跳至主要内容
临床试验/NCT04904289
NCT04904289招募中不适用

Early Recognition and Dynamic Risk Warning System of Multiple Organ Dysfunction Syndrome Caused by Sepsis

Sun Yat-sen University18 个研究点 分布在 1 个国家目标入组 60,000 人开始时间: 2022年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60,000
试验地点
18
主要终点
Sensitivity of the MODS recognized system

研究概览

简要总结

Background Sepsis still the main challenge of ICU patients, because of its high morbidity and mortality. The proportion of sepsis, severe sepsis, and septic shock in china were 3.10%, 43.6%, and 53.3% with a 2.78%, 17.69%, and 51.94%, of 90-day mortality, respectively.

Besides, according to the latest definition of sepsis- "a life-threatening organ dysfunction caused by a dysregulated host response to infection. ", it is a disease with intrinsic heterogeneity. Sepsis as a syndrome with such great heterogeneity, there will be significant differences in the severity of sepsis. As a result, there will be significant differences in the treatment and monitoring intensity required by patients with severe sepsis and mild sepsis. No matter from the economic perspective or from the risk of treatment, a proper level of treatment will be the best chose of patient. However, the evaluation of the sepsis severity was not satisfied. Such of SOFA, the AUC of predict patients' mortality was only 69%. Weather these patients occurred multiple organ dysfunction syndrome (MODS) may had totally different outcome and needed totally different treatment. All these treatments need early interference, in order to achieve a good prognosis. Hence, early recognition of MODS caused by sepsis became an imperious demand.

Study design On the base of regional critical medicine clinical information platform, a multi-center, sepsis big data platform (including clinical information database and biological sample database) and a long-term follow-up database will be established. Thereafter, an early identification, risk classification and dynamic early warning system of sepsis induced MODS will be established. This system was based on the real-time dynamic vital signs and clinical information, combined with biomarker and multi-omics information. And this system was evaluated sepsis patients via artificial intelligence, machine learning, bioinformatics analysis techniques.

Finally, optimize the early diagnosis of sepsis induced MODS, standardized the treatment strategy, reduce the morbidity and mortality of MODS through this system.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with sepsis3.0

排除标准

  • Patients' data missing is greater than 20%

结局指标

主要结局

Sensitivity of the MODS recognized system

时间窗: 90 days

Specificity of the MODS recognized system

时间窗: 90 days

The AUC of the MODS recognized system ROC

时间窗: 90 days

次要结局

  • The mortality of MODS in sepsis patients(90 days)
  • The Incidence rate of MODS in sepsis patients(90 days)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wu Jianfeng

prof

Sun Yat-sen University

研究点 (18)

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