股骨颈术前营养试验（POINT）——脆性髋部骨折患者的碳水化合物负荷：一项随机对照试验的研究方案

Pre-Operative nutrition In Neck of femur Trial (POINT)--carbohydrate loading in patients with fragility hip fracture: study protocol for a randomised controlled trial.

作者信息

Moppett Iain K, Greenhaff Paul L, Ollivere Ben J, Joachim Theophillus, Lobo Dileep N, Rowlands Martin

机构信息

Associate Professor and Honorary Consultant Anaesthetist, Anaesthesia and Critical Care Research Group, Division of Clinical Neuroscience, University of Nottingham, Nottingham NG7 2UH, UK.

出版信息

Trials. 2014 Dec 4;15:475. doi: 10.1186/1745-6215-15-475.

DOI:10.1186/1745-6215-15-475

PMID:25472724

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4289274/

Abstract

BACKGROUND

Trauma such as hip fracture initiates a neurohumoral stress response that changes the balance between anabolism and catabolism resulting in muscle breakdown and reduced mobilisation. Various studies have demonstrated a reduction in catabolism with pre-operative carbohydrate loading but only in an elective setting.

METHODS/DESIGN: This is a two-centre, randomised double-blinded trial in the United Kingdom. Sample size will be 30 patients (approximately 15 from each centre). Randomisation will be web based using computer-generated concealed tables. Both participants and investigators will be blinded to group allocation. Participants will be >70 years of age, cognitively intact (Abbreviated Mental Score ≥ 7), able to give informed consent, and admitted directly through the emergency department with fractured neck of femur requiring hemiarthroplasty. Intervention will consist of two carbohydrate drinks (Nutricia pre-Op) given the night before, and the morning of the surgery. The control will receive two placebo drinks of equal volume. All participants will receive standard hospital care at the discretion of the clinical team. The primary outcome is the difference between groups in insulin resistance calculated by a glucose tolerance test administered pre-operatively and 24 hours postoperatively. Secondary endpoints will be changes in muscle carbohydrate metabolism (biopsy), mobility (Cumulative Ambulation Score) and subjective measures of tolerability.

DISCUSSION

This is a small-scale pilot study, investigating the benefits and tolerability of carbohydrate loading in an emergency setting in a frail elderly group with known high morbidity and mortality. Positive findings will provide the basis for a larger scale study.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN91109766 (7 April 2014); NRES ref: 13/EM/0214Trial Sponsor: University of Nottingham Ref.13036.

摘要

背景

诸如髋部骨折之类的创伤会引发神经体液应激反应，这种反应会改变合成代谢与分解代谢之间的平衡，导致肌肉分解和活动能力下降。多项研究表明，术前碳水化合物负荷可减少分解代谢，但仅适用于择期手术情况。

方法/设计：这是一项在英国进行的两中心随机双盲试验。样本量为30名患者（每个中心约15名）。随机分组将通过基于网络的计算机生成的隐蔽表格进行。参与者和研究人员都将对分组情况不知情。参与者年龄大于70岁，认知功能完好（简易精神状态评分≥7），能够给予知情同意，并且因股骨颈骨折需要进行半髋关节置换术而直接通过急诊科入院。干预措施包括在手术前一晚和手术当天上午给予两杯碳水化合物饮料（Nutricia术前饮料）。对照组将接受两杯等量的安慰剂饮料。所有参与者将由临床团队酌情提供标准的医院护理。主要结局是术前和术后24小时通过葡萄糖耐量试验计算的两组之间胰岛素抵抗的差异。次要终点将是肌肉碳水化合物代谢（活检）、活动能力（累积行走评分）的变化以及耐受性的主观指标。