Perioperative Glycemic Control With a Computerized Algorithm vs. Conventional Glycemic Control in Cardio-surgical Patients Undergoing Cardiopulmonary Bypass With Blood Cardioplegia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Time within a blood glucose corridor of 80 - 150 mg/dl
研究概览
简要总结
The debate about tight glycemic control (TGC) in the operating room and on the intensive care unit is ongoing, especially in cardio-surgical patients treated with blood cardioplegia, due to high blood glucose levels during operations and subsequent high rates of sternal wound infections. We showed in a feasibility study that early computer based insulin therapy starting in the operating room is a safe therapy that allows to better warrant normoglycemia in patients undergoing major cardiac surgery with the use of blood cardioplegia.
详细描述
Patients are enrolled and randomized into 3 groups. Start of therapy is determined as the beginning of cardiopulmonary bypass. Group A: Therapy with computer-based algorithm and measurement of blood glucose every 30 min. Group B: Measurement of blood glucose every 15 min using the identical computer-based algorithm. Group C: Conventional therapy using a fixed insulin dosing scheme. End of therapy is defined as discharge from ICU.
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
- •patients over 18 scheduled for elective cardiac surgery with the use of cardiopulmonary bypass and blood cardioplegia
排除标准
- •under 18 years of age, or if patients had a premedical history of steroid therapy
研究组 & 干预措施
Group A
With start of the cardiopulmonary bypass, computerized algorithmic application of insulin was performed with a dedicated computerized syringe pump system (Space GlucoseControl System, B. Braun, Germany). The targeted corridor for blood glucose was determined with 80 - 150 mg/dl. During surgery, blood glucose was measured every 30 min, and on the ICU every 2 hours. TGC management was continued until ICU discharge.
干预措施: Space GlucoseControl System, B. Braun, Melsungen, Germany (Device)
Group B
Corresponding computerized algorithmic application of insulin management was used as for group A. However, only the interval of blood glucose measurement during surgery was adjusted to 15 minutes.
干预措施: Space GlucoseControl System, B. Braun, Melsungen, Germany (Device)
Group C
With start of the cardiopulmonary bypass conventional therapy with a fixed insulin dosing scheme was initiated. If blood glucose was > 150 mg/dl, manual insulin therapy was started following a fixed insulin dosing scheme. Measurements of blood glucose were performed during surgery every 30 minutes, and on the ICU every 2 hours until discharge (Routine Care).
干预措施: Conventional therapy with a fixed insulin dosing scheme (Other)
结局指标
主要结局
Time within a blood glucose corridor of 80 - 150 mg/dl
时间窗: From start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48 -72 hrs.
The primary endpoint was defined as the time within a given blood glucose corridor from 80 - 150 mg/dl during therapy
次要结局
- Hypoglycemic events(From beginning of cardiopulmonary bypass during surgery until discharge from the ICU, which is approximately after 48-72 hrs.)
研究者
Prof. Dr. med. Daniel Reuter
Professor of anesthesiology
Universitätsklinikum Hamburg-Eppendorf