Homocysteine in Patients With Sepsis

NCT04548414 | Unknown

• 1 other identifier: aztec04030910
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

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

  one month

Study Arms (2)

Sepsis group

The patients in this group are diagnosed sepsis with the sepsis 3.0 definition.

Other: No.

Control group

The recruited volunteers in this group are healthy.

Interventions

No. OTHER

This is an observational study with no intervention.

Sepsis group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients with sepsis and volunteers who are healthy.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 14, 2020
• Study Start: September 20, 2020
• Primary Completion: May 19, 2022
• Study Completion: September 19, 2022
• Last Updated: September 14, 2020

Record last verified: 2020-09