Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients: A Cross-over Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Glycemic Variability
研究概览
简要总结
Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these patients receive enteral feeding. There is controversy about ideal carbohydrate composition of these diets. The aim of this study was to compare an enteral formula with the same proportion of carbohydrates with and without fructose on blood glucose levels.
详细描述
Randomized, cross-over, controlled, double-blind clinical trial without washout. Adult patients admitted to the ICU who presented capillary glycemia values> 180mg / dl with a full and exclusive enteral diet. They were randomized and observed for 4 days (2 days with each diet: with / without fructose). Capillary glycemia was measured 4 / 4h.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Critical Illness
- •Exclusive enteral diet
- •Enteral diet with full nutritional value
- •Hyperglycemia ≥180 mg / dl
排除标准
- •Oral feeding
- •NPT (Total or Partial Parenteral Nutrition)
- •Patient without indication of use of study diets
结局指标
主要结局
Glycemic Variability
时间窗: four days
To evaluate the glycemic oscillation during the use of enteral feedings
次要结局
未报告次要终点
研究者
Magali Kumbier
Nutritionist
Hospital Moinhos de Vento