Comparing early and late ECMO treatment for severe respiratory failure
Early Versus Late Initiation of ECMO Trial (ELIEO-Trial)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 508 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT04208126 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with severe ARDS within 96 hours of symptom onset.
Not a fit: Patients who are not committed to full intensive care support or those who are pregnant will not benefit from this study.
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 performed: Previous studies have explored ECMO in ARDS, but this specific timing comparison is novel and has not been extensively tested.
Eligibility criteria
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 this trial is running
Tübingen
- University hospital Tübingen — Tübingen, Germany (Recruiting)
Study contacts
- Principal investigator: Peter Rosenberger, Prof. — University Hospital Tübingen
- Study coordinator: Peter Rosenberger, Prof.
- Email: peter.rosenberger@med.uni-tuebingen.de
- Phone: +49707129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.