Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: fangyi Li; Phone Number: +8615603056533; Email: lfyhnxn@126.com
• Study Contact Backup: Name: Jihao Xu; Phone Number: +8615626499617

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Contact: fangyi Li; Phone Number: +8615603056533; Email: lfyhnxn@126.com
      • Contact: Jihao Xu; Phone Number: +8615626498617
      • Principal Investigator: fangyi Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Department of Intensive Care Unit, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
coagulation disorder tests	Laboratory tests of coagulation disorder,such as PT,APTT,INR,TEG,fibrin degradation products , D-dimers.	Day 1- Day 14

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Study Chair: minggen Zhou, Department of Intensive Care Unit, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 15, 2020
• Primary Completion (ANTICIPATED): July 15, 2021
• Study Completion (ANTICIPATED): July 15, 2021

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (ACTUAL): August 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Dysbiosis
• Other Study ID Numbers: SYSEC-KY-KS-2020-107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No