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

Primary Purpose

Critical Illness, Hyperglycemia, Dietary Modification

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

T-Diet plus Diabet IR

ISOSOURCE PROTEIN FIBRE

GLUCERNA SELECT

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring Critical illness, Hyperglycemia, Mechanical Ventilation, Enteral nutrition, T-Diet plus Diabet IR, Malnutrition, Insulin resistance, Metabolic stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Intensive Care Unit. Hospital Universitario 12 de Octubre
Intensive Care Unit. Hospital Clinico Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

T-DIET PLUS DIABET IR

ISOSOURCE PROTEIN FIBRE

GLUCERNA SELECT

Arm Description

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

Patients 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

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

Outcomes

Primary Outcome Measures

Measure of Biochemical Parameters and Evaluation of Infectious Complications 1

The variables recorded related to glycemic control in mg/dL are provided in this table.

Measure of Biochemical Parameters and Evaluation of Infectious Complications 2

The variables recorded related to administered insulin in IU/day are provided in this table

Measure of Biochemical Parameters and Evaluation of Infectious Complications 3

The variables recorded related to number of capillary glycemia measurements are provided in this table

Measure of Biochemical Parameters and Evaluation of Infectious Complications 4

The variables recorded related to the number of measurements per patient per day are provided in this table

Measure of Biochemical Parameters and Evaluation of Infectious Complications 5

The variables recorded related to Glycemic CV (%) are provided in this table: Glycemic Coeficient of variation (%) after 28 days in ICU Glycemic Coeficient of variation (%) after 7 days in ICU.

Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1

This table shows the number of capillary glycemia measurements

Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2

This table shows the rates of: Controls analysis on 80-150 mg/dL: optimal level of glycemia rate. Hypoglycemia (50-80 mg/dL): moderate hypoglycemia rate. Hypoglycemia (<50 mg/dL): severe hypoglycemia episodes rate.

Secondary Outcome Measures

Assessment of Critical Ill Patients Progress During Hospital Stay 1

Infectious complication incidence rate per 100 days of treatment are provided in this table.

Assessment of Critical Ill Patients Progress During Hospital Stay 2

Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table

Assessment of Critical Ill Patients Progress During Hospital Stay 3

The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.

Assessment of Critical Ill Patients Progress During Hospital Stay 4

Number of participants with infectious complications is provided in this table.

Full Information

NCT ID

NCT01233726

First Posted

October 29, 2010

Last Updated

July 20, 2016

Sponsor

Vegenat, S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01233726

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vegenat, S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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 eicosapentanoic acid (EPA) and docosahexaenoic acid (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Critical illness, Hyperglycemia, Mechanical Ventilation, Enteral nutrition, T-Diet plus Diabet IR, Malnutrition, Insulin resistance, Metabolic stress

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

T-DIET PLUS DIABET IR

Arm Type

Experimental

Arm Description

Arm Title

ISOSOURCE PROTEIN FIBRE

Arm Type

Active Comparator

Arm Description

Arm Title

GLUCERNA SELECT

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

T-Diet plus Diabet IR

Other Intervention Name(s)

DIABA HP

Intervention Description

Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

Intervention Type

Dietary Supplement

Intervention Name(s)

ISOSOURCE PROTEIN FIBRE

Other Intervention Name(s)

ISS PROT FIB

Intervention Description

Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

Intervention Type

Dietary Supplement

Intervention Name(s)

GLUCERNA SELECT

Other Intervention Name(s)

GLUC SEL

Intervention Description

Group 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.

Primary Outcome Measure Information:

Title

Measure of Biochemical Parameters and Evaluation of Infectious Complications 1

Description

The variables recorded related to glycemic control in mg/dL are provided in this table.

Time Frame

28 days post-admission

Title

Measure of Biochemical Parameters and Evaluation of Infectious Complications 2

Description

The variables recorded related to administered insulin in IU/day are provided in this table

Time Frame

28 days post-admission

Title

Measure of Biochemical Parameters and Evaluation of Infectious Complications 3

Description

The variables recorded related to number of capillary glycemia measurements are provided in this table

Time Frame

28 days post-admission

Title

Measure of Biochemical Parameters and Evaluation of Infectious Complications 4

Description

The variables recorded related to the number of measurements per patient per day are provided in this table

Time Frame

28 days post-admission

Title

Measure of Biochemical Parameters and Evaluation of Infectious Complications 5

Description

The variables recorded related to Glycemic CV (%) are provided in this table: Glycemic Coeficient of variation (%) after 28 days in ICU Glycemic Coeficient of variation (%) after 7 days in ICU.

Time Frame

28 days post-admission

Title

Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1

Description

This table shows the number of capillary glycemia measurements

Time Frame

28 days post-admission

Title

Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2

Description

Time Frame

28 days post-admission

Secondary Outcome Measure Information:

Title

Assessment of Critical Ill Patients Progress During Hospital Stay 1

Description

Infectious complication incidence rate per 100 days of treatment are provided in this table.

Time Frame

100 days of treatment

Title

Assessment of Critical Ill Patients Progress During Hospital Stay 2

Description

Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table

Time Frame

28 days post-admission

Title

Assessment of Critical Ill Patients Progress During Hospital Stay 3

Description

The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.

Time Frame

28 days post-admission

Title

Assessment of Critical Ill Patients Progress During Hospital Stay 4

Description

Number of participants with infectious complications is provided in this table.

Time Frame

100 days of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alfonso Mesejo, PhD

Organizational Affiliation

Hospital Clinico Universitario de Valencia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Juan Carlos Montejo, PhD

Organizational Affiliation

Hospital Universitario 12 de Octubre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Intensive Care Unit. Hospital Universitario 12 de Octubre

City

Madrid

Country

Spain

Facility Name

Intensive Care Unit. Hospital Clinico Universitario de Valencia

City

Valencia

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

26549276

Citation

Mesejo A, Montejo-Gonzalez JC, Vaquerizo-Alonso C, Lobo-Tamer G, Zabarte-Martinez M, Herrero-Meseguer JI, Acosta-Escribano J, Blesa-Malpica A, Martinez-Lozano F. Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study. Crit Care. 2015 Nov 9;19:390. doi: 10.1186/s13054-015-1108-1.

Results Reference

derived

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

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