Outcomes of Sepsis Patients in China (CHINA-SEP)

NCT ID: NCT07066553

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

5775 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-18

Study Completion Date

2027-08-31

Brief Summary

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Sepsis poses a significant public health challenge in China. However, longitudinal real-world evidence on guideline adherence and patient outcomes remains scarce. This registry aims to address these gaps by systematically capturing guideline-concordant treatment patterns and associated outcomes in ICU patients diagnosed according to Sepsis-3.0 criteria across diverse settings, thereby generating actionable evidence to improve the quality of sepsis care nationwide.

Detailed Description

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Sepsis is a major public health challenge in China and remains one of the leading causes of intensive care unit (ICU) admissions, accounting for approximately 20.6% of all ICU cases. However, longitudinal real-world data on adherence to clinical guidelines and associated patient outcomes remain limited. This multicenter observational registry is designed to systematically capture real-world management data from adult ICU patients diagnosed with sepsis according to Sepsis-3.0 criteria. The study will assess current treatment practices and document infection types, anatomical sites, pathogen profiles, and key clinical outcomes. By examining the relationship between treatment patterns and outcomes, this study aims to generate actionable evidence to improve the quality of sepsis care in China. The findings will help identify practice variability, support updates to national guidelines, and promote standardized, evidence-based management across the country.

Conditions

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Sepsis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Sepsis Group

The sepsis group comprised patients diagnosed with sepsis (Sepsis-3 criteria).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Hospitalized patients aged ≥18 years
* Sepsis diagnosis meeting Sepsis-3 criteria
* Informed consent signed by patient or legally authorized representative

Exclusion Criteria

* Patients with a prior history of sepsis
* Sepsis diagnosis \>48 hours prior to enrollment
* Current participation in clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Songqiao Liu

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongda hospital, Southeast University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Professor Liu Songqiao

Role: CONTACT

+86 25 83262553

References

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Xie J, Wang H, Kang Y, Zhou L, Liu Z, Qin B, Ma X, Cao X, Chen D, Lu W, Yao C, Yu K, Yao X, Shang H, Qiu H, Yang Y; CHinese Epidemiological Study of Sepsis (CHESS) Study Investigators. The Epidemiology of Sepsis in Chinese ICUs: A National Cross-Sectional Survey. Crit Care Med. 2020 Mar;48(3):e209-e218. doi: 10.1097/CCM.0000000000004155.

Reference Type BACKGROUND
PMID: 31804299 (View on PubMed)

Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.

Reference Type BACKGROUND
PMID: 31954465 (View on PubMed)

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

Reference Type BACKGROUND
PMID: 26903338 (View on PubMed)

Other Identifiers

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2025ZDSYLL251-P01

Identifier Type: -

Identifier Source: org_study_id

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