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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366921
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
European chapter of the Extracorporeal Life Support Organization
Erasmus Medical Center
Leiden University Medical Center
UMC Utrecht
St. Orsola Hospital
Papa Giovanni XXIII Hospital
Niguarda Hospital
Ospedale San Donato
Ospedale S. Giovanni Bosco
IRCCS Policlinico S. Matteo
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Ospedale dell'Angelo, Venezia-Mestre
University Hospital, Udine, Italy
San Gerardo Hospital
Ospedali Riuniti Ancona
San Camillo Hospital, Rome
San Giorgio Clinic
GVM Care & Research
San Raffaele University Hospital, Italy
Ospedale San Bortolo di Vicenza
Klinik Hirslanden, Zurich
University of Zurich
Cardiocentro Ticino
Vilnius University Hospital Santaros Klinikos
Universitätsklinikum Düsseldorf
Klinikum Nürnberg
Hannover Medical School
Heart Center Leipzig - University Hospital
University Hospital Regensburg
University Hospital, Essen
German Heart Center
University Hospital, Aachen
University Heart Center Freiburg - Bad Krozingen
Klinikum Kassel
General University Hospital, Prague
Universitaire Ziekenhuizen Leuven
Onze Lieve Vrouwziekenhuis Aalst
Erasme University Hospital
University Hospital, Antwerp
Hôpital Civil Marie Curie de Charleroi
University Hospital, Ghent
Centre Hospitalier Universitaire Saint Pierre
Hospital Vall d'Hebron
Hospital Universitario Ramon y Cajal
Hospital Miguel Servet
Henri Mondor University Hospital
Hospices Civils de Lyon
Pitié-Salpêtrière Hospital
Rennes University Hospital
Guy's and St Thomas' NHS Foundation Trust
Karolinska University Hospital
Hospital Sao Joao
Medical University of Warsaw
Universitätskliniken Innsbruck
Medical University of Vienna
University Hospital, Alexandroupolis
Novosibirsk City Hospital #2
City Clinical Hospital No. 67, Moscow, Russia
City Hospital No 40, Saint Petersburg, Russia
Krasnodar Regional Hospital no 1
Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash
City Hospital No 41, Ekaterinburg, Russia
G. Pasquinucci Heart Hospital, Massa
Charles University, Czech Republic
University Hospital, Bordeaux
Bambino Gesù Hospital and Research Institute
Policlinico Hospital Milan
Gaslini Children's Hospital
Children's Medical Hospital, University of Essen, Essen, Germany
University Hospital, Geneva
Newcastle-upon-Tyne Hospitals NHS Trust
Paediatric Intensive Care Glasgow
Paris South University Hospitals
University of Groningen
Great Ormond Street Hospital for Children NHS Foundation Trust
Hospital Sant Joan de Deu
Heim Pal Children's Hospital
University Hospital, Montpellier
Royal Brompton & Harefield NHS Foundation Trust
Lund University Hospital
Landesklinikum Sankt Polten
Chelyabinsk Regional Clinical Hospital
ECMO Centers Israel
Copenhagen University Hospital at Herlev
Ospedale Maurizio Bufalini
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Mauriziano Umberto I Hospital
University of Bern
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
University Hospital Tuebingen
Universitätsklinikum Köln
Chirec
Universitair Ziekenhuis Brussel
CHU de Liege
La Louvière Hopital
Leicester Royal Infirmary NHS Trust
Information provided by (Responsible Party):
Maastricht University Medical Center

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.


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

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO
Actual Study Start Date : April 10, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021





Primary Outcome Measures :
  1. Age [ Time Frame: at baseline ]
    age in years

  2. Gender [ Time Frame: at baseline ]
    male/female

  3. Weight [ Time Frame: at baseline ]
    in kilograms

  4. Height [ Time Frame: at baseline ]
    in meters

  5. BMI [ Time Frame: at baseline ]
    weight and height combined to calculate BMI in kg/m^2

  6. Pre-existing pulmonary disease y/n [ Time Frame: at baseline ]
    Asthma 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

  7. Main co-morbidities y/n [ Time Frame: at baseline ]
    diabetes 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

  8. Date of signs of COVID-19 infection [ Time Frame: at baseline or date of occurence ]
    in dd-mm-yyyy or mm-dd-yyyy

  9. Date of positive swab [ Time Frame: at baseline or date of occurence ]
    in dd-mm-yyyy or mm-dd-yyyy

  10. Pre-ECMO length of hospital stay [ Time Frame: at or during ECMO-implant ]
    in days

  11. Pre-ECMO length of ICU stay [ Time Frame: at or during ECMO-implant ]
    in days

  12. Pre-ECMO length of mechanical ventilation days [ Time Frame: at or during ECMO-implant ]
    in days

  13. Use of antibiotics [ Time Frame: up to 6 months ]
    y/n, what kind

  14. Use of anti-viral treatment [ Time Frame: up to 6 months ]
    y/n, what kind

  15. Use of second line treatment [ Time Frame: up to 6 months ]
    y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)

