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Atlanta, Georgia 30322


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.


Study summary:

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.


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.


NCT ID:

NCT01369147


Primary Contact:

Principal Investigator
Thomas R Ziegler, MD
Emory University


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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