Effect of Different Enteral Nutrition Formulas on Glucose Homeostasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- average daily glucose
研究概览
简要总结
Different enteral nutrition formulas are tested on their effect on glucose homeostasis in critically ill medical patients.
详细描述
To assess whether enteral nutrition fomulas based either on fat or glucose influence glucose homeostasis differently in critically ill medical patients. All patients are admitted to a tertiary ICU and require mechanical ventilation.
Resting energy expenditure is assessed at baseline in the fasting state by indirect calorimetry. Total energy demand is calculated and patients are randomized to receive fat-based or glucose-based nutrition which is administered continously for 7 days. Indirect calorimetry is repeated on days 3 and 7 under continous nutrition. During the study period, various parameters of glucose homeostasis are assessed. Daily, there will be at least 3 measurements of blood glucose, more if the treating physician deems it necessary. Daily average glucose, daily glucose variability, overall area under the curve for glucose are calculated. Furthermore, energy intake by nutrition, medications (i.e. propofol), and glucose infusion, as well as substrate intake, and insulin demand per 24hrs are determined daily. Adverse effects such as episodes of hyper- or hypoglycemia, cholestasis, hypertriglyceridemia, diarrhea, vomiting, and the amount of gastric residual volume are noted.
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
- •medical patient with need for mechanical ventilation
- •FiO2 requirement < 60%
- •need for nutritional support
排除标准
- •contraindications against nutritional therapy
- •hemodynamic shock (lactate of ≥ 4 mmol/l)
- •severe hypertriglyceridemia (≥ 450 mg/dl)
- •contraindications against enteral nutrion (intestinal obstruction, disruption or severe bleeding of upper gastrointestinal tract)
结局指标
主要结局
average daily glucose
时间窗: up to 7 days
次要结局
- glucose variability(up to 7 days)
- insulin demand per 24 hrs(up to 7 days)
- nutrition-related side effects(7 days)
研究者
Marlene Wewalka
MD
Medical University of Vienna
