Clinical trial NCT01233726: Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Hyperglycemia
Dietary Modification
Metabolic Stress Hyperglycemia
Mechanical Ventilation Complication
Keywords: Critical illness
Hyperglycemia
Mechanical Ventilation
Enteral nutrition
T-Diet plus Diabet IR
Malnutrition
Insulin resistance
Metabolic stress
Lead sponsor: Vegenat, S.A.
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure of Biochemical Parameters and Evaluation of Infectious Complications 1
timeFrame: 28 days post-admission
measure: Measure of Biochemical Parameters and Evaluation of Infectious Complications 2
timeFrame: 28 days post-admission
measure: Measure of Biochemical Parameters and Evaluation of Infectious Complications 3
timeFrame: 28 days post-admission
measure: Measure of Biochemical Parameters and Evaluation of Infectious Complications 4
timeFrame: 28 days post-admission
measure: Measure of Biochemical Parameters and Evaluation of Infectious Complications 5
timeFrame: 28 days post-admission
measure: Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1
timeFrame: 28 days post-admission
measure: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2
timeFrame: 28 days post-admission
Secondary outcomes:
measure: Assessment of Critical Ill Patients Progress During Hospital Stay 1
timeFrame: 100 days of treatment
measure: Assessment of Critical Ill Patients Progress During Hospital Stay 2
timeFrame: 28 days post-admission
measure: Assessment of Critical Ill Patients Progress During Hospital Stay 3
timeFrame: 28 days post-admission
measure: Assessment of Critical Ill Patients Progress During Hospital Stay 4
timeFrame: 100 days of treatment
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Intensive Care Unit. Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Intensive Care Unit. Hospital Clinico Universitario de Valencia
Study officials:
affiliation: Hospital Clinico Universitario de Valencia
name: Alfonso Mesejo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario 12 de Octubre
name: Juan Carlos Montejo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mesejo A, Montejo-Gonzalez JC, Vaquerizo-Alonso C, Lobo-Tamer G, Zabarte-Martinez M, Herrero-Meseguer JI, Acosta-Escribano J, Blesa-Malpica A, Martinez-Lozano F. Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study. Crit Care. 2015 Nov 9;19:390. doi: 10.1186/s13054-015-1108-1.