Early Versus Late Initiation of ECMO (Extracorporal Membrane Oxygenation) Trial (ELIEO-Trial)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Early ECMO ECMO is placed immediately after admission to the intensive care unit |
Device: ECMO
ECMO implantation immediately after ICU admission
|
| No Intervention: Control Conservative therapy unless failure of therapy. |
Outcome Measures
Primary Outcome Measures
- 28 day all cause mortality [28 day after study inclusion]
28 day all cause mortality
- 90 day all cause mortality [90 day after study inclusion]
90 day all cause mortality
Secondary Outcome Measures
- Sepsis-related organ failure assessment score (SOFA) Organ Failure Scores [1-14, 28 and 90 days after study inclusion]
SOFA Organ Failure Scores
- Delirium [28 and 90 day after discharge of ICU]
Occurence of Delirium (positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU))
- discharge location [28 and 90 day after discharge of ICU]
discharge location: a) home, b) skilled nursing facility, c) rehabilitation unit
Eligibility Criteria
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University hospital Tübingen | Tübingen | Germany | 72076 |
Sponsors and Collaborators
- University Hospital Tuebingen
Investigators
- Principal Investigator: Peter Rosenberger, Prof., University hospital Tübingen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ELIEO