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临床试验/NCT04614181
NCT04614181已完成不适用

The Feasibility and Benefits of Pre-operative Whey-protein Infused Carbohydrate Loading in Elderly With Hip Fractures Undergoing Surgery: a Pilot Study

University of Malaya2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
The number of participants recruitment

研究概览

简要总结

Pre-operative carbohydrate and protein loading among older people with hip fractures could potentially influence patient outcomes. This mode of intervention has seen good outcomes in a general surgical setting as part of its enhanced recovery pathway. However, its effectiveness and ease of implementation in a hip fracture setting is uncertain. This study aims to study the feasibility of protein and carbohydrate loading as part of hip fracture management compared to usual care.

详细描述

INTRODUCTION AND BACKGROUND

Pre-operative carbohydrate loading is one of the many components of enhanced recovery after surgery (ERAS) protocol. It has been identified as one of the independent predictors among ERAS components to improve peri-operative well-being and reduce post-operative complications. While well-being is a subjective outcome, several surrogate outcomes have been used to quantify some of the aspects. These surrogate outcomes of well-being include post-operative nausea and vomiting, pain, and preservation of muscle strength.

Although the exact mechanism of how pre-operative carbohydrate loading improves these outcomes is unclear, there appears to be an anabolic effect by increasing insulin sensitivity, improving glucose control and reducing catabolism. Patients in anabolic state undergo less post-operative nitrogen and protein loss, which translates to preservation of muscle strength. Carbohydrate loading keeps the body in a fed state during the fasting period before surgery. This abolishes the starvation effects which causes reduced insulin sensitivity commonly seen with conventional fasting practice. This is an independent predictor which prolongs length of hospital stay, preservation of muscle mass and handgrip strength post-operatively.

While most studies have demonstrated benefits of carbohydrate loading in patients undergoing abdominal surgeries, the number of studies conducted in the orthopedic hip fracture population are limited. In addition, there may also be barriers to introducing a new protocol with carbohydrate loading to replace the existing conventional fasting practice. Studies showed diverse feasibility in terms of implementation, which seemed to be multifactorial. More studies are therefore required to identify the factors promoting or impeding such a practice in respective centres. Given that a significant number of the hip fracture population are malnourished elderly who may benefit from this intervention, the gap in literature in this population deserves a thorough attention.

The University Malaya Medical Centre is a tertiary hospital with an average of 200 hip fracture cases annually. To date, these cases are subjected to conventional fasting starting from midnight. They are usually fasted up to extended hours, putting them in a starved state before surgery. It is therefore the great interest of the current multidisciplinary teams involved in the clinical care of hip fracture patients to introduce carbohydrate loading as part of the fasting practice. This study aims to introduce the concept and assess the feasibility of such a practice. The results from this pilot study may be used to revolutionize the fasting practice in our hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients planned for semi-emergency hip surgery (total arthroplasty, hemiarthroplasty, internal fixation)
  • Aged 65 years and above
  • ASA 1-3 (ASA Physical Status Classification System)

排除标准

  • Patients undergoing hip surgery of emergency nature (inadequate time for recruitment and pre-operative intervention)
  • Peri-prosthetic hip fracture and fracture due to underlying malignancy
  • Revision hip surgery
  • Participation in another nutritional program
  • Diabetes mellitus
  • Intolerance to carbohydrate drinks
  • Gastric reflux, risk of aspiration, dysphagia
  • Severe cognitive impairment and delirium

结局指标

主要结局

The number of participants recruitment

时间窗: 6 months

How many participants willing to be recruited, screening to recruitment rate

The number of participants that adhered to nutritional loading

时间窗: 6 months

How many participants adhered to the the total treatment drinks

The attrition rate of participants recruited into the study

时间窗: 6 months

How many participants dropped out or had missing data

Safety profile: How many participants had an adverse reaction

时间窗: 6 months

How many participants had an adverse reaction

次要结局

  • Change in muscle strength(6 months)
  • Prevalence of post-operative nausea and/or vomiting(6 months)
  • Prevalence of post-operative complications(6 months)
  • Severity of post-operative pain(6 months)
  • Length of stay(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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