Sepsis and Acute Respiratory Distress Syndrome in China (SEARCH): A Multicenter Prospective Observational Study of Clinical and Biological Phenotypes
Sponsor study identifier
observational
6,000
1 country
24
Study Start
May 1, 2022
Actual (reported)Primary Completion
May 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2022
Actual (reported)September 22, 2026
Actual (reported)October 7, 2026
Actual (reported)May 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
All cause mortality
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.
1, 6, 12, 24 month(s)
60-day all-cause mortality
60 days after ARDS diagnosis
90-day all-cause mortality
90 days after ARDS diagnosis
ICU mortality
From ICU admission through ICU discharge, up to 90 days
In-hospital mortality
From hospital admission through hospital discharge, up to 90 days
Ventilator-Free Days (VFD)
28 days after ARDS diagnosis
Extracorporeal Membrane Oxygenation-Free Days (ECMO-free days)
28 days after ARDS diagnosis
Renal Replacement Therapy-Free Days
28 days after ARDS diagnosis
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.
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.
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.
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.
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.
Fudan University Zhongshan Hospital Xiamen Hospital
Xiamen, Fujian, 361015, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
First Submitted
September 22, 2026
First Posted
October 7, 2026
Study Start
May 1, 2022
Actual (reported)Primary Completion
May 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
TRIM25 in Septic Patients
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.
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.
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 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 (BALF) will be collected on Day 1, Day 3, and Day 7 and stored for later testing.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Jiangyin People's Hospital
Jiangyin, Jiangsu, 214400, China
Wuxi People's Hospital Affiliated to Nanjing Medical University
Wuxi, Jiangsu, 214023, China
Wuxi Huishan District People's Hospital
Wuxi, Jiangsu, 214187, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225001, China
Yixing People's Hospital
Yixing, Jiangsu, 214200, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272029, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Jiaxing First Hospital
Jiaxing, Zhejiang, 314001, China
Tenth People's Hospital of Tongji University
Shanghai, 200072, China
Shanghai General Hospital
Shanghai, 200080, China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200092, China
Shanghai East Hospital
Shanghai, 200120, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200127, China
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200127, China
Shanghai Gongli Hospital
Shanghai, 200135, China
Shanghai Xuhui District Central Hospital
Shanghai, 200237, China
Minhang Hospital, Fudan University
Shanghai, 201199, China
Pudong Hospital, Fudan University
Shanghai, 201399, China
Jinshan Hospital, Fudan University
Shanghai, 201508, China
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 7, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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