Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction

Study Overview
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Brief Summary
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Title: Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction Research center: Single-center study. Design of the research: A prospective and cohort study. Object of the research: Patients with age≥18 years those who meet the diagnostic criteria of sepsis 3.0 complicated with GI and grouped into GI group and non-GI adults as control. Sample size of the research: Not less than 30 patients in each group. Research approach: After admission to ICU, patients were assigned to the indicated groups according to the criteria. In addition, blood samples were collected within 24 hours for detecting serum levels of HO-1, PINK1, PLK1as well as oxidative stress and inflammatory markers.For those who requiring intestinal surgery as treatment, the intestinal tissue specimens are retained. Aim of the research: The find out the potential biomarkers in serum to help the diagnose and management of gastrointestinal dysfunction in septic patients. Statistical analysis: Analytical study. The estimated duration of the study#1-2 years.

Detailed Description
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This study is a single-center, prospective, cohort study. In this study, the serum samples of septic patients complicated with or without GI are detected. The serum levels of HO-1, PINK1, PLK1as well as oxidative stress and inflammatory markers are compared in different groups. For those who requiring intestinal surgery as treatment, the intestinal tissue specimens are retained. Meanwhile, the clinical symptoms, intestinal motility indicators and intestinal barrier indicators are recorded. In addition, a biomarker model was established to provide important reference for diagnose and management of gastrointestinal dysfunction in septic patients.

Official Title
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Study of Biomarkers in Blood and Tissue Samples of Septic Patients Complicated With Gastrointestinal Dysfunction

Conditions
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Sepsis, Gastrointestinal Dysfunction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Patients with sepsis who meet the criteria for sepsis 3.0 Patients complicated gastrointestinal dysfunction with AGI grade II or above Agree to participate in this study and sign informed consent Exclusion Criteria: Refuse to participate in this study Those who have chronic gastrointestinal diseases such as Crohn's disease and ulcerative colitis Those who have recently used gastrointestinal motility drugs and within 5 times the half-life Those who are participating in other drug clinical trials Patient with HIV infection, patients in pregnancy or breast stage In the opinion of the attending physician or researcher, there are other conditions that are not appropriate for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Non-sepsis and non-GI adults | |
| Sepsis patients without GI<br>Patients who meet the criteria of sepsis3.0 with AGI grade I or less | |
| Sepsis patients with GI<br>Patients who meet the criteria of sepsis3.0 with AGI grade II or above | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multivariate data analysis of the metabolites | Record the different metabolites between the control group and septic patients | an average of one year | 
| Multivariate data analysis of the metabolites | Record the different metabolites between the septic patient with or without GI | an average of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening of differentially expressed metabolites as potential mortality predictors for sepsis complicated with GI | Investigated the metabolites to distinguish the non-survivors from the survivors of sepsis complicated with GI | an average of one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, gastrointestinal dysfunction, biomarkers