European/Euro-ELSO Survey on Adult and Neonatal/ Pediatric COVID-19 Patients in ECMO (EuroECMO-COVID)
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|ClinicalTrials.gov Identifier: NCT04366921|
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|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|
- Age [ Time Frame: at baseline ]age in years
- Gender [ Time Frame: at baseline ]male/female
- Weight [ Time Frame: at baseline ]in kilograms
- Height [ Time Frame: at baseline ]in meters
- BMI [ Time Frame: at baseline ]weight and height combined to calculate BMI in kg/m^2
- 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
- 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
- Date of signs of COVID-19 infection [ Time Frame: at baseline or date of occurence ]in dd-mm-yyyy or mm-dd-yyyy
- Date of positive swab [ Time Frame: at baseline or date of occurence ]in dd-mm-yyyy or mm-dd-yyyy
- Pre-ECMO length of hospital stay [ Time Frame: at or during ECMO-implant ]in days
- Pre-ECMO length of ICU stay [ Time Frame: at or during ECMO-implant ]in days
- Pre-ECMO length of mechanical ventilation days [ Time Frame: at or during ECMO-implant ]in days
- Use of antibiotics [ Time Frame: up to 6 months ]y/n, what kind
- Use of anti-viral treatment [ Time Frame: up to 6 months ]y/n, what kind
- Use of second line treatment [ Time Frame: up to 6 months ]y/n, what kind (eg prone-position, recruitment manoeuvers, neuromuscular blockade etc)
- Indications for ECMO-implant [ Time Frame: at ECMO-implant ]respiratory or cardiac
- Type of ECMO-implant [ Time Frame: at ECMO-implant ]veno-venous, veno-arterial or veno-venoarterial
- Type of access [ Time Frame: at ECMO-implant ]peripheral or central
- Date of ECMO implant [ Time Frame: at ECMO-implant ]in dd-mm-yyyy or mm-dd-yyyy
- 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
- 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
- ECMO configuration change [ Time Frame: up to 6 months ]y/n
- Date of ECMO configuration change [ Time Frame: up to 6 months ]in dd-mm-yyyy or mm-dd-yyyy
- New ECMO configuration [ Time Frame: up to 6 months ]veno-venous, veno-arterial, veno-venoarterial, other
- Indications for ECMO configuration change [ Time Frame: up to 6 months ]right ventricular failure, left ventricular failure, refractory hypoxemia
- 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
- 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
- Frequency of ECMO circuit change [ Time Frame: up to 6 months ]amount of ECMO circuit changes (1, 2, 3 etc.)
- ECMO complications [ Time Frame: up to 6 months ]Hemorrhagic, infection, other complications
- 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
- 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
- Main cause of death [ Time Frame: 6 months ]
- Type of discharge [ Time Frame: up to 6 months ]Ward, another ICU, rehabilitation center, home
- Alive/deceased [ Time Frame: 6 months ]
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
|Contact: Lorusso, Prof. Dr.||+ 31(0) email@example.com|
|Principal Investigator:||Lorusso, Prof. Dr.||Maastricht University Hospital|