Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia
Sponsor
Vegenat, S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT01233726
Collaborator
(none)
159
2
3
58.1
79.5
1.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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.
Study Start Date
:
Apr 1, 2010
Actual Primary Completion Date
:
Feb 1, 2015
Actual Study Completion Date
:
Feb 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: T-DIET PLUS DIABET IR 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
Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
Other Names:
|
| Active Comparator: ISOSOURCE PROTEIN FIBRE 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 |
Dietary Supplement: ISOSOURCE PROTEIN FIBRE
Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
Other Names:
|
| Active Comparator: GLUCERNA SELECT 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
Group 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Measure of Biochemical Parameters and Evaluation of Infectious Complications 1 [28 days post-admission]
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 [28 days post-admission]
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 [28 days post-admission]
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 [28 days post-admission]
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 [28 days post-admission]
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 [28 days post-admission]
This table shows the number of capillary glycemia measurements
- Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 [28 days post-admission]
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 [100 days of treatment]
Infectious complication incidence rate per 100 days of treatment are provided in this table.
- Assessment of Critical Ill Patients Progress During Hospital Stay 2 [28 days post-admission]
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 [28 days post-admission]
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 [100 days of treatment]
Number of participants with infectious complications is provided in this table.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
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 (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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Intensive Care Unit. Hospital Universitario 12 de Octubre | Madrid | Spain | ||
| 2 | Intensive Care Unit. Hospital Clinico Universitario de Valencia | Valencia | Spain |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Vegenat, S.A.
ClinicalTrials.gov Identifier:
NCT01233726
Other Study ID Numbers:
- IR2009
- DIABET IR IDI-20080283
First Posted:
Nov 3, 2010
Last Update Posted:
Sep 1, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Vegenat, S.A.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | This study examines whether a high-protein diabetes-specific formula reduces insulin needs, improves glycemic control and reduces ICU-adquired infection in critically ill, hyperglycemic patients on mechanical ventilation (MV) |
|---|---|
| Pre-assignment Detail | The study was performed over the period April 2010 to May 2012. A website was constructed to record data and to randoize patients to each EN formula. Data were collected online using an electronic case report form. |
| Arm/Group Title | DIABA HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric. | Patients of this group received 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric. | Patients of this group received 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. GLUCERNA SELECT group will received 25 kcal / kg / day for 28 days, via gastric or transpyloric. |
| Period Title: Overall Study | |||
| STARTED | 53 | 53 | 53 |
| COMPLETED | 52 | 53 | 52 |
| NOT COMPLETED | 1 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | DIABA HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT | Total |
|---|---|---|---|---|
| Arm/Group Description | Patients of this group received new-generation diabetes-specific high-protein formula (Diaba HP®, Vegenat, Badajoz, Spain); as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. DIABA HP group received, 25 kcal / kg/ day for 28 days, via gastric or transpyloric. | Patients of this group will received ISOSOURCE PROTEIN FIBRE (Nestlé Health Science, barcelona, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric. | Patients of this group will receive GLUCERNA SELECT (Abbott Nutrition, Madrid, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. GLUCERNA SELECT group received 25 kcal / kg / day for 28 days, via gastric or transpyloric. | Total of all reporting groups |
| Overall Participants | 52 | 53 | 52 | 157 |
| Age (years) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [years] |
57
|
60
|
58
|
58
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
15
28.8%
|
10
18.9%
|
13
25%
|
38
24.2%
|
| Male |
37
71.2%
|
43
81.1%
|
39
75%
|
119
75.8%
|
| Body Mass Index (BMI) (kg/m^2) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [kg/m^2] |
