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

Acute Respiratory Distress Syndrome Clinical Trial

— ELIEO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04208126
• Other study ID #: ELIEO
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2022
• Est. completion date: August 2025

Study information

• Verified date: January 2022
• Source: University Hospital Tuebingen
• Contact: Peter Rosenberger, Prof.
• Phone: +49707129
• Email: peter.rosenberger[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• ECMO
ECMO implantation immediately after ICU admission

Locations

Country	Name	City	State
Germany	University hospital Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

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