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NCT04548414 Clinical Trial

Homocysteine in Patients With Sepsis

Sepsis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04548414
Other study ID # aztec04030910
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 20, 2020
Est. completion date September 19, 2022

Study information
Verified date September 2020
Source Nanjing University of Traditional Chinese Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date September 19, 2022
Est. primary completion date May 19, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No.
This is an observational study with no intervention.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Nanjing University of Traditional Chinese Medicine

Outcome
Type Measure Description Time frame Safety issue
Primary 28-day mortality the correlation with the level of Hcy and 28-day mortality one month
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