Trial Outcomes & Findings for Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia (NCT NCT01233726)
NCT ID: NCT01233726
Last Updated: 2016-09-01
Results Overview
The variables recorded related to glycemic control in mg/dL are provided in this table.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
159 participants
Primary outcome timeframe
28 days post-admission
Results posted on
2016-09-01
Participant Flow
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)
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.
Participant milestones
| Measure |
DIABA HP
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.
|
ISOSOURCE PROTEIN FIBRE
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.
|
GLUCERNA SELECT
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
53
|
53
|
|
Overall Study
COMPLETED
|
52
|
53
|
52
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of a Complete Diet in Critically Ill Patients With Stress Hyperglycemia
Baseline characteristics by cohort
| Measure |
DIABA HP
n=52 Participants
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.
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57 years
n=93 Participants
|
60 years
n=4 Participants
|
58 years
n=27 Participants
|
58 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
119 Participants
n=483 Participants
|
|
Body Mass Index (BMI)
|
26 kg/m^2
n=93 Participants
|
26 kg/m^2
n=4 Participants
|
26 kg/m^2
n=27 Participants
|
26 kg/m^2
n=483 Participants
|
|
APACHE II
|
17 units on a scale
n=93 Participants
|
19 units on a scale
n=4 Participants
|
19 units on a scale
n=27 Participants
|
19 units on a scale
n=483 Participants
|
|
SOFA score
|
8 units on a scale
n=93 Participants
|
7 units on a scale
n=4 Participants
|
7 units on a scale
n=27 Participants
|
8 units on a scale
n=483 Participants
|
|
Calorie requirements
|
1690.4 kcal/day
STANDARD_DEVIATION 384.9 • n=93 Participants
|
1707.1 kcal/day
STANDARD_DEVIATION 275.4 • n=4 Participants
|
1728.2 kcal/day
STANDARD_DEVIATION 309.2 • n=27 Participants
|
1708.6 kcal/day
STANDARD_DEVIATION 323.2 • n=483 Participants
|
|
Start of EN
|
23.4 hours
n=93 Participants
|
25.1 hours
n=4 Participants
|
26.7 hours
n=27 Participants
|
25.1 hours
n=483 Participants
|
|
Noninsulin-dependent diabetes
|
11 participants
n=93 Participants
|
7 participants
n=4 Participants
|
12 participants
n=27 Participants
|
30 participants
n=483 Participants
|
|
HbA1c
|
6.34 percentaje of glycated hemoglobin
STANDARD_DEVIATION 1.38 • n=93 Participants
|
5.76 percentaje of glycated hemoglobin
STANDARD_DEVIATION 0.95 • n=4 Participants
|
6.07 percentaje of glycated hemoglobin
STANDARD_DEVIATION 1.39 • n=27 Participants
|
6.1 percentaje of glycated hemoglobin
STANDARD_DEVIATION 1.24 • n=483 Participants
|
|
Capillary glucose level
|
148.8 mg/dL
STANDARD_DEVIATION 38.8 • n=93 Participants
|
149.9 mg/dL
STANDARD_DEVIATION 38.9 • n=4 Participants
|
151.5 mg/dL
STANDARD_DEVIATION 39.23 • n=27 Participants
|
150 mg/dL
STANDARD_DEVIATION 38.98 • n=483 Participants
|
|
Plasma glucose level
|
152.1 mg/dL
STANDARD_DEVIATION 54.6 • n=93 Participants
|
147.01 mg/dL
STANDARD_DEVIATION 55.93 • n=4 Participants
|
152.1 mg/dL
STANDARD_DEVIATION 57.12 • n=27 Participants
|
150.4 mg/dL
STANDARD_DEVIATION 55.88 • n=483 Participants
|
|
Insulinemia
|
21.59 microU/mL
STANDARD_DEVIATION 36.06 • n=93 Participants
|
17.39 microU/mL
STANDARD_DEVIATION 23.77 • n=4 Participants
|
19.15 microU/mL
STANDARD_DEVIATION 20.5 • n=27 Participants
|
19.38 microU/mL
STANDARD_DEVIATION 26.78 • n=483 Participants
|
|
C-peptide
|
4.61 ng/mL
STANDARD_DEVIATION 3.24 • n=93 Participants
|
4.49 ng/mL
STANDARD_DEVIATION 2.92 • n=4 Participants
|
4.27 ng/mL
STANDARD_DEVIATION 3.67 • n=27 Participants
|
4.46 ng/mL
STANDARD_DEVIATION 3.28 • n=483 Participants
|
|
HOMA2 IR
|
2.94 units on a scale
STANDARD_DEVIATION 4.19 • n=93 Participants
|
2.48 units on a scale
STANDARD_DEVIATION 2.76 • n=4 Participants
|
3.38 units on a scale
STANDARD_DEVIATION 2.37 • n=27 Participants
|
2.93 units on a scale
STANDARD_DEVIATION 3.11 • n=483 Participants
|
|
HOMA2 %B
|
102.6 % of beta cell function
STANDARD_DEVIATION 57.81 • n=93 Participants
|
110.5 % of beta cell function
STANDARD_DEVIATION 74.34 • n=4 Participants
|
96.55 % of beta cell function
STANDARD_DEVIATION 85.09 • n=27 Participants
|
103.21 % of beta cell function
STANDARD_DEVIATION 72.41 • n=483 Participants
|
|
HOMA2 %S
|
79.12 % of insulin sensitivity
STANDARD_DEVIATION 75.2 • n=93 Participants
|
69.6 % of insulin sensitivity
STANDARD_DEVIATION 48.7 • n=4 Participants
|
68.09 % of insulin sensitivity
STANDARD_DEVIATION 66.9 • n=27 Participants
