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OpenTrials
Completed

NCT Number: NCT05338593

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

veno-venous extracorporeal membrane oxygenation

Exclusion criteria

veno-arterial extracorporeal membrane oxygenation

Treatment and study plan

Outcome

Other

Mortality rate of prolonged therapy.

Primary outcomes

  1. Mortality

    Time frame: During intensive care treatment (Usually within 25 weeks)

    Mortality rate under ongoing veno-venous extracorporeal membrane oxygenation over time

Secondary outcomes

  1. Major bleeding

    Time frame: During intensive care treatment (Usually within 25 weeks)

    Number of patients with critical bleeding events during therapy, needing red blood cell transfusion

  2. critical device error

    Time frame: During intensive care treatment (Usually within 25 weeks)

    Number of patients with a critical device errors of the veno-venous extracorporeal membrane oxygenation device.

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2022
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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