  16. Indications for ECMO-implant [ Time Frame: at ECMO-implant ]
    respiratory or cardiac

  17. Type of ECMO-implant [ Time Frame: at ECMO-implant ]
    veno-venous, veno-arterial or veno-venoarterial

  18. Type of access [ Time Frame: at ECMO-implant ]
    peripheral or central

  19. Date of ECMO implant [ Time Frame: at ECMO-implant ]
    in dd-mm-yyyy or mm-dd-yyyy

  20. ECMO blood flow rate [ Time Frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months ]
    l/min

  21. ECMO gas flow rate [ Time Frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months ]
    l/min

  22. ECMO configuration change [ Time Frame: up to 6 months ]
    y/n

  23. Date of ECMO configuration change [ Time Frame: up to 6 months ]
    in dd-mm-yyyy or mm-dd-yyyy

  24. New ECMO configuration [ Time Frame: up to 6 months ]
    veno-venous, veno-arterial, veno-venoarterial, other

  25. Indications for ECMO configuration change [ Time Frame: up to 6 months ]
    right ventricular failure, left ventricular failure, refractory hypoxemia

  26. Ventilator setting on ECMO [ Time Frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months ]
    settings of ventilator

  27. Anticoagulation during ECMO [ Time Frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months ]
    heparin, bivalirudin, nothing

  28. Frequency of ECMO circuit change [ Time Frame: up to 6 months ]
    amount of ECMO circuit changes (1, 2, 3 etc.)

  29. ECMO complications [ Time Frame: up to 6 months ]
    Hemorrhagic, infection, other complications

  30. ECMO Weaning [ Time Frame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months ]
    y/n

  31. ICU discharge [ Time Frame: from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months ]
    y/n, date

  32. Main cause of death [ Time Frame: 6 months ]
  33. Type of discharge [ Time Frame: up to 6 months ]
    Ward, another ICU, rehabilitation center, home

  34. Alive/deceased [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with confirmed COVID-19 infection who require ECMO support
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366921


Contacts
Layout table for location contacts
Contact: Lorusso, Prof. Dr. + 31(0) 433877095 roberto.lorussobs@gmail.com

Locations
Show Show 97 study locations
Sponsors and Collaborators
Maastricht University Medical Center
European chapter of the Extracorporeal Life Support Organization
Erasmus Medical Center
Leiden University Medical Center
UMC Utrecht
St. Orsola Hospital
Papa Giovanni XXIII Hospital
Niguarda Hospital
Ospedale San Donato
Ospedale S. Giovanni Bosco
IRCCS Policlinico S. Matteo
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Ospedale dell'Angelo, Venezia-Mestre
University Hospital, Udine, Italy
San Gerardo Hospital
Ospedali Riuniti Ancona
San Camillo Hospital, Rome
San Giorgio Clinic
GVM Care & Research
San Raffaele University Hospital, Italy
Ospedale San Bortolo di Vicenza
Klinik Hirslanden, Zurich
University of Zurich
Cardiocentro Ticino
Vilnius University Hospital Santaros Klinikos
Universitätsklinikum Düsseldorf
Klinikum Nürnberg
Hannover Medical School
Heart Center Leipzig - University Hospital
University Hospital Regensburg
University Hospital, Essen
German Heart Center
University Hospital, Aachen
University Heart Center Freiburg - Bad Krozingen
Klinikum Kassel
General University Hospital, Prague
Universitaire Ziekenhuizen Leuven
Onze Lieve Vrouwziekenhuis Aalst
Erasme University Hospital
University Hospital, Antwerp
Hôpital Civil Marie Curie de Charleroi
University Hospital, Ghent
Centre Hospitalier Universitaire Saint Pierre
Hospital Vall d'Hebron
Hospital Universitario Ramon y Cajal
Hospital Miguel Servet
Henri Mondor University Hospital
Hospices Civils de Lyon
Pitié-Salpêtrière Hospital
Rennes University Hospital
Guy's and St Thomas' NHS Foundation Trust
Karolinska University Hospital
Hospital Sao Joao
Medical University of Warsaw
Universitätskliniken Innsbruck
Medical University of Vienna
University Hospital, Alexandroupolis
Novosibirsk City Hospital #2
City Clinical Hospital No. 67, Moscow, Russia
City Hospital No 40, Saint Petersburg, Russia
Krasnodar Regional Hospital no 1
Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash
City Hospital No 41, Ekaterinburg, Russia
G. Pasquinucci Heart Hospital, Massa
Charles University, Czech Republic
University Hospital, Bordeaux
Bambino Gesù Hospital and Research Institute
Policlinico Hospital Milan
Gaslini Children's Hospital
Children's Medical Hospital, University of Essen, Essen, Germany
University Hospital, Geneva
Newcastle-upon-Tyne Hospitals NHS Trust
Paediatric Intensive Care Glasgow
Paris South University Hospitals
University of Groningen
Great Ormond Street Hospital for Children NHS Foundation Trust
Hospital Sant Joan de Deu
Heim Pal Children's Hospital
University Hospital, Montpellier
Royal Brompton & Harefield NHS Foundation Trust
Lund University Hospital
Landesklinikum Sankt Polten
Chelyabinsk Regional Clinical Hospital
ECMO Centers Israel
Copenhagen University Hospital at Herlev
Ospedale Maurizio Bufalini
A.O.U. Città della Salute e della Scienza - Molinette Hospital
Mauriziano Umberto I Hospital
University of Bern
University Hospital, Basel, Switzerland
University of Lausanne Hospitals
University Hospital Tuebingen
Universitätsklinikum Köln
Chirec
Universitair Ziekenhuis Brussel
CHU de Liege
La Louvière Hopital
Leicester Royal Infirmary NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: Lorusso, Prof. Dr. Maastricht University Hospital
Publications:

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT04366921    
Other Study ID Numbers: METC 2020-1343
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Adult
Shock, Cardiogenic
Shock
Hypoxia
Pathologic Processes
Signs and Symptoms, Respiratory
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders