SepsisNCT07863908
Multicenter Prospective Cohort of Sepsis and ARDS in China
An observational study of Sepsis and ARDS, run by Shanghai Zhongshan Hospital at 24 sites in China.
Trial summary
This prospective, multicenter, observational cohort study enrolls 6,000 adults with sepsis and/or acute respiratory distress syndrome (ARDS) at multiple hospitals in China. Clinical data, treatment information, biological samples, and follow-up data are collected to characterize patient features and outcomes and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Surveys, 6-Minute Walk Test and Blood collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 6,000 participants
- Where
- 24 sitesChina
- Study dates
- 1 May 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥18 years.
- 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.
- Admitted to an ICU or other designated inpatient unit at a participating study center, including emergency or respiratory care units where appropriate.
- Written informed consent is obtained from the participant or a legally authorized representative, or deferred consent is used when permitted by local ethical requirements.
Who cannot join
- 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.
- Terminal illness with an expected survival of <24 hours, or a decision for comfort measures only has been made before enrollment.
- Informed consent cannot be obtained in accordance with applicable ethical requirements.
- 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.
- Any other condition that, in the investigator's judgment, makes participation inappropriate.
- Withdrawal and Loss to Follow-up:
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- 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.
- 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.
- 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.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Yiyu Deng, MD, +86 15013287340, yiyudeng666@163.com
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Zhaocai He, MD, +86 13758131998, zhangzhaocai@zju.edu.cn
- Recruiting
Jiangyin People's Hospital
Jiangyin, Jiangsu, 214400
Jianing Xu, MD, +86 18921251155, shipnew@yeah.net
- Recruiting
Jiaxing First Hospital
Jiaxing, Zhejiang, 314001
Jiangang Zhu, MD, +86 13586464970, smilezhumz@163.com
- Recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029
Yong Li, MD, +86 13515374839, 13515374839@163.com
- Recruiting
Tenth People's Hospital of Tongji University
Shanghai, 200072
Hu Peng, MD, +86 18917683122, penghu@tongji.edu.cn
- Recruiting
Shanghai General Hospital
Shanghai, 200080
Ruilan Wang, MD, +86 13917138008, wangyusun@hotmail.com
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Chengjin Gao, MD, +86 15801985172, gaochengjin@xinhuamed.com.cn
- Recruiting
Shanghai East Hospital
Shanghai, 200120
Lunxian Tang, MD, +86 13621759045, 456tlx@163.com
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
Zhenyu He, MD, +86 15900909475, hzyyy@163.com
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
Xueling Wu, PhD, +86 18321035326, wuxueling76@126.com
- Recruiting
Shanghai Gongli Hospital
Shanghai, 200135
Miao Chen, MD, +86 13916161843, marcy_cm@hotmail.com
- Recruiting
Shanghai Xuhui District Central Hospital
Shanghai, 200237
Weifeng Huang, MD, +86 15821636060, breeze-huang@hotmail.com
- Recruiting
Minhang Hospital, Fudan University
Shanghai, 201199
Keyu Sun, MD, +86 18930536861, hoceima@126.com
- Recruiting
Pudong Hospital, Fudan University
Shanghai, 201399
Yao Shen, MD, +86 136111692261, 136111692261@163.com
- Recruiting
Jinshan Hospital, Fudan University
Shanghai, 201508
Lin Zhang, MD, +86 18930819256, linzhang0315@fudan.edu.cn
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Xiaojing Zou, MD, +86 13995518630, 249126734@qq.com
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060
Liying Zhan, MD, +86 15327408448, zhanliying@whu.edu.cn
- Recruiting
Wuxi People's Hospital Affiliated to Nanjing Medical University
Wuxi, Jiangsu, 214023
Yun Zhang, MD, +86 15722991660, zhangyun@njmu.edu.cn
- Recruiting
Wuxi Huishan District People's Hospital
Wuxi, Jiangsu, 214187
Feng Lu, MD, +86 18921194863, lfwx@163.com
- Recruiting
Fudan University Zhongshan Hospital Xiamen Hospital
Xiamen, Fujian, 361015
Zhenju Song, MD, +86 138 1660 7453, song.zhenju@zs-hospital.sh.cn
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001
Dingyu Tan, MD, +86 18051061672, tandingyu1981@163.com
- Recruiting
Yixing People's Hospital
Yixing, Jiangsu, 214200
Junjie Lu, MD, +86 13606157979, staff806@yxph.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
QI Liu, MD, +86 15981898607, qi.liu@vip.163.com
About this study
Official title: Sepsis and Acute Respiratory Distress Syndrome in China (SEARCH): A Multicenter Prospective Observational Study of Clinical and Biological Phenotypes
This prospective, multicenter, observational cohort study enrolls 6,000 adults with sepsis and/or acute respiratory distress syndrome (ARDS) at multiple hospitals in China. Clinical data, treatment information, biological samples, and follow-up data are collected to characterize patient features and outcomes and to establish a multicenter clinical cohort and biobank.
