - Recruiting

  • Landesklinikum Sankt Polten

    St.Pölten,
    Austria

    Active - Recruiting

  • Medical University of Vienna

    Vienna,
    Austria

    Active - Recruiting

  • Onze Lieve Vrouwziekenhuis Aalst

    Aalst,
    Belgium

    Active - Recruiting

  • University Hospital, Antwerp

    Antwerp,
    Belgium

    Active - Recruiting

  • Erasme University Hospital

    Brussel,
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Brussel

    Brussel,
    Belgium

    Active - Recruiting

  • Centre Hospitalier Universitaire Saint Pierre

    Brussels,
    Belgium

    Active - Recruiting

  • Chirec

    Brussels,
    Belgium

    Active - Recruiting

  • Hôpital Civil Marie Curie de Charleroi

    Charleroi,
    Belgium

    Active - Recruiting

  • University Hospital, Ghent

    Ghent,
    Belgium

    Active - Recruiting

  • La Louvière Hopital

    La Louvière,
    Belgium

    Active - Recruiting

  • Universitaire Ziekenhuizen Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • CHU de Liege

    Liège,
    Belgium

    Active - Recruiting

  • Charles University, Czech Republic

    Praha,
    Czechia

    Active - Recruiting

  • General University Hospital, Prague

    Praha,
    Czechia

    Active - Recruiting

  • Copenhagen University Hospital at Herlev

    Copenhagen,
    Denmark

    Active - Recruiting

  • University Hospital, Bordeaux

    Bourdeaux,
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Lyon,
    France

    Active - Recruiting

  • University Hospital, Montpellier

    Montpellier,
    France

    Active - Recruiting

  • Henri Mondor University Hospital

    Paris,
    France

    Active - Recruiting

  • Paris South University Hospitals

    Paris,
    France

    Active - Recruiting

  • Pitié-Salpêtrière Hospital

    Paris,
    France

    Active - Recruiting

  • Rennes University Hospital

    Rennes,
    France

    Active - Recruiting

  • University Hospital, Aachen

    Aachen,
    Germany

    Active - Recruiting

  • German Heart Center

    Berlin,
    Germany

    Active - Recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf,
    Germany

    Active - Recruiting

  • Children's Medical Hospital, University of Essen, Essen, Germany

    Essen,
    Germany

    Active - Recruiting

  • University Hospital, Essen

    Essen,
    Germany

    Active - Recruiting

  • University Heart Center Freiburg - Bad Krozingen

    Freiburg,
    Germany

    Active - Recruiting

  • Hannover Medical School

    Hannover,
    Germany

    Active - Recruiting

  • Klinikum Kassel

    Kassel,
    Germany

    Active - Recruiting

  • Universitätsklinikum Köln

    Köln,
    Germany

    Active - Recruiting

  • Heart Center Leipzig - University Hospital

    Leipzig,
    Germany

    Active - Recruiting

  • Klinikum Nürnberg

    Nürnberg,
    Germany

    Active - Recruiting

  • University Hospital Regensburg

    Regensburg,
    Germany

    Active - Recruiting

  • University Hospital Tuebingen

    Tuebingen,
    Germany

    Active - Recruiting

  • University Hospital, Alexandroupolis

    Alexandroupolis,
    Greece

    Active - Recruiting

  • Heim Pal Children's Hospital

    Budapest,
    Hungary

    Active - Recruiting

  • ECMO Centers Israel

    Jerusalem,
    Israel

    Active - Recruiting

  • San Giorgio Clinic

    Alessandria,
    Italy

    Active - Recruiting

  • Ospedali Riuniti Ancona

    Ancona,
    Italy

    Active - Recruiting

  • Papa Giovanni XXIII Hospital

    Bergamo,
    Italy

    Active - Recruiting

  • St. Orsola Hospital

    Bologna,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia,
    Italy

    Active - Recruiting

  • Ospedale Maurizio Bufalini

    Cesena,
    Italy

    Active - Recruiting

  • Gaslini Children's Hospital

    Genua,
    Italy

    Active - Recruiting

  • G. Pasquinucci Heart Hospital, Massa

    Massa,
    Italy

    Active - Recruiting

  • Niguarda Hospital

    Milan,
    Italy

    Active - Recruiting

  • Ospedale San Donato

