Optimized Caloric-proteic Nutrition in Critically Ill Patients: Impact on Short and Long-term Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- PCS of SF-36
研究概览
简要总结
In this prospective randomized controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and a high protein intake (2.0 to 2.2 g/kg/day) with a nutritional regimen based on 25 Kcal/kg/day and protein intake usually recommended to critically ill patients (1.4 to 1.5 grams/kg/day).
详细描述
OBJECTIVES
To evaluate the effect of nutritional therapy with caloric intake determined by indirect calorimetry and high protein intake (2.0 to 2.2 g/kg/day) compared to nutritional therapy with 25 kcal/kg/day and 1.4 to 1, 5 g/kg/day of protein on short-term outcomes and physical component (PCS) of quality of life after 3 and 6 months of randomization in severe ICU patients.
The primary objective will be the evaluation of the physical component summary (PCS) of SF-36 (Short Form 36), a questionnaire used to evaluate quality of life, validated for the Brazilian population. Patients will be assessed at least 3 and 6 months after randomization.
Secondary objectives: Measurement of handgrip strength measured on the 7th and 14th day of the study and on discharge from the ICU, ICU mortality, hospital mortality, mechanical ventilation time and length of stay in the ICU.
METHODS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Critically ill patients Mechanically ventilated Expected length in the ICU > 3 days
排除标准
- •Pregnancy Requirement for inspired oxygen (FIO2) > 0.60 High output bronchopleural fistula
结局指标
主要结局
PCS of SF-36
时间窗: 6 months after randomization
Physical component summary of Short Form 36
次要结局
- Handgrip strength(7th, 14th after admission and up to 30 days)
- ICU mortality(Up to 30 days)
- Hospital mortality(Up to 6 months)
研究者
José Raimundo Araujo de Azevedo
PhD
Hospital Sao Domingos