The study focuses on the clinical and biological heterogeneity of sepsis and ARDS. Longitudinal clinical data are integrated with information on organ function, inflammatory and immune responses, and multi-omics profiles to identify clinically relevant phenotypes and biological subgroups. Biomarkers associated with disease severity, organ dysfunction, treatment response, and mortality are explored, together with models for outcome prediction. Follow-up after hospitalization evaluates long-term survival and recovery, including pulmonary function, physical function, quality of life, and psychological health.
Read the detailed description
Background:
Sepsis and acute respiratory distress syndrome (ARDS) are common life-threatening conditions in critically ill patients and are associated with high mortality and long-term functional impairment. Sepsis is an important cause of ARDS, and the two conditions frequently overlap. Both syndromes show substantial heterogeneity in clinical presentation, organ dysfunction, inflammatory and immune responses, and outcomes. Better characterization of this heterogeneity may improve disease classification, risk assessment, and prognostic prediction.
Study Design and Data Collection:
This is a prospective, multicenter, observational cohort study enrolling 6,000 adults with sepsis and/or ARDS at multiple hospitals in China.
Clinical data collected during hospitalization include demographic characteristics, comorbidities, disease severity, laboratory findings, organ function, treatments, organ support, complications, and clinical outcomes. Longitudinal data are collected to assess changes in disease status and organ function over time. Peripheral blood and other available biological samples are collected at predefined time points and stored for subsequent biomarker and multi-omics studies, forming a multicenter clinical cohort and biobank.
Biological and Phenotypic Analyses:
Clinical data are integrated with inflammatory and immune markers and multi-omics profiles to investigate the clinical and biological heterogeneity of sepsis and ARDS. Analyses focus on identifying relevant phenotypes and biological subgroups and exploring biomarkers associated with disease severity, organ dysfunction, treatment response, and mortality. Clinical and biological data will also be used to develop and evaluate models for risk stratification and outcome prediction.
Outcomes and Long-term Follow-up:
The primary outcome is all-cause mortality at 90 days. Secondary outcomes include 28-day mortality, in-hospital mortality, ventilator-free days alive through day 28, organ support-free days alive through day 28, and other clinically relevant outcomes during hospitalization.
Survivors of ARDS are followed at 1, 6, 12, and 24 months after hospital discharge. Follow-up assessments include survival status, rehospitalization, pulmonary function, respiratory muscle strength, six-minute walk distance, chest computed tomography, inflammatory markers, quality of life, and psychological health.
The overall objective is to establish a large, multicenter clinical cohort and biobank for sepsis and ARDS in China, characterize their clinical and biological heterogeneity, identify clinically relevant phenotypes and biomarkers, and develop models for risk stratification and outcome prediction.
- Being tested
- Surveys, 6-Minute Walk Test, Blood collection, Pulmonary & Respiratory Muscle Function Testing, CT Scan
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysOther
Participants will complete the EuroQol-5 Dimension-5 Level (EQ-5D-5L) quality of life assessment in person. Assessments will be conducted at 1, 6, 12, and 24 month(s) following hospitalization. For participants who do not attend in-person follow-up visits, surveys will be conducted via email, text message, or phone.
