Effects of a Complete Diet Rich in Monounsaturated Fatty Acids and Slow Absorption Carbohydrate Administration in Critically Ill Patients With Stress Hyperglycemia. Open Study, Blind Randomised, Multicenter and Controlled.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Measure of Biochemical Parameters and Evaluation of Infectious Complications 2
研究概览
简要总结
The aim of the study is to evaluate the beneficial effects of the administration of a complete diet rich in monounsaturated fatty acids (MUFA) and slow absorption carbohydrate in patients with stress hyperglycemia(T-Diet Plus Diabet IR).
The main objective of this project is to evaluate blood glucose metabolic control, insulin requirements, insulin action resistance, lipid profile and to reduce infectious complications on mechanical ventilation ICU (intensive care unit) patients after the administration of a complete diet enriched in MUFA and slow absorption carbohydrates, without fructose.
详细描述
Enteral formula administration designed for critically ill patients in metabolic stress situations, hyperglycemia and insulin resistance, formulated with monounsaturated fatty acids (MUFA), slowly absorption carbohydrates, omega-3 series polyunsaturated fatty acids (PUFA)enriched in eicosapentanoic acid (EPA) and docosahexaenoic acid (DHA), should be associated with an improvement in metabolic control, based on glucose levels reduction, and a decrease of insulin resistance infectious complications , mechanical ventilation days, ICU and hospital stay. All this against other two high protein conventional specific diets for hyperglycaemia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients over 18 admitted to intensive care units (ICU), with mechanical ventilation.
- •Patients receiving EN (enteral nutrition), for 5 days or more.
- •ICU stay in 48 hours or less, in the time of study inclusion.
- •Patients developing hyperglycemia in 48 hours of stay in ICU.
- •Nutritional support initiation within 48 hours of stay in ICU.
排除标准
- •Patients with a life expectancy less than 48 hours.
- •Patients participating in another study.
- •Patients with APACHE II (Acute Physiology and Chronic Health Evaluation) less than
- •Patients with BMI (body mass index) > 40 Kg/m
- •Patients with Type I Diabetes.
- •Patients on chronic treatment with corticosteroid dose above 1 mg / kg / day of methylprednisolone or equivalent.
- •Pregnant patients.
- •Patients taking lipid-lowering drugs.
- •Acute renal failure patients, defined by the following criteria:
- •Serum creatinine greater than 4 mg / dL with acute rise higher than 0.5 mg / dl / day.
- •Serum creatinine higher than 3 mg/dL.
- •Diuresis < 0.3 ml/kg/h during 24 hours.
- •Anury for 12 hours or more.
- •Hepatic failure patients, defined by the following parameters:
- •Serious acute hepatic failure.
- •Child degrees B-C.
- •Serum bilirubin higher than 3 mg/dL.
- •Patients with parenteral nutrition during study inclusion.
- •Informed consent absence.
研究组 & 干预措施
T-DIET PLUS DIABET IR
Patients of this group will receive T-Diet plus Diabet IR as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
干预措施: T-Diet plus Diabet IR (Dietary Supplement)
ISOSOURCE PROTEIN FIBRE
Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
干预措施: ISOSOURCE PROTEIN FIBRE (Dietary Supplement)
GLUCERNA SELECT
Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric
干预措施: GLUCERNA SELECT (Dietary Supplement)
结局指标
主要结局
Measure of Biochemical Parameters and Evaluation of Infectious Complications 2
时间窗: 28 days post-admission
The variables recorded related to administered insulin in IU/day are provided in this table
Measure of Biochemical Parameters and Evaluation of Infectious Complications 5
时间窗: 28 days post-admission
The variables recorded related to Glycemic CV (%) are provided in this table: * Glycemic Coeficient of variation (%) after 28 days in ICU * Glycemic Coeficient of variation (%) after 7 days in ICU.
Measure of Biochemical Parameters and Evaluation of Infectious Complications 3
时间窗: 28 days post-admission
The variables recorded related to number of capillary glycemia measurements are provided in this table
Measure of Biochemical Parameters and Evaluation of Infectious Complications 4
时间窗: 28 days post-admission
The variables recorded related to the number of measurements per patient per day are provided in this table
Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1
时间窗: 28 days post-admission
This table shows the number of capillary glycemia measurements
Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2
时间窗: 28 days post-admission
This table shows the rates of: * Controls analysis on 80-150 mg/dL: optimal level of glycemia rate. * Hypoglycemia (50-80 mg/dL): moderate hypoglycemia rate. * Hypoglycemia (\<50 mg/dL): severe hypoglycemia episodes rate.
Measure of Biochemical Parameters and Evaluation of Infectious Complications 1
时间窗: 28 days post-admission
The variables recorded related to glycemic control in mg/dL are provided in this table.
次要结局
- Assessment of Critical Ill Patients Progress During Hospital Stay 1(100 days of treatment)
- Assessment of Critical Ill Patients Progress During Hospital Stay 2(28 days post-admission)
- Assessment of Critical Ill Patients Progress During Hospital Stay 3(28 days post-admission)
- Assessment of Critical Ill Patients Progress During Hospital Stay 4(100 days of treatment)