Gut Microbiota and Sepsis-associated Acute Kidney Injury (GMASAKI)

January 30, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University

The Relationship Between Gut Microbiota and Sepsis-associated Acute Kidney Injury in Sepsis Patients：Multicenter Observational Study

Sepsis has emerged as one of the important life-threatening infectious diseases with high morbidity and mortality. Sepsis-associated kidney injury (SAKI) is one of the most common and serious complications of sepsis. It has been found that intestinal flora may affect the occurrence and development of a variety of diseases, and may also affect the pathogenesis of multiple SAKI, which is also regulated by host genetic factors. Therefore, the investigators speculate that gut microbiota composition may be associated with susceptibility to SAKI, and there are no studies reporting the association between gut microbiota and SAKI. The investigators intend to carry out a multicenter study in conjunction with the Department of Intensive Care of Qinghai Provincial People's Hospital. The structure and function of intestinal flora in septic patients with renal injury and septic patients less susceptible to renal injury are studied by 16S rDNA amplicon sequencing technology. The differences in composition, diversity and structural stability of intestinal flora between the two groups are analyzed to explore the genera that play a key role in the occurrence of the disease. By analyzing the differences between renal injury and inflammation levels in each group, the correlation between intestinal flora and SAKI, the possible influencing links involved, and the related factors affecting the prognosis of SAKI were revealed. The results of this study are helpful to further elucidate the pathogenesis of SAKI and provide new ideas and methods for the prevention and treatment of SAKI.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First affliated hospital of Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sepsis patients who met the inclusion criteria were admitted to the First Affiliated Hospital of Xi'an Jiaotong University and Qinghai Provincial People 's Hospital during the study period.

Description

Inclusion Criteria:

  • Age≥18 years；Meet the sepsis definition and diagnostic criteria of Sepsis-3.0 guidelines；No previous history of hypertension or diabetes; No underlying kidney disease such as nephrotic syndrome, no history of rheumatic immune system disease; Normal renal function before onset.

Exclusion Criteria:

  • Patients with hypertension, diabetes, coronary heart disease, tumor, rheumatism immune system disease and other related diseases that may cause kidney injury; Patients with abnormal renal function before onset; Patients with nephrotic syndrome and other underlying kidney disease; Long-term oral administration of drugs with kidney injury; Previous history of gastrointestinal surgery; No diarrhea related diseases or other gastrointestinal diseases in the past 1 month; The use of antibiotics and probiotics in the past 1 month; Exclusion of other primary or secondary renal damage factors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sepsis-associated kidney injury
Sepsis patients and acute kidney injury No intervention
Other: Whether renal injury occurred and differences in intestinal flora
Whether renal injury occurred and differences in intestinal flora
Other Names:
  • No intervention
Sepsis but no renal impairment
Sepsis patients without acute kidney injury
Other: Whether renal injury occurred and differences in intestinal flora
Whether renal injury occurred and differences in intestinal flora
Other Names:
  • No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in gut microbiota composition between the two groups
Time Frame: Within 24 hours of patient enrollment
The differences in the composition of intestinal flora between the two groups were analyzed to identify the correlation with AKI
Within 24 hours of patient enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-6
Time Frame: Within 24 hours of patient enrollment
the concentration of Interleukin 6 (IL-6)
Within 24 hours of patient enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Qinghai Provincial People 's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

February 1, 2023

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2022-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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