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CompletedNCT05338593Updated Aug 29, 2023

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

An observational study in Extracorporeal Membrane Oxygenation Complication and Outcome, Fatal, sponsored by Goethe University. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-29.

Sponsored by Goethe University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Extracorporeal Membrane Oxygenation Complication
  • Outcome, Fatal

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In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's enrollment of 100 is below the median of 130 across 867 observational studies indexed under Critical Illness.

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Lead sponsor

Goethe University is the lead sponsor of 97 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically affected patients treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO). Based on severe acute respiratory distress syndrome (ARDS) and prolonged therapy for more than 2 weeks.

Inclusion criteria

veno-venous extracorporeal membrane oxygenation

Exclusion criteria

Exclusion Criteria:

veno-arterial extracorporeal membrane oxygenation

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • prolonged veno-venous extracorporeal membrane oxygenation

    Critically affected patients treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO). Based on severe acute respiratory distress syndrome (ARDS) and prolonged therapy for more than 2 weeks.

    Other: Outcome

Interventions

  • OtherOutcome

    Mortality rate of prolonged therapy.

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What researchers measure

Primary outcomes

  1. Mortality

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

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

Secondary outcomes

  1. Major bleeding

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

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

  2. critical device error

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

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

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Study locations

1 site
  • University Hospital Frankfurt
    Frankfurt, Hessen 60590, Germany
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References and documents

Individual participant data

Plan to share: No — Sharing patient data is not possible due to national and local legal restrictions.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05338593
Lead sponsor
Goethe University
Responsible party
Armin N. Flinspach (Principal Investigator, Goethe University) — Principal investigator
First posted
Apr 21, 2022
Start date
May 1, 2022
Primary completion
May 1, 2023
Completion
May 15, 2023
Last update
Aug 29, 2023

Study contacts

Armin N Flinspach, M.D.
principal investigator · JWGoethe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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