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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vegenat, S.A.
ClinicalTrials.gov Identifier:
NCT01233726
First received: October 29, 2010
Last updated: November 19, 2014
Last verified: November 2010

October 29, 2010
November 19, 2014
April 2010
January 2015   (final data collection date for primary outcome measure)
Measure of biochemical parameters and evaluation of infectious complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To evaluate blood glucose metabolic control, insulin requirements, insulin action resistance, lipid profile and reduced infectious complications on mechanical ventilation ICU patients after complete diet administration, enriched in MUFA and slow absorption carbohydrates, without fructose.
  • To evaluate infectious complications decreased with the diet under study.
Same as current
Complete list of historical versions of study NCT01233726 on ClinicalTrials.gov Archive Site
Assessment of critical ill patients progress during hospital stay [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • ICU average stay evaluation
  • Hospitable average stay evaluation
  • Mechanical ventilation time evaluation
  • Death rate evaluation after 28 days and 6 months.
  • Enteral nutrition complications evaluation.
Same as current
Not Provided
Not Provided
 
Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia
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.

The aim of the study is to evaluate the beneficial effects of the administration of a complete diet rich in monounsaturated fatty acids 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 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 EPA and 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Critical Illness
  • Hyperglycemia
  • Mechanical Ventilation
  • Enteral Nutrition
  • Metabolic Stress
  • Dietary Supplement: T-Diet plus Diabet IR

    T-Diet plus Diabet IR is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.

    Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

    Other Name: DB IR
  • Dietary Supplement: ISOSOURCE PROTEIN FIBRE

    Isosource protein fibre is a complete high protein diet with fibre mixture.

    Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

    Other Name: ISS PROT FIB
  • Dietary Supplement: GLUCERNA SELECT

    Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.

    Group 3 will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric.

    Other Name: GLUC SEL
  • Experimental: Group 1
    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
    Intervention: Dietary Supplement: T-Diet plus Diabet IR
  • Active Comparator: Group 2
    Patients of this group will receive ISOSOURCE PROTEIN FIBRA (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
    Intervention: Dietary Supplement: ISOSOURCE PROTEIN FIBRE
  • Active Comparator: Group 3
    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
    Intervention: Dietary Supplement: GLUCERNA SELECT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
January 2015
January 2015   (final data collection date for primary outcome measure)

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 less than 10.
  • Patients with BMI > 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01233726
IR2009, DIABET IR IDI-20080283
No
Vegenat, S.A.
Vegenat, S.A.
Not Provided
Principal Investigator: Alfonso Mesejo, PhD Hospital Clinico Universitario de Valencia
Principal Investigator: Juan Carlos Montejo, PhD Hospital Universitario 12 de Octubre
Vegenat, S.A.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP