Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy

• Conditions: Sepsis

• Registration Number: NCT04525677
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-15
• Status Verified: 2020-08
• Study First Submitted: 2020-08-20
• Study First Submitted QC: 2020-08-24
• Last Update Submitted: 2020-08-24
• Study First Posted: 2020-08-25
• Last Update Posted: 2020-08-25
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China