Single-centre, Open Study to Investigate the Feasibility of Blood Glucose Control With the Space TGC System (With Incorporated Software-algorithm eMPC) Over an Extended Glucose Control Range (4.4 to 8.3 mmol/L) for a Maximum of 48 Hours in Postoperative Cardiac Surgery Patients in the ICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- (arterial) blood glucose values -> percentage of time within predefined glucose target range 4.4-8.3 mmol/dL
研究概览
简要总结
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. Space GlucoseControl (TGC system) is a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges. Information on parenteral and enteral nutrition is automatically integrated into the calculations. The primary objective of the current study is to investigate the performance and usability of the Space TGC system for glucose control over an extended glucose control range (4.4 to 8.3 mmol/L) in postoperative cardiac surgery patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •age: > 18 years of age
- •admitted following cardiac surgery
- •stay in the ICU expected to be > 20 h
- •blood glucose > 6.7 mmol/l within 4 hours of ICU admission or patient already on insulin treatment
排除标准
- •patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
- •known or suspected allergy to insulin
- •any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
- •patients participating in another study
- •moribund patients likely to die within 24 hours
- •patients after organ transplantation within the last three months
- •patients under high dose cortisol treatment (cortisol > 1000 mg/day or equivalent doses of hydrocortisol)
研究组 & 干预措施
1
Space TGC system with incorporated eMPC advised insulin titration to establish glycaemic control
干预措施: Space TGC (Device)
结局指标
主要结局
(arterial) blood glucose values -> percentage of time within predefined glucose target range 4.4-8.3 mmol/dL
时间窗: all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h
次要结局
- Hypoglycaemia ≤ 40 md/dL (2.2mM)(all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h)
- Usability parameters like convenience of alarming function; workload; blood sampling frequency(all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h)
- Concomitant medication including insulin infusion rate, parenteral/enteral nutrition(all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h)