Clinical trial NCT04366921: European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO
Official title: European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID Patients in ECMO
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
SARS-CoV-2
ARDS, Human
Refractory Hypoxemia
Cardiogenic Shock
Septic Shock
Extracorporeal Membrane Oxygenation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: European chapter of the Extracorporeal Life Support Organization
name: Erasmus Medical Center
name: Leiden University Medical Center
name: UMC Utrecht
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Papa Giovanni XXIII Hospital
name: Niguarda Hospital
name: Ospedale San Donato
name: Ospedale S. Giovanni Bosco
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
name: Ospedale dell'Angelo, Venezia-Mestre
name: University Hospital, Udine, Italy
name: San Gerardo Hospital
name: Ospedali Riuniti Ancona
name: San Camillo Hospital, Rome
name: San Giorgio Clinic
name: GVM Care & Research
name: San Raffaele University Hospital, Italy
name: Ospedale San Bortolo di Vicenza
name: Klinik Hirslanden, Zurich
name: University of Zurich
name: Cardiocentro Ticino
name: Vilnius University Hospital Santaros Klinikos
name: University Düsseldorf
name: Klinikum Nürnberg
name: Hannover Medical School
name: Heart Center Leipzig - University Hospital
name: University Hospital Regensburg
name: University Hospital, Essen
name: German Heart Center
name: University Hospital, Aachen
name: University Heart Center Freiburg - Bad Krozingen
name: Klinikum Kassel
name: General University Hospital, Prague
name: Universitaire Ziekenhuizen KU Leuven
name: Onze Lieve Vrouwziekenhuis Aalst
name: Erasme University Hospital
name: University Hospital, Antwerp
name: Hôpital Civil Marie Curie de Charleroi
name: University Hospital, Ghent
name: Centre Hospitalier Universitaire Saint Pierre
name: Hospital Vall d'Hebron
name: Hospital Universitario Ramon y Cajal
name: Hospital Miguel Servet
name: Henri Mondor University Hospital
name: Hospices Civils de Lyon
name: Pitié-Salpêtrière Hospital
name: Rennes University Hospital
name: Guy's and St Thomas' NHS Foundation Trust
name: Karolinska University Hospital
name: Hospital Sao Joao
name: Medical University of Warsaw
name: Universitätskliniken Innsbruck
name: Medical University of Vienna
name: University Hospital, Alexandroupolis
name: Novosibirsk City Hospital #2
name: City Clinical Hospital No. 67, Moscow, Russia
name: City Hospital No 40, Saint Petersburg, Russia
name: Krasnodar Regional Hospital no 1
name: Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash
name: City Hospital No 41, Ekaterinburg, Russia
name: G. Pasquinucci Heart Hospital, Massa
name: Charles University, Czech Republic
name: University Hospital, Bordeaux
name: Bambino Gesù Hospital and Research Institute
name: Policlinico Hospital Milan
name: Gaslini Children's Hospital
name: Children's Medical Hospital, University of Essen, Essen, Germany
name: University Hospital, Geneva
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Paediatric Intensive Care Glasgow
name: Paris South University Hospitals
name: University of Groningen
name: Great Ormond Street Hospital for Children NHS Foundation Trust
name: Hospital Sant Joan de Deu
name: Heim Pal Children's Hospital
name: University Hospital, Montpellier
name: Royal Brompton & Harefield NHS Foundation Trust
name: Lund University Hospital
name: Landesklinikum Sankt Polten
name: Chelyabinsk Regional Clinical Hospital
name: ECMO Centers Israel
name: Copenhagen University Hospital at Herlev
name: Ospedale M. Bufalini Cesena
name: A.O.U. Città della Salute e della Scienza - Molinette Hospital
name: Mauriziano Umberto I Hospital
name: University of Bern
name: University Hospital, Basel, Switzerland
name: University of Lausanne Hospitals
name: University Hospital Tuebingen
name: Universitätsklinikum Köln
name: Chirec
name: Universitair Ziekenhuis Brussel
name: Centre Hospitalier Universitaire de Liege
name: La Louvière Hopital
name: Leicester Royal Infirmary NHS Trust
First posted: 2020-04-29
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with confirmed COVID-19 infection who require ECMO support

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.


Eligibility 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.

