Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:

Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05338593
• Other study ID #: prolonged VV-ECMO
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: August 2023
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In the context of the coronavirus (COVID-19) pandemic, healthcare systems worldwide faced an unprecedented shortage of severe ARDS. Critically affected patients were treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO) for complete respiratory failure early in the pandemic. Due to a shortage of resources in the sense of terminal equipment and adequately trained personnel with appropriate expertise in many countries and regions, a strict selection of suitable patients was made. Repeatedly, it was observed that patients under VV-ECMO also needed several weeks to recover sufficiently to generate device sufficient gas exchange. Due to the scarcity of VV-ECMO resources outside of the pandemic, the question arose whether a prolonged therapy still holds a sufficient prospect of success and what the course of treatment of such patients would be like.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 15, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

veno-venous extracorporeal membrane oxygenation

Exclusion Criteria:

veno-arterial extracorporeal membrane oxygenation

Related Conditions & MeSH terms

• Critical Illness
• Extracorporeal Membrane Oxygenation Complication
• Outcome, Fatal

Intervention

Other:
• Outcome
Mortality rate of prolonged therapy.

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality rate under ongoing veno-venous extracorporeal membrane oxygenation over time	During intensive care treatment (Usually within 25 weeks)
Secondary	Major bleeding	Number of patients with critical bleeding events during therapy, needing red blood cell transfusion	During intensive care treatment (Usually within 25 weeks)
Secondary	critical device error	Number of patients with a critical device errors of the veno-venous extracorporeal membrane oxygenation device.	During intensive care treatment (Usually within 25 weeks)