Gut Microbiota and Sepsis-associated Acute Kidney Injury

NCT05718804 | Unknown

• 1 other identifier: XJTU1AF-CRF-2022-016
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis; Acute Kidney Injury

Keywords

Sepsis-associated kidney injury; gut microbiota; metagenome; prognosis

Outcome Measures

Primary Outcomes (1)

• Differences in gut microbiota composition between the two groups

  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 Outcomes (1)

• IL-6

  Within 24 hours of patient enrollment

Study Arms (2)

Sepsis-associated kidney injury

Sepsis patients and acute kidney injury No intervention

Other: Whether renal injury occurred and differences in intestinal flora

Sepsis but no renal impairment

Sepsis patients without acute kidney injury

Other: Whether renal injury occurred and differences in intestinal flora

Interventions

Whether renal injury occurred and differences in intestinal flora OTHER

Whether renal injury occurred and differences in intestinal flora

Also known as: No intervention

Sepsis but no renal impairment; Sepsis-associated kidney injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Qinghai Provincial People 's Hospital: collaborator

Study Sites (1)

First affliated hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury

Interventions

Gastrointestinal Microbiome

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Microbiota; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 8, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)