Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The effectiveness of different TGC management protocols
研究概览
简要总结
A randomized trial to compare three insulin-titration protocols for tight glycemic control in surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath) protocol, and an enhanced model predictive control algorithm (eMPC)
详细描述
120 consecutive post-cardiac surgery patients randomized to the three protocols with a target glycemia range from 4.4 to 6.1 mmol/l. Intravenous insulin was administered continuously or in combination with insulin boluses (Matias protocol). Blood glucose was measured in 1-4 hour intervals as requested by protocols.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients admitted to the postoperative ICU after elective cardiac surgery
排除标准
- •insulin allergy
研究组 & 干预措施
Matias protocol
A protocol based on the absolute glucose value - Matias protocol (Matias)
干预措施: insulin (Drug)
Bath protocol
A protocol based on the relative glucose change - Bath protocol (Bath)
干预措施: insulin (Drug)
eMPC
a computer-based model predictive control algorithm with variable sampling rate (eMPC)
干预措施: insulin (Drug)
结局指标
主要结局
The effectiveness of different TGC management protocols
时间窗: ICU stay
次要结局
- The safety with respect to hypoglycemia(ICU stay)
研究者
Jan Blaha
Principal Investigator
Charles University, Czech Republic