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.
Phase:
Phase 2
Details
Lead Sponsor:
Emory University
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)