Nasal and Gut Microbiota Combined Clinical Events Predicts the Prognosis of Patients With Sepsis: a Prospective, Multicentered, Diagnostic Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- All-cause death at 28 days
研究概览
简要总结
In this prospective, multicentered , diagnostic trial, nasal and fecal specimens will collected from patients with sepsis in two critical care units(ICU) at the enrollment day ,the third, seventh, and fourteen days after enrollment or until ICU discharge (whatever come first). Total DNA from the nasal and fecal specimens will be extracted, amplified, and sequenced to determined the characteristics of gut microbiota and nasal microbiota. Finally, the characteristics of gut microbiota and nasal microbiota combined clinical information will be used to construct a prediction model to predict the prognosis of sepsis.
详细描述
Background:
Sepsis should be defined as life-threatening organ dysfunction caused by a dysregulated host response to infection, with high morbidity and mortality, and its total mortality is 10% to 52%. In sepsis, it is not clear sufficiently about the relationship between intestinal and nasal microbiota character and the development of the sepsis.The study aim to construct a prediction model to predict the prognosis and development of sepsis.
Purpose:
- To construct a prediction model using nasal and gut microbiota combined with clinical events to predict the prognosis of patients with sepsis and development of sepsis.
- Analyze the characteristics of nasal and gut microbiota in patients with sepsis using microbiology.
Methods:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the 2016 International Sepsis Guidelines diagnostic criteria (sepsis 3.0).
- •Serum procalcitonin≥ 2 ng/mL at enrollment.
排除标准
- •Patients will be excluded if participants meet any of the following criteria:
- •age<18 years old or > 80 years
- •pregnancy or lactation
- •solid organ or bone marrow transplant
- •advanced pulmonary fibrosis
- •HIV-positive
- •neutropenia;
- •hematological/lymphatic tumors have no remission;
- •limited care (lack of commitment to full and aggressive support);
- •long-term use of immunosuppressive drugs or immunodeficiency;
- •advanced tumors;
- •combined with noninfectious factors leading to death (uncontrolled large bleeding, cerebral hernia, etc.);
- •Combined with autoimmune diseases
- •Paraquat poisoning
- •Combined with Nasopharyngeal carcinoma
- •Combined with chronic nasosinusitis
- •Combined with severe nasal injuries
结局指标
主要结局
All-cause death at 28 days
时间窗: The outcome will be assessed on the 28th day from enrollment
All-cause mortality from the enrollment to the 28th day
次要结局
- Incidence of persistent inflammation-immunosuppression catabolism syndrome (PICS)(The outcome will be assessed diurnally until ICU discharge，the longest evaluation duration is no more than 28 days)
- Incidence of septic shock(The outcome will be assessed diurnally until ICU discharge，the longest evaluation duration is no more than 28 days)
研究者
Liu Zhanguo
Vice Director of Critical Care Medicine, Principal Investigator
Zhujiang Hospital