Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04525677

Enrollment

Registered

2020-08-25

Start date

2020-07-15

Completion date

2021-07-15

Last updated

2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactFangyi Li

lfyhnxn@126.com+8615603056533

Backup ContactJihao Xu

+8615626499617

Outcome results