Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial
Abstract 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 comp...
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| Format: | Article |
| Language: | English |
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BMC
2019-02-01
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| Series: | BMC Neurology |
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| Online Access: | http://link.springer.com/article/10.1186/s12883-019-1253-2 |
| _version_ | 1818216940643024896 |
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| author | Fang Yuan Fang Yang Wei Zhang Yi Jia Yaling Ma Yongcai Qu Xinglai Wang Kang Huo Chengkai Wang Xiangjun Yuan Chaohui Song Bei Zhang Wen Jiang on behalf of the OPENS study group |
| author_facet | Fang Yuan Fang Yang Wei Zhang Yi Jia Yaling Ma Yongcai Qu Xinglai Wang Kang Huo Chengkai Wang Xiangjun Yuan Chaohui Song Bei Zhang Wen Jiang on behalf of the OPENS study group |
| author_sort | Fang Yuan |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-12T06:59:57Z |
| format | Article |
| id | doaj.art-cfab68deb1004de7ad135e3ee4877c35 |
| institution | Directory Open Access Journal |
| issn | 1471-2377 |
| language | English |
| last_indexed | 2024-12-12T06:59:57Z |
| publishDate | 2019-02-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Neurology |
| spelling | doaj.art-cfab68deb1004de7ad135e3ee4877c352022-12-22T00:33:53ZengBMCBMC Neurology1471-23772019-02-011911810.1186/s12883-019-1253-2Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trialFang Yuan0Fang Yang1Wei Zhang2Yi Jia3Yaling Ma4Yongcai Qu5Xinglai Wang6Kang Huo7Chengkai Wang8Xiangjun Yuan9Chaohui Song10Bei Zhang11Wen Jiang12on behalf of the OPENS study groupDepartment of Neurology, Xijing Hospital, Fourth Military Medical UniversityDepartment of Neurology, Xijing Hospital, Fourth Military Medical UniversityDepartment of Neurology, Tangdu Hospital, Fourth Military Medical UniversityDepartment of Neurology, Xi’an Gaoxing HospitalDepartment of Neurology, Yulin No.1 HospitalDepartment of Neurology, Yan’an University Affiliated HospitalDepartment of Neurology, Xi’an Central HospitalDepartment of Neurology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Neurology, Tongchuan People’s HospitalDepartment of Neurology, Weinan Central HospitalDepartment of Neurology, Tongchuan Mining Bureau HospitalDepartment of Neurology, The First Affiliated Hospital of Xi’an Medical UniversityDepartment of Neurology, Xijing Hospital, Fourth Military Medical UniversityAbstract 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.http://link.springer.com/article/10.1186/s12883-019-1253-2Enteral nutritionSevere strokePermissive underfeedingProkinetic drugCritical careProtocol |
| spellingShingle | Fang Yuan Fang Yang Wei Zhang Yi Jia Yaling Ma Yongcai Qu Xinglai Wang Kang Huo Chengkai Wang Xiangjun Yuan Chaohui Song Bei Zhang Wen Jiang on behalf of the OPENS study group Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial BMC Neurology Enteral nutrition Severe stroke Permissive underfeeding Prokinetic drug Critical care Protocol |
| 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 | Enteral nutrition Severe stroke Permissive underfeeding Prokinetic drug Critical care Protocol |
| url | http://link.springer.com/article/10.1186/s12883-019-1253-2 |
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