Personalized Adapted Diet and Nutritional Follow-up With Therapeutic Education in Critically Ill Patients : Impact on Calorie and Protein Deficit, on Weight, Mortality, and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Impact on the weight 3 months after the renewal of oral intakes
研究概览
简要总结
The purpose of the present study is to evaluate the effects of a personalized oral diet in the critically ill patients during ICU stay and after as compared usual oral diet.
详细描述
This is a prospective randomized controlled single center clinical trial. This trial include patient over 18 year hospitalized in ICU and ventilated more than 5 days and/or with denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress. The randomization is awebsite randomization with stratification on age, presence of sepsis at inclusion, renal failure The day of the resumption of the oral feeding (J0), realization of a protocolized swallowing test then randomization and creation of a control and intervention group
Control group:
- Nutrition in resuscitation according to medical prescription: food recovery with a light meal consisting of soup and desserts and evolution to a normal meal according to the capabilities of patients
- Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.
- Nutritional evaluation before the release of resuscitation.
Intervention group:
- NAP: "Customized Adapted Nutrition"
- Daily quantification of ingesta (calories and proteins) by a dietitian until the exit resuscitation. Comparison with caloric-protein targets.
- Therapeutic education.
- Nutritional evaluation before the release of resuscitation.
- Creation at the exit of resuscitation of a nutritional linkage sheet with instructions food
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •patient 18 yo or above hospitalized in ICU and ventilated more than 5 days and/or with severe denutrition after 5 days of no food intake in ICU without shock and/or respiratory distress
排除标准
- •age under 18 yo, pregnancy,
- •protected patients
- •moribund patient (life expectancy of 48h or below),
- •patient with disorders of swallowing
- •tracheostomy
- •patient with shock and/or respiratory distress
结局指标
主要结局
Impact on the weight 3 months after the renewal of oral intakes
时间窗: at 90 days
Decrease of weight variation 3 months after the renewal of oral intakes
次要结局
- weight at D30(at 30 days)
- mortality at D30(at 30 days)
- mortality at D90(at 90 days)
- length of stay in Intensive car unit(until the 90th day)
- length of stay in rehabilitation center(until the 90th day)
- infectious and non infectious complications(until the 90th day)
- length of stay in Hospital(until the 90th day)
- quality of life and autonomy(at 90 days)