Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula Versus Regular Enteral Nutrition on the Outcome of Critically Ill Sepsis Patients. A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- oxygen supply
研究概览
简要总结
The aim is to compare the efficacy and tolerability of an immune modulating enteral nutrition formula versus the regular formula on the outcomes of critically ill septic patients by assessment of clinical outcomes, immune profile, tolerability and enteral nutrition intolerance and laboratory markers
详细描述
Nutritional formulas are considered important sources of the dietary components that the body requires. They contain the sources of fats, proteins and carbohydrates and compensate any vitamin and mineral deficiency.
There is a special type of formulas called the "immune-enhancing formulas", they supplement the body not only with the energy sources but also, they boost the body's immune system as they contain multiple types of amino and fatty acids.
There is an ongoing debate around the efficacy of the immune-enhancing formulas, some studies show that they make a significant difference in enhancing the clinical outcomes compared to traditional formulas while other studies showed no significant difference between the traditional formulas and immune-enhancing formula.
The immune-enhancing nutritional formula is used in enteral and oral feeding for critically ill patients. It's mainly indicated in cases of malnutrition, post surgeries and traumas and immunocompromised patients.
Its composition:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- •Diagnosed with sepsis according to guideline criteria AND
- •Age ≥18 years
排除标准
- •Gastrointestinal tract complications or intestinal failure or any contraindications to receive enteral nutrition
- •Hemodynamic instability on admission
结局指标
主要结局
oxygen supply
时间窗: 28 days
arterial blood gases
inflammatory markers
时间窗: 28 days
C-Reactive protein
severity of disease classification
时间窗: 28 days
acute physiology and chronic health evaluation score
immune profile
时间窗: 28 days
C-Reactive protein
critical care need
时间窗: 28 days
days on oxygen supply
fluid status
时间窗: 28 days
albumin
Intensive Care Unit mortality
时间窗: 28 days
The Sequential Organ Failure Assessment score
次要结局
未报告次要终点
研究者
Rana Muhammed
Principle Investigator
NewGiza University