Status:
COMPLETED
Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia
Lead Sponsor:
Vegenat, S.A.
Conditions:
Critical Illness
Hyperglycemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 abs...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT01233726
Start Date
April 1 2010
End Date
February 1 2015
Last Update
September 1 2016
Active Locations (2)
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1
Intensive Care Unit. Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
2
Intensive Care Unit. Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain