Currently submitted to: JMIR Research Protocols
Date Submitted: Oct 28, 2025
Open Peer Review Period: Oct 28, 2025 - Dec 23, 2025
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Early versus Late Initiation of ECMO (ELIEO): study protocol of a prospective, randomized, multicenter study
ABSTRACT
Background:
Acute respiratory distress syndrome (ARDS) is caused by an acute pulmonary inflammation, resulting in significant hypoxia. Current treatment is symptomatic, using mechanical ventilation, and in extreme cases the initiation of extracorporeal membrane oxygenation (ECMO).
Objective:
Uncertainty exists regarding the optimal timing of initiation of veno-venous ECMO therapy. In the “Early versus Late Initiation of vvECMO” (ELIEO) trial, we aimed to investigate the impact of early ECMO initiation on outcome in ARDS patients.
Methods:
ELIEO is a prospective randomized multicenter trial assessing whether early initiation of vvECMO could result in improved outcomes in ARDS. Five hundred and eight patients suffering from severe ARDS will be divided into two groups: patients in Group A will begin ECMO therapy within 24 h after admission to the ICU of an ECMO center, while patients in Group B will receive standard treatment according to ARDS Network guidelines and ECMO therapy as a rescue therapy only. During follow-up visits (days 28 and 90), the functional status of patients will be evaluated. The primary endpoint is survival during the 90-d follow-up period. Secondary endpoints include SOFA scores, bleeding complications and ICU-related complications.
Results:
The results of the ELIEO trial will highlight the importance of the time point at which vvECMO therapy is initiated in patients with severe ARDS.
Conclusions:
Given the enormous challenge patients with ARDS pose to the health care system, the findings of this trial might have a significant impact on the structuring of intensive care units and on ARDS therapies. Clinical Trial: The ELIEO trial was first approved by the local ethics committee (University Tübingen, Germany) on December 18, 2020. The trial is registered at clinicaltrials.gov (NCT04208126).
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