Homocysteine in Patients With Sepsis

• Conditions: Sepsis

• Registration Number: NCT04548414
• Lead Sponsor: Nanjing University of Traditional Chinese Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-10
• Last Update Submitted: 2020-09-10
• Study First Posted: 2020-09-14
• Last Update Posted: 2020-09-14
• Study Start: 2020-09-20
• Primary Completion: 2022-05-19
• Study Completion: 2022-09-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
28-day mortality	one month	the correlation with the level of Hcy and 28-day mortality