Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy

NCT04525677 | Unknown

• 1 other identifier: SYSEC-KY-KS-2020-107
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• minggen Zhou

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

  STUDY CHAIR

Central Study Contacts

Fangyi Li

CONTACT

+8615603056533; lfyhnxn@126.com

Jihao Xu

CONTACT

+8615626499617

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 25, 2020
• Study Start: July 15, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

CN (1)