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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK089369 | U.S. NIH Grant/Contract | View source |
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This study was halted pending additional funding and ultimately was terminated due to difficulties with ongoing recruitment, etc.
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The investigators have designed this single-center Randomized Clinical Trial (RCT) to prospectively compare, for the first time, the clinical efficacy of different energy doses in intensive care unit (ICU) patients requiring parenteral nutrition (PN) due to intestinal failure/dysfunction. This study intends to enroll a total of 60 patients (20 per energy dose group) to generate critical preliminary data needed to inform subsequent appropriately powered Phase III multicenter trials.
Protein and/or energy deficits are associated with increased rates of hospital infection, skeletal muscle weakness, impaired wound healing, and prolonged convalescence in ICU patients. To prevent or treat malnutrition, enteral nutrition (EN) and/or parenteral nutrition (PN) are routinely given worldwide to a significant proportion of ICU patients. Optimal caloric requirements in critically ill patients are unknown due to a lack of rigorous randomized clinical trials. The comparative efficacy of energy doses in critically ill patients is unknown and clinical recommendations are conflicting and controversial.
The primary aim of this study is to perform a controlled, double-blind, prospective, randomized, intent-to-treat Phase II clinical trial to test the efficacy of three specific energy doses on 28-day total hospital-acquired infections (primary endpoint), blood stream infections (BSI), and other important clinical outcomes in medical/surgical ICU patients requiring specialized parenteral ± enteral feeding. The investigators would also determine the impact of cumulative and mean daily 28-day energy deficits on clinical outcome endpoints; the practical utility of estimated resting energy expenditure (REE) determined by Harris-Benedict equation versus measured REE across different energy doses. The investigators would also like to determine the impact of administered energy dose and energy deficits on global metabolomic patterns over time and their association with key clinical outcomes.
Participants will be randomized to receive one of three specific energy doses, 0.6, 1.0 and 1.3 times measured REE, given for 28 consecutive days during the ICU and post-ICU course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parenteral nutrition energy dose at 0.6 x measured REE | Experimental | Participants in this study arm will be provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) will be 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 | Active Comparator | Participants in this study arm will be provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of PN will be 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 | Experimental | Participants in this study arm will be provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of PN will be 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral Nutrition | Drug | The PN dose will be written for each 24-hr period taking into account any kilocalories (kcal) provided as part of standard of care from propofol, clevidipine, dextrose-containing IV fluid exceeding 500 mL/day, and enteral feedings. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hospital-acquired Infection | The number of participants with a hospital-acquired infection during the study period is presented here. | Up to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bloodstream Infection | The count of participants acquiring a bloodstream infection during the study period is presented here. | Up to Day 28 |
| Ventilator Free Days | The mean number of ICU ventilator-free days among participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative 28-day Energy Deficit | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas R Ziegler, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis includes participants who have baseline data available; all data were unintentionally destroyed for one participant assigned to the 1.0 REE group.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Hospital-acquired Infection | The number of participants with a hospital-acquired infection during the study period is presented here. | This analysis includes participants with complete data available. | Posted | Count of Participants | Participants | Up to Day 28 |
|
Information on adverse events was collected from the time of participant entry into the study through the end of study participation, up to 28 days.
Collection of non-serious adverse events was limited to those that were expected among ICU patients receiving parenteral nutrition and tube feeding, specifically: clinically significant pulmonary aspiration, pneumothorax, development of worsening renal function with serum creatinine > 5.0 mg/dL or requiring new initiation of renal replacement therapy, development of severe hepatic dysfunction (serum total serum bilirubin > 15.0 mg/dL), hyperglycemia > 250 mg/dL, and hypoglycemia < 50 mg/dL.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Ziegler, MD | Emory University | 404-727-7351 | tzieg01@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2014 | Apr 22, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D006963 | Hyperphagia |
| D044342 | Malnutrition |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D010288 | Parenteral Nutrition |
| D015742 | Propofol |
| C118563 | clevidipine |
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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| Propofol | Drug | The PN dose will be written for each 24-hr period taking into account calories provided as lipid emulsion in the sedative propofol (1.1 kcal/mL). |
|
|
| Clevidipine | Drug | The PN dose will be written for each 24-hr period taking into account calories provided as lipid emulsion in clevidipine (2 kcal/mL). |
|
|
| Dextrose-containing IV Fluids | Drug | The PN dose will be written for each 24-hr period taking into account calories provided from dextrose-containing IV fluid orders exceeding 500 mL/day. |
|
| Enteral feeding | Drug | Enteral nutrition is caloric intake through the gastrointestinal (GI) tract via food consumed through the mouth or a feeding tube delivering nutrition directly to the stomach or small intestines. The PN dose will be written for each 24-hr period taking into account calories provided from any enteral feedings. |
|
| Up to Day 28 |
| Number of Days in Intensive Care Unit (ICU) | The ICU length of stay (in days) is presented here for each study arm. | Up to 28 Days |
| Number of Days in Hospital | The hospitalization length of stay (in days) is presented here for each study arm. | Up to Day 28 |
| Up to Day 28 |
| Mean Daily Energy Deficit | 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. | Up to Day 28 |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II) Score | The APACHE II score is an assessment of hospital mortality risk based on 14 physiological characteristics including patient age, prior health history, and current physiological measurements. Total scores range from 0 to 71 where higher scores indicate increasing risk of hospital death. Scores below 15 are associated with a mortality rate of less than 25%, while scores of 15 and above are associated with a mortality rate of greater than 25% that increases as the APACHE II score increases. Scores of 35 and above are associated with a hospital mortality rate of 85%. | Count of Participants | Participants |
|
| 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. |
| OG002 | 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. |
|
|
| Secondary | Number of Participants With Bloodstream Infection | The count of participants acquiring a bloodstream infection during the study period is presented here. | This analysis includes participants with complete data available. | Posted | Count of Participants | Participants | Up to Day 28 |
|
|
|
| Secondary | Ventilator Free Days | The mean number of ICU ventilator-free days among participants. | This analysis includes participants with complete data available. | Posted | Mean | Standard Deviation | days | Up to Day 28 |
|
|
|
| Secondary | Number of Days in Intensive Care Unit (ICU) | The ICU length of stay (in days) is presented here for each study arm. | This analysis includes participants with complete data available. | Posted | Mean | Standard Deviation | days | Up to 28 Days |
|
|
|
| Secondary | Number of Days in Hospital | The hospitalization length of stay (in days) is presented here for each study arm. | This analysis includes participants with complete data available. | Posted | Mean | Standard Deviation | days | Up to Day 28 |
|
|
|
| Other Pre-specified | Cumulative 28-day Energy Deficit | 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. | This analysis includes participants with complete data available. | Posted | Mean | Standard Deviation | kilocalories (kcal) | Up to Day 28 |
|
|
|
| Other Pre-specified | Mean Daily Energy Deficit | 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. | This analysis includes participants with complete data available. | Posted | Mean | Standard Deviation | kcal/day | Up to Day 28 |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D012816 | Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D007239 | Infections |
| D007049 | Iatrogenic Disease |
| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |