危重症患者的靶向全能量和蛋白质输送：一项初步随机对照试验的研究方案（FEED试验）
Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial).
作者信息
Fetterplace Kate, Deane Adam M, Tierney Audrey, Beach Lisa, Knight Laura D, Rechnitzer Thomas, Forsyth Adrienne, Mourtzakis Marina, Presneill Jeffrey, MacIsaac Christopher
机构信息
1Department of Clinical Nutrition, Allied Health, Royal Melbourne Hospital, Melbourne, Australia.
2Department of Rehabilitation, Nutrition and Sport, School of Allied Health, La Trobe University, Melbourne, Australia.
出版信息
Pilot Feasibility Stud. 2018 Feb 20;4:52. doi: 10.1186/s40814-018-0249-9. eCollection 2018.
BACKGROUND
Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes.
METHODS
This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU) will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein) or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein). The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT) from baseline (prior to randomisation) to ICU discharge and other nutritional and patient-centred outcomes.
DISCUSSION
This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12615000876594 UTN: U1111-1172-8563.
背景
由于随机对照试验的数据有限，目前为重症患者提供蛋白质的指南所依据的证据并不完整。本项初步随机对照试验是一项工作计划的一部分，该计划旨在拓展关于向重症患者提供蛋白质的临床效果的知识。这项初步研究的主要目的是确定，与标准营养方案相比，采用容量目标并额外补充蛋白质的肠内喂养方案是否能为机械通气的重症患者提供更多的蛋白质和能量。次要目的是评估这种喂养策略对肌肉质量及其他以患者为中心的结局的潜在影响。
方法
这项前瞻性、单中心、初步随机对照试验将纳入60名接受机械通气且可进行肠内喂养的参与者。在获得知情同意后，重症监护病房（ICU）中接受肠内营养的参与者将使用随机化算法按1:1的比例分配至干预组（基于每日容量的高蛋白喂养方案，提供25千卡/千克和1.5克/千克蛋白质）或标准治疗组（基于每小时速率的喂养方案，提供25千卡/千克和1克/千克蛋白质）。共同主要结局是随机分组后第15天结束时每日提供的平均蛋白质和能量。次要结局包括从基线（随机分组前）到ICU出院时股四头肌层厚度（QMLT）的变化以及其他营养和以患者为中心的结局。
讨论
本试验旨在研究补充蛋白质的基于容量的喂养方案是否能增加蛋白质和能量的供应。将探讨这种增加对肌肉质量损失的潜在影响。这些结局将有助于制定更大规模的随机对照试验以评估死亡率和发病率。
试验注册
澳大利亚新西兰临床试验注册中心（ANZCTR），ACTRN：12615000876594，UTN：U1111 - 1172 - 8563
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