European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO
NCT ID: NCT04366921
Last Updated: 2021-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2020-04-10
2022-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* ECMO for treatment severe lung disease COVID-19 related
Exclusion Criteria
ALL
No
Sponsors
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European chapter of the Extracorporeal Life Support Organization
UNKNOWN
Erasmus Medical Center
OTHER
Leiden University Medical Center
OTHER
UMC Utrecht
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Papa Giovanni XXIII Hospital
OTHER
Niguarda Hospital
OTHER
Ospedale San Donato
OTHER
Ospedale S. Giovanni Bosco
OTHER
Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
OTHER
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
OTHER
Ospedale dell'Angelo, Venezia-Mestre
OTHER
University Hospital, Udine, Italy
OTHER
San Gerardo Hospital
OTHER
Ospedali Riuniti Ancona
OTHER
San Camillo Hospital, Rome
OTHER
San Giorgio Clinic
UNKNOWN
GVM Care & Research
UNKNOWN
San Raffaele University Hospital, Italy
OTHER
Ospedale San Bortolo di Vicenza
OTHER
Klinik Hirslanden, Zurich
OTHER
University of Zurich
OTHER
Cardiocentro Ticino
OTHER
Vilnius University Hospital Santaros Klinikos
OTHER
University Düsseldorf
OTHER
Klinikum Nürnberg
OTHER
Hannover Medical School
OTHER
Heart Center Leipzig - University Hospital
OTHER
University Hospital Regensburg
OTHER
University Hospital, Essen
OTHER
German Heart Center
OTHER
University Hospital, Aachen
OTHER
University Heart Center Freiburg - Bad Krozingen
OTHER
Klinikum Kassel
OTHER
General University Hospital, Prague
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Onze Lieve Vrouwziekenhuis Aalst
OTHER
Erasme University Hospital
OTHER
University Hospital, Antwerp
OTHER
Hôpital Civil Marie Curie de Charleroi
UNKNOWN
University Hospital, Ghent
OTHER
Centre Hospitalier Universitaire Saint Pierre
OTHER
Hospital Vall d'Hebron
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital Miguel Servet
OTHER
Henri Mondor University Hospital
OTHER
Hospices Civils de Lyon
OTHER
Pitié-Salpêtrière Hospital
OTHER
Rennes University Hospital
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
Karolinska University Hospital
OTHER
Hospital Sao Joao
OTHER
Medical University of Warsaw
OTHER
Universitätskliniken Innsbruck
UNKNOWN
Medical University of Vienna
OTHER
University Hospital, Alexandroupolis
OTHER
Novosibirsk City Hospital #2
OTHER
City Clinical Hospital No. 67, Moscow, Russia
OTHER_GOV
City Hospital No 40, Saint Petersburg, Russia
OTHER
Krasnodar Regional Hospital no 1
UNKNOWN
Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash
UNKNOWN
City Hospital No 41, Ekaterinburg, Russia
OTHER
G. Pasquinucci Heart Hospital, Massa
OTHER
Charles University, Czech Republic
OTHER
University Hospital, Bordeaux
OTHER
Bambino Gesù Hospital and Research Institute
OTHER
Policlinico Hospital Milan
UNKNOWN
Gaslini Children's Hospital
OTHER
Children's Medical Hospital, University of Essen, Essen, Germany
OTHER
University Hospital, Geneva
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Paediatric Intensive Care Glasgow
UNKNOWN
Paris South University Hospitals
UNKNOWN
University of Groningen
OTHER
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Hospital Sant Joan de Deu
OTHER
Heim Pal Children's Hospital
OTHER
University Hospital, Montpellier
OTHER
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Lund University Hospital
OTHER
Landesklinikum Sankt Polten
OTHER
Chelyabinsk Regional Clinical Hospital
OTHER_GOV
ECMO Centers Israel
UNKNOWN
Copenhagen University Hospital at Herlev
OTHER
Ospedale M. Bufalini Cesena
OTHER
A.O.U. Città della Salute e della Scienza - Molinette Hospital
OTHER
Mauriziano Umberto I Hospital
OTHER
University of Bern
OTHER
University Hospital, Basel, Switzerland
OTHER
University of Lausanne Hospitals
OTHER
University Hospital Tuebingen
OTHER
Universitätsklinikum Köln
OTHER
Chirec
OTHER
Universitair Ziekenhuis Brussel
OTHER
Centre Hospitalier Universitaire de Liege
OTHER
La Louvière Hopital
UNKNOWN
Leicester Royal Infirmary NHS Trust
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Lorusso, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Hospital
Locations
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Universitätskliniken Innsbruck
Innsbruck, , Austria
Landesklinikum Sankt Polten
Sankt Pölten, , Austria
Medical University of Vienna
Vienna, , Austria
Onze Lieve Vrouwziekenhuis Aalst
Aalst, , Belgium
University Hospital, Antwerp
Antwerp, , Belgium
