Gut Microbiome Dysbiosis in Sepsis-induced Coagulopathy

NCT ID: NCT04525677

Last Updated: 2020-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-15

Study Completion Date

2021-07-15

Brief Summary

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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

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Conditions

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Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhi-jie He

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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minggen Zhou

Role: STUDY_CHAIR

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

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fangyi Li

Role: CONTACT

+8615603056533

Jihao Xu

Role: CONTACT

+8615626499617

Facility Contacts

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fangyi Li

Role: primary

+8615603056533

Jihao Xu

Role: backup

+8615626498617

Other Identifiers

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SYSEC-KY-KS-2020-107

Identifier Type: -

Identifier Source: org_study_id

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