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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Critical Illness; Mechanical Ventilation Complication; Dietary Modification; Metabolic Stress Hyperglycemia
• Intervention / Treatment: Dietary supplement: T-Diet plus Diabet IR; Dietary supplement: ISOSOURCE PROTEIN FIBRE; Dietary supplement: GLUCERNA SELECT

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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Dietary supplement: T-Diet plus Diabet IR; Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.; Other Names: DIABA HP
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	Dietary supplement: ISOSOURCE PROTEIN FIBRE; Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.; Other Names: ISS PROT FIB
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	Dietary supplement: GLUCERNA SELECT; Group 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.; Other Names: GLUC SEL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of Biochemical Parameters and Evaluation of Infectious Complications 1	The variables recorded related to glycemic control in mg/dL are provided in this table.	28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 2	The variables recorded related to administered insulin in IU/day are provided in this table	28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 3	The variables recorded related to number of capillary glycemia measurements are provided in this table	28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 4	The variables recorded related to the number of measurements per patient per day are provided in this table	28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 5	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.	28 days post-admission
Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1	This table shows the number of capillary glycemia measurements	28 days post-admission
Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2	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.	28 days post-admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Critical Ill Patients Progress During Hospital Stay 1	Infectious complication incidence rate per 100 days of treatment are provided in this table.	100 days of treatment
Assessment of Critical Ill Patients Progress During Hospital Stay 2	Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table	28 days post-admission
Assessment of Critical Ill Patients Progress During Hospital Stay 3	The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.	28 days post-admission
Assessment of Critical Ill Patients Progress During Hospital Stay 4	Number of participants with infectious complications is provided in this table.	100 days of treatment

Collaborators and Investigators

• Sponsor: Vegenat, S.A.
• Investigators: Principal Investigator: Alfonso Mesejo, PhD, Hospital Clinico Universitario de Valencia; Principal Investigator: Juan Carlos Montejo, PhD, Hospital Universitario 12 de Octubre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: October 29, 2010
• First Submitted That Met QC Criteria: November 2, 2010
• First Posted (Estimate): November 3, 2010

Study Record Updates

• Last Update Posted (Estimate): September 1, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Insulin resistance; Critical illness; Hyperglycemia; Mechanical Ventilation; Malnutrition; Enteral nutrition; T-Diet plus Diabet IR; Metabolic stress
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Hyperglycemia; Critical Illness
• Other Study ID Numbers: IR2009; DIABET IR IDI-20080283 (Other Identifier: VEGENAT, S.A.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided