Oxepa in Multiple Trauma: Prospective, Randomized, Comparative, Double-blind, Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Oxygenation (PO2/FIO2 ratio)
研究概览
简要总结
This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study mend to assess the effect of enteral feeding with Oxepa (a fish oil-based nutrition), compared to an isocaloric control, on oxygenation and clinical outcomes in mechanically ventilated trauma patients.
The study population will be adults admitted to the ICU due to multiple-trauma or head trauma as a result of a gun shut, motor vehicle accidents, fall, workplace accident etc.
详细描述
Primary outcome:
Improvement in oxygenation
Secondary outcomes:
Significant improvement in other clinical and laboratory end points.
Primary endpoint:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-90 years with multiple-trauma or head trauma admitted to the ICU.
- •Enteral nutrition can be initiated within 36 hours of admission/ injury.
- •Mechanical ventilation.
排除标准
- •Severe underlying systemic disease and /or treatment with immunosuppressive agents.
- •Contra-indication for Enteral Nutrition (mechanical or functional bowel. obstruction, high-output fistula, severe necrotizing pancreatitis).
- •2nd /3rd degree burns covering > 66% BSA.
- •Participants under the age of 18.
研究组 & 干预措施
Oxepa
Oxepa (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.
干预措施: Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding. (Dietary Supplement)
Oxepa
Oxepa (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.
干预措施: oxepa (Dietary Supplement)
Control group
Pulmocare or Jevity (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
Oxygenation (PO2/FIO2 ratio)
时间窗: 2 years
PO2/FIO2 ratio; assessed by measuring arterial blood gases (AVL Omni Technology, Graz, Austria) and ventilator settings (10)
次要结局
- TNF-α, CRP (markers of inflammatory response)(2 years)
- Fatty acid composition of RBC phospholipids, including n-3:n-6 ratio (markers of n-3 PUFA incorporation into blood cell membranes)(2 years)
研究者
Pierre singer
Professor, MD
Rabin Medical Center