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

NCT04208126 | Recruiting DMC

• 1 other identifier: ELIEO
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome; Extracorporal membrane Oxygenation; Outcome; Ventilation Therapy; QOL

Outcome Measures

Primary Outcomes (1)

• 90 day all cause mortality

  90 day all cause mortality

  90 days after study inclusion

Secondary Outcomes (4)

• Sepsis-related organ failure assessment score (SOFA) Organ Failure Scores

  1-14, 28 and 90 days after study inclusion

• Duration of mechanical ventilation

  within 90 days after study inclusion

• 28 day all cause mortality

  28 days after study inclusion

• ICU length of stay

  overall length of stay

Study Arms (2)

Early ECMO

ACTIVE COMPARATOR

ECMO is placed immediately after admission to the intensive care unit

Device: ECMO

Control

NO INTERVENTION

Conservative therapy unless failure of therapy.

Interventions

ECMO DEVICE

ECMO implantation immediately after ICU admission

Early ECMO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age less than 18 years
• More than 7 days since initiation of mechanical ventilation
• patient, surrogate or physician not committed to full intensive care support
• pregnancy

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University hospital Tübingen

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Peter Rosenberger, Prof.

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Rosenberger, Prof.

CONTACT

+49707129; peter.rosenberger@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 23, 2019
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

DE (1)