Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial

被引:22
作者
Yuan, Fang [1 ]
Yang, Fang [1 ]
Zhang, Wei [2 ]
Jia, Yi [3 ]
Ma, Yaling [4 ]
Qu, Yongcai [5 ]
Wang, Xinglai [6 ]
Huo, Kang [7 ]
Wang, Chengkai [8 ]
Yuan, Xiangjun [9 ]
Song, Chaohui [10 ]
Zhang, Bei [11 ]
Jiang, Wen [1 ,12 ]
机构
[1] Fourth Mil Med Univ, Xijing Hosp, Dept Neurol, Xian 710032, Shaanxi, Peoples R China
[2] Fourth Mil Med Univ, Tangdu Hosp, Dept Neurol, Xian 710038, Shaanxi, Peoples R China
[3] Xian Gaoxing Hosp, Dept Neurol, Xian 710075, Shaanxi, Peoples R China
[4] Yulin 1 Hosp, Dept Neurol, Yulin 719000, Peoples R China
[5] Yanan Univ, Affiliated Hosp, Dept Neurol, Yanan 716000, Peoples R China
[6] Xian Cent Hosp, Dept Neurol, Xian 710003, Shaanxi, Peoples R China
[7] Xi An Jiao Tong Univ, Affiliated Hosp 1, Dept Neurol, Xian 710061, Shaanxi, Peoples R China
[8] Tongchuan Peoples Hosp, Dept Neurol, Tongchuan 727000, Peoples R China
[9] Weinan Cent Hosp, Dept Neurol, Weinan 714000, Peoples R China
[10] Tongchuan Min Bur Hosp, Dept Neurol, Tongchuan 727000, Peoples R China
[11] Xian Med Univ, Affiliated Hosp 1, Dept Neurol, Xian 710077, Shaanxi, Peoples R China
[12] Shaanxi Cerebrovasc Dis Clin Res Ctr, Xian 710032, Shaanxi, Peoples R China
关键词
Enteral nutrition; Severe stroke; Permissive underfeeding; Prokinetic drug; Critical care; Protocol; CRITICALLY-ILL PATIENTS; HEALTH-CARE PROFESSIONALS; ACUTE ISCHEMIC-STROKE; GASTRIC-MOTILITY; GUIDELINES; METOCLOPRAMIDE; ERYTHROMYCIN; RISK; DYSFUNCTION; MANAGEMENT;
D O I
10.1186/s12883-019-1253-2
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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.
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页数:8
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