Influence of Two Enteral Nutrition Formulas on Hyperglycemia and Morbidity in Patients with Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- HYPERGLUCEMIA POST-ENTERAL NUTRITION
研究概览
简要总结
The purpose of this study is to evaluate the effect of a specific nutritional formula for diabetics on the development of hyperglycemia in patients with recent non-diabetic stroke who require admission and enteral nutritional support by nasogastric tube. As well as the effect on metabolic control, development of comorbidities, hospital stay, readmissions, mortality and tolerance of the formula under study.
详细描述
MAIN GOAL:
To evaluate the effect on the development of hyperglycemia diagnosed as glycemia> 126 mg / dl on an empty stomach or> 150 mg / dl during the infusion of enteral nutrition determined by capillary glycemia during the admission of a specific formula in patients with a first episode of ischemic stroke or hemorrhagic entry into the non-diabetic HCUV stroke unit requiring enteral nutrition by nasogastric tube.
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
- Double (Participant, Care Provider)
盲法说明
cover label
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
- •Admitted for a first episode of ischemic or hemorrhagic stroke.
- •Requiring total enteral nutrition by tube for at least 7 days
排除标准
- •Contraindication to enteral nutrition
- •Diabetes Mellitus
- •Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting, abdominal pain
- •Need for admission to the ICU
- •Previous neurodegenerative disease
- •Antibiotherapy for 7 days prior to the inclusion visit
- •Allergies or intolerances to any of the components of the formula under study
- •Pregnant patients
结局指标
主要结局
HYPERGLUCEMIA POST-ENTERAL NUTRITION
时间窗: 2 WEEKS
Glycemia over 150 mg / dl after the beginning of infusion of complete enteral. nutrition determined by capillary glycemia during admission. Dicotomic variable (Yes/No)
次要结局
- MORTALITY(3 months)
- ORAL FEEDING RECOVERY(3 months)
研究者
Daniel de Luis Roman
Profesor Doctor
Endocrinology and Clinical Nutrition Research Center, Spain