Centre Hospitalier Universitaire Saint Pierre
Brussels, , Belgium
Chirec
Brussels, , Belgium
Erasme University Hospital
Brussels, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Hôpital Civil Marie Curie de Charleroi
Charleroi, , Belgium
University Hospital, Ghent
Ghent, , Belgium
La Louvière Hopital
La Louvière, , Belgium
Universitaire Ziekenhuizen Leuven
Leuven, , Belgium
CHU de Liege
Liège, , Belgium
Charles University, Czech Republic
Prague, , Czechia
General University Hospital, Prague
Prague, , Czechia
Copenhagen University Hospital at Herlev
Copenhagen, , Denmark
University Hospital, Bordeaux
Bourdeaux, , France
Hospices Civils de Lyon
Lyon, , France
University Hospital, Montpellier
Montpellier, , France
Henri Mondor University Hospital
Paris, , France
Paris South University Hospitals
Paris, , France
Pitié-Salpêtrière Hospital
Paris, , France
Rennes University Hospital
Rennes, , France
University Hospital, Aachen
Aachen, , Germany
German Heart Center
Berlin, , Germany
Universitätsklinikum Köln
Cologne, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Children's Medical Hospital, University of Essen, Essen, Germany
Essen, , Germany
University Hospital, Essen
Essen, , Germany
University Heart Center Freiburg - Bad Krozingen
Freiburg im Breisgau, , Germany
Hannover Medical School
Hanover, , Germany
Klinikum Kassel
Kassel, , Germany
Heart Center Leipzig - University Hospital
Leipzig, , Germany
Klinikum Nürnberg
Nuremberg, , Germany
University Hospital Regensburg
Regensburg, , Germany
University Hospital Tuebingen
Tübingen, , Germany
University Hospital, Alexandroupolis
Alexandroupoli, , Greece
Heim Pal Children's Hospital
Budapest, , Hungary
ECMO Centers Israel
Jerusalem, , Israel
San Giorgio Clinic
Alessandria, , Italy
Ospedali Riuniti Ancona
Ancona, , Italy
Papa Giovanni XXIII Hospital
Bergamo, , Italy
St. Orsola Hospital
Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
Ospedale Maurizio Bufalini
Cesena, , Italy
Gaslini Children's Hospital
Genoa, , Italy
G. Pasquinucci Heart Hospital, Massa
Massa, , Italy
Niguarda Hospital
Milan, , Italy
Ospedale San Donato
Milan, , Italy
San Raffaele University Hospital, Italy
Milan, , Italy
Policlinico Hospital Milan
Milan, , Italy
San Gerardo Hospital
Monza, , Italy
IRCCS Policlinico S. Matteo
Pavia, , Italy
GVM Care & Research
Puglia, , Italy
Bambino Gesù Hospital and Research Institute
Roma, , Italy
San Camillo Hospital, Rome
Roma, , Italy
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Turin, , Italy
Mauriziano Umberto I Hospital
Turin, , Italy
Ospedale S. Giovanni Bosco
Turin, , Italy
University Hospital, Udine, Italy
Udine, , Italy
Ospedale dell'Angelo, Venezia-Mestre
Venice, , Italy
Ospedale San Bortolo di Vicenza
Vicenza, , Italy
Vilnius University Hospital Santaros Klinikos
Vilnius, , Lithuania
University of Groningen
Groningen, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
Medical University of Warsaw
Warsaw, , Poland
Hospital Sao Joao
Porto, , Portugal
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, , Russia
Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash
Kemerovo, , Russia
Krasnodar Regional Hospital no 1
Krasnodar, , Russia
City Clinical Hospital No. 67, Moscow, Russia
Moscow, , Russia
Novosibirsk City Hospital #2
Novosibirsk, , Russia
City Hospital No 40, Saint Petersburg, Russia
Saint Petersburg, , Russia
City Hospital No 41, Ekaterinburg, Russia
Yekaterinburg, , Russia
Hospital Sant Joan de Deu
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Lund University Hospital
Lund, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
University Hospital, Basel, Switzerland
Basel, , Switzerland
University of Bern
Bern, , Switzerland
University Hospital, Geneva
Geneva, , Switzerland
University of Lausanne Hospitals
Lausanne, , Switzerland
Cardiocentro Ticino
Lugano, , Switzerland
Klinik Hirslanden, Zurich
Zurich, , Switzerland
University of Zurich
Zurich, , Switzerland
Royal Brompton & Harefield NHS Foundation Trust
Brompton, , United Kingdom
Paediatric Intensive Care Glasgow
Glasgow, , United Kingdom
Leicester Children's Hospital
Leicester, , United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Nikolaos Bonaros, Prof.
Role: primary
Christoph Krapf, Dr.
Role: backup
Nikolaos Bonaros, Prof.
Role: primary
Peter Schellongowski, Dr.
Role: primary
Bernard Stockman, Dr.
Role: primary
Gerdy Debeuckelaere
Role: primary
Olivier Germay
Role: primary
Daniel De Backer, Dr.
Role: primary
Fabio Taccone, Prof.
Role: primary
Dimitri Vandeweghe
Role: primary
Patrick Biston, Dr.