6-Minute Walk TestOther
The patient sits at rest while baseline vital signs and exertion scores are taken.The patient then walks back and forth along a flat, marked corridor at their own pace for 6 minutes, followed immediately by repeating vital signs and exertion measurements at the finish.
At visits 1, 6, 12 and 24 month(s) following hospitalization.
Blood collectionOther
Venous blood is collected via direct needle stick into a vein. Arterial blood is collected by a direct needle puncture into an artery (typically the radial artery) using a heparinized syringe.
At visits 1, 6, 12 and 24 month(s) following hospitalization.
Pulmonary & Respiratory Muscle Function TestingDiagnostic test
The patient sits upright, wears a nose clip, and breathes through a mouthpiece connected to the testing device, performing guided forced breathing and single-breath hold maneuvers. Respiratory muscle strength is measured by having the patient inhale and exhale forcefully against a temporarily blocked mouthpiece.
At visits 1, 6, 12 and 24 month(s) following hospitalization.
CT ScanRadiation
The patient lies flat on the CT scanner bed and follows automated breathing prompts to hold their breath for a few seconds while images are acquired. Additional body regions may be scanned if clinically indicated.
At visits 1, 6, 12 and 24 month(s) following hospitalization.
Blood CollectionOther
Blood samples will be collected on Day 1, Day 3, and Day 7. Day 1 samples will be collected within 48 hours after ARDS diagnosis. Day 7 samples can be collected between Day 6 and Day 8.
Plasma、 PBMCs and Serum will be collected in each corresponding tube and will be separated and stored for later testing.
Citrate plasma will be collected in sodium citrate tubes and then will be centrifuged within 1 hour, and the plasma will be stored at -80°C for later testing.
Bronchoalveolar Lavage FluidOther
Bronchoalveolar lavage fluid (BALF) will be collected on Day 1, Day 3, and Day 7 and stored for later testing.
HME filter samplesOther
HME filter samples will be collected on Day 1, Day 3, and Day 7 and stored for later testing.
If the patient is extubated, dies, or leaves the hospital before the planned BALF or HME sample collection, the last sample will be collected before or on the same day.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized Cohort | Patients with Sepsis/ARDS enrolled during hospitalization will undergo prospective collection of clinical data and biospecimens during the acute phase of illness. Clinical characteristics, treatments, organ support, and in-hospital outcomes will also be recorded. Receives: Other: Blood Collection; Other: Bronchoalveolar Lavage Fluid; Other: HME filter samples | |
| Long-term Follow-up Cohort | Participants enrolled in the hospitalized Sepsis/ARDS cohort who survive and are available for follow-up will undergo longitudinal assessments at 1, 6, 12, and 24 months following hospital discharge, including evaluation of quality of life, physical function, pulmonary function, imaging, and biospecimen collection. Receives: Other: Surveys; Other: 6-Minute Walk Test; Other: Blood collection; Diagnostic Test: Pulmonary & Respiratory Muscle Function Testing; Radiation: CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 28-day mortality
EuroQol-5 Dimension-5 Level (EQ-5D-5L) quality of life assessment
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, participants select one of five response levels, ranging from no problems to extreme problems or inability to perform the activity; the distribution of response levels within each dimension will be summarized as percentages. Responses across the five dimensions will also be converted to an EQ-5D-5L index score using a prespecified value set, with higher index scores indicating better health-related quality of life. Participants will additionally rate their overall health using the EQ Visual Analogue Scale (EQ VAS), ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Measured: 1, 6, 12, 24 month(s)
Secondary outcomes (4)
60-day all-cause mortality
Death from any cause within 60 days after ARDS diagnosis
Measured: 60 days after ARDS diagnosis
90-day all-cause mortality
Death from any cause within 90 days after ARDS diagnosis
Measured: 90 days after ARDS diagnosis
ICU mortality
Death occurring during the ICU stay
Measured: From ICU admission through ICU discharge, up to 90 days
In-hospital mortality
Death occurring during the index hospitalization
Measured: From hospital admission through hospital discharge, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 May 2022
- Primary completion1 May 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863908
- Sponsor's protocol ID
- B2022-175
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis and Acute Respiratory Distress Syndrome in China (SEARCH): A Multicenter Prospective Observational Study of Clinical and Biological Phenotypes
- ClinicalTrials.gov ID
- NCT07863908
- Acronym / sponsor ID
- B2022-175
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, multicenter, observational cohort study enrolls 6,000 adults with sepsis and/or acute respiratory distress syndrome (ARDS) at multiple hospitals in China. Clinical data, treatment information, biological samples, and follow-up data are collected to characterize patient features and outcomes and to establish a multicenter clinical cohort and biobank.
