A Randomized Controlled Study of Enteral Nutrition in Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- number of patients consenting to study and remaining compliant with assigned study arm
研究概览
简要总结
There is a paucity of data on the timing and role of enteral nutrition in septic shock.
The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic enteral nutrition to 'no enteral nutrition' in mechanically ventilated septic shock patients to determine feasibility.
详细描述
Septic shock represents the body's dysregulated response to an infection, manifesting as persistent hypotension (mean arterial pressure < 70 mmHg) despite intravenous (IV) fluid resuscitation. Severe sepsis and septic shock are major healthcare problems, affecting millions of people around the world each year In critically ill patients without shock, provision of enteral nutrition within 24-48 hours has shown to preserve intestinal epithelium, maintain brush border enzyme activity, maintenance of barrier function to enhance immune function, and preservation of tight cell junctions to reduce permeability. These benefits of enteral nutrition are postulated to prevent downstream complications of nosocomial infections and the multiple organ dysfunction syndrome (MODS), though direct data addressing this question are lacking.
The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic EN to 'no EN' in mechanically ventilated septic shock patients to determine feasibility of achieving >75% consent and compliance rate and <10% contamination rate.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults greater than or equal to 18 years old
- •Clinical diagnosis of septic shock
- •Mechanically ventilation anticipated for at least 48 hours
排除标准
- •Do not resuscitate order
- •Not able to obtain consent
- •Those not able to be randomized within 18 hours
- •Those with small bowel ischemia or obstruction
- •Protracted ileus, intractable vomiting, major gastrointestinal bleeding defined as needing 2 or more units of packed red cells, and any bowel surgery within the previous 30 days prior to intensive care unit admission
- •Those with a contraindication for placement of a feeding tube
研究组 & 干预措施
Trophic feeding
Mechanically ventilated patients with septic shock > 18 years old randomized to this group will receive more than 50 but less than 600 kilocalories of enteral nutrition per day while on vasopressors. This will be started within 24 hours of intensive care unit admission.
干预措施: Enteral nutrition (Other)
No Enteral Nutrition
Mechanically ventilated patients with septic shock randomized to this group will receive no enteral nutrition while on vasopressor support.
结局指标
主要结局
number of patients consenting to study and remaining compliant with assigned study arm
时间窗: 46 months
consent and compliance rate of \>75% and contamination rate \<10%
次要结局
- intensive care unit free days(30 days)
- Ventilator free days(30 days)
- Hospital mortality(30 days)
- change in 48 hour sequential organ failure assessment score, with higher score representing worse outcome(48 hours)
研究者
Jayshil J. Patel, MD
Principle Investigator
Medical College of Wisconsin