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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04366921
Acronym
EuroECMO-COVID
Enrollment
150
Registered
2020-04-29
Start date
2020-04-10
Completion date
2022-04-30
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

None listed

Sponsors

European chapter of the Extracorporeal Life Support Organization
CollaboratorUNKNOWN
Erasmus Medical Center
CollaboratorOTHER
Leiden University Medical Center
CollaboratorOTHER
UMC Utrecht
CollaboratorOTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
CollaboratorOTHER
Papa Giovanni XXIII Hospital
CollaboratorOTHER
Niguarda Hospital
CollaboratorOTHER
Ospedale San Donato
CollaboratorOTHER
Ospedale S. Giovanni Bosco
CollaboratorOTHER
Fondazione IRCCS Policlinico San Matteo di Pavia
CollaboratorOTHER
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
CollaboratorOTHER
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
CollaboratorOTHER
Ospedale dell'Angelo, Venezia-Mestre
CollaboratorOTHER
University Hospital, Udine, Italy
CollaboratorOTHER
San Gerardo Hospital
CollaboratorOTHER
Ospedali Riuniti Ancona
CollaboratorOTHER
San Camillo Hospital, Rome
CollaboratorOTHER
San Giorgio Clinic
CollaboratorUNKNOWN
GVM Care & Research
CollaboratorUNKNOWN
San Raffaele University Hospital, Italy
CollaboratorOTHER
Ospedale San Bortolo di Vicenza
CollaboratorOTHER
Klinik Hirslanden, Zurich
CollaboratorOTHER
University of Zurich
CollaboratorOTHER
Cardiocentro Ticino
CollaboratorOTHER
Vilnius University Hospital Santaros Klinikos
CollaboratorOTHER
University Düsseldorf
CollaboratorOTHER
Klinikum Nürnberg
CollaboratorOTHER
Hannover Medical School
CollaboratorOTHER
Heart Center Leipzig - University Hospital
CollaboratorOTHER
University Hospital Regensburg
CollaboratorOTHER
University Hospital, Essen
CollaboratorOTHER
German Heart Center
CollaboratorOTHER
University Hospital, Aachen
CollaboratorOTHER
University Heart Center Freiburg - Bad Krozingen
CollaboratorOTHER
Klinikum Kassel
CollaboratorOTHER
General University Hospital, Prague
CollaboratorOTHER
Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
Onze Lieve Vrouwziekenhuis Aalst
CollaboratorOTHER
Erasme University Hospital
CollaboratorOTHER
University Hospital, Antwerp
CollaboratorOTHER
Hôpital Civil Marie Curie de Charleroi
CollaboratorUNKNOWN
University Hospital, Ghent
CollaboratorOTHER
Centre Hospitalier Universitaire Saint Pierre
CollaboratorOTHER
Hospital Vall d'Hebron
CollaboratorOTHER
Hospital Universitario Ramon y Cajal
CollaboratorOTHER
Hospital Miguel Servet
CollaboratorOTHER
Henri Mondor University Hospital
CollaboratorOTHER
Hospices Civils de Lyon
CollaboratorOTHER
Pitié-Salpêtrière Hospital
CollaboratorOTHER
Rennes University Hospital
CollaboratorOTHER
Guy's and St Thomas' NHS Foundation Trust
CollaboratorOTHER
Karolinska University Hospital
CollaboratorOTHER
Hospital Sao Joao
CollaboratorOTHER
Medical University of Warsaw
CollaboratorOTHER
Universitätskliniken Innsbruck
CollaboratorUNKNOWN
Medical University of Vienna
CollaboratorOTHER
University Hospital, Alexandroupolis
CollaboratorOTHER
Novosibirsk City Hospital #2
CollaboratorOTHER
City Clinical Hospital No. 67, Moscow, Russia
CollaboratorOTHER_GOV
City Hospital No 40, Saint Petersburg, Russia
CollaboratorOTHER
Krasnodar Regional Hospital no 1
CollaboratorUNKNOWN
Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash
CollaboratorUNKNOWN
City Hospital No 41, Ekaterinburg, Russia
CollaboratorOTHER
G. Pasquinucci Heart Hospital, Massa
CollaboratorOTHER
Charles University, Czech Republic
CollaboratorOTHER
University Hospital, Bordeaux
CollaboratorOTHER
Bambino Gesù Hospital and Research Institute
CollaboratorOTHER
Policlinico Hospital Milan
CollaboratorUNKNOWN
Gaslini Children's Hospital
CollaboratorOTHER
Children's Medical Hospital, University of Essen, Essen, Germany
CollaboratorOTHER
University Hospital, Geneva
CollaboratorOTHER
Newcastle-upon-Tyne Hospitals NHS Trust
CollaboratorOTHER
Paediatric Intensive Care Glasgow
CollaboratorUNKNOWN
Paris South University Hospitals
CollaboratorUNKNOWN
University of Groningen
CollaboratorOTHER
Great Ormond Street Hospital for Children NHS Foundation Trust
CollaboratorOTHER
Hospital Sant Joan de Deu
CollaboratorOTHER
Heim Pal Children's Hospital
CollaboratorOTHER
University Hospital, Montpellier
CollaboratorOTHER
Royal Brompton & Harefield NHS Foundation Trust
CollaboratorOTHER
Lund University Hospital
CollaboratorOTHER
Landesklinikum Sankt Polten
CollaboratorOTHER
Chelyabinsk Regional Clinical Hospital
CollaboratorOTHER_GOV
ECMO Centers Israel
CollaboratorUNKNOWN
Copenhagen University Hospital at Herlev
CollaboratorOTHER
Ospedale M. Bufalini Cesena
CollaboratorOTHER
A.O.U. Città della Salute e della Scienza - Molinette Hospital
CollaboratorOTHER
Mauriziano Umberto I Hospital
CollaboratorOTHER
University of Bern
CollaboratorOTHER
University Hospital, Basel, Switzerland
CollaboratorOTHER
University of Lausanne Hospitals
CollaboratorOTHER
University Hospital Tuebingen
CollaboratorOTHER
Universitätsklinikum Köln
CollaboratorOTHER
Chirec
CollaboratorOTHER
Universitair Ziekenhuis Brussel
CollaboratorOTHER
Centre Hospitalier Universitaire de Liege
CollaboratorOTHER
La Louvière Hopital
CollaboratorUNKNOWN
Leicester Royal Infirmary NHS Trust
CollaboratorOTHER
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patients treated with ECMO for other concomitant causes.

