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临床试验/NCT02189538
NCT02189538Unknown不适用

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

Centro Nacional de Quemados, Uruguay1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

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

Experimental

Modular low fat diet (18%) including 9% as ω-3 PUFA

干预措施: ω-3 PUFA (Dietary Supplement)

Low fat enteral diet

Active Comparator

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

发起方
Centro Nacional de Quemados, Uruguay
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serrana Tihista

dietitian

Centro Nacional de Quemados, Uruguay

研究点 (1)

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