26
|
26
|
26
|
26
|
| APACHE II (units on a scale) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [units on a scale] |
17
|
19
|
19
|
19
|
| SOFA score (units on a scale) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [units on a scale] |
8
|
7
|
7
|
8
|
| Calorie requirements (kcal/day) [Geometric Mean (Standard Deviation) ] | ||||
| Geometric Mean (Standard Deviation) [kcal/day] |
1690.4
(384.9)
|
1707.1
(275.4)
|
1728.2
(309.2)
|
1708.6
(323.2)
|
| Start of EN (hours) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [hours] |
23.4
|
25.1
|
26.7
|
25.1
|
| Noninsulin-dependent diabetes (participants) [Number] | ||||
| Number [participants] |
11
21.2%
|
7
13.2%
|
12
23.1%
|
30
19.1%
|
| HbA1c (percentaje of glycated hemoglobin) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [percentaje of glycated hemoglobin] |
6.34
(1.38)
|
5.76
(0.95)
|
6.07
(1.39)
|
6.1
(1.24)
|
| Capillary glucose level (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
148.8
(38.8)
|
149.9
(38.9)
|
151.5
(39.23)
|
150
(38.98)
|
| Plasma glucose level (mg/dL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dL] |
152.1
(54.6)
|
147.01
(55.93)
|
152.1
(57.12)
|
150.4
(55.88)
|
| Insulinemia (microU/mL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [microU/mL] |
21.59
(36.06)
|
17.39
(23.77)
|
19.15
(20.5)
|
19.38
(26.78)
|
| C-peptide (ng/mL) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [ng/mL] |
4.61
(3.24)
|
4.49
(2.92)
|
4.27
(3.67)
|
4.46
(3.28)
|
| HOMA2 IR (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
2.94
(4.19)
|
2.48
(2.76)
|
3.38
(2.37)
|
2.93
(3.11)
|
| HOMA2 %B (% of beta cell function) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [% of beta cell function] |
102.6
(57.81)
|
110.5
(74.34)
|
96.55
(85.09)
|
103.21
(72.41)
|
| HOMA2 %S (% of insulin sensitivity) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [% of insulin sensitivity] |
79.12
(75.2)
|
69.6
(48.7)
|
68.09
(66.9)
|
72.27
(63.6)
|
| Infection (participants) [Number] | ||||
| Number [participants] |
13
25%
|
15
28.3%
|
8
15.4%
|
36
22.9%
|
| Diagnostic group: Medical (participants) [Number] | ||||
| Number [participants] |
32
61.5%
|
36
67.9%
|
30
57.7%
|
98
62.4%
|
| Diagnostic group: Trauma (participants) [Number] | ||||
| Number [participants] |
13
25%
|
9
17%
|
15
28.8%
|
37
23.6%
|
| Diagnostic group: Surgery (participants) [Number] | ||||
| Number [participants] |
7
13.5%
|
8
15.1%
|
7
13.5%
|
22
14%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission. |
| Arm/Group Title | Diaba HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. Group Diaba HP received, 25 kcal / kg /day for 28 days | 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric. |
| Measure Participants | 52 | 53 | 52 |
| Plasma glucose level (mg/dL) |
138.6
(39.1)
|
146.1
(49.9)
|
143.9
(45.9)
|
| Capillary glucose level (mg/dL) |
146.1
(45.8)
|
155.3
(63.6)
|
150.1
(41.9)
|
| Mean capillary glycemia on ICU day 1 (mg/dL) |
147.5
(40.2)
|
160
(55.5)
|
145.6
(46.6)
|
| Peak glucose level (mg/dL) |
181.3
(52)
|
193.6
(74.6)
|
191.3
(65.8)
|
| Glycemic variability SD (mg/dL) (ICU days 1-28) |
33.6
(18.4)
|
49.1
(21.5)
|
41.1
(9.3)
|
| Glycemic variability SD (mg/dL) (ICU days 1-7) |
43.2
(4.9)
|
68.5
(13.5)
|
42.5
(2.7)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission. |
| Arm/Group Title | Diaba HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. Group Diaba HP received, 25 kcal / kg /day for 28 days | 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric. |
| Measure Participants | 52 | 53 | 52 |
| Mean (Standard Deviation) [IU/day] |
19.1
(13.1)
|
23.7
(40.1)
|
20.3
(30.1)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission. |
| Arm/Group Title | Diaba HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. Group Diaba HP received, 25 kcal / kg /day for 28 days | 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric. |
| Measure Participants | 52 | 53 | 52 |
| Number [Capillary glycemia measurements] |
3605
|
3523
|
3557
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission. |
| Arm/Group Title | Diaba HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. Group Diaba HP received, 25 kcal / kg /day for 28 days | 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric. |
| Measure Participants | 52 | 53 | 52 |
| Mean (Standard Deviation) [Measurements per patient/day] |
5.7
(3.4)
|
5.81
(3.2)
|
5.46
(2.9)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission. |
| Arm/Group Title | Diaba HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. Group Diaba HP received, 25 kcal / kg /day for 28 days | 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric. |
| Measure Participants | 52 | 53 | 52 |
| Glycemic CV (%) (ICU days 1-28) |
27.9
(5.8)
|
32.4
(11.2)
|
27.8
(5.2)
|
| Glycemic CV (%) (ICU days 1-7) |
28.3
(1.9)
|
42.6
(8.2)
|
28.4
(2.1)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Diaba HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. Group Diaba HP received, 25 kcal / kg /day for 28 days | 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric. |