The study focuses on the clinical and biological heterogeneity of sepsis and ARDS. Longitudinal clinical data are integrated with information on organ function, inflammatory and immune responses, and multi-omics profiles to identify clinically relevant phenotypes and biological subgroups. Biomarkers associated with disease severity, organ dysfunction, treatment response, and mortality are explored, together with models for outcome prediction. Follow-up after hospitalization evaluates long-term survival and recovery, including pulmonary function, physical function, quality of life, and psychological health.
Detailed description
Background:
Sepsis and acute respiratory distress syndrome (ARDS) are common life-threatening conditions in critically ill patients and are associated with high mortality and long-term functional impairment. Sepsis is an important cause of ARDS, and the two conditions frequently overlap. Both syndromes show substantial heterogeneity in clinical presentation, organ dysfunction, inflammatory and immune responses, and outcomes. Better characterization of this heterogeneity may improve disease classification, risk assessment, and prognostic prediction.
Study Design and Data Collection:
This is a prospective, multicenter, observational cohort study enrolling 6,000 adults with sepsis and/or ARDS at multiple hospitals in China.
Clinical data collected during hospitalization include demographic characteristics, comorbidities, disease severity, laboratory findings, organ function, treatments, organ support, complications, and clinical outcomes. Longitudinal data are collected to assess changes in disease status and organ function over time. Peripheral blood and other available biological samples are collected at predefined time points and stored for subsequent biomarker and multi-omics studies, forming a multicenter clinical cohort and biobank.
Biological and Phenotypic Analyses:
Clinical data are integrated with inflammatory and immune markers and multi-omics profiles to investigate the clinical and biological heterogeneity of sepsis and ARDS. Analyses focus on identifying relevant phenotypes and biological subgroups and exploring biomarkers associated with disease severity, organ dysfunction, treatment response, and mortality. Clinical and biological data will also be used to develop and evaluate models for risk stratification and outcome prediction.
Outcomes and Long-term Follow-up:
The primary outcome is all-cause mortality at 90 days. Secondary outcomes include 28-day mortality, in-hospital mortality, ventilator-free days alive through day 28, organ support-free days alive through day 28, and other clinically relevant outcomes during hospitalization.
Survivors of ARDS are followed at 1, 6, 12, and 24 months after hospital discharge. Follow-up assessments include survival status, rehospitalization, pulmonary function, respiratory muscle strength, six-minute walk distance, chest computed tomography, inflammatory markers, quality of life, and psychological health.
The overall objective is to establish a large, multicenter clinical cohort and biobank for sepsis and ARDS in China, characterize their clinical and biological heterogeneity, identify clinically relevant phenotypes and biomarkers, and develop models for risk stratification and outcome prediction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Cohort | – | Other: Blood Collection, Other: Bronchoalveolar Lavage Fluid, Other: HME filter samplesPatients with Sepsis/ARDS enrolled during hospitalization will undergo prospective collection of clinical data and biospecimens during the acute phase of illness. Clinical characteristics, treatments, organ support, and in-hospital outcomes will also be recorded. |
| Long-term Follow-up Cohort | – | Other: Surveys, Other: 6-Minute Walk Test, Other: Blood collection, Diagnostic Test: Pulmonary & Respiratory Muscle Function Testing, Radiation: CT ScanParticipants enrolled in the hospitalized Sepsis/ARDS cohort who survive and are available for follow-up will undergo longitudinal assessments at 1, 6, 12, and 24 months following hospital discharge, including evaluation of quality of life, physical function, pulmonary function, imaging, and biospecimen collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Age ≥18 years.
- 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.
- Admitted to an ICU or other designated inpatient unit at a participating study center, including emergency or respiratory care units where appropriate.
