Efficiency and Tolerance of a Small-peptide Enteral Feeding Formula Compared to a Whole-protein Formula in the Critically Ill Patient : a Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 206
- 试验地点
- 2
- 主要终点
- the nutritional efficacy of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula in traumatic and non-traumatic brain injured critically ill patients
研究概览
简要总结
An early and efficient enteral nutritional support could improve the clinical outcomes of brain injured critically ill patients. Gastrointestinal feeding intolerance defined as an increased gastric residual volume frequently occurs in these patients.
Previous experimental studies have suggested that a small-peptide enteral feeding formula could promote the gastric emptying compared to a whole-protein formula. An improved gastrointestinal tolerance of enteral nutrition should allow a rapid increase in the daily caloric intake and enhance nutritional support of brain injured critically ill patients.
详细描述
This open-labelled prospective randomized trial aims to compare 2 groups of patients: the Study Group and the Control Group. The randomization process will concern the allocation of the type of enteral feeding formula administered for nutritional support: Peptamen® AF in the Study Group, and Sondalis® HP in the Control Group. 2 centers are involved in this study.
Each patient admitted in the critical care unit will be assessed for eligibility. After written informed consent is obtained from relatives, patient without any exclusion criteria will be included in the study.
The allocation of the type of enteral nutritional feeding formula will be randomized after inclusion.
Enteral nutrition according to the randomization group will start within the 48 hours of admission and up to 10 days, if requested. Beyond the 10th day, all patients will receive standard enteral nutrition formula.
After inclusion, data regarding efficacy and tolerance will be assessed daily up to day 10.
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
- •Admission in our surgical critical care unit.
- •Traumatic brain injury.
- •Non-traumatic brain injury: stroke, intracranial and/or subarachnoid hemorrhage, subdural and/or extradural hematoma.
- •Expected duration of mechanical ventilation > 48 hours.
排除标准
- •Abdominal surgery in the previous 30 days.
- •Pregnancy.
- •Breast-feeding.
- •Hemodynamic instability defined as infusion of norepinephrine > 3 mg/h, or epinephrine > 1 mg/h, or as increasing needs in vasopressive or inotropic drugs.
结局指标
主要结局
the nutritional efficacy of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula in traumatic and non-traumatic brain injured critically ill patients
时间窗: Day3 to Day5
To compare the nutritional efficacy of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula in traumatic and non-traumatic brain injured critically ill patients.
次要结局
- impact on morbidity and mortality of a small-peptide (Peptamen AF®) to that of a whole-protein (Sondalis HP®) enteral feeding formula.(Day 10)