Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy

Sepsis Clinical Trial

Official title:

Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04525677
• Other study ID #: SYSEC-KY-KS-2020-107
• Status: Recruiting
• Start date: July 15, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: August 2020
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Fangyi Li
• Phone: +8615603056533
• Email: lfyhnxn[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In the diagnosis and treatment of patients with sepsis, through routine stool testing and dynamic testing of coagulation function, we found that patients often have stools that are not formed, the proportion of main fecal bacteria is imbalanced, the level of blood bacterial toxins rises, and the abnormal coagulation status indicate the gut microbiome dysbiosis may play an important regulatory role in abnormal blood coagulation in patients with sepsis. Therefore, we propose that the gut microbiome dysbiosis is involved in sepsis-induced coagulopathy. This project intends to prospectively observe the changes in gut microbiome dysbiosis and blood coagulation function in patients with sepsis before and after treatment, and explore whether the changes in gut microbiome dysbiosis promote the development of sepsis through coagulation disorders, provide new research perspectives for diagnosis and treatment for sepsis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age =18 years and =85 years

• Sign the informed consent form

• Expected ICU hospital stay> 24 hours

• ?SOFA score =2 and confirmed or suspected infection

Exclusion Criteria:

• Pregnant or breastfeeding women

• Estimated survival time <24 hours

• Diagnosis of sepsis time> 24 hours

• The length of ICU stay before diagnosis of sepsis> 7 days

• Sepsis from which the source of infection cannot be determined

• Congenital coagulopathy

Related Conditions & MeSH terms

• Dysbiosis
• Sepsis
• Toxemia

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut Microbiome alterations	Taxonomic alterations,bacterial alpha diversity alterations,beta-diversity alterations of gut microbiome by performing metagenomic sequencing analysis of fecal samples	Day 1- Day 14
Primary	coagulation disorder tests	Laboratory tests of coagulation disorder,such as PT,APTT,INR,TEG,fibrin degradation products , D-dimers.	Day 1- Day 14