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

Acute Respiratory Distress Syndrome Clinical Trial

Official title: Early Versus Late Initiation of ECMO Trial (ELIEO-Trial)

Status Not yet recruiting

Clinical Trial 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 96h of the onset of symptoms of ARDS and will be randomized according to standard procedure. Follow-up will be performed until hospital discharge.

Clinical Trial 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 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 28-days. Key secondary endpoints are: 1) 90 day all cause mortality 3) ICU length of stay 4) duration of mechanical ventilation support 5) frequency and duration of renal replacement therapy 6) bleeding requiring transfusions in the ICU 7) SOFA score ;

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

• NCT number: NCT04208126
• Study type: Interventional
• Source: University Hospital Tuebingen
• Contact: Peter Rosenberger, Prof.
• Phone: +49707129
• Email: peter.rosenberger@med.uni-tuebingen.de
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Completion date: August 2025