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The Energy Dose Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369147
First Posted: June 8, 2011
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Thomas R. Ziegler, MD, Emory University
  Purpose

The investigators have designed this pilot, single-center Randomized Clinical Trial (RCT) to prospectively compare, for the first time, the clinical efficacy of different energy doses in ICU patients requiring PN due to intestinal failure/dysfunction. A total of 60 patients will be studied (20 per energy dose group) to generate critical preliminary data needed to inform subsequent appropriately powered Phase III multicenter trials.

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 [0.6, 1.0 and 1.3 x measured REE (resting energy expenditure), respectively], given for 28 consecutive days during the ICU and post-ICU course, 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, in these subjects A) the impact of cumulative and mean daily 28-day energy deficits [energy intake-measured REE] on clinical outcome endpoints; and B) the practical utility of estimated 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.


Condition Intervention Phase
Critical Illness Drug: Parenteral nutrition energy dose at 0.6 x measured REE Drug: Parenteral nutrition energy dose at 1.0 x measured REE Drug: Parenteral nutrition energy dose at 1.3 X measured REE Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Energy Doses in Critical Illness

Resource links provided by NLM:


Further study details as provided by Thomas R. Ziegler, MD, Emory University:

Primary Outcome Measures:
  • To compare the effect of three specific energy doses [0.6, 1.0 and 1.3 x measured Resting Energy Expenditure, respectively], on total hospital acquired infection incidence rates in patients in the ICU over a 28 day period. [ Time Frame: 2 years ]
    To perform a controlled, double-blind, prospective, randomized, parallel group, intent-to-treat Phase II clinical trial to compare the effect of three specific energy doses [0.6, 1.0 and 1.3 x measured REE (metabolic cart), respectively]on total hospital-acquired infections incidence rates in medical/surgical ICU patients, over a 28 day period.


Secondary Outcome Measures:
  • To examine the impact of cumulative and mean daily 28-day energy deficits on nosocomial infection incidence rates [ Time Frame: 2 years ]
    Daily energy deficit will be calculated by subtracting the calculated mean daily Measured Resting Energy Expenditure (using a metabolic cart) during each study week from the actual daily energy intake ( per subject nutrition intake records). We will compare the daily 28 day energy deficits for each of the three study groups to determine how they relate to the nosocomial infection incidence rates


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parenteral nutrition energy dose at 0.6x measured REE
Participants in this study arm will be provided a total daily calorie (kcal) intake [from parenteral nutrition (PN) + dextrose-containing IV fluids (> 500 mL/day) + propofol/clevidipine + any enteral feedings) at 0.6 x resting energy expenditure (REE).
Drug: Parenteral nutrition energy dose at 0.6 x measured REE
Participants will be provided a total daily calorie (kcal) intake from parenteral nutrition (PN), dextrose-containing IV fluids (> 500 mL/day), propofol/clevidipine, and any enteral feedings at 0.6 x baseline metabolic energy expenditure (MEE). Total energy dosing based on real-time REE measurements will be adjusted during the ICU stay. 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) or clevidipine (2 kcal/mL), and any dextrose-containing IV fluid orders exceeding 500 mL/day. Participants will receive a maximum of 28 days of the double blind study energy dose and will be transitioned from PN to enteral feeds as soon as tolerated and clinically indicated.
Other Name: Intralipid® 30%
Active Comparator: Parenteral nutrition energy dose at 1.0 x measured REE
Participants in this study arm will be provided a total daily calorie (kcal) intake [from parenteral nutrition (PN) + dextrose-containing IV fluids (> 500 mL/day) + propofol/clevidipine + any enteral feedings) at 1.0 x resting energy expenditure (REE).
Drug: Parenteral nutrition energy dose at 1.0 x measured REE
Participants will be provided a total daily calorie (kcal) intake from parenteral nutrition (PN), dextrose-containing IV fluids (> 500 mL/day), propofol/clevidipine, and any enteral feedings at 1.0 x baseline metabolic energy expenditure (MEE). Total energy dosing based on real-time REE measurements will be adjusted during the ICU stay. 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) or clevidipine (2 kcal/mL), and any dextrose-containing IV fluid orders exceeding 500 mL/day. Participants will receive a maximum of 28 days of the double blind study energy dose and will be transitioned from PN to enteral feeds as soon as tolerated and clinically indicated.
Other Name: Intralipid® 30%
Experimental: Parenteral nutrition energy dose at 1.3 x measured REE
Participants in this study arm will be provided a total daily calorie (kcal) intake [from parenteral nutrition (PN) + dextrose-containing IV fluids (> 500 mL/day) + propofol/clevidipine + any enteral feedings) at 1.3 x resting energy expenditure (REE).
Drug: Parenteral nutrition energy dose at 1.3 X measured REE
Participants will be provided a total daily calorie (kcal) intake from parenteral nutrition (PN), dextrose-containing IV fluids (> 500 mL/day), propofol/clevidipine, and any enteral feedings at 1.3 x baseline metabolic energy expenditure (MEE). Total energy dosing based on real-time REE measurements will be adjusted during the ICU stay. 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) or clevidipine (2 kcal/mL), and any dextrose-containing IV fluid orders exceeding 500 mL/day. Participants will receive a maximum of 28 days of the double blind study energy dose and will be transitioned from PN to enteral feeds as soon as tolerated and clinically indicated.
Other Name: Intralipid® 30%

