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

Critical Illness research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Critical Illness

Hyperglycemia

Dietary Modification

Metabolic Stress Hyperglycemia

Mechanical Ventilation Complication

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:T-Diet plus Diabet IRGroup 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

Dietary Supplement:ISOSOURCE PROTEIN FIBREGroup 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

Dietary Supplement:GLUCERNA SELECTGroup 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

T-DIET PLUS DIABET IRPatients 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

ISOSOURCE PROTEIN FIBREPatients 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

GLUCERNA SELECTPatients 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

Study Status

Completed

Start Date: April 2010

Completed Date: February 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 1

Secondary Outcome: Assessment of Critical Ill Patients Progress During Hospital Stay 1

Study sponsors, principal investigator, and references

Principal Investigator: Alfonso Mesejo, PhD

Lead Sponsor: Vegenat, S.A.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01233726

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