Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia

Vegenat

Status: Completed

Conditions: Mechanical Ventilation Complication; Hyperglycemia; Metabolic Stress Hyperglycemia; Critical Illness; Dietary Modification

Treatments: Dietary Supplement: T-Diet plus Diabet IR; Dietary Supplement: ISOSOURCE PROTEIN FIBRE; Dietary Supplement: GLUCERNA SELECT

Study type: Interventional

Funder types: Industry

Identifiers

NCT01233726

IR2009

DIABET IR IDI-20080283 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 10.

• Patients with BMI (body mass index) > 40 Kg/m2.

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 3 patient groups

T-DIET PLUS DIABET IR

Experimental group

Description:

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

Treatment:

Dietary Supplement: T-Diet plus Diabet IR

ISOSOURCE PROTEIN FIBRE

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: ISOSOURCE PROTEIN FIBRE

GLUCERNA SELECT

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: GLUCERNA SELECT