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Completed

NCT Number: NCT01233726

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

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.

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Key information

Conditions

Critical Illness Dietary Modification Disease Attributes Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Malnutrition Mechanical Ventilation Complication Metabolic Diseases Metabolic Stress Hyperglycemia Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Care Unit. Hospital Universitario 12 de Octubre, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

T-Diet plus Diabet IR

Dietary Supplement

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

Other names: DIABA HP

ISOSOURCE PROTEIN FIBRE

Dietary Supplement

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

Other names: ISS PROT FIB

GLUCERNA SELECT

Dietary Supplement

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

Other names: GLUC SEL

Primary outcomes

  1. Measure of Biochemical Parameters and Evaluation of Infectious Complications 1

    Time frame: 28 days post-admission

    The variables recorded related to glycemic control in mg/dL are provided in this table.

  2. Measure of Biochemical Parameters and Evaluation of Infectious Complications 2

    Time frame: 28 days post-admission

    The variables recorded related to administered insulin in IU/day are provided in this table

  3. Measure of Biochemical Parameters and Evaluation of Infectious Complications 3

    Time frame: 28 days post-admission

    The variables recorded related to number of capillary glycemia measurements are provided in this table

  4. Measure of Biochemical Parameters and Evaluation of Infectious Complications 4

    Time frame: 28 days post-admission

    The variables recorded related to the number of measurements per patient per day are provided in this table

  5. Measure of Biochemical Parameters and Evaluation of Infectious Complications 5

    Time frame: 28 days post-admission

    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.

  6. Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1

    Time frame: 28 days post-admission

    This table shows the number of capillary glycemia measurements

  7. Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2

    Time frame: 28 days post-admission

    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.

Secondary outcomes

  1. Assessment of Critical Ill Patients Progress During Hospital Stay 1

    Time frame: 100 days of treatment

    Infectious complication incidence rate per 100 days of treatment are provided in this table.

  2. Assessment of Critical Ill Patients Progress During Hospital Stay 2

    Time frame: 28 days post-admission

    Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table

  3. Assessment of Critical Ill Patients Progress During Hospital Stay 3

    Time frame: 28 days post-admission

    The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.

  4. Assessment of Critical Ill Patients Progress During Hospital Stay 4

    Time frame: 100 days of treatment

    Number of participants with infectious complications is provided in this table.

Sponsors and collaborators

Lead sponsor

Vegenat, S.A.

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Nov 3, 2010
Registry last updated
Sep 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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