Immune Mechanisms and ECMO Strategies for Moderate-to-Severe ARDS
Mechanistic Investigation of Inflammatory and Immune Dysregulation in Moderate-to-Severe ARDS and Rescue Strategies With Extracorporeal Membrane Oxygenation
2 other identifiers
observational
1,776
1 country
39
Brief Summary
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:
- 1.How can moderate-to-severe ARDS be classified into distinct clinical-immune phenotypes, and what are the optimal therapeutic targets for each phenotype?
- 2.What are the molecular mechanisms underlying severe complications in ARDS patients receiving ECMO support?
- 3.Which key immune biomarkers are associated with clinical benefit from awake ECMO?
- 4.How should mechanical ventilation strategies be optimized in moderate-to-severe ARDS patients supported with ECMO?
- 5.How can a comprehensive, full-cycle ECMO management pathway be established for patients with moderate-to-severe ARDS?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Typical duration for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 16, 2026
CompletedFirst Submitted
Initial submission to the registry
July 21, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
July 27, 2026
May 1, 2026
3.5 years
July 21, 2026
July 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 90 days after enrollment
Secondary Outcomes (15)
Successful Liberation From Mechanical Ventilation
From initiation of invasive mechanical ventilation to 7 days after liberation from mechanical ventilation, assessed up to hospital discharge
ICU Mortality
From ICU admission to ICU discharge or death, assessed up to 90 days after ECMO initiation
Hospital Mortality
From hospital admission to hospital discharge or death, assessed up to 90 days after ECMO initiation
28-Day All-Cause Mortality
From enrollment to 28 days after enrollment.
Bleeding complications during ECMO support
From ECMO initiation to ECMO discontinuation, ICU discharge, or day 90, whichever occurs first.
- +10 more secondary outcomes
Study Arms (2)
ECMO Supported Group
Moderate-to-severe ARDS patients who receive Extracorporeal Membrane Oxygenation (ECMO) support as part of their clinical management.
Non-ECMO Control Group
Moderate-to-severe ARDS patients who receive standard-of-care mechanical ventilation and medical management without Extracorporeal Membrane Oxygenation (ECMO) support.
Eligibility Criteria
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.
You may qualify if:
- Age ≥ 18 years 2.Meet the global new definition of moderate-to-severe Acute Respiratory Distress Syndrome (ARDS).
You may not qualify if:
- \- 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.
- Patients with comorbid cardiogenic shock requiring VA-ECMO or VAV-ECMO support.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Hospital of Jilin University
Changchun, China
The First People's Hospital of Chenzhou
Chenzhou, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Hangzhou First People's Hospital, Westlake University School of Medicine
Hangzhou, China
The First Affiliated Hospital of Harbin Medical University
Ha’erbin, China
The Second Affiliated Hospital of Harbin Medical University
Ha’erbin, China
Huai'an First People's Hospital
Huai'an, China
Kunshan First People's Hospital
Kunshan, China
The First Hospital of Lanzhou University
Lanzhou, China
The First People's Hospital of Lianyungang
Lianyungang, China
Liuzhou People's Hospital
Liuzhou, China
People's Hospital of Guangxi Zhuang Autonomous Region
Naning, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum Tower Hospital
Nanjing, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, China
Affiliated Hospital of Nantong University
Nantong, China
General Hospital of Ningxia Medical University
Ningxiang, China
Quzhou People's Hospital
Quzhou, China
West China Tianfu Hospital, Sichuan University
Sichuan, China
Suining Central Hospital
Suining, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Wuxi People's Hospital
Wuxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Affiliated Hospital of Qinghai University
Xining, China
Xinyang Central Hospital
Xinyang, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Subei People's Hospital
Yangzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 90 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director of ICU
Study Record Dates
First Submitted
July 21, 2026
First Posted
July 27, 2026
Study Start
June 16, 2026
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
February 1, 2030
Last Updated
July 27, 2026
Record last verified: 2026-05