Primary outcomes:
measure: Age
timeFrame: at baseline
measure: Gender
timeFrame: at baseline
measure: Weight
timeFrame: at baseline
measure: Height
timeFrame: at baseline
measure: BMI
timeFrame: at baseline
measure: Pre-existing pulmonary disease y/n
timeFrame: at baseline
measure: Main co-morbidities y/n
timeFrame: at baseline
measure: Date of signs of COVID-19 infection
timeFrame: at baseline or date of occurence
measure: Date of positive swab
timeFrame: at baseline or date of occurence
measure: Pre-ECMO length of hospital stay
timeFrame: at or during ECMO-implant
measure: Pre-ECMO length of ICU stay
timeFrame: at or during ECMO-implant
measure: Pre-ECMO length of mechanical ventilation days
timeFrame: at or during ECMO-implant
measure: Use of antibiotics
timeFrame: up to 6 months
measure: Use of anti-viral treatment
timeFrame: up to 6 months
measure: Use of second line treatment
timeFrame: up to 6 months
measure: Indications for ECMO-implant
timeFrame: at ECMO-implant
measure: Type of ECMO-implant
timeFrame: at ECMO-implant
measure: Type of access
timeFrame: at ECMO-implant
measure: Date of ECMO implant
timeFrame: at ECMO-implant
measure: ECMO blood flow rate
timeFrame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
measure: ECMO gas flow rate
timeFrame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
measure: ECMO configuration change
timeFrame: up to 6 months
measure: Date of ECMO configuration change
timeFrame: up to 6 months
measure: New ECMO configuration
timeFrame: up to 6 months
measure: Indications for ECMO configuration change
timeFrame: up to 6 months
measure: Ventilator setting on ECMO
timeFrame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
measure: Anticoagulation during ECMO
timeFrame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
measure: Frequency of ECMO circuit change
timeFrame: up to 6 months
measure: ECMO complications
timeFrame: up to 6 months
measure: ECMO Weaning
timeFrame: from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months
measure: ICU discharge
timeFrame: from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months
measure: Main cause of death
timeFrame: 6 months
measure: Type of discharge
timeFrame: up to 6 months
measure: Alive/deceased
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Universitätskliniken Innsbruck
city: St.Pölten
country: Austria
facility: Landesklinikum Sankt Polten
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Aalst
country: Belgium
facility: Onze Lieve Vrouwziekenhuis Aalst
city: Antwerp
country: Belgium
facility: University Hospital, Antwerp
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire Saint Pierre
city: Brussels
country: Belgium
facility: Chirec
city: Brussel
country: Belgium
facility: Erasme University Hospital
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Charleroi
country: Belgium
facility: Hôpital Civil Marie Curie de Charleroi
city: Ghent
country: Belgium
facility: University Hospital, Ghent
city: La Louvière
country: Belgium
facility: La Louvière Hopital
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Liège
country: Belgium
facility: CHU de Liege
city: Praha
country: Czechia
facility: Charles University, Czech Republic
city: Praha
country: Czechia
facility: General University Hospital, Prague
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital at Herlev
city: Bourdeaux
country: France
facility: University Hospital, Bordeaux
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Montpellier
country: France
facility: University Hospital, Montpellier
city: Paris
country: France
facility: Henri Mondor University Hospital
city: Paris
country: France
facility: Paris South University Hospitals
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Aachen
country: Germany
facility: University Hospital, Aachen
city: Berlin
country: Germany
facility: German Heart Center
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Essen
country: Germany
facility: Children's Medical Hospital, University of Essen, Essen, Germany
city: Essen
country: Germany
facility: University Hospital, Essen
city: Freiburg
country: Germany
facility: University Heart Center Freiburg - Bad Krozingen
city: Hannover
country: Germany
facility: Hannover Medical School
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Leipzig
country: Germany
facility: Heart Center Leipzig - University Hospital
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
city: Alexandroupolis
country: Greece
facility: University Hospital, Alexandroupolis
city: Budapest
country: Hungary
facility: Heim Pal Children's Hospital
city: Jerusalem
country: Israel
facility: ECMO Centers Israel
city: Alessandria
country: Italy
facility: San Giorgio Clinic
city: Ancona
country: Italy
facility: Ospedali Riuniti Ancona
city: Bergamo
country: Italy
facility: Papa Giovanni XXIII Hospital
city: Bologna
country: Italy
facility: St. Orsola Hospital
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Cesena
country: Italy
facility: Ospedale Maurizio Bufalini
city: Genua
country: Italy
facility: Gaslini Children's Hospital
city: Massa
country: Italy
facility: G. Pasquinucci Heart Hospital, Massa
city: Milano
country: Italy
facility: Policlinico Hospital Milan
city: Milan
country: Italy
facility: Niguarda Hospital
city: Milan
country: Italy
facility: Ospedale San Donato
city: Milan
country: Italy
facility: San Raffaele University Hospital, Italy
city: Monza
country: Italy
facility: San Gerardo Hospital
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo
city: Puglia
country: Italy
facility: GVM Care & Research
city: Roma
country: Italy
facility: Bambino Gesù Hospital and Research Institute
city: Roma
country: Italy
facility: San Camillo Hospital, Rome
city: Turin
country: Italy
facility: A.O.U. Città della Salute e della Scienza - Molinette Hospital
city: Turin
country: Italy
facility: Mauriziano Umberto I Hospital
city: Turin
country: Italy
facility: Ospedale S. Giovanni Bosco
city: Udine
country: Italy
facility: University Hospital, Udine, Italy
city: Venice
country: Italy
facility: Ospedale dell'Angelo, Venezia-Mestre
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Groningen
country: Netherlands
facility: University of Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Porto
country: Portugal
facility: Hospital Sao Joao
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Hospital
city: Ekaterinburg
country: Russian Federation
facility: City Hospital No 41, Ekaterinburg, Russia
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash
city: Krasnodar
country: Russian Federation
facility: Krasnodar Regional Hospital no 1
city: Moscow
country: Russian Federation
facility: City Clinical Hospital No. 67, Moscow, Russia
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk City Hospital #2
city: Saint Petersburg
country: Russian Federation
facility: City Hospital No 40, Saint Petersburg, Russia
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Deu
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Lund
country: Sweden
facility: Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Basel
country: Switzerland
facility: University Hospital, Basel, Switzerland
city: Bern
country: Switzerland
facility: University of Bern
city: Geneva
country: Switzerland
facility: University Hospital, Geneva
city: Lausanne
country: Switzerland
facility: University of Lausanne Hospitals
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Zürich
country: Switzerland
facility: Klinik Hirslanden, Zurich
city: Zürich
country: Switzerland
facility: University of Zurich
city: Brompton
country: United Kingdom
facility: Royal Brompton & Harefield NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Paediatric Intensive Care Glasgow
city: Leicester
country: United Kingdom
facility: Leicester Children's Hospital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle-upon-Tyne Hospitals NHS Trust
Study officials:
affiliation: Maastricht University Hospital
name: Lorusso, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
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