NCT03791866Unknown不适用
The Roles of Th9/IL-9 in the Mechanisms of Early Enteral Nutrition Maintaining Intestinal Mucosal Barrier in Sepsis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 28-d mortality
研究概览
简要总结
The investigators aim to evaluate the roles of Th9/IL-9 in the mechanisms of early enteral nutrition (EEN) maintaining intestinal mucosal barrier in sepsis. The results of this study would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of sepsis and provide a new idea to the early treatment of sepsis. In addition, the investigators also aim to evaluate the effects of different proportions of target total enteral nutrition on the prognosis of sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of sepsis
- •Within 3 days of sepsis onset before ICU admission
- •No artificial nutrition (enteral or parenteral nutrition) were provided before ICU admission
排除标准
- •Digestive tract hemorrhage
- •Inflammatory bowel disease
- •Abdominal hypertension (IAP >25mmHg)
- •Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)
- •Malnutrition or immunodeficiency
- •Long-term use of hormones
研究组 & 干预措施
30% target total enteral nutrition
Experimental
干预措施: Nutrition (Other)
60% target total enteral nutrition
Experimental
干预措施: Nutrition (Other)
100% target total enteral nutrition
Active Comparator
干预措施: Nutrition (Other)
结局指标
主要结局
28-d mortality
时间窗: 28 days
次要结局
- Serum Th9 lymphocyte percentages(7 days)
- Concentration of serum IL-9(7 days)
- Concentration of serum iFABP(7 days)
- Concentration of serum DAO(7 days)
研究者
XiangWang
Director
Nanjing First Hospital, Nanjing Medical University
研究点 (1)
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