JMIR Publications

ABSTRACT

Background:

Acute respiratory distress syndrome (ARDS) is characterized by severe inflammatory lung injury leading to life-threatening hypoxemia. Standard treatment includes lung-protective mechanical ventilation and adjunctive measures, while veno-venous extracorporeal membrane oxygenation (vvECMO) is used as rescue therapy in refractory cases. However, the optimal timing for initiation of vvECMO remains uncertain, with official recommendations naming it as a rescue therapy, while there is emerging evidence that implementation of vvECMO earlier on in the disease might hold benefits.

Objective:

The Early versus Late Initiation of vvECMO (ELIEO) trial aims to determine whether early initiation of vvECMO improves survival and clinical outcomes compared with a conventional strategy in patients with severe ARDS.

Methods:

ELIEO is a prospective, randomized, multicenter clinical trial enrolling 508 adult patients with severe ARDS. Participants will be randomized to one of two groups: (A) early vvECMO initiation within 24 hours after admission to the intensive care unit (ICU) of an ECMO center, or (B) conventional management according to ARDS Network guidelines with vvECMO used only as rescue therapy. All-cause mortality at day 90 as the primary outcome will be analyzed using a two-sided log-rank test within an O’Brien–Fleming group-sequential design. Secondary endpoints include Sequential Organ Failure Assessment (SOFA) scores, functional status at days 28 and 90, bleeding events, and ICU-related complications and will be analyzed using appropriate regression and nonparametric methods, with adjusted Cox models for sensitivity analyses.

Results:

Patient recruitment started on March 1, 2025 and is ongoing; the approximate completion is expected for August 2028. An interim analysis is planned after the 94th patient. The trial is designed to evaluate whether early initiation of vvECMO reduces 90-day mortality and improves organ function and functional recovery compared with a conventional rescue strategy. Results will be reported after completion of enrollment and follow-up.

Conclusions:

The ELIEO trial will provide robust evidence regarding the optimal timing of vvECMO initiation in severe ARDS. The findings may influence clinical decision-making, resource allocation, and organizational strategies for the management of ARDS in specialized intensive care settings. Clinical Trial: ClinicalTrials.gov: NCT04208126. Approved by the Ethics Committee of the University of Tübingen, Germany (December 18, 2020).