Continuous Postoperative Blood Glucose Monitoring and Control by an Artificial Pancreas in Patients Undergoing Pancreatic Resection: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas
研究概览
简要总结
This study evaluated a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection.
详细描述
This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study recruited 32 patients undergoing elective pancreatic resection for pancreatic disease.
排除标准
- •weight loss greater than 10% during the previous 6 months
- •signs of distant metastasis
- •respiratory, renal,or heart disease
- •Patients provided written informed consent prior to enrollment
研究组 & 干预措施
2
Thirty patients who underwent pancreatic resection for pancreatic neoplasm were prospectively randomized. Perioperative blood glucose levels were continuously monitored using an artificial endocrine pancreas (STG-22). Glucose levels were controlled using either the sliding scale method or the artificial pancreas.
干预措施: Artificial Pancreas (STG-22) (Device)
结局指标
主要结局
the incidence of severe hypoglycemia (< 40 mg/dl) during the intensive care period following pancreatic resection in patients monitored using the artificial pancreas
时间窗: the first postoperative 18 hours in the surgical intensive care unit
次要结局
- the total amount of insulin required for glycemic control after pancreatic resection(the first postoperative 18 hours in the surgical intensive care unit)