| Measure Participants | 52 | 53 | 52 |
| Number [number of capillary glycemia measurement] |
3605
|
3523
|
3557
|
| Title | Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2 |
|---|---|
| Description | 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. |
| Time Frame | 28 days post-admission |
Outcome Measure Data
| Analysis Population Description |
|---|
| Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission. |
| Arm/Group Title | Diaba HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. Group Diaba HP received, 25 kcal / kg /day for 28 days | 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric. |
| Measure Participants | 52 | 53 | 52 |
| Controls on 80-150 mg/dL |
59
|
57.6
|
59.59
|
| Hypoglycemia (50-80 mg/dL) |
1.48
|
3.63
|
1.25
|
| Hypoglycemia (<50 mg/dL) |
0
|
0.11
|
0.02
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission. |
| Arm/Group Title | DIABA HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. DIABA HP GROUP received, 25 kcal / kg /day for 28 days, 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric. |
| Measure Participants | 52 | 53 | 52 |
| Number [percentage of patients with infection] |
22
|
24
|
24
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission. |
| Arm/Group Title | DIABA HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. DIABA HP GROUP received, 25 kcal / kg /day for 28 days, 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric. |
| Measure Participants | 52 | 53 | 52 |
| Catether-related bloodstream infection |
1
1.9%
|
1
1.9%
|
2
3.8%
|
| Primary bloodstream infection |
3
5.8%
|
1
1.9%
|
3
5.8%
|
| Urinary tract infection |
1
1.9%
|
1
1.9%
|
1
1.9%
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission. |
| Arm/Group Title | DIABA HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. DIABA HP GROUP received, 25 kcal / kg /day for 28 days, 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric. |
| Measure Participants | 52 | 53 | 52 |
| Tracheobonchitis incidence rate |
7
|
10
|
7
|
| Ventilator-associated pneumonia |
8
|
10
|
6
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Age ≥18 years, ICU stay ≤48 hours upon randomization to EN formula, mechanical ventilation, EN indicated for an expected time ≥5 days. Patients were also required to meet American Diabetes Association criteria for diabetes/hyperglycemia (baseline blood glucose >126 mg/dL after fasting or>200 mg/dL otherwise) in the first 48 h of ICU admission. |
| Arm/Group Title | Diaba HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT |
|---|---|---|---|
| Arm/Group Description | Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. Group Diaba HP received, 25 kcal / kg /day for 28 days | 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric. |
| Measure Participants | 52 | 53 | 52 |
| Number [participants] |
18
34.6%
|
23
43.4%
|
23
44.2%
|
Adverse Events
| Time Frame | All participants were followed at the ICU for a maximum of 28 days. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | No adverse effects have been observed and/or registered related with the products intake during the clinical trial period. Data provided in outcome measure are related with the individual patology of each patient, not with the product intake (enteral nutrition intake). | |||||
| Arm/Group Title | DIABA HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT | |||
| Arm/Group Description | Patients of this group received Diaba HP® as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition. DIABA HP group received, 25 kcal / kg /day for 28 days, 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 ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture. ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, 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 GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates. GLUCERNA SELECT group will receive 25 kcal / kg / day for 28 days, via gastric or transpyloric. | |||
All Cause Mortality |
||||||
| DIABA HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| DIABA HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/52 (0%) | 0/53 (0%) | 0/52 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| DIABA HP | ISOSOURCE PROTEIN FIBRE | GLUCERNA SELECT | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/52 (0%) | 0/53 (0%) | 0/52 (0%) | |||
Limitations/Caveats
No overall limitations and caveats have been observed and/or registered related with the products intake during the clinical trial period.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Alfonso Mesejo |
|---|---|
| Organization | Intensive Care Unit, Hospital Clínico Universitario |
| Phone | 961 97 35 00 |
| mesejo_alf@gva.es |
Responsible Party:
Vegenat, S.A.
ClinicalTrials.gov Identifier:
NCT01233726
Other Study ID Numbers:
- IR2009
- DIABET IR IDI-20080283
First Posted:
Nov 3, 2010
Last Update Posted:
Sep 1, 2016
Last Verified:
Jul 1, 2016