Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Critical Illness Hyperglycemia Mechanical Ventilation Enteral Nutrition Metabolic Stress |
Dietary Supplement: T-Diet plus Diabet IR Dietary Supplement: ISOSOURCE PROTEIN FIBRE Dietary Supplement: GLUCERNA SELECT |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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. |
- Measure of biochemical parameters and evaluation of infectious complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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.
- Assessment of critical ill patients progress during hospital stay [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- 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.
| Estimated Enrollment: | 240 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
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
|
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. Other Name: DB IR
|
|
Active Comparator: Group 2
Patients of this group will receive ISOSOURCE PROTEIN FIBRA (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
|
Dietary Supplement: 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. Other Name: ISS PROT FIB
|
|
Active Comparator: Group 3
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
|
Dietary Supplement: 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. Other Name: GLUC SEL
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Alfonso Mesejo, PhD | +34 963 862 600 | mesejo_alf@gva.es |
| Contact: Juan Carlos Montejo, PhD | +34 91 390 81 51 | jmontejo.hdoc@salud.madrid.org |
| Spain | |
| Intensive Care Unit. Hospital Universitario 12 de Octubre | Recruiting |
| Madrid, Spain | |
| Contact: Juan Carlos Montejo, PhD +34 91 390 81 51 jmontejo.hdoc@salud.madrid.org | |
| Intensive Care Unit. Hospital Clinico Universitario de Valencia | Recruiting |
| Valencia, Spain | |
| Contact: Alfonso Mesejo, PhD +34 963 862 600 mesejo_alf@gva.es | |
| Principal Investigator: | Alfonso Mesejo, PhD | Hospital Clinico Universitario de Valencia |
| Principal Investigator: | Juan Carlos Montejo, PhD | Hospital Universitario 12 de Octubre |
More Information
No publications provided
| Responsible Party: | Vegenat, S.A. |
| ClinicalTrials.gov Identifier: | NCT01233726 History of Changes |
| Other Study ID Numbers: | IR2009, DIABET IR IDI-20080283 |
| Study First Received: | October 29, 2010 |
| Last Updated: | June 21, 2012 |
| Health Authority: | Spain: Ministry of Health and Consumption |
Keywords provided by Vegenat, S.A.:
|
Critical illness Hyperglycemia Mechanical Ventilation Enteral nutrition |
T-Diet plus Diabet IR Malnutrition Insulin resistance Metabolic stress |
Additional relevant MeSH terms:
|
Critical Illness Hyperglycemia Disease Attributes Pathologic Processes Glucose Metabolism Disorders Metabolic Diseases Phentermine Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Appetite Depressants Anti-Obesity Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013