Trial record 5 of 198 for:    Open Studies | "Hyperglycemia"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Vegenat, S.A..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Vegenat, S.A.
ClinicalTrials.gov Identifier:
NCT01233726
First received: October 29, 2010
Last updated: June 21, 2012
Last verified: November 2010
  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.

Resource links provided by NLM:


Further study details as provided by Vegenat, S.A.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233726

Contacts
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

Locations
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   
Sponsors and Collaborators
Vegenat, S.A.
Investigators
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

ClinicalTrials.gov processed this record on September 16, 2014