Effect of Omega-3 PUFA From Fish in Major Burn Patients. EFECTO DE ÁCIDOS GRASOS POLIINSATURADOS OMEGA 3 DERIVADOS DE ACEITE DE PESCADO, EN QUEMADOS GRAVES
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of infections
研究概览
简要总结
Studies have shown that burn patients may benefit from low fat diets, but there is still no strong data regarding the impact of fatty acid composition used for feeding. The trial test the hypothesis that the inclusion of omega-3 PUFA in a low fat diet may improve outcome. Prospective randomised controlled trial in adult patients admitted for burns > 15% body surface area (BSA), and inhalation injury requiring mechanical ventilation and enteral nutrition. On admission randomization to receive a low-fat (18% energy as fat) modular enteral diet (LF-EN) and identical with the half of fat provided by fish oil (FO-EN). Study endpoints: mechanical ventilation time, inflammation (CRP), infectious and other complications, mortality until discharge.
The study is planed as 2 parts: 1) preliminary study testing the feasibility of the study, 2) the study completed with information from the preliminary phase, both phases being randomised and controlled.
详细描述
Randomisation within the first 24 hours of admission to 2 types of enteral feeds: 1) ω 3 PUFA (FO-EN) or 2) control solution which is the hospitals standard low 18% fat containing solution.
The patients are fed as long as clinically required with the initial solution.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 80 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult >16 years, burns > 15% BSA, mechanical ventilation, next of kin consent
排除标准
- •absence of the above, absence of commitment to full treatment
- •comorbidities (cancer, COPD, diabetes, liver failure (Child Pugh B and C)
- •pregnancy
研究组 & 干预措施
ω-3 PUFA
Modular low fat diet (18%) including 9% as ω-3 PUFA
干预措施: ω-3 PUFA (Dietary Supplement)
Low fat enteral diet
Modular low fat (18%)
干预措施: Low fat enteral diet (Dietary Supplement)
结局指标
主要结局
Number of infections
时间窗: up to Day 28 after burn injury
Infectious complications will be recorded according to CDC criteria, and grouped as pulmonary, blood stream infections (catheter related or not), cutaneous, abdominal and others
次要结局
- Non infectious complications(up to day 28)
研究者
Serrana Tihista
dietitian
Centro Nacional de Quemados, Uruguay
