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NCT Number: NCT07066553

Outcomes of Sepsis Patients in China (CHINA-SEP)

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongda hospital, Southeast University

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 28-day all-cause mortality

    Time frame: 28 days after enrollment.

Secondary outcomes

  1. Rate of compliance with sepsis bundle elements

    Time frame: Patient compliance with sepsis bundles will be assessed within 24 hours after ICU admission.

    This outcome quantifies the compliance rate, defined as the proportion of patients who completed all required sepsis bundle elements within the assigned 1-, 3-, or 6-hour window from time zero (time of sepsis recognition). Compliance rate is calculated as the number of patients who completed all clinically indicated bundle elements within the assigned time frame divided by the total number of eligible patients. The bundle elements include serum lactate measurement, blood culture collection prior to antibiotic administration, initiation of intravenous antibiotics, and administration of intravenous crystalloids for patients with hypotension or lactate levels greater than 4 mmol/L.

  2. ICU mortality

    Time frame: From ICU admission to ICU discharge or death, up to 28 days

  3. Ventilator-free days

    Time frame: 28 days after enrollment.

Study contacts

Contact information is provided by the study sponsor or research team.

Professor Liu Songqiao

CONTACT

[email protected]

+86 25 83262553

Sponsors and collaborators

Lead sponsor

Southeast University, China

Other

Registry information

Official study title

Outcomes of Sepsis Patients in China: A Registry

Acronym: CHINA-SEP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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