Effect of Enteral Feeding's Macronutrient Composition on Inflammatory Mediators, Oxidative Stress and Outcomes in Intensive Care Unit Patients With Acute Respiratory Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- length of ventilation
研究概览
简要总结
This study aimed to investigate the effect of enteral feeding's macronutrient composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients with acute respiratory failure. In this double-blind randomized control trial, 42 patients of both sexes and diagnosed with acute respiratory failure in ICU that receive enteral feeding, will be randomly assigned to three groups of 14 each. First Intervention group; high-protein low-carbohydrate diet with high olive oil, the second intervention group; high-protein low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula. Intravenous levels of uric acid, high sensitive C-Reactive Protein (hs-CRP), Interleukin 6 (IL-6) and Total Antioxidant Capacity (TAC) measured at days 0 and 10. As well as, organ failure, duration of ventilation, length of ICU stay and mortality rates will be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •enrolled in ICU
- •age older than 18 years old
- •need to be mechanically ventilation
- •have enteral feeding
- •no previous diabetes
- •no previous HIV infection
- •no previous nervous system
- •no previous liver failure
- •no previous nephrotic syndrome
- •not passed more than 48 hours from diagnose of acute respiratory failure
排除标准
- •death at less than three days of enteral feeding administration
- •extubation at less than three days of enteral feeding administration
结局指标
主要结局
length of ventilation
时间窗: The number of days at least 3, to which days that patient extubated
The number of days from the patient intubation to his/her extubation
次要结局
- Levels of Interleukin 6 (IL-6) in patient's vein blood(10 days)
- Levels of uric acid in patient's vein blood(10 days)
- Levels of high sensitive C-Reactive Protein (hs-CRP) in patient's vein blood(10 days)
- Levels of Total Antioxidant Capacity (TAC) in patient's vein blood(10 days)
研究者
Zahra Vahdat Shariatpanahi
Assistant professor
Shahid Beheshti University