A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial.
Abstract
BACKGROUND: Nutrition guidelines recommendations differ on the use of parenteral nutrition
(PN), and existing clinical trial data are inconclusive. Our recent observational
data show that amounts of energy/protein received early in the intensive care unit
(ICU) affect patient mortality, particularly for inadequate nutrition intake in patients
with body mass indices (BMIs) of <25 or >35. Thus, we hypothesized increased nutrition
delivery via supplemental PN (SPN) + enteral nutrition (EN) to underweight and obese
ICU patients would improve 60-day survival and quality of life (QoL) versus usual
care (EN alone). METHODS: In this multicenter, randomized, controlled pilot trial
completed in 11 centers across four countries, adult ICU patients with acute respiratory
failure expected to require mechanical ventilation for >72 hours and with a BMI of
<25 or ≥35 were randomized to receive EN alone or SPN + EN to reach 100% of their
prescribed nutrition goal for 7 days after randomization. The primary aim of this
pilot trial was to achieve a 30% improvement in nutrition delivery. RESULTS: In total,
125 patients were enrolled. Over the first 7 post-randomization ICU days, patients
in the SPN + EN arm had a 26% increase in delivered calories and protein, whereas
patients in the EN-alone arm had a 22% increase (both p < 0.001). Surgical ICU patients
received poorer EN nutrition delivery and had a significantly greater increase in
calorie and protein delivery when receiving SPN versus medical ICU patients. SPN proved
feasible to deliver with our prescribed protocol. In this pilot trial, no significant
outcome differences were observed between groups, including no difference in infection
risk. Potential, although statistically insignificant, trends of reduced hospital
mortality and improved discharge functional outcomes and QoL outcomes in the SPN + EN
group versus the EN-alone group were observed. CONCLUSIONS: Provision of SPN + EN
significantly increased calorie/protein delivery over the first week of ICU residence
versus EN alone. This was achieved with no increased infection risk. Given feasibility
and consistent encouraging trends in hospital mortality, QoL, and functional endpoints,
a full-scale trial of SPN powered to assess these clinical outcome endpoints in high-nutritional-risk
ICU patients is indicated-potentially focusing on the more poorly EN-fed surgical
ICU setting. TRIAL REGISTRATION: NCT01206166.
Type
Journal articleSubject
Calorie deliveryCritical care
Intensive care
Malnutrition
Parenteral Nutrition
Protein
Quality of life
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https://hdl.handle.net/10161/14928Published Version (Please cite this version)
10.1186/s13054-017-1736-8Publication Info
Wischmeyer, Paul E; Hasselmann, Michel; Kummerlen, Christine; Kozar, Rosemary; Kutsogiannis,
Demetrios James; Karvellas, Constantine J; ... Heyland, Daren K (2017). A randomized trial of supplemental parenteral nutrition in underweight and overweight
critically ill patients: the TOP-UP pilot trial. Crit Care, 21(1). pp. 142. 10.1186/s13054-017-1736-8. Retrieved from https://hdl.handle.net/10161/14928.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Paul Edmund Wischmeyer
Professor of Anesthesiology
Paul Wischmeyer M.D., EDIC, FASPEN, FCCM is a critical care, perioperative, and nutrition
physician-researcher who specializes in enhancing preparation and recovery from surgery,
critical care and COVID-19. He serves as a Tenured Professor of Anesthesiology and
Surgery at Duke. He also serves as the Associate Vice Chair for Clinical Research
in the Dept. of Anesthesiology and Director of the TPN/Nutrition Team at Duke. Dr.
Wischmeyer earned his medical degree with honors at T

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