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临床试验/NCT04548414
NCT04548414Unknown不适用

The Effect of Homocysteine on the Prognosis of Patients With sepsis-an Observational Study

Nanjing University of Traditional Chinese Medicine0 个研究点目标入组 120 人开始时间: 2020年9月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
28-day mortality

研究概览

简要总结

After stimulation by lipopolysaccharide (LPS), the one-carbon metabolism of macrophages was significantly up-regulated, the expression of key enzyme 5,10-methylenetetrahydrofolate reductase increased. In vitro experiments we found that LPS stimulation can increase the expression of MTHFR mRNA and protein in macrophages, suggesting that aerobic glycolysis may trigger cytokine storm through one-carbon metabolism. Homocysteine (homocysteine, Hcy) is an important intermediate product of one-carbon metabolism. A number of studies have shown that Hcy is positively correlated with the level of pro-inflammatory factors, significantly enhancing cytokine storm. However, the relationship between Hcy and serum pro-inflammatory factors in patients with sepsis and the effect of Hcy on the prognosis of patients with sepsis are still unclear. Based on the previous work, our research group intends to carry out single-center, prospective, observational clinical research to observe the relationship between homocysteine and the mortality of patients with sepsis, and to provide new indicators for accurately judging the prognosis of sepsis , To provide new targets for clinical development of drugs for the treatment of 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

  • Patients with sepsis and the age limits between 18-80 years.

排除标准

  • Non-septic patients with hyperhomocysteinemia caused by various reasons. ②After the onset, other medicines for the treatment of folate deficiency and hyperhomocysteinemia have been used. ③Women during pregnancy and lactation. ④ Suspected or did have a history of alcohol or drug abuse. ⑤Patients who are participating in clinical trials of other drugs.

结局指标

主要结局

28-day mortality

时间窗: one month

the correlation with the level of Hcy and 28-day mortality

次要结局

未报告次要终点

研究者

发起方
Nanjing University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun Lu, MD

Doctor

Nanjing University of Traditional Chinese Medicine

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