Role: primary
Michael Piagnerelli
Role: backup
Harlinde Peperstraete
Role: primary
Romain Courcelle
Role: primary
Leen Vercaemst, Dr.
Role: primary
Marc Lagny
Role: primary
Vaclav Vobruba
Role: primary
Jan Belohlavek, Prof.
Role: primary
Finn Moeller Pedersen, Dr.
Role: primary
Olivier Brissaud
Role: primary
Matteo Pozzi, Dr.
Role: primary
Phillipe Gaudard
Role: primary
Gabriel Saiydoun, Dr.
Role: primary
Pierre Tissieres
Role: primary
Alain Combes, Prof.
Role: primary
Thierry Folliguet, Prof.
Role: backup
Alessandro Paradiso, Dr.
Role: primary
Alexander Kersten, Dr.
Role: primary
Felix Hennig, Dr.
Role: primary
Simone Schafer, Dr.
Role: primary
Udo Boeken, Prof.
Role: primary
Malaika Mendoca
Role: primary
Matthias Thielman, Prof.
Role: primary
David Schibilsky, Dr.
Role: primary
Sven Maier, Dr.
Role: backup
Jan Schmitto, Prof.
Role: primary
Christian Napp, Dr.
Role: backup
Ralf Muellenbach, Prof
Role: primary
Torje Iuliu, Dr.
Role: backup
Diyar Saeed, Prof.
Role: primary
Justyna Swol, Dr.
Role: primary
Maximillian Malfertheiner, Dr.
Role: primary
Esther Dreier, Dr.
Role: backup
Philipp Hen, Dr.
Role: primary
Aron Frederik Popov, Prof.
Role: backup
Dimitrios Soufleris
Role: primary
Veronika Maraczi
Role: primary
Maged Makhoul, Dr.
Role: primary
Gil Bolotin, Dr.
Role: backup
Sandrelli Luca, Dr.
Role: primary
Roberto Carozza
Role: primary
Davide Ghitti, Dr.
Role: primary
Antonio Loforte, Dr.
Role: primary
Giovanni Chiarini, Dr.
Role: primary
Allesandro Circelli, Dr.
Role: primary
Andrea Moscatelli
Role: primary
Paolo Del Sarto
Role: primary
Paolof Meani, Dr.
Role: primary
Antioco Cappai, Dr.
Role: backup
Dario Fina, Dr.
Role: primary
Marco Ranucci, Dr.
Role: backup
Giovenni Landoni
Role: primary
Mara Scandroglio
Role: backup
Giacomo Cavallaro
Role: primary
Marco Giani, Dr.
Role: primary
Roberto Rona, Dr.
Role: backup
Mirko Belliato, Dr.
Role: primary
Antonella Degani
Role: backup
Ignazio Condello
Role: primary
Marco Moscarelli, Dr.
Role: backup
Matteo Di Nardo
Role: primary
Andrea Montalto, Dr.
Role: primary
Vito Fanelli, Dr.
Role: primary
Maria Elena De Piero, Dr.
Role: primary
Maria Elena De Piero, Dr.
Role: primary
Sandro Sponga, Dr.
Role: primary
Reina Gianfranco, Dr.
Role: primary
Marco Piccichè
Role: primary
Robertas Samalavicius, Dr.
Role: primary
Martin Kneyber
Role: primary
Dario Candura, Dr.
Role: primary
Jacinta Maas, Dr.
Role: backup
Lorusso, Prof. Dr.
Role: primary
Dinis Reis Miranda, Dr.
Role: primary
J.J. van der Heijden, Dr.
Role: primary
Mariusz Kowaleswsky, Dr.
Role: primary
Luis Filipe Pinto, Dr.
Role: primary
Alexandr Turchaninov
Role: primary
Roman Komelyuk
Role: primary
Alexander Skopets
Role: primary
Ivan Akufov
Role: primary
Alexandra Shilova
Role: backup
Igor Komilov
Role: primary
Daniil Shelukhin
Role: primary
Sergei Minin
Role: backup
Alexandr Turchaninov
Role: primary
Susana Segura Matute
Role: primary
Jordi Riero del Brio, Dr.
Role: primary
Aaron Blandino, Ortiz
Role: primary
Pablo Ruiz, Dr.
Role: primary
Edgars Grins
Role: primary
Lars Broman, Dr.
Role: primary
Thomas Doebele
Role: primary
Jolanda Consiglio
Role: primary
Jenni Hansjoerg
Role: backup
Angelo Polito
Role: primary
Xavier Bechtold
Role: primary
Gianluca Agus, Dr.
Role: primary
Halbe Maximillian, Dr.
Role: primary
Alberto Weber, Prof. Dr.
Role: primary
Grünenfelder Jürg, Prof. Dr.
Role: backup
Verna Aquino
Role: primary
Mark Davidson
Role: primary
Claire Westrope
Role: primary
Katherine Brown
Role: primary
Nicholas Bartlett, Dr.
Role: primary
Judit Llevadias
Role: primary
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
METC 2020-1343
Identifier Type: -
Identifier Source: org_study_id
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