Critical IllnessPhase 2NCT01369147
The Energy Dose Study
A Phase 2 study testing Parenteral Nutrition, Propofol and Clevidipine in people with Critical Illness, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Parenteral Nutrition, Propofol and Clevidipine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to 2 Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A signed informed consent is in place on the patient's chart
- The patient is at least 18 but not more than 90 years of age at time of ICU admission
- The patient has a body mass index (BMI) less than 40 kg/m^2
- The patient has been admitted to either a medical or surgical (non-neurological) ICU and is expected to survive and remain in the ICU for at least 72 hours after entry
- There is central venous access for administration of the study PN
- The patient's primary physician(s) will allow the investigative team to manage the study PN and enteral feedings during the current hospitalization
- The patient is expected to require total or partial central venous PN for 7 or more subsequent days after entry on a clinical basis
Who cannot join
- The patient is pregnant
- The patient has unresuscitated clinical sepsis, defined as unstable blood pressure despite vasopressor support and mean arterial pressure (MAP) < 60 mm Hg on at least 3 consecutive readings within a 3-hour period during the 24 hours prior to study entry
- The patient was admitted to the ICU following trauma or burns
- The patient has significant renal dysfunction (defined as serum creatinine > 2.5 mg/dL or deemed to have significant acute kidney injury by the primary physicians) and is not receiving continuous renal replacement therapy (CRRT) or intermittent hemodialysis
- The patient has previously undergone an organ transplantation
- The patient has a current malignancy or is currently receiving an active regimen of chemotherapy and/or radiotherapy to treat a previously diagnosed malignancy
Show all 9Show fewer
- The patient has a history of HIV/AIDS
- The patient has received any investigational drug within 60 days prior to study entry
- The patient is unable or unwilling to participate in study procedures such as longitudinal blood draws and administration of study nutrient formulations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of Energy Doses in Critical Illness
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.
Read the detailed description
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.
- Conditions
- Critical Illness
- Being tested
- Parenteral Nutrition, Propofol, Clevidipine, Dextrose-containing IV Fluids, Enteral feeding
- Keywords
- Surgical Intensive Care Unit (SICU), Calories, Total Parenteral Nutrition (TPN), Tube Feeding, Optimum Energy Dose in SICU, Malnutrition, Hospital-acquired Infection
- Medical subject headings
- Critical Illness, Hyperphagia, Malnutrition, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral NutritionDrug
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.
PropofolDrug
Also called Diprivan
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).
ClevidipineDrug
Also called Cleviprex
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 FluidsDrug
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 feedingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Parenteral Nutrition; Drug: Propofol; Drug: Clevidipine; Drug: Dextrose-containing IV Fluids; Drug: Enteral feeding |
| 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. Receives: Drug: Parenteral Nutrition; Drug: Propofol; Drug: Clevidipine; Drug: Dextrose-containing IV Fluids; Drug: Enteral feeding |
| 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. Receives: Drug: Parenteral Nutrition; Drug: Propofol; Drug: Clevidipine; Drug: Dextrose-containing IV Fluids; Drug: Enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hospital-acquired Infection
The number of participants with a hospital-acquired infection during the study period is presented here.
Measured: Up to Day 28
Secondary outcomes (4)
Number of Participants With Bloodstream Infection
The count of participants acquiring a bloodstream infection during the study period is presented here.
Measured: Up to Day 28
Ventilator Free Days
The mean number of ICU ventilator-free days among participants.
Measured: 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.
Measured: Up to 28 Days
Number of Days in Hospital
The hospitalization length of stay (in days) is presented here for each study arm.
