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Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial
BACKGROUND: Malnutrition is one of the crucial factors associated with poor prognosis in critical ill patients, yet a significant evidence gap surrounds the management of initial enteral feeding in severe stroke. The Optimizing Early Enteral Nutrition in Severe Stroke (OPENS) trial will compare a st...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6371599/ https://www.ncbi.nlm.nih.gov/pubmed/30755171 http://dx.doi.org/10.1186/s12883-019-1253-2 |
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author | Yuan, Fang Yang, Fang Zhang, Wei Jia, Yi Ma, Yaling Qu, Yongcai Wang, Xinglai Huo, Kang Wang, Chengkai Yuan, Xiangjun Song, Chaohui Zhang, Bei Jiang, Wen |
author_facet | Yuan, Fang Yang, Fang Zhang, Wei Jia, Yi Ma, Yaling Qu, Yongcai Wang, Xinglai Huo, Kang Wang, Chengkai Yuan, Xiangjun Song, Chaohui Zhang, Bei Jiang, Wen |
author_sort | Yuan, Fang |
collection | PubMed |
description | BACKGROUND: Malnutrition is one of the crucial factors associated with poor prognosis in critical ill patients, yet a significant evidence gap surrounds the management of initial enteral feeding in severe stroke. The Optimizing Early Enteral Nutrition in Severe Stroke (OPENS) trial will compare a strategy of modified full enteral nutrition (EN) (standard full EN in conjunction with prokinetic drug) and a strategy of permissive underfeeding (40 to 60% of estimated caloric requirements) with standard full EN (advancement to target nutrition goals) in patients with severe stroke. METHODS: The OPENS trial is a multicenter randomized controlled study. A total of 600 adult patients with severe stroke will be enrolled in 12 study sites in China, and randomized to standard full EN, modified full EN, or permissive underfeeding. The primary outcome measurement is the proportion of participants with a poor outcome (modified Rankin Scale ≥3) at day 90 of enrollment. Secondary outcomes include incidence rates of complications during hospitalization, disability at hospital discharge, and the ability of activities of daily living at day 90 of enrollment. The relationship between intervention and the primary outcome will be analyzed using multivariate logistic regression adjusted for study site, demographics, and baseline characteristics. DISCUSSION: The OPENS trial will explore the optimum initial feeding strategy for acute severe stroke. This trial is, therefore, an important step in bridging the evidence gap surrounding the enteral feeding for patients with severe stroke during the first week of hospitalization. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02982668; First Posted: December 5, 2016. |
format | Online Article Text |
id | pubmed-6371599 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-63715992019-02-25 Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial Yuan, Fang Yang, Fang Zhang, Wei Jia, Yi Ma, Yaling Qu, Yongcai Wang, Xinglai Huo, Kang Wang, Chengkai Yuan, Xiangjun Song, Chaohui Zhang, Bei Jiang, Wen BMC Neurol Study Protocol BACKGROUND: Malnutrition is one of the crucial factors associated with poor prognosis in critical ill patients, yet a significant evidence gap surrounds the management of initial enteral feeding in severe stroke. The Optimizing Early Enteral Nutrition in Severe Stroke (OPENS) trial will compare a strategy of modified full enteral nutrition (EN) (standard full EN in conjunction with prokinetic drug) and a strategy of permissive underfeeding (40 to 60% of estimated caloric requirements) with standard full EN (advancement to target nutrition goals) in patients with severe stroke. METHODS: The OPENS trial is a multicenter randomized controlled study. A total of 600 adult patients with severe stroke will be enrolled in 12 study sites in China, and randomized to standard full EN, modified full EN, or permissive underfeeding. The primary outcome measurement is the proportion of participants with a poor outcome (modified Rankin Scale ≥3) at day 90 of enrollment. Secondary outcomes include incidence rates of complications during hospitalization, disability at hospital discharge, and the ability of activities of daily living at day 90 of enrollment. The relationship between intervention and the primary outcome will be analyzed using multivariate logistic regression adjusted for study site, demographics, and baseline characteristics. DISCUSSION: The OPENS trial will explore the optimum initial feeding strategy for acute severe stroke. This trial is, therefore, an important step in bridging the evidence gap surrounding the enteral feeding for patients with severe stroke during the first week of hospitalization. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02982668; First Posted: December 5, 2016. BioMed Central 2019-02-12 /pmc/articles/PMC6371599/ /pubmed/30755171 http://dx.doi.org/10.1186/s12883-019-1253-2 Text en © The Author(s). 2019 Open Access This 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 | Study Protocol Yuan, Fang Yang, Fang Zhang, Wei Jia, Yi Ma, Yaling Qu, Yongcai Wang, Xinglai Huo, Kang Wang, Chengkai Yuan, Xiangjun Song, Chaohui Zhang, Bei Jiang, Wen Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial |
title | Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial |
title_full | Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial |
title_fullStr | Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial |
title_full_unstemmed | Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial |
title_short | Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial |
title_sort | optimizing early enteral nutrition in severe stroke (opens): protocol for a multicentre randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6371599/ https://www.ncbi.nlm.nih.gov/pubmed/30755171 http://dx.doi.org/10.1186/s12883-019-1253-2 |
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