Extracorporeal Membrane Oxygenation Complication Clinical Trial
Official title:
Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.
NCT number | NCT05338593 |
Other study ID # | prolonged VV-ECMO |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | May 15, 2023 |
Verified date | August 2023 |
Source | Goethe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Frankfurt | Frankfurt | Hessen |
Lead Sponsor | Collaborator |
---|---|
Goethe University |
Germany,
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) |
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