A Feasibility Randomized Control Trial to Investigate the in Silico Optimization of Insulin Treatments
试验速览
- 阶段
- 不适用
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Exposure to risk of hypoglycemia
研究概览
简要总结
The primary objective of this study is to assess the performance of an in silico designed alternative protocol for control of stress hyperglycemia of inpatients treated for Coronary Artery Bypass Graft (CABG) or valve replacement surgery in the University of Virginia cardiothoracic ICU.
详细描述
The hypothesis of the study is that settings for the Glucommander protocol can be optimized in silico to achieve statistically improved low blood glucose index (LBGI) within the subpopulation of CABG and valve replacement patients who both receive Glucommander-based insulin therapy and meet Manufacturer's guidelines for starting with an initial multiplier value of .052, without risking clinically significant increase in exposure to hyperglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted for CABG and/or open heart valve surgery
- •Must have a 0.05 initial multiplier setting for the Glucommander based on the manufacturers recommendations
- •Age of 40-75, inclusive
排除标准
- •History of severe hypoglycemia within six months of hospital admission
- •Currently undergoing dialysis or renal replacement therapy
- •Women of childbearing potential
- •Patients with endocarditis needing valve replacement
- •Participation in another clinical trial at the time of screening.
研究组 & 干预措施
Optimized Glucommander (OGM)
CABG or open valve surgery patients treated for stress hyperglycemia with in silico optimized Glucomander protocol
干预措施: Optimized Glucommander (OGM) (Other)
Standard Glucommander Protocol (SGP)
CABG or open valve surgery patients treated for stress hyperglycemia with the standard Glucomander protocol according to the manufacturer recommendations
干预措施: Standard Glucommander Protocol (SGP) (Other)
结局指标
主要结局
Exposure to risk of hypoglycemia
时间窗: 24 hours of post-operative hospital stay
Exposure to risk of hypoglycemia as measured by the Low Blood Glucose Index (LBGI).
次要结局
- Exposure to risk of hypoglycemia(48 hours of post-operative hospital stay)
研究者
Anthony McCall
Principal Investigator
University of Virginia