Effects of Nutritional Preconditioning on the Nutritional Status of Patients Undergoing Major General Surgeries and Subsequent Operative Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patient length of hospital stay
研究概览
简要总结
Malnutrition is a serious problem in patients undergoing major surgeries and has a direct association with increased morbidity, mortality, length of stay (LOS), increased readmissions and cost of care. Studies suggest several advantages of supplementation with protein or specific amino acids in malnourished patients. Dietary leucine or its metabolite β-hydroxy β-methylbutyrate (HMB) can improve skeletal muscle mass and function by increasing transcriptional level of protein synthase, while other high protein or amino acids like Glutamine or Arginine supplements only provide protein-amino acids pool for patients while body's preferred fuel during metabolic stress is endogens protein, rather than exogenous diet.
In this study the investigators seek to achieve two distinct goals:
- Determine the patients' nutritional status before and after major surgeries by baseline and subsequent nutritional assessments, according to ASPEN's criteria. In addition, the investigators were going to use indirect calorimetry to determine the Resting Energy Expenditure (REE) in different phases of pre- and postoperative periods. The investigators also propose to compare different serum protein markers and their ratios in order to correlate them with ASPEN's criteria for nutritional status quantification. In Summary, three discrete tools including ASPEN's criteria, indirect calorimetry, and serum biomarkers are going to be used in conjunction with each other to delineate the patients' nutritional status in various pre- and post-operative periods.
- Patients undergoing major surgeries were supplemented with high protein with ß-hydroxy ß-methylbutyrate (HMB) (Ensure, Envile) or HMB only as a control, in order to improve their nutritional status and improve postoperative outcomes. The investigators looked for depict meaningful improvements in surgical outcomes by nutritional supplementation with or without HMB.
详细描述
Hypotheses:
We hypothesize that patients receiving high protein nutritional supplementation with HMB (Ensure Enlive) will have meaningful improvements in surgical outcomes rather than if they receive HMB only. Also, by comparing different methods of malnutrition designation, we are hypothesizing that by conduction this study, we will have a better understanding of malnutrition and its consequences in the Central Valley of California. Furthermore, we are planning to improve patient outcomes and significantly reduce the health care costs of the Valley by proper nutritional supplementation.
Specific Aims:
Demonstrate the important role β-hydroxy β-methyl butyrate (HMB) supplementation with or without high protein nutrition supplement in patients undergoing major surgeries and their outcomes.
Develop the current ERAS protocol used in Community Regional Medical Center by determining the best oral nutrition supplement prior to surgery Emphasize the importance of using oral nutrition supplements before major surgeries to decrease the patient's recovery after surgeries.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dr. Amir Fathi as attending surgeon
- •Adult patients (age >18) undergoing major abdominal and GI surgeries
- •Patients at risk for malnutrition based on the ASPEN and The Academy malnutrition criteria
排除标准
- •Pediatric patients
- •Patients undergoing chemotherapy or radiation
- •Patients with known allergies to products (Ensure Enlive, HMB)
- •Patients that are unable to comply with all requirements
- •Vegan patients
- •Pregnant patients
- •Prisoners
结局指标
主要结局
Patient length of hospital stay
时间窗: day seven and day thirty after surgery
Length of hospital stay (LOS) will be measured for all participating patients. Average LOS in the intervention group will be compared with the average LOS in the control group.
次要结局
- Change in transcriptional key proteins expression level(one year)