Acute Respiratory Distress SyndromeELIEONCT04208126
Early Versus Late Initiation of ECMO (Extracorporal Membrane Oxygenation) Trial (ELIEO-Trial)
A study testing ECMO in people with Acute Respiratory Distress Syndrome, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- ECMO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University hospital Tübingen
Tübingen, 72076
Peter Rosenberger, Prof., +49707129 ext. 86622, peter.rosenberger@med.uni-tuebingen.de
About this study
Official title: Early Versus Late Initiation of ECMO Trial (ELIEO-Trial)
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.
Read the 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 (v) less than 96 hours from onset of ARDS (vi) less than 7 days from the initiation of mechanical ventilation 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 90-days.
Key secondary endpoints are:
- 28 day all cause mortality 3. SOFA Organ Failure Scores at day at day 1-7, 14, 28 and 90 days 4. Duration of mechanical ventilation support 5. ICU length of stay
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- ECMO
- Keywords
- Acute Respiratory Distress Syndrome, Extracorporal membrane Oxygenation, Outcome, Ventilation Therapy, QOL
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMODevice
ECMO implantation immediately after ICU admission
| Study group | Role | What they receive |
|---|---|---|
| Early ECMO | Active comparator | ECMO is placed immediately after admission to the intensive care unit Receives: Device: ECMO |
| Control | No intervention | Conservative therapy unless failure of therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 day all cause mortality
90 day all cause mortality
Measured: 90 days after study inclusion
Secondary outcomes (4)
Sepsis-related organ failure assessment score (SOFA) Organ Failure Scores
SOFA Organ Failure Scores
Measured: 1-14, 28 and 90 days after study inclusion
Duration of mechanical ventilation
Duration of mechanical ventilation
Measured: within 90 days after study inclusion
28 day all cause mortality
28 day all cause mortality
Measured: 28 days after study inclusion
ICU length of stay
overall length of stay on ICU
Measured: overall length of stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start1 Mar 2025
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Rosenberger, Prof., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208126
- Sponsor's protocol ID
- ELIEO
- Acronym
- ELIEO
- Status last verified
- May 2025
- First submitted
- 5 Dec 2019
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bernard A, Haeberle H, Mirakaj V, Zago M, Koeppen M, Fodi CK, Martus P, Rosenberger P. Early vs Late Initiation of Extracorporeal Membrane Oxygenation: Protocol for a Prospective, Randomized, Multicenter Study. JMIR Res Protoc. 2026 Jun 17;15:e86652. doi: 10.2196/86652.
PubMed 42308517
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Late Initiation of ECMO Trial (ELIEO-Trial)
- ClinicalTrials.gov ID
- NCT04208126
- Acronym / sponsor ID
- ELIEO / ELIEO
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, Extracorporal membrane Oxygenation, Outcome, Ventilation Therapy, QOL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 508 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (v) less than 96 hours from onset of ARDS (vi) less than 7 days from the initiation of mechanical ventilation 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 90-days.
Key secondary endpoints are:
- 28 day all cause mortality 3. SOFA Organ Failure Scores at day at day 1-7, 14, 28 and 90 days 4. Duration of mechanical ventilation support 5. ICU length of stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Early ECMO | Active comparator | Device: ECMOECMO is placed immediately after admission to the intensive care unit |
| Control | No intervention | –Conservative therapy unless failure of therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECMOECMO implantation immediately after ICU admission | Device | Early ECMO |
Primary outcome
90 day all cause mortality
Time frame: 90 days after study inclusion
90 day all cause mortality
4 secondary outcomes
Sepsis-related organ failure assessment score (SOFA) Organ Failure Scores
Time frame: 1-14, 28 and 90 days after study inclusion
Duration of mechanical ventilation
Time frame: within 90 days after study inclusion
28 day all cause mortality
Time frame: 28 days after study inclusion
ICU length of stay
Time frame: overall length of stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Derived from this study: PubMed 42308517Bernard A, Haeberle H, Mirakaj V, Zago M, Koeppen M, Fodi CK, Martus P, Rosenberger P. Early vs Late Initiation of Extracorporeal Membrane Oxygenation: Protocol for a Prospective, Randomized, Multicenter Study. JMIR Res Protoc. 2026 Jun 17;15:e86652. doi: 10.2196/86652.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Rosenberger, Prof. principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECMO in people with Acute Respiratory Distress Syndrome, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Rosenberger, Prof. (+49707129 ext. 86622, peter.rosenberger@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90 day all cause mortality (time frame: 90 days after study inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.