ImpACt of Very High Protein Content Enteral nUtrition Formulas on Protein Metabolism and Residual Gastric Volume in Critically Ill MUltipLe trAuma paTiEnts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Calorie and protein target
研究概览
简要总结
This prospective observational randomized study aims to determine energy, protein intake and gastrointestinal tolerance while using enteral nutrition formulas with very high protein content and enteral nutrition formulas with normal protein content.
- Differences regarding achieving protein and calorie daily targets when using enteral nutrition formulas with different protein content
- Differences regarding residual gastric volume when using enteral nutrition formulas with different protein content
- Differences regarding body composition when using enteral nutrition formulas with different protein content
详细描述
ImpACt of very high protein Content enteral nUtrition formulas on protein metabolism and residual gastric volume in critically ill MUltipLe trAuma paTiEnts
- ACCUMULATE trial -
Background and rationale:
Despite an increased survival among critically ill patients, many of the ICU "survivors" may develop prolonged functional disabilities. It has already been proven that nutritional therapy is essential, considering that an adequate provision of calories and proteins may influence patients prognostic.
Multiple trauma patients are on a particular nutritional risk, since their high nitrogen demands and associated nutritional therapy challenges, caused by repeated surgical intervention or multiple imagistic procedures. Although nutritional therapy impact on mortality is still in debate, clear, positive results were obtained in decreasing ICU and hospital stay after adequate nutritional support.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (>18 yrs) admitted to the ICU
- •Multiple trauma (Injury severity score > 18)
- •Intubation and mechanical ventilation upon admission in ICU or during the first 24 hours of admission, for at least 48 h
排除标准
- •Age < 18 years
- •Pregnant women
- •Patients not intubated or not mechanically ventilated or receiving only non-invasive ventilation
- •Patients with enteral feeding contraindication 48 h after admission
- •Patients with recent gastrointestinal surgical intervention
- •Patients on chronic therapy with corticosteroids
结局指标
主要结局
Calorie and protein target
时间窗: on day 10
Differences regarding achieving protein and calorie daily targets in grams per kilogram of body weight (g/kg BW) at day 5 of the intervention period and at day 10 when using enteral nutrition formulas with different protein content
次要结局
- Body composition - Fat-free body mass(5 days after extubation)
- Body composition - Phase angle(5 days after extubation)
- Ultrasound-guided assessment of gastric residual volume(on day 10)
- Body composition - Total body water(5 days after extubation)
- Muscle function(5 days after extubation)
- Body composition - ultrasound(on day 15)
- Inflammation - CRP(on day 10)
- Inflammation - prealbumin(on day 10)