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RECRUITING
NCT07863908

Multicenter Prospective Cohort of Sepsis and ARDS in China

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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

Conditions

Interventions

OTHER

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.

OTHER

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.

OTHER

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.

DIAGNOSTIC_TEST

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.

RADIATION

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.

OTHER

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.

OTHER

Bronchoalveolar Lavage Fluid

Bronchoalveolar lavage fluid (BALF) will be collected on Day 1, Day 3, and Day 7 and stored for later testing.

OTHER

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