NCT02337556已完成不适用
The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU
Société des Produits Nestlé (SPN)14 个研究点 分布在 2 个国家目标入组 106 人开始时间: 2014年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 14
- 主要终点
- Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl
研究概览
简要总结
To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •New admit to the ICU and expected to remain in ICU 5 days
- •Ventilator dependent up to 48 hours prior to admission to the study
- •Requiring tube feeding enteral nutrition (EN) 5 days
- •Expected to receive 50% of caloric needs within 72 hours
- •Body Mass Index 26-45
排除标准
- •Trauma patients
- •Major surgery in past 30 days or planned for next 7 days
- •Diabetes mellitus (DM) type 1
- •Admitted with diagnosis of diabetic ketoacidosis as primary diagnosis
- •Pregnant or lactating
- •Non-functioning GI tract
- •Use of parenteral nutrition in past 30 days
- •Admitted with burns > 20% body surface area
- •Traumatic brain injury
- •Hemodynamic instability that prevents delivery of EN > 24hr
- •Unable to access GI tract for feeding via tube, unable to receive EN
- •Other contraindication to tube feeding
- •Any other condition that would not allow patient to complete the study protocol
- •Use of enteral formula at enrollment that cannot be changed to the investigational product
结局指标
主要结局
Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl
时间窗: First seven days in the ICU
Number of glycemic events outside the serum glucose range of 110-150 mg/dl
次要结局
- Glucose variability - Number of episodes of hyperglycemia (glucose > 180 mg/dl)(First seven days in the ICU)
- Glucose variability - Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl(First seven days in the ICU)
- Glucose variability - Number of episodes of hypoglycemia (glucose < 80 mg/dl)(First seven days in the ICU)
- Glucose variability - Average glucose levels(First seven days in the ICU)
- Need for exogenous insulin administration(First seven days in the ICU)
- Nursing time(First seven days in the ICU)
- Need for exogenous glucose administration(First seven days in the ICU)
研究者
研究点 (14)
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