NCT04647201

Study of Biomarkers in Patients of Sepsis Complicated With Gastrointestinal Dysfunction

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Jianbo Yu · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Gastrointestinal Dysfunction

Timeline

• Start date: 2020-11-23
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2020-11-30
• Last updated: 2020-11-30

Locations

1 site across 1 country: China