The Energy Dose Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Emory University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas R. Ziegler, MD, Emory University
ClinicalTrials.gov Identifier:
NCT01369147
First received: May 25, 2011
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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 our 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 us 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.


Condition Intervention Phase
Critical Illness
Other: 0.6x measured REE
Other: 1.0 x measured REE
Other: 1.3 X measured REE
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Energy Doses in Critical Illness

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.6x measured REE Other: 0.6x measured REE
Dose of calories administered to subjects while in the study
Experimental: 1.0 x measured REE Other: 1.0 x measured REE
Dose of calories given to subject while in the study
Experimental: 1.3 x measured REE Other: 1.3 X measured REE
Dose of calories given to subject while in the study

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369147

Contacts
Contact: Thomas R Ziegler, MD 404-727-7351 tzieg01@emory.edu
Contact: Jennifer L Jones, PhD 404-727-5806 jennifer.l.jones@emory.edu

Locations
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Thomas R Ziegler, M.D.    404-727-7351    tzieg01@emory.edu   
Sponsors and Collaborators
Emory University
  More Information

No publications provided

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
Study First Received: May 25, 2011
Last Updated: June 17, 2014
Health Authority: United States: Emory University IRB
United States: NIDDK

Keywords provided by Emory University:
SICU
calories
TPN
tube feeding
Optimum Energy Dose in SICU

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014