Glucerna in Critically Ill Patients (GluCip Trial): Investigating the Glycaemic Effects of a Reduced-carbohydrate, Modified-fat, Fiber-containing Enteral Formula (Glucerna®) in Critically Ill Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Glucose variability
研究概览
简要总结
To investigate whether the administration of Glucerna achieves less glycaemic variability, defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to a standard high-carbohydrate enteral formula. Continuous glucose monitoring technology will be used to evaluate glycaemic variability and glycaemic control.
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
- •Age ≥ 18 years;
- •Patients with an anticipated stay of at least 48 hours of admission to the intensive care
- •Expected to receive enteral feeding for at least 48 hrs
- •Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
- •Patient or surrogate understands and signs informed consent document.
排除标准
- •Patients with pre-existing contraindications to enteral feeding or to placement of a continuous glucose monitoring system
- •Patients previously randomised into the GluCip trial
- •Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient.
研究组 & 干预措施
Fresubin
Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.
干预措施: Fresubin (Dietary Supplement)
Glucerna
Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.
干预措施: Glucerna (Dietary Supplement)
结局指标
主要结局
Glucose variability
时间窗: 72 hours
The primary outcome is the extent of glucose variability, defined as the mean absolute glucose (MAG) change (delta glucose/delta time) in mmol/l/hr.
次要结局
- Amount of insulin use(72 hours)
- Duration of severe hypoglycemic events(72 hours)
- Number of severe hypoglycemic events(72 hours)
- Mean glucose and standarddeviation(72 hours)
- Duration of severe hyperglycemic events(72 hours)
- Daily calorie administration(72 hours)
- Daily nutrient administration(72 hours)
- Time in target range(72 hours)
- Number of severe hyperglycemic events(72 hours)
研究者
PHJ van der Voort
Prof., MD, PhD, MSc
Onze Lieve Vrouwe Gasthuis