N/A N=159 Randomized Supportive Care

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

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

Bottom Line

View on ClinicalTrials.gov: NCT01233726 ↗

Enrolled (actual)

159

Serious AEs

0.0%

Results posted

Sep 2016

Primary outcome: Primary: Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 — 138.6; 146.1; 143.9; 146.1 mg/dL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: T-Diet plus Diabet IR (Dietary_supplement); ISOSOURCE PROTEIN FIBRE (Dietary_supplement); GLUCERNA SELECT (Dietary_supplement)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vegenat, S.A.
Primary completion: Feb 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Measure of Biochemical Parameters and Evaluation of Infectious Complications 1	138.6; 146.1; 143.9; 146.1; 155.3; 150.1	—
PRIMARY Measure of Biochemical Parameters and Evaluation of Infectious Complications 2	19.1; 23.7; 20.3	—
PRIMARY Measure of Biochemical Parameters and Evaluation of Infectious Complications 3	3605; 3523; 3557	—
PRIMARY Measure of Biochemical Parameters and Evaluation of Infectious Complications 4	5.7; 5.81; 5.46	—
PRIMARY Measure of Biochemical Parameters and Evaluation of Infectious Complications 5	27.9; 32.4; 27.8; 28.3; 42.6; 28.4	—
PRIMARY Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1	3605; 3523; 3557	—
PRIMARY Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2	59; 57.6; 59.59; 1.48; 3.63; 1.25	—
SECONDARY Assessment of Critical Ill Patients Progress During Hospital Stay 1	22; 24; 24	—
SECONDARY Assessment of Critical Ill Patients Progress During Hospital Stay 2	1; 1; 2; 3; 1; 3	—
SECONDARY Assessment of Critical Ill Patients Progress During Hospital Stay 3	7; 10; 7; 8; 10; 6	—
SECONDARY Assessment of Critical Ill Patients Progress During Hospital Stay 4	18; 23; 23	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01233726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.