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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vegenat, S.A.
ClinicalTrials.gov Identifier:
NCT01233726
First received: October 29, 2010
Last updated: July 20, 2016
Last verified: July 2016

October 29, 2010
July 20, 2016
April 2010
February 2015   (final data collection date for primary outcome measure)
  • Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]
    The variables recorded related to glycemic control in mg/dL are provided in this table.
  • Measure of Biochemical Parameters and Evaluation of Infectious Complications 2 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]
    The variables recorded related to administered insulin in IU/day are provided in this table
  • Measure of Biochemical Parameters and Evaluation of Infectious Complications 3 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]
    The variables recorded related to the number of measurements per patient per day are provided in this table
  • Measure of Biochemical Parameters and Evaluation of Infectious Complications 5 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]

    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.
  • Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]
    This table shows the number of capillary glycemia measurements
  • Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]

    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 [ 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.
Complete list of historical versions of study NCT01233726 on ClinicalTrials.gov Archive Site
  • Assessment of Critical Ill Patients Progress During Hospital Stay 1 [ Time Frame: 100 days of treatment ] [ Designated as safety issue: No ]
    Infectious complication incidence rate per 100 days of treatment are provided in this table.
  • Assessment of Critical Ill Patients Progress During Hospital Stay 2 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]
    Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table
  • Assessment of Critical Ill Patients Progress During Hospital Stay 3 [ Time Frame: 28 days post-admission ] [ Designated as safety issue: No ]
    The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.
  • Assessment of Critical Ill Patients Progress During Hospital Stay 4 [ Time Frame: 100 days of treatment ] [ Designated as safety issue: No ]
    Number of participants with infectious complications is provided in this table.
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.
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 (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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Critical Illness
  • Hyperglycemia
  • Dietary Modification
  • Metabolic Stress Hyperglycemia
  • Mechanical Ventilation Complication
  • Dietary Supplement: T-Diet plus Diabet IR
    Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
    Other Name: DIABA HP
  • Dietary Supplement: ISOSOURCE PROTEIN FIBRE
    Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
    Other Name: ISS PROT FIB
  • Dietary Supplement: GLUCERNA SELECT
    Group 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
    Other Name: GLUC SEL
  • Experimental: 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
    Intervention: Dietary Supplement: T-Diet plus Diabet IR
  • Active Comparator: 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
    Intervention: Dietary Supplement: ISOSOURCE PROTEIN FIBRE
  • Active Comparator: 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
    Intervention: Dietary Supplement: GLUCERNA SELECT
Mesejo A, Montejo-González 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
February 2015
February 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 (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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01233726
IR2009, DIABET IR IDI-20080283
No
Undecided
Not Provided
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.
July 2016

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