European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO
- Conditions
- Extracorporeal Membrane OxygenationCOVIDARDS, HumanRefractory HypoxemiaSARS-CoV-2Cardiogenic ShockSeptic Shock
- Registration Number
- NCT04366921
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Laboratory-confirmed COVID-19 infection by real-time PCR (polymerase chain reaction)
- ECMO for treatment severe lung disease COVID-19 related
- Patients treated with ECMO for other concomitant causes.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Date of signs of COVID-19 infection at baseline or date of occurence in dd-mm-yyyy or mm-dd-yyyy
Weight at baseline in kilograms
Date of positive swab at baseline or date of occurence in dd-mm-yyyy or mm-dd-yyyy
Date of ECMO configuration change up to 6 months in dd-mm-yyyy or mm-dd-yyyy
Anticoagulation during ECMO from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months heparin, bivalirudin, nothing
Frequency of ECMO circuit change up to 6 months amount of ECMO circuit changes (1, 2, 3 etc.)
Main co-morbidities y/n 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
Pre-ECMO length of mechanical ventilation days at or during ECMO-implant in days
Use of second line treatment up to 6 months y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)
Indications for ECMO-implant at ECMO-implant respiratory or cardiac
ECMO blood flow rate from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months l/min
ICU discharge from day of ICU-admission for every 24 hours until date of discharge or death, up to 6 months y/n, date
Age at baseline age in years
Gender at baseline male/female
Height at baseline in meters
Pre-existing pulmonary disease y/n 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
Pre-ECMO length of ICU stay at or during ECMO-implant in days
Date of ECMO implant at ECMO-implant in dd-mm-yyyy or mm-dd-yyyy
Ventilator setting on ECMO from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months settings of ventilator
Alive/deceased 6 months Pre-ECMO length of hospital stay at or during ECMO-implant in days
Type of ECMO-implant at ECMO-implant veno-venous, veno-arterial or veno-venoarterial
Use of antibiotics up to 6 months y/n, what kind
Use of anti-viral treatment up to 6 months y/n, what kind
Type of access at ECMO-implant peripheral or central
ECMO configuration change up to 6 months y/n
Main cause of death 6 months ECMO gas flow rate from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months l/min
New ECMO configuration up to 6 months veno-venous, veno-arterial, veno-venoarterial, other
Indications for ECMO configuration change up to 6 months right ventricular failure, left ventricular failure, refractory hypoxemia
ECMO complications up to 6 months Hemorrhagic, infection, other complications
ECMO Weaning from day of ECMO-implant for every 24 hours until date of weaning or death, up to 6 months y/n
Type of discharge up to 6 months Ward, another ICU, rehabilitation center, home
BMI at baseline weight and height combined to calculate BMI in kg/m\^2
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (97)
Paris South University Hospitals
🇫🇷Paris, France
Henri Mondor University Hospital
🇫🇷Paris, France
Landesklinikum Sankt Polten
🇦🇹St.Pölten, Austria
Medical University of Vienna
🇦🇹Vienna, Austria
Onze Lieve Vrouwziekenhuis Aalst
🇧🇪Aalst, Belgium
Centre Hospitalier Universitaire Saint Pierre
🇧🇪Brussels, Belgium
University Hospital, Antwerp
🇧🇪Antwerp, Belgium
Erasme University Hospital
🇧🇪Brussel, Belgium
Chirec
🇧🇪Brussels, Belgium
La Louvière Hopital
🇧🇪La Louvière, Belgium
Universitaire Ziekenhuizen Leuven
🇧🇪Leuven, Belgium
Charles University, Czech Republic
🇨🇿Praha, Czechia
CHU de Liege
🇧🇪Liège, Belgium
General University Hospital, Prague
🇨🇿Praha, Czechia
Copenhagen University Hospital at Herlev
🇩🇰Copenhagen, Denmark
University Hospital, Bordeaux
🇫🇷Bourdeaux, France
University Hospital, Montpellier
🇫🇷Montpellier, France
Pitié-Salpêtrière Hospital
🇫🇷Paris, France
Rennes University Hospital
🇫🇷Rennes, France
University Hospital, Aachen
🇩🇪Aachen, Germany
German Heart Center
🇩🇪Berlin, 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, Germany
Hannover Medical School
🇩🇪Hannover, Germany
Universitätsklinikum Köln
🇩🇪Köln, Germany
University Hospital, Alexandroupolis
🇬🇷Alexandroupolis, Greece
ECMO Centers Israel
🇮🇱Jerusalem, Israel
St. Orsola Hospital
🇮🇹Bologna, Italy
Gaslini Children's Hospital
🇮🇹Genua, Italy
Ospedale San Donato
🇮🇹Milan, Italy
Bambino Gesù Hospital and Research Institute
🇮🇹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 San Bortolo di Vicenza
🇮🇹Vicenza, Italy
University of Groningen
🇳🇱Groningen, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Chelyabinsk Regional Clinical Hospital
🇷🇺Chelyabinsk, Russian Federation
Krasnodar Regional Hospital no 1
🇷🇺Krasnodar, Russian Federation
Kemerovo Regional Clinical Cardiological Center named after academician L.S. Barbarash
🇷🇺Kemerovo, Russian Federation
City Clinical Hospital No. 67, Moscow, Russia
🇷🇺Moscow, Russian Federation
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Sant Joan de Deu
🇪🇸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
🇨ðŸ‡Basel, Switzerland
University of Bern
🇨ðŸ‡Bern, Switzerland
University of Lausanne Hospitals
🇨ðŸ‡Lausanne, Switzerland
Klinik Hirslanden, Zurich
🇨ðŸ‡Zürich, Switzerland
Cardiocentro Ticino
🇨ðŸ‡Lugano, Switzerland
Royal Brompton & Harefield NHS Foundation Trust
🇬🇧Brompton, United Kingdom
Paediatric Intensive Care Glasgow
🇬🇧Glasgow, United Kingdom
Leicester Children's Hospital
🇬🇧Leicester, United Kingdom
Newcastle-upon-Tyne Hospitals NHS Trust
🇬🇧Newcastle Upon Tyne, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
🇬🇧London, United Kingdom
Heart Center Leipzig - University Hospital
🇩🇪Leipzig, Germany
Policlinico Hospital Milan
🇮🇹Milano, Italy
Niguarda Hospital
🇮🇹Milan, Italy
Heim Pal Children's Hospital
ðŸ‡ðŸ‡ºBudapest, Hungary
Universitair Ziekenhuis Brussel
🇧🇪Brussel, Belgium
University Hospital Tuebingen
🇩🇪Tuebingen, Germany
San Giorgio Clinic
🇮🇹Alessandria, Italy
San Gerardo Hospital
🇮🇹Monza, Italy
IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy
Universitätskliniken Innsbruck
🇦🇹Innsbruck, Austria
Hôpital Civil Marie Curie de Charleroi
🇧🇪Charleroi, Belgium
University Hospital, Ghent
🇧🇪Ghent, Belgium
Ospedali Riuniti Ancona
🇮🇹Ancona, Italy
Azienda Ospedaliera Spedali Civili di Brescia
🇮🇹Brescia, Italy
San Raffaele University Hospital, Italy
🇮🇹Milan, Italy
Ospedale dell'Angelo, Venezia-Mestre
🇮🇹Venice, Italy
Klinikum Nürnberg
🇩🇪Nürnberg, Germany
Papa Giovanni XXIII Hospital
🇮🇹Bergamo, Italy
Ospedale Maurizio Bufalini
🇮🇹Cesena, Italy
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
University Hospital, Geneva
🇨ðŸ‡Geneva, Switzerland
University of Zurich
🇨ðŸ‡Zürich, Switzerland
Hospices Civils de Lyon
🇫🇷Lyon, France
Klinikum Kassel
🇩🇪Kassel, Germany
University Hospital Regensburg
🇩🇪Regensburg, Germany
G. Pasquinucci Heart Hospital, Massa
🇮🇹Massa, Italy
GVM Care & Research
🇮🇹Puglia, Italy
Medical University of Warsaw
🇵🇱Warsaw, Poland
Hospital Sao Joao
🇵🇹Porto, Portugal
San Camillo Hospital, Rome
🇮🇹Roma, Italy
Novosibirsk City Hospital #2
🇷🇺Novosibirsk, Russian Federation
Vilnius University Hospital Santaros Klinikos
🇱🇹Vilnius, Lithuania
City Hospital No 40, Saint Petersburg, Russia
🇷🇺Saint Petersburg, Russian Federation
UMC Utrecht
🇳🇱Utrecht, Netherlands
City Hospital No 41, Ekaterinburg, Russia
🇷🇺Ekaterinburg, Russian Federation
Guy's and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom