The Effect of Hyperinsulinemic Glucose Control on Outcomes Following Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,439
- 试验地点
- 2
- 主要终点
- Any Major Morbidity/30-day Mortality
研究概览
简要总结
Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood glucose levels intra-operatively. Group B will be administered insulin at the standard of care levels established by the participating institution. Patients will be followed at 10 days, 15 days and one year post-operatively.
详细描述
Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite outcome (one or more) of 30-day postoperative mortality and serious postoperative cardiac, renal, neurologic, and infectious postoperative complications in patients undergoing cardiac surgery.
Our secondary hypothesis is that hyperinsulinemic normoglycemic therapy will reduce length of stay in intensive care unit, atrial dysrhythmias, creatinine elevation, hospital readmission, all-cause and cardiac one-year mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Age 18-90 years old
- •Scheduled for cardiac surgery requiring cardiopulmonary bypass
排除标准
- •Off-pump surgical procedures
- •Anticipated deep hypothermic circulatory arrest
- •In available, baseline cardiac troponin I (>0.5 ng/L) or troponin T (> 0.1 ng/mL) levels (at RVH or CC, respectively)
- •Any contraindications to the proposed interventions
- •Active infection, including patients with endocarditis or infected pacemaker leads.
- •Any infection requiring long- term antibiotics ( > 14 days)
- •kidney disease requiring renal replacement therapy
研究组 & 干预措施
Hyperinsulinemic-normoglycemic clamp
Patients will be randomized to receive the hyperinsulinemic-normoglycemic clamp titrating the blood glucose to 80-110 mg/dL.
干预措施: Hyperinsulinemic-normoglycemic clamp (Other)
Insulin at the standard of care levels
Group B will be administered insulin at the standard of care levels established by the participating institution.
干预措施: insulin at the standard of care levels (Other)
结局指标
主要结局
Any Major Morbidity/30-day Mortality
时间窗: within 30 days post surgery
a composite (any versus none) of the following major postoperative complications occurring: 1. all-cause postoperative mortality 2. failure to wean from cardiopulmonary bypass or postoperative low cardiac index requiring mechanical circulatory support with intraaortic balloon counterpulsation, ventricular assist device, and/or extracorporeal mechanical oxygenation 3. serious postoperative infection 4. acute postoperative kidney injury requiring renal replacement therapy; 5. new postoperative focal or global neurologic deficit.
次要结局
- Duration of Intensive Care Stay(ICU stay hours during hospital stay after surgery, on average of 25 hours)
- Post Operative Atrial Fibrillation(15 - 30 days post operative)
- a Composite of Minor Postoperative Complications(within 30 days after surgery)
- Duration of Hospitalization(starting post operative day one to discharge from hospital, on an average of 8 days)
- All-cause Mortality(one year post operative)