|
72.27 % of insulin sensitivity
STANDARD_DEVIATION 63.6 • n=483 Participants
|
|
Infection
|
13 participants
n=93 Participants
|
15 participants
n=4 Participants
|
8 participants
n=27 Participants
|
36 participants
n=483 Participants
|
|
Diagnostic group: Medical
|
32 participants
n=93 Participants
|
36 participants
n=4 Participants
|
30 participants
n=27 Participants
|
98 participants
n=483 Participants
|
|
Diagnostic group: Trauma
|
13 participants
n=93 Participants
|
9 participants
n=4 Participants
|
15 participants
n=27 Participants
|
37 participants
n=483 Participants
|
|
Diagnostic group: Surgery
|
7 participants
n=93 Participants
|
8 participants
n=4 Participants
|
7 participants
n=27 Participants
|
22 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 28 days post-admissionPopulation: 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.
The variables recorded related to glycemic control in mg/dL are provided in this table.
Outcome measures
| Measure |
Diaba HP
n=52 Participants
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
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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 of Biochemical Parameters and Evaluation of Infectious Complications 1
Plasma glucose level (mg/dL)
|
138.6 mg/dL
Standard Deviation 39.1
|
146.1 mg/dL
Standard Deviation 49.9
|
143.9 mg/dL
Standard Deviation 45.9
|
|
Measure of Biochemical Parameters and Evaluation of Infectious Complications 1
Capillary glucose level (mg/dL)
|
146.1 mg/dL
Standard Deviation 45.8
|
155.3 mg/dL
Standard Deviation 63.6
|
150.1 mg/dL
Standard Deviation 41.9
|
|
Measure of Biochemical Parameters and Evaluation of Infectious Complications 1
Mean capillary glycemia on ICU day 1 (mg/dL)
|
147.5 mg/dL
Standard Deviation 40.2
|
160 mg/dL
Standard Deviation 55.5
|
145.6 mg/dL
Standard Deviation 46.6
|
|
Measure of Biochemical Parameters and Evaluation of Infectious Complications 1
Peak glucose level (mg/dL)
|
181.3 mg/dL
Standard Deviation 52
|
193.6 mg/dL
Standard Deviation 74.6
|
191.3 mg/dL
Standard Deviation 65.8
|
|
Measure of Biochemical Parameters and Evaluation of Infectious Complications 1
Glycemic variability SD (mg/dL) (ICU days 1-28)
|
33.6 mg/dL
Standard Deviation 18.4
|
49.1 mg/dL
Standard Deviation 21.5
|
41.1 mg/dL
Standard Deviation 9.3
|
|
Measure of Biochemical Parameters and Evaluation of Infectious Complications 1
Glycemic variability SD (mg/dL) (ICU days 1-7)
|
43.2 mg/dL
Standard Deviation 4.9
|
68.5 mg/dL
Standard Deviation 13.5
|
42.5 mg/dL
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: 28 days post-admissionPopulation: 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.
The variables recorded related to administered insulin in IU/day are provided in this table
Outcome measures
| Measure |
Diaba HP
n=52 Participants
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
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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 of Biochemical Parameters and Evaluation of Infectious Complications 2
|
19.1 IU/day
Standard Deviation 13.1
|
23.7 IU/day
Standard Deviation 40.1
|
20.3 IU/day
Standard Deviation 30.1
|
PRIMARY outcome
Timeframe: 28 days post-admissionPopulation: 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.
The variables recorded related to number of capillary glycemia measurements are provided in this table
Outcome measures
| Measure |
Diaba HP
n=52 Participants
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
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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 of Biochemical Parameters and Evaluation of Infectious Complications 3
|
3605 Capillary glycemia measurements
|
3523 Capillary glycemia measurements
|
3557 Capillary glycemia measurements
|
PRIMARY outcome
Timeframe: 28 days post-admissionPopulation: 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.
The variables recorded related to the number of measurements per patient per day are provided in this table
Outcome measures
| Measure |
Diaba HP
n=52 Participants
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
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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 of Biochemical Parameters and Evaluation of Infectious Complications 4
|
5.7 Measurements per patient/day
Standard Deviation 3.4
|
5.81 Measurements per patient/day
Standard Deviation 3.2
|
5.46 Measurements per patient/day
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: 28 days post-admissionPopulation: 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.
