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临床试验/NCT07066553
NCT07066553尚未招募不适用

Outcomes of Sepsis Patients in China: A Registry

Southeast University, China1 个研究点 分布在 1 个国家目标入组 5,775 人开始时间: 2025年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
5,775
试验地点
1
主要终点
28-day all-cause mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patients with a prior history of sepsis
  • Sepsis diagnosis >48 hours prior to enrollment
  • Current participation in clinical trial

结局指标

主要结局

28-day all-cause mortality

时间窗: 28 days after enrollment.

次要结局

  • ICU mortality(From ICU admission to ICU discharge or death, up to 28 days)
  • Ventilator-free days(28 days after enrollment.)
  • Rate of compliance with sepsis bundle elements(Patient compliance with sepsis bundles will be assessed within 24 hours after ICU admission.)

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Songqiao Liu

Prof

Southeast University, China

研究点 (1)

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