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

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.

Conditions

• COVID
• SARS-CoV-2
• ARDS, Human
• Refractory Hypoxemia
• Cardiogenic Shock
• Septic Shock
• Extracorporeal Membrane Oxygenation

Sponsors & Collaborators

• European chapter of the Extracorporeal Life Support Organization

  collaborator UNKNOWN

• Erasmus Medical Center

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• Papa Giovanni XXIII Hospital

  collaborator OTHER

• Niguarda Hospital

  collaborator OTHER

• Ospedale San Donato

  collaborator OTHER

• Ospedale S. Giovanni Bosco

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  collaborator OTHER

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

  collaborator OTHER

• Ospedale dell'Angelo, Venezia-Mestre

  collaborator OTHER

• University Hospital, Udine, Italy

  collaborator OTHER

• San Gerardo Hospital

  collaborator OTHER

• Ospedali Riuniti Ancona

  collaborator OTHER

• San Camillo Hospital, Rome

  collaborator OTHER

• San Giorgio Clinic

  collaborator UNKNOWN

• GVM Care & Research

  collaborator UNKNOWN

• San Raffaele University Hospital, Italy

  collaborator OTHER

• Ospedale San Bortolo di Vicenza

  collaborator OTHER

• Klinik Hirslanden, Zurich

  collaborator OTHER

• University of Zurich

  collaborator OTHER

• Cardiocentro Ticino

  collaborator OTHER

• Vilnius University Hospital Santaros Klinikos

  collaborator OTHER

• University Düsseldorf

  collaborator OTHER

• Klinikum Nürnberg

  collaborator OTHER

• Hannover Medical School

  collaborator OTHER

• Heart Center Leipzig - University Hospital

  collaborator OTHER

• University Hospital Regensburg

  collaborator OTHER

• University Hospital, Essen

  collaborator OTHER

• German Heart Center

  collaborator OTHER

• University Hospital, Aachen

  collaborator OTHER

• University Heart Center Freiburg - Bad Krozingen

  collaborator OTHER

• Klinikum Kassel

  collaborator OTHER

• General University Hospital, Prague

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• Onze Lieve Vrouwziekenhuis Aalst

  collaborator OTHER

• Erasme University Hospital

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• Hôpital Civil Marie Curie de Charleroi

  collaborator UNKNOWN

• University Hospital, Ghent

  collaborator OTHER

• Centre Hospitalier Universitaire Saint Pierre

  collaborator OTHER

• Hospital Vall d'Hebron

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital Miguel Servet

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• Pitié-Salpêtrière Hospital

  collaborator OTHER

• Rennes University Hospital

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• Karolinska University Hospital

  collaborator OTHER

• Hospital Sao Joao

  collaborator OTHER

• Medical University of Warsaw

  collaborator OTHER

• Universitätskliniken Innsbruck

  collaborator UNKNOWN

• Medical University of Vienna

  collaborator OTHER

• University Hospital, Alexandroupolis

  collaborator OTHER

• Novosibirsk City Hospital #2

  collaborator OTHER

• City Clinical Hospital No. 67, Moscow, Russia

  collaborator OTHER_GOV

• City Hospital No 40, Saint Petersburg, Russia

  collaborator OTHER

• Krasnodar Regional Hospital no 1

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• City Hospital No 41, Ekaterinburg, Russia

  collaborator OTHER

• G. Pasquinucci Heart Hospital, Massa

  collaborator OTHER

• Charles University, Czech Republic

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• Bambino Gesù Hospital and Research Institute

  collaborator OTHER

• Policlinico Hospital Milan

  collaborator UNKNOWN

• Gaslini Children's Hospital

  collaborator OTHER

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

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  collaborator OTHER

• Paediatric Intensive Care Glasgow

  collaborator UNKNOWN

• Paris South University Hospitals

  collaborator UNKNOWN

• University of Groningen

  collaborator OTHER

• Great Ormond Street Hospital for Children NHS Foundation Trust

  collaborator OTHER

• Hospital Sant Joan de Deu

  collaborator OTHER

• Heim Pal Children's Hospital

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• Lund University Hospital

  collaborator OTHER

• Landesklinikum Sankt Polten

  collaborator OTHER

• Chelyabinsk Regional Clinical Hospital

  collaborator OTHER_GOV

• ECMO Centers Israel

  collaborator UNKNOWN

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• Ospedale M. Bufalini Cesena

  collaborator OTHER

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

  collaborator OTHER

• Mauriziano Umberto I Hospital

  collaborator OTHER

• University of Bern

  collaborator OTHER

• University Hospital, Basel, Switzerland

  collaborator OTHER

• University of Lausanne Hospitals

  collaborator OTHER

• University Hospital Tuebingen

  collaborator OTHER

• Universitätsklinikum Köln

  collaborator OTHER

• Chirec

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• Centre Hospitalier Universitaire de Liege

  collaborator OTHER

• La Louvière Hopital

  collaborator UNKNOWN

• Leicester Royal Infirmary NHS Trust

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Lorusso, Prof. Dr. · Maastricht University Hospital

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-04-10

Primary Completion

2022-04-30

Completion

2022-04-30

Countries

• Austria
• Belgium
• Czechia
• Denmark
• France
• Germany
• Greece
• Hungary
• Israel
• Italy
• Lithuania
• Netherlands
• Poland
• Portugal
• Russia
• Spain
• Sweden
• Switzerland
• United Kingdom

Study Locations