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; this issue is the focus of this study.

The investigators have designed this pilot, single-center Randomized Clinical Trial (RCT) to prospectively compare, for the first time, the clinical efficacy of different energy doses in ICU patients requiring PN due to intestinal failure/dysfunction. A total of 60 patients will be studied (20 per energy dose group) to generate critical preliminary data needed to inform subsequent appropriately powered Phase III multicenter trials.

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 [0.6, 1.0 and 1.3 x measured REE (resting energy expenditure), respectively], given for 28 consecutive days during the ICU and post-ICU course, 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, in these subjects A) the impact of cumulative and mean daily 28-day energy deficits [energy intake-measured REE] on clinical outcome endpoints; and B) the practical utility of estimated 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.

This study will allow the researchers to generate needed data on the effect of energy dose and energy deficits on global metabolomic patterns over time that may be associated with key clinical outcomes in ICU patients. This exploratory research is also needed to develop new methods that evaluate the metabolic responses to nutrition support and their potential relationships to clinical outcomes.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A signed informed consent is in place on the patient's chart;
  2. The patient is at least 18 but not more than 90 years of age at time of ICU admission;
  3. The patient has a body mass index (BMI) between 18.5 and 40 kg/m2;
  4. The patient has been admitted to either a medical or surgical (non-neurological) ICU within the previous 72 hours and is expected to survive and remain in the ICU for at least 96 hours after entry;
  5. The patient is expected to require mechanical ventilation for at least 72 hours after entry and a metabolic cart-derived REE is possible;
  6. There is central venous access for administration of the study PN;
  7. The patient's primary physician(s) will allow the investigative team to manage the study PN and enteral feedings during the current hospitalization; and
  8. The patient is expected to require total or partial central venous PN for 7 or more subsequent days after entry on a clinical basis (e.g. following massive small bowel ± colonic resection, the presence of high output fistulae or perforated small bowel, with demonstrated intolerance to EN or when EN may be contraindicated, as with severe diarrhea or emesis, partial or complete bowel obstruction, severe gastrointestinal bleeding and severe hemodynamic instability, such as with escalating vasopressor requirements).

Exclusion Criteria:

  1. The patient is pregnant;
  2. 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;
  3. The patient had a do-not-resuscitate order at the time of screening;
  4. The patient was admitted to the ICU following trauma or burns;
  5. 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;
  6. The patient has previously undergone an organ transplantation;
  7. the patient has a history of cancer (except non-melanoma skin cancer that is considered cured or distant cancer diagnosed more than 5 years previously and not requiring further therapy);
  8. the patient has a history of HIV/AIDS;
  9. The patient has received any investigational drug within 60 days prior to study entry; and
  10. The patient is unable or unwilling to participate in study procedures such as longitudinal blood draws and administration of study nutrient formulations.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01369147


Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Responsible Party: Thomas R. Ziegler, MD, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT01369147     History of Changes
Other Study ID Numbers: IRB00049495
1R21HL11044-01 ( Other Identifier: Other )
First Submitted: May 25, 2011
First Posted: June 8, 2011
Last Update Posted: September 22, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas R. Ziegler, MD, Emory University:
SICU
calories
TPN
tube feeding
Optimum Energy Dose in SICU

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Propofol
Soybean oil, phospholipid emulsion
Clevidipine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action