跳至主要内容
临床试验/NCT04525677
NCT04525677Unknown不适用

Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
coagulation disorder tests

研究概览

简要总结

In the diagnosis and treatment of patients with sepsis, through routine stool testing and dynamic testing of coagulation function, we found that patients often have stools that are not formed, the proportion of main fecal bacteria is imbalanced, the level of blood bacterial toxins rises, and the abnormal coagulation status indicate the gut microbiome dysbiosis may play an important regulatory role in abnormal blood coagulation in patients with sepsis. Therefore, we propose that the gut microbiome dysbiosis is involved in sepsis-induced coagulopathy. This project intends to prospectively observe the changes in gut microbiome dysbiosis and blood coagulation function in patients with sepsis before and after treatment, and explore whether the changes in gut microbiome dysbiosis promote the development of sepsis through coagulation disorders, provide new research perspectives for diagnosis and treatment for sepsis.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years and ≤85 years
  • Sign the informed consent form
  • Expected ICU hospital stay> 24 hours
  • △SOFA score ≥2 and confirmed or suspected infection

排除标准

  • Pregnant or breastfeeding women
  • Estimated survival time <24 hours
  • Diagnosis of sepsis time> 24 hours
  • The length of ICU stay before diagnosis of sepsis> 7 days
  • Sepsis from which the source of infection cannot be determined
  • Congenital coagulopathy

结局指标

主要结局

coagulation disorder tests

时间窗: Day 1- Day 14

Laboratory tests of coagulation disorder,such as PT,APTT,INR,TEG,fibrin degradation products , D-dimers.

Gut Microbiome alterations

时间窗: Day 1- Day 14

Taxonomic alterations,bacterial alpha diversity alterations,beta-diversity alterations of gut microbiome by performing metagenomic sequencing analysis of fecal samples

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhi-jie He

Clinical Professor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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