Multicenter group study of sepsis and ARDS in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational cohort enrolling about 6,000 adults with sepsis and/or ARDS at multiple Chinese hospitals. It collects clinical data, treatments, biological samples, and follow-up information to characterize patient features and outcomes. Integrated analyses will link organ function, inflammation, immune responses, and multi-omics data to identify clinical and biological subgroups and to develop outcome-prediction models. Long-term follow-up includes survival, pulmonary function, physical function, quality of life, and psychological health. A multicenter clinical cohort and biobank will support future biomarker and translational research.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years.
2. Meets the diagnostic criteria for sepsis and/or acute respiratory distress syndrome (ARDS):

   Sepsis: Sepsis is defined according to the Sepsis-3 criteria as suspected or confirmed infection accompanied by acute organ dysfunction attributable to infection, operationalized as an increase in the Sequential Organ Failure Assessment (SOFA) score of ≥2 points from baseline.

   ARDS: ARDS is diagnosed according to the 2024 Global Definition of ARDS, including an acute predisposing condition or risk factor, acute onset or worsening of respiratory symptoms, bilateral pulmonary opacities on chest imaging or lung ultrasound not fully explained by pleural effusion, atelectasis, or pulmonary nodules, hypoxemia meeting the corresponding oxygenation criteria, and pulmonary edema not primarily attributable to cardiogenic causes or fluid overload.
3. Admitted to an ICU or other designated inpatient unit at a participating study center, including emergency or respiratory care units where appropriate.
4. Written informed consent is obtained from the participant or a legally authorized representative, or deferred consent is used when permitted by local ethical requirements.

Exclusion Criteria:

1. The acute clinical condition is primarily explained by an alternative diagnosis without sepsis or ARDS, such as isolated cardiogenic pulmonary edema or fluid overload without ARDS.
2. Terminal illness with an expected survival of \<24 hours, or a decision for comfort measures only has been made before enrollment.
3. Informed consent cannot be obtained in accordance with applicable ethical requirements.
4. Previous enrollment in this cohort. Each participant may be enrolled only once; subsequent episodes of sepsis and/or ARDS may be recorded as clinical events but will not result in repeated enrollment.
5. Any other condition that, in the investigator's judgment, makes participation inappropriate.

Withdrawal and Loss to Follow-up:

1. Participant withdrawal: Participants or their legally authorized representatives may withdraw consent at any time. No new study-specific data will be collected after withdrawal. The use of previously collected data and stored biological samples will follow the participant's consent and applicable ethical requirements.
2. Investigator-initiated withdrawal: Participants may be withdrawn if subsequent review identifies a major protocol violation, duplicate enrollment, unreliable study data, or another condition that makes continued participation inappropriate.
3. Loss to follow-up: Participants who cannot be contacted after repeated attempts and for whom follow-up information cannot be obtained through other permitted sources will be considered lost to follow-up. Data collected before loss to follow-up may be retained and analyzed according to the statistical analysis plan.

Where it's running

• Fudan University Zhongshan Hospital Xiamen Hospital
  Xiamen, Fujian, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting
• Renmin Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting
• Jiangyin People's Hospital
  Jiangyin, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Zhenju Song, MD
• Email: song.zhenju@zs-hospital.sh.cn
• Phone: +86 138 1660 7453

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.