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

Critical Illness Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233726
• Other study ID #: IR2009
• Secondary ID: DIABET IR IDI-20
• Status: Completed
• Phase: N/A
• First received: October 29, 2010
• Last updated: February 5, 2015
• Start date: April 2010
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Vegenat, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Critical Illness
• Enteral Nutrition
• Hyperglycemia
• Mechanical Ventilation
• Metabolic Stress

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Intensive Care Unit. Hospital Universitario 12 de Octubre	Madrid
Spain	Intensive Care Unit. Hospital Clinico Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Vegenat, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of biochemical parameters and evaluation of infectious complications	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.	1 year	No
Secondary	Assessment of critical ill patients progress during hospital stay	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.	1 year	No