Perioperative Nutrition Optimization for Reducing Complications After Surgical Fracture Fixation
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Compare clinical benefit of oral supplementation with CEAA versus a placebo for reducing fracture-related infection after lower extremity fracture fixation.
概览
简要总结
The objective of this multi-center, prospective, placebo-controlled, randomized study is to compare oral conditionally essential amino acid (CEAA) supplementation for decreasing the key postoperative complications of fracture-related infection, fracture nonunion, and skeletal muscle wasting with a placebo control (PC) after lower extremity fracture fixation. Investigators hypothesize that perioperative oral supplementation with an investigational CEAA supplement (ICS) will reduce postoperative fracture-related infections, fracture nonunion rates, and skeletal muscle wasting in patients with traumatic lower extremity fractures. This is supported by strong pilot data. Conducting a randomized controlled trial at five civilian tertiary referral centers and one military treatment facility will further study the potential benefits of oral CEAA supplementation for preventing the stated key postoperative complications in patients following high energy lower extremity orthopedic trauma. This low cost, low risk intervention has demonstrated potential to expedite Warfighter return to duty as well as potentially reducing delayed limb amputations and mortality in severely injured patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18-55 years
- •Open or closed fracture of the lower extremity including femur, tibia and/or fibula, calcaneus, talus, Lisfranc joint (OTA/AO 31, 32, 33, 41, 42, 43, 44, 4F, 81, 82, 83, 85)
- •Ability to begin supplementation within 72 hours of injury
排除标准
- •BMI \<18.5 kg/m 2 (underweight) or BMI \> 45 kg/m 2 (severe obesity) to exclude patients with severely increased baseline risk of adverse outcome due to preoperative poor nutrition
- •Non-ambulatory prior to injury
- •Currently pregnant
- •Medical contraindication to CEAA supplementation (e.g., phenylketonuria)
- •Inability to provide informed consent due to intellectual disability
- •Protected populations (e.g., prisoners)
- •Inability to follow up (e.g., homeless at time of surgery, home address out of state of treating facility)
- •Documented dementia, mild or moderate traumatic brain injury
- •Inability to consume supplement or placebo due to head or neck trauma
- •Low-energy fragility fracture (i.e. ground level falls)
研究组 & 干预措施
Patients randomized to CEAA
Patients with lower extremity fractures indicated for operative fracture fixation at six tertiary trauma centers
干预措施: CEAA supplementation (Dietary Supplement)
patients randomized to placebo
Patients with with lower extremity fractures indicated for operative fracture fixation at six tertiary trauma centers
干预措施: Placebo (Other)
结局指标
主要结局
Compare clinical benefit of oral supplementation with CEAA versus a placebo for reducing fracture-related infection after lower extremity fracture fixation.
时间窗: 12 months
Investigators will record the number of participants with fracture-related infection for 12 months following lower extremity fracture fixation. The measurement will be based on Metsemakers consensus definition (Metsemakers et al. (2018). We will enroll 1,000 participants and anticipate 15% loss to attrition (426 in each arm). Using the observed fracture-related infection rates of 16.5% and 10% from a previous study, 426 participants would be needed for each group to detect a significant difference with 80% power and alpha value of 0.05 based upon Pearson Chi-Square test and pooled standard deviation.
次要结局
未报告次要终点