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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
159
Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
Group 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
Intensive Care Unit. Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Intensive Care Unit. Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain
Measure of Biochemical Parameters and Evaluation of Infectious Complications 1
The variables recorded related to glycemic control in mg/dL are provided in this table.
Time frame: 28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 2
The variables recorded related to administered insulin in IU/day are provided in this table
Time frame: 28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 3
The variables recorded related to number of capillary glycemia measurements are provided in this table
Time frame: 28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 4
The variables recorded related to the number of measurements per patient per day are provided in this table
Time frame: 28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 5
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.
Time frame: 28 days post-admission
Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1
This table shows the number of capillary glycemia measurements
Time frame: 28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2
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.
Time frame: 28 days post-admission
Assessment of Critical Ill Patients Progress During Hospital Stay 1
Infectious complication incidence rate per 100 days of treatment are provided in this table.
Time frame: 100 days of treatment
Assessment of Critical Ill Patients Progress During Hospital Stay 2
Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table
Time frame: 28 days post-admission
Assessment of Critical Ill Patients Progress During Hospital Stay 3
The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.
Time frame: 28 days post-admission
Assessment of Critical Ill Patients Progress During Hospital Stay 4
Number of participants with infectious complications is provided in this table.
Time frame: 100 days of treatment
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