Oral Versus Parenteral Perioperative Nutrition Support to Improve Protein Balance: Stable Isotope Study in Colorectal Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Whole body protein balance
研究概览
简要总结
A prospective, randomized controlled study, using stable isotope methodology, is proposed to determine whether an oral nutrition support regimen, containing pressurized whey protein and glucose, is more effective at normalizing the metabolic response to surgery than a standard peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in colorectal surgical patients studied before and after surgery. The effectiveness of the nutrition support regimens will be determined by: whole body protein balance, synthesis rates of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well as circulating metabolites concentrations.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The American Society of Anesthesiologists' (ASA) class 1 to 3
- •Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
- •Nutrition status: 18.5 < body mass index < 30 kg/m2, stable weight over the preceding three months (< 10% body weight loss), serum albumin > 35g/l
排除标准
- •History of hepatic failure (Child-Pugh score A-C and transaminases outside the normal range)
- •Renal impairment (Serum Creatinine outside normal range)
- •Cardiac failure (New York Heart Association (NYHA) classes I-IV)
- •Hepatic, Renal, Cardiac transplant
- •Endocrine disorders: diabetes type I & II, hyper and hypothyroidism
- •Active inflammatory bowel or diverticular disease (Crohn's Disease, Ulcerative Colitis)
- •Musculoskeletal or neuromuscular disease
- •Anemia defined as hematocrit < 30, hemoglobin < 10 g/dl, albumin < 25 mg/dl
- •Previous spine surgery or scoliosis limiting use of epidural
- •Use of Steroids
- •Milk protein allergy or intolerance
结局指标
主要结局
Whole body protein balance
时间窗: 1 year
Whole body protein balance (the difference between protein synthesis and protein breakdown) as assessed by the kinetics of a stable, non-radioactive, isotope tracer infusion of L-\[1-13C\] leucine
次要结局
- Synthesis rates of hepatic secretory proteins(1 year)
研究者
Franco Carli
Dr. Franco Carli
McGill University Health Centre/Research Institute of the McGill University Health Centre