The Effects of Perioperative Nutritional Optimization on Blood Markers of Nutritional Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Difference in blood markers in patients
研究概览
简要总结
The purpose of this study is to see if taking an oral nutrition supplement (Ensure Nutrition Shake) before and after lumbar spine surgery affects blood tests related the nutritional status of patients. Patients with poor nutritional statuses who undergo elective lumbar spine surgery are at increased risk for complications and longer hospitalizations.
详细描述
The study will examine whether a simple and cost-effective perioperative nutritional program will affect blood markers of nutritional status (albumin, pre-albumin, transferrin, electrolytes). All patients 55 years and older who are undergoing lumbar spine surgery at our institution by a single surgeon and meet all inclusion criteria will be added to this study. Patients will be randomized into one of two arms; the interventional group will be provide with daily Ensure protein drinks for two weeks pre-operatively and four weeks post-operatively, while the control group will be instructed to continue their current diet plans. Four weeks post-operatively, blood markers (serum albumin, pre-albumin, transferrin, electrolyes) will be obtained to assess objective differences in nutritional status.
N/A
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 55 years and older undergoing primary lumbar spine surgery for the treatment of radiculopathy and other lumbar pathologies
- •Patients have the willingness and ability to participate in a study procedure
排除标准
- •Patients who are younger than 55 years old
- •Patients undergoing revision surgery
- •Patients undergoing surgery due to trauma/fractures
- •Patients with lactose intolerance
研究组 & 干预措施
Arm 2
The control group will be instructed to continue to their regular diets.
Arm 1
The treatment arm will receive 6 week supply of daily Ensure protein drinks, while the control arm will be instructed to continue their current diet. This includes 2 weeks pre-operatively and 4 weeks post-operatively.
干预措施: Ensure (Dietary Supplement)
结局指标
主要结局
Difference in blood markers in patients
时间窗: Baseline, 4 weeks post-operative visit
Nutritional status of patients undergoing lumbar surgery will be measured by their blood markers. T-tests with a p value of 0.05 will be used for these tests. Chi square and t-tests will be used.
次要结局
未报告次要终点