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Why sepsis hits some patients harder: 6,000-Person study hunts for answers

NCT ID NCT07863908

Knowledge-focused Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 07, 2026 · Last updated Oct 08, 2026 · Updated 1 time

Summary

Sepsis and acute respiratory distress syndrome (ARDS) can look very different from one patient to the next, and doctors lack reliable ways to predict who will recover. This observational study follows 6,000 adults with sepsis, ARDS, or both at hospitals across China. Researchers collect clinical data, biological samples, and long-term follow-up on survival, lung function, physical recovery, and quality of life. The goal is to identify distinct patient subtypes and biomarkers that could guide future treatment and prognosis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the study identifies distinct biological subtypes of sepsis and ARDS, doctors could one day match treatments to the subtype that fits each patient, and better predict who is likely to recover.
What could go wrong
This is an observational study, so it cannot prove that any treatment works. The findings may not apply to patients outside China or to hospitals with different care practices.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 6,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A total of 6,000 adult patients with sepsis and/or acute respiratory distress syndrome (ARDS) will be enrolled across multiple medical centers in China. The cohort will include hospitalized adults who meet the study diagnostic criteria for sepsis and/or ARDS. Clinical data and biological samples will be collected during hospitalization to characterize the clinical and biological features of sepsis and ARDS. Biological samples will support biomarker and multi-omics analyses, and survivors with ARDS will be followed after hospital discharge to assess long-term survival, pulmonary and physical function, quality of life, psychological health, and rehospitalization.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome infectious disease with sepsis Sepsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ARDS Sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Jining Medical University

    RECRUITING

    Jining, Shandong, 272029, China

  • Fudan University Zhongshan Hospital Xiamen Hospital

    RECRUITING

    Xiamen, Fujian, 361015, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Jiangyin People's Hospital

    RECRUITING

    Jiangyin, Jiangsu, 214400, China

  • Jiaxing First Hospital

    RECRUITING

    Jiaxing, Zhejiang, 314001, China

  • Jinshan Hospital, Fudan University

    RECRUITING

    Shanghai, 201508, China

  • Minhang Hospital, Fudan University

    RECRUITING

    Shanghai, 201199, China

  • Northern Jiangsu People's Hospital

    RECRUITING

    Yangzhou, Jiangsu, 225001, China

  • Pudong Hospital, Fudan University

    RECRUITING

    Shanghai, 201399, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, 200127, China

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, 200127, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, Hubei, 430060, China

  • Shanghai East Hospital

    RECRUITING

    Shanghai, 200120, China

  • Shanghai General Hospital

    RECRUITING

    Shanghai, 200080, China

  • Shanghai Gongli Hospital

    RECRUITING

    Shanghai, 200135, China

  • Shanghai Xuhui District Central Hospital

    RECRUITING

    Shanghai, 200237, China

  • Tenth People's Hospital of Tongji University

    RECRUITING

    Shanghai, 200072, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Wuxi Huishan District People's Hospital

    RECRUITING

    Wuxi, Jiangsu, 214187, China

  • Wuxi People's Hospital Affiliated to Nanjing Medical University

    RECRUITING

    Wuxi, Jiangsu, 214023, China

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, 200092, China

  • Yixing People's Hospital

    RECRUITING

    Yixing, Jiangsu, 214200, China

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