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临床试验/NCT03012867
NCT03012867已完成4 期

Effect of Different Enteral Nutrition Formulas on Glucose Homeostasis

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年6月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marlene Wewalka

MD

Medical University of Vienna

研究点 (2)

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