Key exclusion criteria (9 listed)
- 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.
- Terminal illness with an expected survival of <24 hours, or a decision for comfort measures only has been made before enrollment.
- Informed consent cannot be obtained in accordance with applicable ethical requirements.
- 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.
- Any other condition that, in the investigator's judgment, makes participation inappropriate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysParticipants will complete the EuroQol-5 Dimension-5 Level (EQ-5D-5L) quality of life assessment in person. Assessments will be conducted at 1, 6, 12, and 24 month(s) following hospitalization. For participants who do not attend in-person follow-up visits, surveys will be conducted via email, text message, or phone. | Other | Long-term Follow-up Cohort |
| 6-Minute Walk TestThe patient sits at rest while baseline vital signs and exertion scores are taken.The patient then walks back and forth along a flat, marked corridor at their own pace for 6 minutes, followed immediately by repeating vital signs and exertion measurements at the finish. At visits 1, 6, 12 and 24 month(s) following hospitalization. | Other | Long-term Follow-up Cohort |
| Blood collectionVenous blood is collected via direct needle stick into a vein. Arterial blood is collected by a direct needle puncture into an artery (typically the radial artery) using a heparinized syringe. At visits 1, 6, 12 and 24 month(s) following hospitalization. | Other | Long-term Follow-up Cohort |
| Pulmonary & Respiratory Muscle Function TestingThe patient sits upright, wears a nose clip, and breathes through a mouthpiece connected to the testing device, performing guided forced breathing and single-breath hold maneuvers. Respiratory muscle strength is measured by having the patient inhale and exhale forcefully against a temporarily blocked mouthpiece. At visits 1, 6, 12 and 24 month(s) following hospitalization. | Diagnostic test | Long-term Follow-up Cohort |
| CT ScanThe patient lies flat on the CT scanner bed and follows automated breathing prompts to hold their breath for a few seconds while images are acquired. Additional body regions may be scanned if clinically indicated. At visits 1, 6, 12 and 24 month(s) following hospitalization. | Radiation | Long-term Follow-up Cohort |
| Blood CollectionBlood samples will be collected on Day 1, Day 3, and Day 7. Day 1 samples will be collected within 48 hours after ARDS diagnosis. Day 7 samples can be collected between Day 6 and Day 8. Plasma、 PBMCs and Serum will be collected in each corresponding tube and will be separated and stored for later testing. Citrate plasma will be collected in sodium citrate tubes and then will be centrifuged within 1 hour, and the plasma will be stored at -80°C for later testing. | Other | Hospitalized Cohort |
| Bronchoalveolar Lavage FluidBronchoalveolar lavage fluid (BALF) will be collected on Day 1, Day 3, and Day 7 and stored for later testing. | Other | Hospitalized Cohort |
| HME filter samplesHME filter samples will be collected on Day 1, Day 3, and Day 7 and stored for later testing. If the patient is extubated, dies, or leaves the hospital before the planned BALF or HME sample collection, the last sample will be collected before or on the same day. | Other | Hospitalized Cohort |
Primary outcome
All cause mortality
Time frame: 28-day mortality
EuroQol-5 Dimension-5 Level (EQ-5D-5L) quality of life assessment
Time frame: 1, 6, 12, 24 month(s)
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire assesses health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each dimension, participants select one of five response levels, ranging from no problems to extreme problems or inability to perform the activity; the distribution of response levels within each dimension will be summarized as percentages. Responses across the five dimensions will also be converted to an EQ-5D-5L index score using a prespecified value set, with higher index scores indicating better health-related quality of life. Participants will additionally rate their overall health using the EQ Visual Analogue Scale (EQ VAS), ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
4 secondary outcomes
60-day all-cause mortality
Time frame: 60 days after ARDS diagnosis
90-day all-cause mortality
Time frame: 90 days after ARDS diagnosis
ICU mortality
Time frame: From ICU admission through ICU discharge, up to 90 days
In-hospital mortality
Time frame: From hospital admission through hospital discharge, up to 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and ARDS, run by Shanghai Zhongshan Hospital at 24 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenju Song, MD (+86 138 1660 7453, song.zhenju@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 28-day mortality). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.