Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction

• Conditions: Sepsis; Gastrointestinal Dysfunction

• Registration Number: NCT04647201
• Lead Sponsor: Jianbo Yu

Brief Summary

1. Title: Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction

2. Research center: Single-center study.

3. Design of the research: A prospective and cohort study.

4. 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.

5. Sample size of the research: Not less than 30 patients in each group.

6. 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.

7. Aim of the research: The find out the potential biomarkers in serum to help the diagnose and management of gastrointestinal dysfunction in septic patients.

8. Statistical analysis: Analytical study.

9. The estimated duration of the study#1-2 years.

Detailed Description

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-22
• Study First Submitted QC: 2020-11-22
• Last Update Submitted: 2020-11-22
• Study Start: 2020-11-23
• Study First Posted: 2020-11-30
• Last Update Posted: 2020-11-30
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. At least 18 years old
2. Patients with sepsis who meet the criteria for sepsis 3.0
3. Patients complicated gastrointestinal dysfunction with AGI grade II or above
4. Agree to participate in this study and sign informed consent

Exclusion Criteria

1. Refuse to participate in this study
2. Those who have chronic gastrointestinal diseases such as Crohn's disease and ulcerative colitis
3. Those who have recently used gastrointestinal motility drugs and within 5 times the half-life
4. Those who are participating in other drug clinical trials
5. Patient with HIV infection, patients in pregnancy or breast stage
6. In the opinion of the attending physician or researcher, there are other conditions that are not appropriate for the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multivariate data analysis of the metabolites	an average of one year	Record the different metabolites between the septic patient with or without GI

Secondary Outcome Measures

Name	Time	Method
Screening of differentially expressed metabolites as potential mortality predictors for sepsis complicated with GI	an average of one year	Investigated the metabolites to distinguish the non-survivors from the survivors of sepsis complicated with GI

Trial Locations

Locations (1)

Tianjin Nankai Hospital; 🇨🇳 Tianjin, China