比较危重症患者连续与间断肠内营养（COINN）：一项随机对照有效性试验的研究方案。
Comparison of continuous versus intermittent enteral nutrition in critically ill patients (COINN): study protocol for a randomized comparative effectiveness trial.
机构信息
Department of Anesthesiology and Intensive Care Medicine, University Hospital Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic.
Department of Pharmacology, Faculty of Medicine, Masaryk University, VVI CZECRIN, Brno, Czech Republic.
出版信息
Trials. 2020 Nov 23;21(1):955. doi: 10.1186/s13063-020-04866-2.
BACKGROUND
Enteral nutrition is part of the treatment of critically ill patients. Administration of enteral nutrition may be associated with signs of intolerance, such as high gastric residual volumes, diarrhea, and vomiting. Clinical trials regarding the effects of the mode of administration of enteral nutrition on the occurrence of these complications have yielded conflicting results. This trial aims to investigate whether the mode of administration of enteral nutrition affects the time to reach nutritional targets, intolerance, and complications.
METHODS
COINN is a randomized, monocentric study for critically ill adult patients receiving enteral nutrition. Patients will be randomly assigned to two groups receiving (1) continuous or (2) intermittent administration of enteral nutrition. Enhancement of enteral nutrition will depend on signs of tolerance, mainly the gastric residual volume. The primary outcome will be the time to reach the energetic target. Secondary outcomes will be the time to reach the protein target, tolerance, complications, hospital and ICU lengths of stay, and 28-day mortality.
DISCUSSION
This trial aims to evaluate whether the mode of application of enteral nutrition affects the time to reach nutritional targets, signs of intolerance, and complications.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03573453. Registered on 29 June 2018.
背景
肠内营养是危重症患者治疗的一部分。肠内营养的给予可能与不耐受的迹象相关，如胃残留量高、腹泻和呕吐。关于肠内营养给予方式对这些并发症发生影响的临床试验结果存在矛盾。本试验旨在研究肠内营养给予方式是否影响达到营养目标的时间、不耐受和并发症。
方法
COINN 是一项针对接受肠内营养的成年危重症患者的随机、单中心研究。患者将被随机分配到两组，分别接受（1）连续或（2）间歇性肠内营养给予。肠内营养的增强将取决于耐受的迹象，主要是胃残留量。主要结局将是达到能量目标的时间。次要结局将是达到蛋白质目标的时间、耐受情况、并发症、住院和 ICU 时间以及 28 天死亡率。
讨论
本试验旨在评估肠内营养的应用方式是否影响达到营养目标的时间、不耐受和并发症。
试验注册
ClinicalTrials.gov NCT03573453. 注册于 2018 年 6 月 29 日。
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