An observational study in Acute Respiratory Distress Syndrome (ARDS), sponsored by Southeast University, China. Recruiting at 39 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Southeast University, China · Observational
Acute respiratory distress syndrome (ARDS) poses a major threat to human health. Despite extracorporeal membrane oxygenation (ECMO) support, mortality among patients with ARDS remains high due to severe complications and suboptimal mechanical ventilation strategies. Elucidating the mechanisms underlying ECMO-related complications and lung injury repair, and establishing a precision intervention pathway covering the entire course of ECMO management, are urgent unmet needs for improving outcomes in ARDS patients and addressing major public health challenges.
This project focuses on five key scientific questions:
The project consists of five interrelated subprojects:
Subproject 1. Construction of Clinical-Immune Phenotypes and Identification of Therapeutic Targets in Moderate-to-Severe ARDS Clinical phenotypes and longitudinal multidimensional biospecimens collected throughout the disease course in moderate-to-severe ARDS patients, including those receiving ECMO support, will be analyzed to characterize the heterogeneity and spatiotemporal interactions of inflammatory and immune cell subsets and to identify effective therapeutic targets.
Subproject 2. Mechanisms and Interventions for Immune Dysregulation Underlying Severe ECMO-Related Complications This subproject aims to elucidate the inflammatory and immune mechanisms responsible for major complications occurring in ARDS patients receiving ECMO support. Major complications of interest include acute kidney injury, bleeding and thrombosis, and infection.
Subproject 3. Development and Validation of a Clinical-Immune Phenotype-Guided Decision System for Awake ECMO By integrating multidimensional data, a comprehensive ARDS phenotyping framework will be established to identify patients most likely to benefit from awake ECMO. A clinical decision-making system will be developed and subsequently validated through multicenter studies to assess its effectiveness.
Subproject 4. Molecular Mechanisms of Lung Repair and Optimization of Mechanical Ventilation During ECMO Support This subproject will investigate the lung-protective effects of different invasive mechanical ventilation strategies and ventilation parameters during ECMO support. Multi-omics analyses of ARDS biospecimens will be performed to elucidate the mechanisms through which lung rest promotes tissue repair and recovery.
Subproject 5. Establishment and Evaluation of a Full-Cycle ECMO Management Strategy for Moderate-to-Severe ARDS Based on evidence-based medicine and multidisciplinary collaboration, a comprehensive ECMO management pathway covering the entire disease course will be developed for patients with moderate-to-severe ARDS. Real-world studies will be conducted to evaluate its clinical effectiveness and facilitate continuous optimization.
Overall, this project aims to provide mechanistic insights into immune dysregulation, ECMO-related complications, and lung repair, while establishing a precision, full-cycle ECMO management framework to improve outcomes in patients with moderate-to-severe ARDS.**
Acute respiratory distress syndrome (ARDS) poses a major threat to public health and consumes substantial healthcare resources. Based on the National Hospital Quality Monitoring System (HQMS), our group found that more than 2.5 million patients with ARDS are admitted to intensive care units (ICUs) annually in China, resulting in total hospitalization costs of approximately RMB 29.32 billion. The in-hospital mortality rate is about 39%, which is substantially higher than the international average (12-37%). Extracorporeal membrane oxygenation (ECMO) represents the most important rescue therapy for patients with moderate-to-severe ARDS; however, mortality among ARDS patients receiving ECMO support remains as high as 60%. Therefore, reducing mortality in moderate-to-severe ARDS is essential for achieving the goals of the Healthy China 2030 Initiative.
Inflammatory and immune dysregulation occurs in 38.7-70% of patients with ARDS, frequently leading to multiple organ dysfunction. Despite ECMO support, mortality among patients with severe ARDS remains extremely high. Three major challenges contribute to poor outcomes. First, immune dysregulation under ECMO support significantly increases the incidence and mortality of severe complications, while targeted therapeutic strategies based on underlying mechanisms are lacking. Second, the marked heterogeneity of ARDS complicates the identification of optimal timing and modalities of ECMO support. Third, the effects of different invasive mechanical ventilation strategies on lung injury and repair remain poorly understood, and mechanism-guided precision ventilation approaches are still unavailable.
Building upon the largest ARDS and ECMO clinical-biological database in China established by our group, this project aims to develop a Chinese precision management strategy for ECMO-supported patients with moderate-to-severe ARDS.
Perspectives and Expected Impact Focusing on the major challenges in the management of moderate-to-severe ARDS, this project will elucidate the mechanisms responsible for severe complications during ECMO support, establish a multidimensional phenotyping framework to identify patients most likely to benefit from awake ECMO, and decode the mechanisms of lung injury and repair to develop individualized ventilation strategies. Ultimately, this work will provide a comprehensive precision management framework for ECMO-supported ARDS patients, improve the standard of care for moderate-to-severe ARDS in China, and reduce disease-related mortality.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 1,776 is above the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Southeast University, China is the lead sponsor of 168 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of adult patients diagnosed with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS) who are admitted to the Intensive Care Units (ICUs) of participating tertiary hospitals. This cohort includes patients requiring advanced respiratory support, specifically focusing on those managed with or without Extracorporeal Membrane Oxygenation (ECMO) based on clinical indications.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- 1.Patients with a prior tracheostomy. 2.Patients who have received a lung transplant or initiated VV-ECMO support as a bridge to lung transplantation.
