The randomized study of enteral nutrition with rapid versus conventional administration in acute stroke patients; the protocol of rapid EN trial

Kentaro Suzuki, Hidetaka Onodera, Rie Sugiyama, S. Okubo, Naoto Kimura, S. Kaku, Rieko Seki, Satoshi Fujita, Koichi Nomura, Taiki Takagiwa, Izumi Katafuchi, Homare Nakamura, T. Kanamaru, Momoyo Oda, Shohei Kimura, Shota Sonoda, H. Kakita, Toshiaki Otsuka, Kazumi Kimura
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Abstract

Enteral nutrition is beneficial for stroke patients with oral intake difficulties. However, it is time consuming and may interfere with routine medical care. Therefore, there is a clinical benefit if enteral nutrition can be safely administered in a short time. Although our retrospective study showed the safety of rapid administration, it remains unclear whether rapid administration of enteral nutrition is as safe as conventional administration.The randomized study of Enteral Nutrition with Rapid versus conventional administration in acute stroke patients (Rapid EN trial) aims to clarify the safety of rapid feeding of enteral nutrition compared with conventional feeding.This is an investigator-initiated, multicenter, prospective, randomized, open-label, blinded end-point clinical trial. Eligible criteria include acute stroke patients who have difficulty with oral intake defined as severe altered consciousness (Japan Coma Scale 10–300) or modified water swallowing test <4. The target enrollment is 700 patients, with 350 patients receiving rapid enteral nutrition at a rate of 100 mL in 5 min (Rapid EN group) and 350 patients receiving conventional enteral nutrition at a rate of 100 mL in 30 min (Conventional EN group).The primary outcome is the incidence of one or more complications of vomiting or diarrhea or pneumonia within 7 days would be non-inferior in the rapid EN group compared to the conventional EN group. Secondary outcomes were total time spent on enteral nutrition within 7 days from enteral nutrition, the incidence of vomiting, diarrhea and pneumonia within 3 or 7 days, and the rate of favorable clinical outcome.Since no previous reports have focused on the speed of administration, we felt it was necessary to prove the safety of rapid administration. If this study shows positive results, it will not only benefit patients, but also reduce the burden of medical care. We believe this study is novel and will be useful in clinical practice.https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000046610 Identifier UMIN000046610.
急性脑卒中患者肠内营养快速给药与常规给药的随机研究;快速 EN 试验方案
肠内营养对有口腔摄入困难的中风患者有益。但是,肠内营养耗时较长,可能会影响常规医疗护理。因此,如果能在短时间内安全地给予肠内营养,则会带来临床益处。尽管我们的回顾性研究显示快速给药是安全的,但快速给肠内营养是否与常规给药一样安全仍不清楚。"急性脑卒中患者肠内营养快速给药与常规给药的随机研究(Rapid EN 试验)"旨在明确肠内营养快速喂养与常规喂养相比的安全性。这是一项由研究者发起的多中心、前瞻性、随机、开放标签、终点盲法临床试验。符合条件的患者包括急性脑卒中患者,其口腔摄入困难定义为严重的意识改变(日本昏迷量表 10-300)或改良水吞咽测试 <4。目标注册人数为 700 名患者,其中 350 名患者接受 5 分钟内 100 毫升的快速肠内营养(快速肠内营养组),350 名患者接受 30 分钟内 100 毫升的常规肠内营养(常规肠内营养组)。主要结果是快速肠内营养组与常规肠内营养组相比,7 天内一种或多种呕吐、腹泻或肺炎并发症的发生率不劣于常规肠内营养组。次要结果是:从肠内营养开始 7 天内使用肠内营养的总时间,3 天或 7 天内呕吐、腹泻和肺炎的发生率,以及临床结果良好率。由于之前没有任何报告关注给药速度,我们认为有必要证明快速给药的安全性。如果这项研究显示出积极的结果,它不仅会造福患者,还会减轻医疗负担。我们相信这项研究具有新颖性,并将在临床实践中发挥作用。https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000046610 Identifier UMIN000046610。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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