Comparing early and late ECMO treatment for severe respiratory failure
Official title: Early Versus Late Initiation of ECMO Trial (ELIEO-Trial)
Run by University Hospital Tuebingen · NCT04208126 · Data updated 2026-11-12
This study is testing whether starting ECMO treatment right away or waiting to see if other treatments work first is better for people with severe respiratory failure caused by ARDS.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 508 (estimated) |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | August 2028 |
| Study ends | December 2028 |
| Registry record updated | May 23, 2025 |
| Trial ID | NCT04208126 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have been diagnosed with severe ARDS within 96 hours of symptom onset.
✕Probably not a fit
Patients who are not committed to full intensive care support or those who are pregnant will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial is a prospective randomized multicenter trial that investigates the timing of Extracorporal Membrane Oxygenation (ECMO) treatment in patients with Acute Respiratory Distress Syndrome (ARDS). Patients will be assigned to receive ECMO immediately upon admission to the intensive care unit or to undergo conservative treatment initially, with ECMO as a rescue option if conservative therapy fails. The study aims to enroll patients within 24 hours of ARDS symptom onset and will follow them for 90 days to assess outcomes such as mortality and organ failure scores.
Why it matters
Potential benefit: If successful, this study could improve survival rates and quality of life for patients with severe ARDS.
How similar studies have gone: Previous studies have explored ECMO in ARDS, but this specific timing comparison is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * ARDS as defined according to the Berlin Definition1 * The term "acute onset" is defined as follow: the duration of the hypoxemia criterion and the chest radiograph criterion must be ≤ 7 days at the time of randomization. * Patients must be enrolled within 96 hours of onset of ARDS and no later than 7 days from the initiation of mechanical ventilation. Exclusion Criteria: * Age less than 18 years * More than 7 days since initiation of mechanical ventilation * more than 96 hours since meeting inclusion criteria * patient, surrogate or physician not committed to full intensive care support * pregnancy
Where it's running
-
University hospital Tübingen
Tübingen, Germany Recruiting
Study contacts
- Principal investigator: Peter Rosenberger, Prof. — University Hospital Tuebingen
- Study coordinator: Peter Rosenberger, Prof.
- Email: peter.rosenberger@med.uni-tuebingen.de
- Phone: +49707129
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This project will follow adults with ARDS on mechanical ventilation to see how positive‑pressure breathing affects the right heart over time and how that relates to circulation.
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Umbilical‑cord mesenchymal stem cell and secretome therapy for severe ARDS
This trial tests whether IV umbilical‑cord mesenchymal stem cells, alone or with secretome, help adults with severe ARDS recover lung function and reduce inflammation.
-
Human umbilical cord mesenchymal stem cell injection for moderate to severe ARDS
This will test whether a single injection of human umbilical cord mesenchymal stem cells can help adults with moderate to severe ARDS that hasn't improved after standard treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.