Extracorporeal Membrane Oxygenation in Coronavirus Disease (COVID-19), Influenza and ARDS of Other Ethiologies

COVID-19 Clinical Trial

Official title:

Extracorporeal Membrane Oxygenation in COVID-19, Influenza and ARDS of Other Ethiologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05353725
• Other study ID #: ECMO in ARDS
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: March 1, 2022

Study information

• Verified date: April 2022
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Influenza
• Influenza, Human

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	180-day survival	180-day survival from ECMO implantation	From day of ECMO-implant for every 24 hours until date of death or survival at 180 days
Secondary	Days on ECMO	Days on ECMO from ECMO implantation	From day of ECMO-implant for every 24 hours until date of weaning or death
Secondary	Weaning from ECMO	Weaning from ECMO	From day of ECMO-implant until date of death or weaning
Secondary	ICU length of stay	ICU length of stay from ECMO implantation	From day of ICU-admission for every 24 hours until date of death or date of ICU discharge
Secondary	ICU survival	ICU survival from ECMO implantation	From day of ICU-admission for every 24 hours until date of death or survival at ICU discharge
Secondary	Hospital survival	Hospital survival from ECMO implantation	From day of hospital admission for every 24 hours until date of death or survival at hospital discharge
Secondary	30-day survival	30-day survival from ECMO implantation	From day of ECMO-implant for every 24 hours until date of death or survival at 30 days
Secondary	90-day survival	90-day survival from ECMO implantation	From day of ECMO-implant for every 24 hours until date of death or survival at 90 days