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.
Outcome measures
| Measure |
Diaba HP
n=52 Participants
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
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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 of Biochemical Parameters and Evaluation of Infectious Complications 5
Glycemic CV (%) (ICU days 1-28)
|
27.9 percentage of Glycemic CV
Standard Deviation 5.8
|
32.4 percentage of Glycemic CV
Standard Deviation 11.2
|
27.8 percentage of Glycemic CV
Standard Deviation 5.2
|
|
Measure of Biochemical Parameters and Evaluation of Infectious Complications 5
Glycemic CV (%) (ICU days 1-7)
|
28.3 percentage of Glycemic CV
Standard Deviation 1.9
|
42.6 percentage of Glycemic CV
Standard Deviation 8.2
|
28.4 percentage of Glycemic CV
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 28 days post-admissionThis table shows the number of capillary glycemia measurements
Outcome measures
| Measure |
Diaba HP
n=52 Participants
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
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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.
|
|---|---|---|---|
|
Primary Outcome: Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.1
|
3605 number of capillary glycemia measurement
|
3523 number of capillary glycemia measurement
|
3557 number of capillary glycemia measurement
|
PRIMARY outcome
Timeframe: 28 days post-admissionPopulation: 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.
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.
Outcome measures
| Measure |
Diaba HP
n=52 Participants
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
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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 of Biochemical Parameters and Evaluation of Infectious Complications 6.2
Hypoglycemia (<50 mg/dL)
|
0 % of capillary glycemia measurements
|
0.11 % of capillary glycemia measurements
|
0.02 % of capillary glycemia measurements
|
|
Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2
Controls on 80-150 mg/dL
|
59 % of capillary glycemia measurements
|
57.6 % of capillary glycemia measurements
|
59.59 % of capillary glycemia measurements
|
|
Measure of Biochemical Parameters and Evaluation of Infectious Complications 6.2
Hypoglycemia (50-80 mg/dL)
|
1.48 % of capillary glycemia measurements
|
3.63 % of capillary glycemia measurements
|
1.25 % of capillary glycemia measurements
|
SECONDARY outcome
Timeframe: 100 days of treatmentPopulation: 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.
Infectious complication incidence rate per 100 days of treatment are provided in this table.
Outcome measures
| Measure |
Diaba HP
n=52 Participants
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
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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.
|
|---|---|---|---|
|
Assessment of Critical Ill Patients Progress During Hospital Stay 1
|
22 percentage of patients with infection
|
24 percentage of patients with infection
|
24 percentage of patients with infection
|
SECONDARY outcome
Timeframe: 28 days post-admissionPopulation: 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.
Number of participants with catheter-associated bloodstream infection, primary bloodstream infection or urinary tract infection are provided in this table
Outcome measures
| Measure |
Diaba HP
n=52 Participants
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
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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.
|
|---|---|---|---|
|
Assessment of Critical Ill Patients Progress During Hospital Stay 2
Catether-related bloodstream infection
|
1 participants
|
1 participants
|
2 participants
|
|
Assessment of Critical Ill Patients Progress During Hospital Stay 2
Primary bloodstream infection
|
3 participants
|
1 participants
|
3 participants
|
|
Assessment of Critical Ill Patients Progress During Hospital Stay 2
Urinary tract infection
|
1 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 28 days post-admissionPopulation: 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.
The incidence of tracheobronchitis and ventilator-associated pneumonia per 1000 days of mechanical ventilation are provided in this table.
Outcome measures
| Measure |
Diaba HP
n=52 Participants
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
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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.
|
|---|---|---|---|
|
Assessment of Critical Ill Patients Progress During Hospital Stay 3
Tracheobonchitis incidence rate
|
7 number of new cases per 1000 days
|
10 number of new cases per 1000 days
|
7 number of new cases per 1000 days
|
|
Assessment of Critical Ill Patients Progress During Hospital Stay 3
Ventilator-associated pneumonia
|
8 number of new cases per 1000 days
|
10 number of new cases per 1000 days
|
6 number of new cases per 1000 days
|
SECONDARY outcome
Timeframe: 100 days of treatmentPopulation: 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.
Number of participants with infectious complications is provided in this table.
Outcome measures
| Measure |
Diaba HP
n=52 Participants
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
|
ISOSOURCE PROTEIN FIBRE
n=53 Participants
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.
|
GLUCERNA SELECT
n=52 Participants
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.
|
|---|---|---|---|
|
Assessment of Critical Ill Patients Progress During Hospital Stay 4
|
18 participants
|
23 participants
|
23 participants
|
Adverse Events
DIABA HP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ISOSOURCE PROTEIN FIBRE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GLUCERNA SELECT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alfonso Mesejo
Intensive Care Unit, Hospital Clínico Universitario
Phone: 961 97 35 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place