β-羟基-β-甲基丁酸（HMB）补充剂与多发伤患者的功能结局：一项试点随机临床试验的研究方案（BOOST试验）
β-Hydroxy-β-methylbutyrate (HMB) supplementation and functional outcomes in multi-trauma patients: a study protocol for a pilot randomised clinical trial (BOOST trial).
作者信息
Wittholz Kym, Fetterplace Kate, Ali Abdelhamid Yasmine, Presneill Jeffrey J, Beach Lisa, Thomson Benjamin, Read David, Koopman René, Deane Adam M
机构信息
Department of Allied Health, The Royal Melbourne Hospital, 300 Grattan Street, Parkville, Melbourne, VIC, 3050, Australia.
Department of Critical Care, Melbourne Medical School, The University of Melbourne, Melbourne, Australia.
出版信息
Pilot Feasibility Stud. 2022 Jan 31;8(1):21. doi: 10.1186/s40814-022-00990-9.
BACKGROUND
There are no therapies proven to diminish the muscle wasting that occurs in patients after major trauma who are admitted to the intensive care unit (ICU). β-Hydroxy-β-methylbutyrate (HMB) is a nutrition intervention that may attenuate muscle loss and, thereby, improve recovery. The primary aim of this study is to determine the feasibility of a blinded randomised clinical trial of HMB supplementation to patients after major trauma who are admitted to the ICU. Secondary aims are to establish estimates for the impact of HMB when compared to placebo on muscle mass and nutrition-related patient outcomes.
METHODS
This prospective, single-centre, blinded, randomised, placebo-controlled, parallel-group, feasibility trial with allocation concealment will recruit 50 participants over 18 months. After informed consent, participants will be randomised [1:1] to receive either the intervention (three grams of HMB dissolved in either 150 ml of orange juice for those allowed oral intake or 150 ml of water for those being enterally fed) or placebo (150 ml of orange juice for those allowed oral intake or 150 ml of water for those being enterally fed). The intervention will be commenced in ICU, continued after ICU discharge and ceased at hospital discharge or day 28 post randomisation, whichever occurs first. The primary outcome is the feasibility of administering the intervention. Secondary outcomes include change in muscle thickness using ultrasound and other nutritional and patient-centred outcomes.
DISCUSSION
This study aims to determine the feasibility of administering HMB to critically ill multi-trauma patients throughout ICU admission until hospital discharge. Results will inform design of a larger randomised clinical trial.
TRIAL REGISTRATION
The protocol is registered with Australian New Zealand Clinical Trials Registry (ANZCTR) ANZCTR: 12620001305910 . UTN: U1111-1259-5534.
背景
对于入住重症监护病房（ICU）的重大创伤患者出现的肌肉萎缩，尚无经证实有效的治疗方法。β-羟基-β-甲基丁酸（HMB）是一种营养干预措施，可能减轻肌肉流失，从而促进康复。本研究的主要目的是确定对入住ICU的重大创伤患者补充HMB进行双盲随机临床试验的可行性。次要目的是评估与安慰剂相比，HMB对肌肉质量和营养相关患者结局的影响。
方法
这项前瞻性、单中心、双盲、随机、安慰剂对照、平行组、有分配隐藏的可行性试验将在18个月内招募50名参与者。获得知情同意后，参与者将按[1:1]随机分组，分别接受干预措施（对于允许经口摄入的患者，将3克HMB溶解于150毫升橙汁中；对于接受肠内喂养的患者，将3克HMB溶解于150毫升水中）或安慰剂（对于允许经口摄入的患者，给予150毫升橙汁；对于接受肠内喂养的患者，给予150毫升水）。干预措施将在ICU开始，在ICU出院后继续进行，并在出院或随机分组后第28天停止，以先发生者为准。主要结局是实施干预措施的可行性。次要结局包括使用超声测量的肌肉厚度变化以及其他营养和以患者为中心的结局。
讨论
本研究旨在确定在整个ICU住院期间直至出院对重症多发伤患者给予HMB的可行性。研究结果将为更大规模随机临床试验的设计提供依据。
试验注册
该方案已在澳大利亚新西兰临床试验注册中心（ANZCTR）注册，注册号：ANZCTR: 12620001305910 。UTN: U1111-1259-5534。
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