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJul 2011
- Primary completion2 Dec 2014
- Study completion2 Dec 2014
Why it stopped: This study was halted pending additional funding and ultimately was terminated due to difficulties with ongoing recruitment, etc.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas R. Ziegler, Emory University
- Investigators
- Thomas R Ziegler, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369147
- Sponsor's protocol ID
- IRB00049495
- Other IDs
- 1R21DK089369
- Status last verified
- May 2022
- First submitted
- 25 May 2011
- Last updated
- 10 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Energy Doses in Critical Illness
- ClinicalTrials.gov ID
- NCT01369147
- Acronym / sponsor ID
- IRB00049495
- Conditions
- Critical Illness
- Keywords
- Surgical Intensive Care Unit (SICU), Calories, Total Parenteral Nutrition (TPN), Tube Feeding, Optimum Energy Dose in SICU, Malnutrition, Hospital-acquired Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was halted pending additional funding and ultimately was terminated due to difficulties with ongoing recruitment, etc.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jul 2011 (actual)
- Primary completion
- 2 Dec 2014 (actual)
- Study completion
- 2 Dec 2014 (actual)
- First posted
- 8 Jun 2011 (estimated)
- Results
- Posted 10 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parenteral nutrition energy dose at 0.6 x measured REE | Experimental | Drug: Parenteral Nutrition, Drug: Propofol, Drug: Clevidipine, Drug: Dextrose-containing IV Fluids, Drug: Enteral feedingParticipants 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 | Drug: Parenteral Nutrition, Drug: Propofol, Drug: Clevidipine, Drug: Dextrose-containing IV Fluids, Drug: Enteral feedingParticipants 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 | Drug: Parenteral Nutrition, Drug: Propofol, Drug: Clevidipine, Drug: Dextrose-containing IV Fluids, Drug: Enteral feedingParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A signed informed consent is in place on the patient's chart
- The patient is at least 18 but not more than 90 years of age at time of ICU admission
- The patient has a body mass index (BMI) less than 40 kg/m^2
- The patient has been admitted to either a medical or surgical (non-neurological) ICU and is expected to survive and remain in the ICU for at least 72 hours after entry
- There is central venous access for administration of the study PN
Key exclusion criteria (9 listed)
- The patient is pregnant
- The patient has unresuscitated clinical sepsis, defined as unstable blood pressure despite vasopressor support and mean arterial pressure (MAP) < 60 mm Hg on at least 3 consecutive readings within a 3-hour period during the 24 hours prior to study entry
- The patient was admitted to the ICU following trauma or burns
- The patient has significant renal dysfunction (defined as serum creatinine > 2.5 mg/dL or deemed to have significant acute kidney injury by the primary physicians) and is not receiving continuous renal replacement therapy (CRRT) or intermittent hemodialysis
- The patient has previously undergone an organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenteral NutritionThe 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. | Drug | Parenteral nutrition energy dose at 0.6 x measured REE, Parenteral nutrition energy dose at 1.0 x measured REE, Parenteral nutrition energy dose at 1.3 x measured REE |
| PropofolAlso: DiprivanThe 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). | Drug | Parenteral nutrition energy dose at 0.6 x measured REE, Parenteral nutrition energy dose at 1.0 x measured REE, Parenteral nutrition energy dose at 1.3 x measured REE |
| ClevidipineAlso: CleviprexThe PN dose will be written for each 24-hr period taking into account calories provided as lipid emulsion in clevidipine (2 kcal/mL). | Drug | Parenteral nutrition energy dose at 0.6 x measured REE, Parenteral nutrition energy dose at 1.0 x measured REE, Parenteral nutrition energy dose at 1.3 x measured REE |
| Dextrose-containing IV FluidsThe 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. | Drug | Parenteral nutrition energy dose at 0.6 x measured REE, Parenteral nutrition energy dose at 1.0 x measured REE, Parenteral nutrition energy dose at 1.3 x measured REE |
| Enteral feedingEnteral 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. | Drug | Parenteral nutrition energy dose at 0.6 x measured REE, Parenteral nutrition energy dose at 1.0 x measured REE, Parenteral nutrition energy dose at 1.3 x measured REE |
Primary outcome
Number of Participants With Hospital-acquired Infection
Time frame: Up to Day 28
The number of participants with a hospital-acquired infection during the study period is presented here.
4 secondary outcomes
Number of Participants With Bloodstream Infection
Time frame: Up to Day 28
Ventilator Free Days
Time frame: Up to Day 28
Number of Days in Intensive Care Unit (ICU)
Time frame: Up to 28 Days
Number of Days in Hospital
Time frame: Up to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R Ziegler, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Parenteral Nutrition, Propofol and Clevidipine in people with Critical Illness, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Hospital-acquired Infection (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.