Study of Biomarkers in Blood and Tissue Samples of Septic Patients Complicated With Gastrointestinal Dysfunction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Multivariate data analysis of the metabolites
研究概览
简要总结
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Multivariate data analysis of the metabolites
时间窗: an average of one year
Record the different metabolites between the septic patient with or without GI
次要结局
- Screening of differentially expressed metabolites as potential mortality predictors for sepsis complicated with GI(an average of one year)
研究者
Jianbo Yu
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor
Tianjin Nankai Hospital