NCT04208126

Early Versus Late Initiation of ECMO (Extracorporal Membrane Oxygenation) Trial (ELIEO-Trial)

Early Versus Late Initiation of ECMO Trial (ELIEO-Trial)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 508 (estimated)
• Sponsor: University Hospital Tuebingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a prospective randomized multicenter trial that assigns patients to either a treatment for Acute Respiratory Distress Syndrome (ARDS) with an Extracorporal Membrane Oxygenation (ECMO) immediately after admission to the intensive care unit or conservative treatment. The later can undergo ECMO following failure of conservative therapy as a rescue therapy. Patients will be included within 24 hours of the onset of symptoms of ARDS and will be randomized according to standard procedure. Follow-up will be performed until day 90 after study inclusion.

Detailed description

Patients suffering acute ARDS defined according to the Berlin Definition starting from severe stage with acute onset and (i) ratio partial arterial pressure of oxygen fraction of inspired oxygen inspired oxygen fraction (PaO2/ FiO2) ≤ 200 (ii) Bilateral opacities consistent with pulmonary edema on frontal chest radiograph, and (iii) requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation (iv) no clinical evidence of left atrial hypertension, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mm Hg (v) less than 96 hours from onset of ARDS (vi) less than 7 days from the initiation of mechanical ventilation will be treated by ECMO either within 24 hours to referral to an ARDS ECMO center or as rescue therapy after failure of conventional therapy. Outcome measures have been chosen according to robustness and sensitivity to change. They are of high clinical impact and reflect the treatment effect desired by clinicians. Primary efficacy endpoint: All cause mortality by 90-days. Key secondary endpoints are: 2\. 28 day all cause mortality 3. SOFA Organ Failure Scores at day at day 1-7, 14, 28 and 90 days 4. Duration of mechanical ventilation support 5. ICU length of stay

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
DEVICE	ECMO	ECMO implantation immediately after ICU admission

Timeline

• Start date: 2025-03-01
• Primary completion: 2028-08-01
• Completion: 2028-12-01
• First posted: 2019-12-23
• Last updated: 2025-05-23

Locations

1 site across 1 country: Germany