Design outcomes

Primary

MeasureTime frameDescription
Ageat baselineage in years
Genderat baselinemale/female
Weightat baselinein kilograms
Heightat baselinein meters
BMIat baselineweight and height combined to calculate BMI in kg/m\^2
Pre-existing pulmonary disease y/nat baselineAsthma y/n, cystic fibrosis y/n, chronic obstructive pulmonary disease y/n, pulmonary hypertension y/n, pulmonary fibrosis y/n, chronic restrictive lung disease y/n
Main co-morbidities y/nat baselinediabetes mellitus y/n, chronic renal failure y/n, ischemic heart disease y/n, heart failure y/n, chronic liver failure y/n, neurological impairment y/n
Date of signs of COVID-19 infectionat baseline or date of occurencein dd-mm-yyyy or mm-dd-yyyy
Date of positive swabat baseline or date of occurencein dd-mm-yyyy or mm-dd-yyyy
Pre-ECMO length of hospital stayat or during ECMO-implantin days
Pre-ECMO length of ICU stayat or during ECMO-implantin days
Pre-ECMO length of mechanical ventilation daysat or during ECMO-implantin days
Use of antibioticsup to 6 monthsy/n, what kind
Use of anti-viral treatmentup to 6 monthsy/n, what kind
Use of second line treatmentup to 6 monthsy/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)
Indications for ECMO-implantat ECMO-implantrespiratory or cardiac
Type of ECMO-implantat ECMO-implantveno-venous, veno-arterial or veno-venoarterial
Type of accessat ECMO-implantperipheral or central
Date of ECMO implantat ECMO-implantin dd-mm-yyyy or mm-dd-yyyy
ECMO blood flow ratefrom day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 monthsl/min
ECMO gas flow ratefrom day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 monthsl/min
ECMO configuration changeup to 6 monthsy/n
Date of ECMO configuration changeup to 6 monthsin dd-mm-yyyy or mm-dd-yyyy
New ECMO configurationup to 6 monthsveno-venous, veno-arterial, veno-venoarterial, other
Indications for ECMO configuration changeup to 6 monthsright ventricular failure, left ventricular failure, refractory hypoxemia
Ventilator setting on ECMOfrom day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 monthssettings of ventilator
Anticoagulation during ECMOfrom day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 monthsheparin, bivalirudin, nothing
Frequency of ECMO circuit changeup to 6 monthsamount of ECMO circuit changes (1, 2, 3 etc.)
ECMO complicationsup to 6 monthsHemorrhagic, infection, other complications
ECMO Weaningfrom day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 monthsy/n
ICU dischargefrom day of ICU-admission for every 24 hours until date of discharge or death, up to 6 monthsy/n, date
Main cause of death6 months
Type of dischargeup to 6 monthsWard, another ICU, rehabilitation center, home
Alive/deceased6 months

Countries

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

Contacts

Primary ContactLorusso, Prof. Dr.
roberto.lorussobs@gmail.com+ 31(0) 433877095

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026