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危重症患者采用高蛋白配方间歇性和持续性肠内营养中的蛋白质递送:前瞻性随机对照概念验证蛋白推注营养(Pro BoNo)研究方案。

Protein delivery in intermittent and continuous enteral nutrition with a protein-rich formula in critically ill patients-a protocol for the prospective randomized controlled proof-of-concept Protein Bolus Nutrition (Pro BoNo) study.

机构信息

Intensive Care Unit, University Hospital Basel, Basel, Switzerland.

Department of Biomedicine, University Hospital Basel, Basel, Switzerland.

出版信息

Trials. 2020 Aug 25;21(1):740. doi: 10.1186/s13063-020-04635-1.

DOI:10.1186/s13063-020-04635-1
PMID:32843075
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7449093/
Abstract

BACKGROUND

Critically ill patients rapidly develop muscle wasting resulting in sarcopenia, long-term disability and higher mortality. Bolus nutrition (30-60 min period), whilst having a similar incidence of aspiration as continuous feeding, seems to provide metabolic benefits through increased muscle protein synthesis due to higher leucine peaks. To date, clinical evidence on achievement of nutritional goals and influence of bolus nutrition on skeletal muscle metabolism in ICU patients is lacking. The aim of the Pro BoNo study (Protein Bolus Nutrition) is to compare intermittent and continuous enteral feeding with a specific high-protein formula. We hypothesise that target quantity of protein is reached earlier (within 36 h) by an intermittent feeding protocol with a favourable influence on muscle protein synthesis.

METHODS

Pro BoNo is a prospective randomised controlled study aiming to compare the impact of intermittent and continuous enteral feeding on preventing muscle wasting in 60 critically ill patients recruited during the first 48 h after ICU admission. The primary outcome measure is the time until the daily protein target (≥ 1.5 g protein/kg bodyweight/24 h) is achieved. Secondary outcome measures include tolerance of enteral feeding and evolution of glucose, urea and IGF-1. Ultrasound and muscle biopsy of the quadriceps will be performed.

DISCUSSION

The Basel Pro BoNo study aims to collect innovative data on the effect of intermittent enteral feeding of critically ill patients on muscle wasting.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03587870 . Registered on July 16, 2018. Swiss National Clinical Trials Portal SNCTP000003234. Last updated on July 24, 2019.

摘要

背景

危重症患者会迅速出现肌肉消耗,导致肌肉减少症、长期残疾和更高的死亡率。推注营养(30-60 分钟)与连续喂养相比,似乎通过增加亮氨酸峰值来提供代谢益处,从而增加肌肉蛋白质合成。迄今为止,关于 ICU 患者营养目标的实现和推注营养对骨骼肌代谢的影响的临床证据尚缺乏。Pro BoNo 研究(蛋白质推注营养)的目的是比较间歇性和连续性肠内喂养与特定高蛋白配方。我们假设间歇喂养方案能更早(在 36 小时内)达到目标蛋白质量,并对肌肉蛋白质合成产生有利影响。

方法

Pro BoNo 是一项前瞻性随机对照研究,旨在比较间歇和连续肠内喂养对预防 60 名 ICU 入院后 48 小时内新入 ICU 的危重症患者肌肉消耗的影响。主要观察指标是达到每日蛋白质目标(≥1.5 g/kg/24 h)的时间。次要观察指标包括肠内喂养的耐受性和血糖、尿素和 IGF-1 的演变。将进行股四头肌的超声和肌肉活检。

讨论

巴塞尔 Pro BoNo 研究旨在收集关于间歇喂养危重症患者对肌肉消耗影响的创新数据。

试验注册

ClinicalTrials.gov NCT03587870。于 2018 年 7 月 16 日注册。瑞士国家临床试验门户 SNCTP000003234。2019 年 7 月 24 日更新。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b20e/7449093/32f46e669fa9/13063_2020_4635_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b20e/7449093/32f46e669fa9/13063_2020_4635_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b20e/7449093/32f46e669fa9/13063_2020_4635_Fig1_HTML.jpg

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