跳至主要内容
临床试验/NCT04427371
NCT04427371Unknown不适用

Zhongda Hospital, School of Medicine, Southeast University

Jianfeng Xie1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
28-day mortality

研究概览

简要总结

Sepsis is a life-threatening disease characterized by multi-organ failure due to dysregulated host response to infection, with high global mortality of 30-50%. One of the most important pathophysiologic hallmarks in sepsis is vascular endothelial injury that contributes to the severity and outcome of the syndrome. Effective treatments for endothelial cell injury in sepsis have been lacking to improve prognosis. Endothelial pyroptosis is a vital mechanism of vascular endothelial injury in sepsis; mitigation or abolishment of endothelial cell pyroptosis alleviate vascular endothelial damage and improve the prognosis of sepsis mice. Gasdermin D (GSDMD) mediated endothelial pyroptosis plays a critical role in modulating vascular endothelial injury in sepsis.

Long non-coding RNA (lncRNA), as a class of non-coding protein RNA longer than 200 kD, contributes to a variety of cell biological processes. The dysregulation of lncRNA results in the occurrence and development of tumors, diabetes, sepsis and other diseases. Therefore, we detected lncRNA and mRNA expression profile in 26 blood samples of septic patients using Arraystar LncRNA Microarray. We found lncRNA NBR2 regulates septic endothelial pyroptosis.

To assess any correlation of pyroptosis levels with relevant endothelial cell injury parameters and determine the prognostic value in septic patients. we measured the levels of pyroptosis in patients admitted to the Department of Critical Care Medicine for sepsis and investigated the correlation with related markers of endothelium injury. Furthermore, we determined the prognostic value of pyroptosis levels for the mortality of patients with sepsis.

详细描述

We measured the levels of pyroptosis in patients admitted to the Department of Critical Care Medicine for sepsis and investigated the correlation with related markers of endothelium injury. Furthermore, we determined the prognostic value of pyroptosis levels for the mortality of patients with sepsis.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Suspected or confirmed infection
  • The sequential organ failure score (SOFA score) increases by more than or equal to 2 points on the basis
  • Sign the informed consent

排除标准

  • the age < 18 or > 80 years of age
  • viral hepatitis or liver cirrhosis
  • chronic renal tubular nephritis, chronic renal insufficiency
  • ulcerative colitis or crohn's disease
  • active systemic lupus erythematosus (SLE)
  • acute myocardial infarction
  • acute pancreatitis
  • engaged in other clinical subjects

结局指标

主要结局

28-day mortality

时间窗: 28-day

all-cause 28-day mortality

次要结局

未报告次要终点

研究者

发起方
Jianfeng Xie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jianfeng Xie

Dr.

Southeast University, China

研究点 (1)

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