The Impact of Optimized Caloric-proteic Nutrition on Clinical Outcome and Physical Component Summary (PCS) of Quality of Life in Septic and Septic Shock Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 主要终点
- Physical function measured through the tool Physical Component Summary - PCS of Short Form 36
研究概览
简要总结
In this pilot randomized prospective controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and high protein intake with nutritional regimen based on 25 Kcal / kg / day and protein intake usually recommended for critically ill patients (1.4 to 1.5 grams / kg / day of protein).
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
- •Patients admitted to the ICU with sepsis and septic shock according to 3rd International Sepsis Consensus Conference Definitions for sepsis and septic shock
- •Mechanically ventilated
- •Expected length of stay in ICU ≥ 4 days
- •Written informed consent obtained from authorized surrogates
排除标准
- •Pregnancy
- •Requirement for inspired oxygen content (FIO2) > 0.60
- •High output bronchopleural fistula
研究组 & 干预措施
Study group
Individualization of caloric administration with indirect calorimetry and 2.0 to 2.2 g/kg/day of protein. Early initiation of nutritional support (24 hours of admission)
干预措施: Peptamen intense (Other)
Control group
Nutritional support initiated in the first 24 hours of admission. Protein and caloric goals calculated as 25 Kcal/kg/day and 1.4 to 1.5 g/kg/day of protein.
干预措施: Novasource senior (Other)
结局指标
主要结局
Physical function measured through the tool Physical Component Summary - PCS of Short Form 36
时间窗: Three months after randomization
次要结局
- Hospital mortality(Up to 1 year)
- Length of ICU stay(Up to 1 year)
研究者
José Raimundo Araujo de Azevedo
MD, PhD
Hospital Sao Domingos