Clinical trial NCT04383678: Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome
Official title: Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome: A Multicenter European Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Extracorporeal Membrane Oxygenation Complication
Acute Respiratory Distress Syndrome
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PCR-confirmed or suspected COVID-19 infection with ARDS who require veno-venous or veno-arterial ECMO therapy

Brief summary: This study aims to investigate outcomes and predictors of outcome after extracorporeal membrane oxygenation (ECMO) therapy for severe acute respiratory syndrome (ARDS) in COVID-19 patients.

Detailed description: We evaluated the outcome of adult patients with coronavirus disease 2019 (COVID-19)-related acute respiratory distress syndrome (ARDS) requiring the use of extracorporeal membrane oxygenation (ECMO).

Eligibility criteria: Inclusion Criteria:

* PCR-confirmed or suspected COVID-19 infection with ARDS who require any ECMO therapy

Exclusion Criteria:

* None

Primary outcomes:
measure: In-hospital mortality
timeFrame: Immediately after the intervention/procedure/surgery
Secondary outcomes:
measure: Death on ECMO
timeFrame: During the intervention/procedure/surgery
measure: Stroke
timeFrame: Immediately after the intervention/procedure/surgery
measure: Blood stream infection
timeFrame: Immediately after the intervention/procedure/surgery
measure: Lung complications requiring surgical treatment
timeFrame: Immediately after the intervention/procedure/surgery
measure: Blood transfusion
timeFrame: Immediately after the intervention/procedure/surgery
measure: Acute kidney injury
timeFrame: Immediately after the intervention/procedure/surgery
measure: Duration of mechanical ventilation
timeFrame: During index hospital stay follow-up until 1 year after ECMO initiation
measure: Deep vein thrombosis
timeFrame: Immediately after the intervention/procedure/surgery
measure: Pulmonary embolism
timeFrame: Immediately after the intervention/procedure/surgery
measure: Length of intensive care unit stay
timeFrame: Immediately after the intervention/procedure/surgery
measure: Length of hospital stay
timeFrame: Immediately after the intervention/procedure/surgery
measure: Death after hospital discharge
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Besançon
country: France
facility: University Hospital Jean Minjoz
city: Nancy
country: France
facility: Nancy University Hospital
city: Paris
country: France
facility: Henri Mondon Unoversity Hospital
city: Reims
country: France
facility: Robert Debré University Hospital
city: Hamburg
country: Germany
facility: Hamburg University Heart Center
city: Münster
country: Germany
facility: Münster University Hospital
city: Bologna
country: Italy
facility: S. Orsola Hospital
city: Lecco
country: Italy
facility: Lecco Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
Study officials:
affiliation: Helsinki University Central Hospital
name: Fausto Biancari, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biancari F, Mariscalco G, Dalen M, Settembre N, Welp H, Perrotti A, Wiebe K, Leo E, Loforte A, Chocron S, Pacini D, Juvonen T, Broman LM, Perna DD, Yusuff H, Harvey C, Mongardon N, Maureira JP, Levy B, Falk L, Ruggieri VG, Zipfel S, Folliguet T, Fiore A. Six-Month Survival After Extracorporeal Membrane Oxygenation for Severe COVID-19. J Cardiothorac Vasc Anesth. 2021 Jul;35(7):1999-2006. doi: 10.1053/j.jvca.2021.01.027. Epub 2021 Jan 19.