Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Net protein balance
研究概览
简要总结
The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists class<3
- •age>18 years
- •colorectal surgery for non-metastatic colorectal adenocarcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy sigmoid and low anterior resection
- •ability to give informed consent
排除标准
- •BMI>30 Kg/meter squared
- •confirmed diagnosis of diabetes mellitus or a HbA1c>6.0%
- •significant cardiorespiratory, hepatic, renal and neurological disease
- •musculoskeletal or neuromuscular disease
- •ingestion of drugs known to affect protein, glucose and lipid metabolism (e.g. steroids)
- •severe anemia (hemoglobin<10 g/dL
- •pregnancy
- •history of severe sciatica, back surgery or other conditions which contraindicate the use of epidural catheters
研究组 & 干预措施
Insulin, Travasol (35%) postop
Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, .
干预措施: Travasol (amino acid injection) (Dietary Supplement)
Insulin, Travasol (35%) postop
Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, .
干预措施: Insulin (Drug)
Insulin, Travasol (20%) postop
Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery.
干预措施: Travasol (amino acid injection) (Dietary Supplement)
Insulin, Travasol (20%) postop
Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery.
干预措施: Insulin (Drug)
Insulin, no protein after surgery
Insulin (hyperinsulinemic-normoglycemic clamp, an insulin infusion between 2 and 5 microunits/kg with glucose at a variable rated titrated to maintain normoglycemia, blood glucose 4-6 mmol/L) with no protein supplementation from start of surgery to 6 hours after.
干预措施: Insulin (Drug)
结局指标
主要结局
Net protein balance
时间窗: 6 hours after surgery
The difference in total body protein after randomization to one of the three treatment arms.
次要结局
未报告次要终点
研究者
Thomas Schricker
Chief of Anesthesia
McGill University Health Centre/Research Institute of the McGill University Health Centre