Trial Outcomes & Findings for The Energy Dose Study (NCT NCT01369147)
NCT ID: NCT01369147
Last Updated: 2022-06-10
Results Overview
The number of participants with a hospital-acquired infection during the study period is presented here.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Up to Day 28
Results posted on
2022-06-10
Participant Flow
Participant milestones
| Measure |
Parenteral Nutrition Energy Dose at 0.6 x Measured REE
Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x resting energy expenditure (REE) for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.0 x Measured REE
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.3 x Measured REE
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
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|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Parenteral Nutrition Energy Dose at 0.6 x Measured REE
Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x resting energy expenditure (REE) for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.0 x Measured REE
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.3 x Measured REE
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
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|---|---|---|---|
|
Overall Study
All collected data were unintentionally destroyed
|
0
|
1
|
0
|
Baseline Characteristics
The Energy Dose Study
Baseline characteristics by cohort
| Measure |
Parenteral Nutrition Energy Dose at 0.6 x Measured REE
n=3 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.0 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.3 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Total
n=11 Participants
Total of all reporting groups
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|---|---|---|---|---|
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Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II) Score
APACHE II Score of 15 or Less
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Continuous
|
47.05 years
STANDARD_DEVIATION 21.50 • n=5 Participants
|
60.56 years
STANDARD_DEVIATION 14.90 • n=7 Participants
|
51.73 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
53.66 years
STANDARD_DEVIATION 15.18 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II) Score
APACHE II Score Greater Than 15
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Day 28Population: This analysis includes participants with complete data available.
The number of participants with a hospital-acquired infection during the study period is presented here.
Outcome measures
| Measure |
Parenteral Nutrition Energy Dose at 0.6 x Measured REE
n=3 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.0 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.3 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
|---|---|---|---|
|
Number of Participants With Hospital-acquired Infection
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: This analysis includes participants with complete data available.
The count of participants acquiring a bloodstream infection during the study period is presented here.
Outcome measures
| Measure |
Parenteral Nutrition Energy Dose at 0.6 x Measured REE
n=3 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.0 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.3 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
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|---|---|---|---|
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Number of Participants With Bloodstream Infection
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: This analysis includes participants with complete data available.
The mean number of ICU ventilator-free days among participants.
Outcome measures
| Measure |
Parenteral Nutrition Energy Dose at 0.6 x Measured REE
n=3 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.0 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.3 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
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|---|---|---|---|
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Ventilator Free Days
|
20.67 days
Standard Deviation 9.45
|
19.75 days
Standard Deviation 3.40
|
17.25 days
Standard Deviation 9.32
|
SECONDARY outcome
Timeframe: Up to 28 DaysPopulation: This analysis includes participants with complete data available.
The ICU length of stay (in days) is presented here for each study arm.
Outcome measures
| Measure |
Parenteral Nutrition Energy Dose at 0.6 x Measured REE
n=3 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.0 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.3 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
|---|---|---|---|
|
Number of Days in Intensive Care Unit (ICU)
|
7.33 days
Standard Deviation 3.21
|
14.25 days
Standard Deviation 14.75
|
4.00 days
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Up to Day 28Population: This analysis includes participants with complete data available.
The hospitalization length of stay (in days) is presented here for each study arm.
Outcome measures
| Measure |
Parenteral Nutrition Energy Dose at 0.6 x Measured REE
n=3 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.0 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.3 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
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|---|---|---|---|
|
Number of Days in Hospital
|
27.33 days
Standard Deviation 1.15
|
25.00 days
Standard Deviation 3.56
|
17.75 days
Standard Deviation 9.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Day 28Population: This analysis includes participants with complete data available.
The daily energy deficit of kilocalories was calculated by subtracting the calculated mean daily Measured Resting Energy Expenditure (measured using a metabolic cart) from the actual daily energy intake obtained from participant nutrition intake records. The cumulative energy deficit is the sum of daily energy deficits during the time participants were hospitalized, up to 28 days.
Outcome measures
| Measure |
Parenteral Nutrition Energy Dose at 0.6 x Measured REE
n=3 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.0 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.3 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
|---|---|---|---|
|
Cumulative 28-day Energy Deficit
|
2631 kilocalories (kcal)
Standard Deviation 3076.04
|
11511.50 kilocalories (kcal)
Standard Deviation 14765.43
|
2414.75 kilocalories (kcal)
Standard Deviation 1562.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to Day 28Population: This analysis includes participants with complete data available.
The daily energy deficit of kilocalories was calculated by subtracting the calculated mean daily Measured Resting Energy Expenditure (measured using a metabolic cart) from the actual daily energy intake obtained from participant nutrition intake records. The mean daily energy deficit was calculated during the time participants were hospitalized, up to 28 days.
Outcome measures
| Measure |
Parenteral Nutrition Energy Dose at 0.6 x Measured REE
n=3 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.0 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
Parenteral Nutrition Energy Dose at 1.3 x Measured REE
n=4 Participants
Participants in this study arm were provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of parenteral nutrition (PN) was adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.
|
|---|---|---|---|
|
Mean Daily Energy Deficit
|
647.33 kcal/day
Standard Deviation 561.46
|
1065.75 kcal/day
Standard Deviation 716.01
|
1076.50 kcal/day
Standard Deviation 613.34
|
Adverse Events
Parenteral Nutrition Energy Dose at 0.6 x Measured REE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parenteral Nutrition Energy Dose at 1.0 x Measured REE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parenteral Nutrition Energy Dose at 1.3 x Measured REE
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place