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Multicenter Prospective Cohort of Sepsis and ARDS in China
Sponsor: Shanghai Zhongshan Hospital
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 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.
Official title: Sepsis and Acute Respiratory Distress Syndrome in China (SEARCH): A Multicenter Prospective Observational Study of Clinical and Biological Phenotypes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
6000
Start Date
2022-05-01
Completion Date
2028-12-31
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
Surveys
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 Test
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 collection
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 Testing
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 Scan
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 Collection
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 Fluid
Bronchoalveolar lavage fluid (BALF) will be collected on Day 1, Day 3, and Day 7 and stored for later testing.
HME filter samples
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.
Locations (24)
Fudan University Zhongshan Hospital Xiamen Hospital
Xiamen, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Jiangyin People's Hospital
Jiangyin, Jiangsu, China
Wuxi People's Hospital Affiliated to Nanjing Medical University
Wuxi, Jiangsu, China
Wuxi Huishan District People's Hospital
Wuxi, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Yixing People's Hospital
Yixing, Jiangsu, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Jiaxing First Hospital
Jiaxing, Zhejiang, China
Tenth People's Hospital of Tongji University
Shanghai, China
Shanghai General Hospital
Shanghai, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai East Hospital
Shanghai, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Shanghai Gongli Hospital
Shanghai, China
Shanghai Xuhui District Central Hospital
Shanghai, China
Minhang Hospital, Fudan University
Shanghai, China
Pudong Hospital, Fudan University
Shanghai, China
Jinshan Hospital, Fudan University
Shanghai, China