BIomarkers to Predict the Outcomes of Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 28d all-cause mortality
研究概览
简要总结
Sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. However, sepsis remains the main threat to global health. Due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. The purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.
详细描述
Sepsis is an organ dysfunction syndrome caused by the host's immune response to infection, and is one of the common critical illnesses. There are reports that the mortality rate of sepsis patients is 25-30%, and the hospital mortality rate of septic shock is as high as 40-60%. According to Lancet data, in 2017, there were 48.9 million cases of sepsis worldwide, resulting in approximately 11 million deaths, accounting for 19.7% of the total global deaths. Surviving sepsis patients often experience secondary infections and chronic organ dysfunction, which affects their long-term quality of life and poses a huge socio-economic burden. The World Health Organization (WHO) has identified sepsis as a global health priority and called for improving the level of sepsis prevention and treatment. With the advancement of medical technology, the diagnostic and treatment guidelines for sepsis are constantly updated, and clinical treatment capabilities have been improved. However, sepsis remains the main threat to global health. Due to the high heterogeneity, the diagnosis of sepsis is difficult, and it is particularly important to find biomarkers that can predict changes in the patient's condition and prognosis. The purpose of this study is to collect patient blood samples for testing and identify biomarkers related to the prognosis of sepsis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The clinical diagnostic criteria for sepsis or septic shock that comply with the 3rd edition of the International Consensus on Sepsis and Sepsis Shock (Sepsis-3.0) are:
- •Sepsis-3.0 sepsis diagnosis criteria: infection or suspected infection with a Sequential Organ Failure Score (SOFA score) ≥ 2 points;
- •Sepsis-3.0 diagnostic criteria for septic shock: Sepsis with persistent hypotension, after sufficient fluid resuscitation, still requires vasopressor drugs to maintain average arterial pressure ≥ 65mmHg, and serum lactate level>2mmol/L (18mg/dL).
- •Age 18 to 85 years old
排除标准
- •patients with autoimmune disease, acquired immunodeficiency syndrome, agranulocytosis (<0.5 × 109/L), malignant tumors or other serious chronic diseases (heart failure, Liver failure, end-stage renal disease, etc.);
- •Receiving glucocorticoid treatment;
- •Refuse enrollment or give up active treatment. -
结局指标
主要结局
28d all-cause mortality
时间窗: 28 days
28d all-cause mortality
次要结局
- all-cause mortality(90 days)
- 28-day ICU-free days(28-day)
- Sepsis liver injury(28-day)
- Incidence of secondary infection(Day 0 to 28)
- Sepsis renal injury(28-day)
- Out-of-hospital mortality rate(Discharge for one year)
- Hospital stays(90 days)
- SOFA score(at days -1, 7, 14 and 28)
- ICU mortality(90 days)
- 28-day ventilator-free days(28-day)
- 28-day CRRT-free days(28-day)
- 28-day Vasoactive agents-free days(28-day)
- Septic shock(28-day)
- ICU stays(90 days)
- re-hospitalization rate(90 days)
- Sepsis heart injury(28-day)