Homocysteine in Patients With Sepsis

Sponsor

Nanjing University of Traditional Chinese Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04548414

Collaborator

(none)

120

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Other: No.

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 20, 2020

Anticipated Primary Completion Date :

May 19, 2022

Anticipated Study Completion Date :

Sep 19, 2022

Arms and Interventions

Arm	Intervention/Treatment
Sepsis group The patients in this group are diagnosed sepsis with the sepsis 3.0 definition.	Other: No. This is an observational study with no intervention.
Control group The recruited volunteers in this group are healthy.

Arm

Intervention/Treatment

Sepsis group

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

Other: No.

This is an observational study with no intervention.

Control group

The recruited volunteers in this group are healthy.

Outcome Measures

Primary Outcome Measures

28-day mortality [one month]
the correlation with the level of Hcy and 28-day mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nanjing University of Traditional Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jun Lu, MD, Doctor, Nanjing University of Traditional Chinese Medicine

ClinicalTrials.gov Identifier:

NCT04548414

Other Study ID Numbers:

aztec04030910

First Posted:

Sep 14, 2020

Last Update Posted:

Sep 14, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sepsis

Toxemia

Study Results

No Results Posted as of Sep 14, 2020