Clinical trial NCT05353725: Extracorporeal Membrane Oxygenation in Coronavirus Disease (COVID-19), Influenza and ARDS of Other Ethiologies
Official title: Extracorporeal Membrane Oxygenation in COVID-19, Influenza and ARDS of Other Ethiologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
COVID-19
Influenza
Keywords: Extracorporeal Membrane Oxygenation
ARDS
COVID-19
Influenza
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO)

Brief summary: A comparison of clinical characteristics and outcomes of patients on extracorporeal membrane oxygenation (ECMO) in COVID-19, influenza and ARDS of other ethiologies

Detailed description: All ARDS patients on extracorporeal membrane oxygenation (ECMO) during January 1st 2016 and January 10th 2022 in University Medical Center Ljubljana were included and their clinical characteristics and outcomes were studied according to ARDS ethiology: COVID-19, influenza and other ethiologies.

Eligibility criteria: Inclusion Criteria:

* Patient with acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO)
* 18 years or older

Exclusion Criteria:

* Patient not eligible for ECMO treatment per institutional guidelines (terminal illness, palliative care)

Primary outcomes:
measure: 180-day survival
timeFrame: From day of ECMO-implant for every 24 hours until date of death or survival at 180 days
Secondary outcomes:
measure: Days on ECMO
timeFrame: From day of ECMO-implant for every 24 hours until date of weaning or death
measure: Weaning from ECMO
timeFrame: From day of ECMO-implant until date of death or weaning
measure: ICU length of stay
timeFrame: From day of ICU-admission for every 24 hours until date of death or date of ICU discharge
measure: ICU survival
timeFrame: From day of ICU-admission for every 24 hours until date of death or survival at ICU discharge
measure: Hospital survival
timeFrame: From day of hospital admission for every 24 hours until date of death or survival at hospital discharge
measure: 30-day survival
timeFrame: From day of ECMO-implant for every 24 hours until date of death or survival at 30 days
measure: 90-day survival
timeFrame: From day of ECMO-implant for every 24 hours until date of death or survival at 90 days
Other outcomes:
Locations:
Study officials:
References:
citation: Fanelli V, Giani M, Grasselli G, Mojoli F, Martucci G, Grazioli L, Alessandri F, Mongodi S, Sales G, Montrucchio G, Pizzi C, Richiardi L, Lorini L, Arcadipane A, Pesenti A, Foti G, Patroniti N, Brazzi L, Ranieri V. Extracorporeal membrane oxygenation for COVID-19 and influenza H1N1 associated acute respiratory distress syndrome: a multicenter retrospective cohort study. Crit Care. 2022 Feb 5;26(1):34. doi: 10.1186/s13054-022-03906-4.
citation: Chong WH, Saha BK, Medarov BI. A systematic review and meta-analysis comparing the clinical characteristics and outcomes of COVID-19 and influenza patients on ECMO. Respir Investig. 2021 Nov;59(6):748-756. doi: 10.1016/j.resinv.2021.07.006. Epub 2021 Aug 17.
citation: Blazoski CM, Baram M, Yang Q, Hirose H. Outcomes of extracorporeal membrane oxygenation in influenza versus COVID-19 during the first wave of COVID-19. J Card Surg. 2021 Oct;36(10):3740-3746. doi: 10.1111/jocs.15888. Epub 2021 Aug 9.