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A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial

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...

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Autores principales: Wischmeyer, Paul E., Hasselmann, Michel, Kummerlen, Christine, Kozar, Rosemary, Kutsogiannis, Demetrios James, Karvellas, Constantine J., Besecker, Beth, Evans, David K., Preiser, Jean-Charles, Gramlich, Leah, Jeejeebhoy, Khursheed, Dhaliwal, Rupinder, Jiang, Xuran, Day, Andrew G., Heyland, Daren K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5466764/
https://www.ncbi.nlm.nih.gov/pubmed/28599676
http://dx.doi.org/10.1186/s13054-017-1736-8
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author Wischmeyer, Paul E.
Hasselmann, Michel
Kummerlen, Christine
Kozar, Rosemary
Kutsogiannis, Demetrios James
Karvellas, Constantine J.
Besecker, Beth
Evans, David K.
Preiser, Jean-Charles
Gramlich, Leah
Jeejeebhoy, Khursheed
Dhaliwal, Rupinder
Jiang, Xuran
Day, Andrew G.
Heyland, Daren K.
author_facet Wischmeyer, Paul E.
Hasselmann, Michel
Kummerlen, Christine
Kozar, Rosemary
Kutsogiannis, Demetrios James
Karvellas, Constantine J.
Besecker, Beth
Evans, David K.
Preiser, Jean-Charles
Gramlich, Leah
Jeejeebhoy, Khursheed
Dhaliwal, Rupinder
Jiang, Xuran
Day, Andrew G.
Heyland, Daren K.
author_sort Wischmeyer, Paul E.
collection PubMed
description 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 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13054-017-1736-8) contains supplementary material, which is available to authorized users.
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spelling pubmed-54667642017-06-14 A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial Wischmeyer, Paul E. Hasselmann, Michel Kummerlen, Christine Kozar, Rosemary Kutsogiannis, Demetrios James Karvellas, Constantine J. Besecker, Beth Evans, David K. Preiser, Jean-Charles Gramlich, Leah Jeejeebhoy, Khursheed Dhaliwal, Rupinder Jiang, Xuran Day, Andrew G. Heyland, Daren K. Crit Care Research 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 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13054-017-1736-8) contains supplementary material, which is available to authorized users. BioMed Central 2017-06-09 /pmc/articles/PMC5466764/ /pubmed/28599676 http://dx.doi.org/10.1186/s13054-017-1736-8 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research
Wischmeyer, Paul E.
Hasselmann, Michel
Kummerlen, Christine
Kozar, Rosemary
Kutsogiannis, Demetrios James
Karvellas, Constantine J.
Besecker, Beth
Evans, David K.
Preiser, Jean-Charles
Gramlich, Leah
Jeejeebhoy, Khursheed
Dhaliwal, Rupinder
Jiang, Xuran
Day, Andrew G.
Heyland, Daren K.
A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial
title A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial
title_full A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial
title_fullStr A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial
title_full_unstemmed A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial
title_short A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial
title_sort randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the top-up pilot trial
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5466764/
https://www.ncbi.nlm.nih.gov/pubmed/28599676
http://dx.doi.org/10.1186/s13054-017-1736-8
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