    Milan,
    Italy

    Active - Recruiting

  • San Raffaele University Hospital, Italy

    Milan,
    Italy

    Active - Recruiting

  • Policlinico Hospital Milan

    Milano,
    Italy

    Active - Recruiting

  • San Gerardo Hospital

    Monza,
    Italy

    Active - Recruiting

  • IRCCS Policlinico S. Matteo

    Pavia,
    Italy

    Active - Recruiting

  • GVM Care & Research

    Puglia,
    Italy

    Active - Recruiting

  • Bambino Gesù Hospital and Research Institute

    Roma,
    Italy

    Active - Recruiting

  • San Camillo Hospital, Rome

    Roma,
    Italy

    Active - Recruiting

  • A.O.U. Città della Salute e della Scienza - Molinette Hospital

    Turin,
    Italy

    Active - Recruiting

  • Mauriziano Umberto I Hospital

    Turin,
    Italy

    Active - Recruiting

  • Ospedale S. Giovanni Bosco

    Turin,
    Italy

    Active - Recruiting

  • University Hospital, Udine, Italy

    Udine,
    Italy

    Active - Recruiting

  • Ospedale dell'Angelo, Venezia-Mestre

    Venice,
    Italy

    Active - Recruiting

  • Ospedale San Bortolo di Vicenza

    Vicenza,
    Italy

    Active - Recruiting

  • Vilnius University Hospital Santaros Klinikos

    Vilnius,
    Lithuania

    Active - Recruiting

  • University of Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Center

    Maastricht,
    Netherlands

    Active - Recruiting

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Active - Recruiting

  • UMC Utrecht

    Utrecht,
    Netherlands

    Active - Recruiting

  • Medical University of Warsaw

    Warsaw,
    Poland

    Active - Recruiting

  • Hospital Sao Joao

    Porto,
    Portugal

    Active - Recruiting

  • Chelyabinsk Regional Clinical Hospital

    Chelyabinsk,
    Russian Federation

    Active - Recruiting

  • City Hospital No 41, Ekaterinburg, Russia

    Ekaterinburg,
    Russian Federation

    Active - Recruiting

  • Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash

    Kemerovo,
    Russian Federation

    Active - Recruiting

  • Krasnodar Regional Hospital no 1

    Krasnodar,
    Russian Federation

    Active - Recruiting

  • City Clinical Hospital No. 67, Moscow, Russia

    Moscow,
    Russian Federation

    Active - Recruiting

  • Novosibirsk City Hospital #2

    Novosibirsk,
    Russian Federation

    Active - Recruiting

  • City Hospital No 40, Saint Petersburg, Russia

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

  • Hospital Sant Joan de Deu

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Vall d'Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Miguel Servet

    Zaragoza,
    Spain

    Active - Recruiting

  • Lund University Hospital

    Lund,
    Sweden

    Active - Recruiting

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Active - Recruiting

  • University Hospital, Basel, Switzerland

    Basel,
    Switzerland

    Active - Recruiting

  • University of Bern

    Bern,
    Switzerland

    Active - Recruiting

  • University Hospital, Geneva

    Geneva,
    Switzerland

    Active - Recruiting

  • University of Lausanne Hospitals

    Lausanne,
    Switzerland

    Active - Recruiting

  • Cardiocentro Ticino

    Lugano,
    Switzerland

    Active - Recruiting

  • Klinik Hirslanden, Zurich

    Zürich,
    Switzerland

    Active - Recruiting

  • University of Zurich

    Zürich,
    Switzerland

    Active - Recruiting

  • Royal Brompton & Harefield NHS Foundation Trust

    Brompton,
    United Kingdom

    Active - Recruiting

  • Paediatric Intensive Care Glasgow

    Glasgow,
    United Kingdom

    Active - Recruiting

  • Leicester Children's Hospital

    Leicester,
    United Kingdom

    Active - Recruiting

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • Guy's and St Thomas' NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

  • Newcastle-upon-Tyne Hospitals NHS Trust

    Newcastle Upon Tyne,
    United Kingdom

    Active - Recruiting

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