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.

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10.1186/s13054-017-1736-8

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Wischmeyer, Paul E, Michel Hasselmann, Christine Kummerlen, Rosemary Kozar, Demetrios James Kutsogiannis, Constantine J Karvellas, Beth Besecker, David K Evans, et al. (2017). A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial. Crit Care, 21(1). p. 142. 10.1186/s13054-017-1736-8 Retrieved from https://hdl.handle.net/10161/14928.

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Wischmeyer

Paul Edmund Wischmeyer

Professor of Anesthesiology

Paul Wischmeyer M.D., EDIC, FASPEN, FCCM is a nutrition, exercise, critical care, and perioperative  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 The University of Chicago Pritzker School of Medicine, where he was elected into the honor society of Alpha Omega Alpha for outstanding academic achievement. He completed his pediatric internship at University of Colorado Children’s Hospital and his anesthesiology/critical care residency training at the University of Chicago. He also completed a Clinical Pharmacology fellowship and the NIH K30 Clinical Research Scientist Training Program while at University of Chicago.
   Dr. Wischmeyer’s clinical and research focus is in critical care, perioperative care exercise, and nutrition to help patients prepare and recover from illness and surgery. His research interests include surgical and ICU nutrition and exercise rehabilitation; role of parenteral, enteral, and oral nutrition to improve patient outcomes; perioperative optimization; post-illness muscle mass and functional recovery; and probiotics/microbiome. His research interests have also recently been focused on COVID-19 research into COVID-19 metabolism, role of probiotics in COVID19 prevention and treatment, and exercise and nutrition programs to recover from COVID-19 and Long COVID-19. Dr. Wischmeyer’s research group has been awarded multiple NIH, DOD, and other peer reviewed grants to perform research ranging from basic mechanistic cell work to large-scale multi-center clinical trials in the fields of critical care, perioperative medicine, nutrition, illness metabolism, microbiome/probiotics, and exercise interventions to improve functional outcomes. For his research work and clinical work, Dr. Wischmeyer has received numerous awards from national and international societies including, The Jeffrey Silverstein Award and Memorial Lecture for Humanism in Medicine from the American Delirium Society, The John M. Kinney Award for the most significant contribution to field of general nutrition, the Stanley Dudrick Research Scholar Award by the American Society for Parenteral and Enteral Nutrition and The Lifetime Achievement Award of the International Parenteral Nutrition Society (IPENEMA) for significant contributions to the field of nutrition.  Dr. Wischmeyer has over 200 peer-reviewed publications in critical care, anesthesiology, and nutrition, including in the New England Journal of Medicine. Finally, he has been an invited speaker at numerous national and international medical meetings delivering over 900 invited presentations over his career. He has an H-index of 73 with over 16,500 citations to his work, including 1 publication with > 1000 citations and 55 publications with > 100 citations. He is also the founder and director of the Duke Online Clinical Nutrition Fellowship, an international fellowship to provide clinical nutrition training to healthcare providers worldwide, as well as unique scholarship opportunities for healthcare providers in developing nations.
    Dr. Wischmeyer passion for helping patients recover from illness and surgery arises from his personal experiences as both doctor and patient in the ICU. Dr. Wischmeyer has undergone over 27 major surgeries and personally experienced multiple ICU stays due to a childhood GI illness that took more than half of his intestinal tract. Thus, preparation for surgery/critical care and recovery from illness are a way of life for Dr. Wischmeyer that he is passionate about teaching his patients and other caregivers worldwide.

 


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