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

NCT ID: NCT01233726

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2015-02-28

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.

Conditions

Critical Illness; Hyperglycemia; Dietary Modification; Metabolic Stress Hyperglycemia; Mechanical Ventilation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

T-Diet plus Diabet IR

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: ACTIVE_COMPARATOR

ISOSOURCE PROTEIN FIBRE

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: ACTIVE_COMPARATOR

GLUCERNA SELECT

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

T-Diet plus Diabet IR

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

Intervention Type: DIETARY_SUPPLEMENT

ISOSOURCE PROTEIN FIBRE

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

Intervention Type: DIETARY_SUPPLEMENT

GLUCERNA SELECT

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

DIABA HP; ISS PROT FIB; GLUC SEL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vegenat, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alfonso Mesejo, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico Universitario de Valencia

Juan Carlos Montejo, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario 12 de Octubre

Locations

Intensive Care Unit. Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Intensive Care Unit. Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 26549276 (View on PubMed)

Other Identifiers

DIABET IR IDI-20080283

Identifier Type: OTHER

Identifier Source: secondary_id

IR2009

Identifier Type: -

Identifier Source: org_study_id