Benefit of Tight Glycemic Control in Surgical Patients: Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- The incidence of hypoglycemia
研究概览
简要总结
Hyperglycaemia has been repeatedly associated with risk of mortality and morbidity in the intensive care unit (ICU). The evidence currently available is in favour of a 'normal ≤ 6.1 mmol/l' level for blood glucose control in ICUs according to two large randomized control trials of Van den Berghe G and is not supportive of J. Miles's viewpoint in this debate. In this study, the investigators would like to evaluate that the target of blood glucose level, whether is a normal level (80-110 mg/dL) or another level (140-160 mg/dL), should be set for the reduction of perioperative mortality and complications.
详细描述
Our previous prospective randomized clinical trial suggested that the postoperative morbidities were reduced by tight glycemic control of a normal level for blood glucose using artificial pancreas. However, the most feared one is hypoglycaemia, which, when severe and prolonged, may cause convulsions, coma and brain damage, as well as cardiac arrhythmias. Recently, Ven den Berghe G report that the development of accurate, continuous blood glucose monitoring devices, and preferably closed-loop systems for computer-assisted blood glucose control in the ICU, will help to avoid hypoglycaemia. In our study, no hypoglycemia showed in more than 100 patients who performed perioperative tight glycemic control by artificial pancreas.
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who were suffering from liver, pancreas or cardio-vascular diseases, were informed of the purpose and details of the study, and written consent was obtained from them prior to enrolment.
排除标准
- •Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery
- •The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
结局指标
主要结局
The incidence of hypoglycemia
时间窗: during hospitalization
次要结局
- The incidence of postoperative infectious complications and calculate the total costs during hospitalization(during hospitalization)