3.Patients with comorbid cardiogenic shock requiring VA-ECMO or VAV-ECMO support.
Moderate-to-severe ARDS patients who receive Extracorporeal Membrane Oxygenation (ECMO) support as part of their clinical management.
Moderate-to-severe ARDS patients who receive standard-of-care mechanical ventilation and medical management without Extracorporeal Membrane Oxygenation (ECMO) support.
90-day Mortality
The proportion of participants in each group (ECMO vs. Non-ECMO) who die from any cause within 90 days after enrollment. This will be used to evaluate the survival benefit associated with the precision ECMO salvage system compared to conventional treatment.
Time frame: Up to 90 days after enrollment
Successful Liberation From Mechanical Ventilation
Successful liberation from mechanical ventilation is defined as survival without reintubation or death within 7 days after extubation in patients without tracheostomy, or survival without reconnection to mechanical ventilation or death within 7 days after discontinuation of ventilatory support in patients with tracheostomy.
Time frame: From initiation of invasive mechanical ventilation to 7 days after liberation from mechanical ventilation, assessed up to hospital discharge
ICU Mortality
The proportion of participants who die during the ICU stay will be compared between the pre-implementation usual care group and the post-implementation ECMO management pathway group.
Time frame: From ICU admission to ICU discharge or death, assessed up to 90 days after ECMO initiation
Hospital Mortality
The proportion of participants who die during hospitalization will be compared between the pre-implementation usual care group and the post-implementation ECMO management pathway group.
Time frame: From hospital admission to hospital discharge or death, assessed up to 90 days after ECMO initiation
28-Day All-Cause Mortality
The proportion of participants who die from any cause within 28 days after ECMO initiation will be compared between the pre-implementation usual care group and the post-implementation ECMO management pathway group.
Time frame: From enrollment to 28 days after enrollment.
Bleeding complications during ECMO support
Bleeding complications during ECMO support will be recorded and classified as major or minor bleeding. Major bleeding is defined as life-threatening bleeding, bleeding requiring surgical intervention, or transfusion of ≥2 units of red blood cells within 24 hours due to active bleeding. Minor bleeding is defined as persistent oozing that does not meet the criteria for major bleeding.
Time frame: From ECMO initiation to ECMO discontinuation, ICU discharge, or day 90, whichever occurs first.
Thrombotic complications during ECMO support
Thrombotic complications will include cerebral infarction, pulmonary embolism, venous thrombosis, ECMO circuit thrombosis, and oxygenator thrombosis. ECMO circuit thrombosis is defined as thrombosis requiring replacement of the circuit or any circuit component.
Time frame: From ECMO initiation to ECMO discontinuation, ICU discharge, or day 90, whichever occurs first.
Infectious complications during ECMO support
Infectious complications will be recorded according to infection site, including bloodstream infection, respiratory tract infection, ventilator-associated pneumonia, surgical site infection, catheter-related infection, urinary tract infection, abdominal infection, skin and soft tissue infection, or other infections. The causative pathogen will be recorded when available.
Time frame: From ECMO initiation to ECMO discontinuation, ICU discharge, or day 90, whichever occurs first.
Hemolysis during ECMO support
Hemolysis is defined as plasma-free hemoglobin greater than 50 mg/dL during ECMO support.
Time frame: From ECMO initiation to ECMO discontinuation, ICU discharge, or day 90, whichever occurs first.
Cannulation-related complications during ECMO support
Cannulation-related complications will include vascular injury, cannulation-site bleeding requiring surgical intervention, retroperitoneal bleeding, pneumothorax, cardiac perforation, cardiac tamponade, and limb ischemia.
Time frame: From ECMO initiation to ECMO discontinuation, ICU discharge, or day 90, whichever occurs first.
Acute kidney injury during ECMO support
Acute kidney injury will be defined and staged according to KDIGO criteria. The need for continuous renal replacement therapy will also be recorded.
Time frame: From ECMO initiation to ECMO discontinuation, ICU discharge, or day 90, whichever occurs first.
Oxygenator replacement during ECMO support
Oxygenator replacement is defined as replacement of the ECMO oxygenator during ECMO support. The date and time of replacement will be recorded.
Time frame: From ECMO initiation to ECMO discontinuation, ICU discharge, or day 90, whichever occurs first.
ICU Length of Stay
ICU length of stay is defined as the number of days from ICU admission to ICU discharge or death.
Time frame: From ICU admission to ICU discharge, assessed up to 90 days after ECMO initiation
Respiratory Support at ICU Discharge
Respiratory support status at ICU discharge will be recorded, including tracheostomy, invasive mechanical ventilation, noninvasive ventilation or high-flow nasal cannula, conventional oxygen therapy, or no oxygen therapy.
Time frame: At ICU discharge, assessed up to 90 days after ECMO initiation
Hospital Length of Stay
Hospital length of stay is defined as the number of days from hospital admission to hospital discharge or death.
Time frame: From hospital admission to hospital discharge, assessed up to 90 days after ECMO initiation
Respiratory Support at Hospital Discharge
Respiratory support status at hospital discharge will be recorded, including tracheostomy, invasive mechanical ventilation, noninvasive ventilation or high-flow nasal cannula, conventional oxygen therapy, or no oxygen therapy.
Time frame: At hospital discharge, assessed up to 90 days after ECMO initiation
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