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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: ECMO


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial is a prospective randomized multicenter trial that assigns patients to either a treatment for ARDS with an ECMO immediately after admission to the intensive care unit or conservative treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early ECMO<br>ECMO is placed immediately after admission to the intensive care unit | Device: ECMO<br>* ECMO implantation immediately after ICU admission<br>|
| No Intervention: Control<br>Conservative therapy unless failure of therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 day all cause mortality | 28 day all cause mortality | 28 day after study inclusion | 
| 90 day all cause mortality | 90 day all cause mortality | 90 day after study inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sepsis-related organ failure assessment score (SOFA) Organ Failure Scores | SOFA Organ Failure Scores | 1-14, 28 and 90 days after study inclusion | 
| Delirium | Occurence of Delirium (positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)) | 28 and 90 day after discharge of ICU | 
| discharge location | discharge location: a) home, b) skilled nursing facility, c) rehabilitation unit | 28 and 90 day after discharge of ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Respiratory Distress Syndrome, Extracorporal membrane Oxygenation, Outcome, Ventilation Therapy, QOL