Myocardial Protection of Glucose - Insulin - Potassium in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 930
- 试验地点
- 1
- 主要终点
- Number of participants of the major adverse cardiac events
研究概览
简要总结
The purpose of this study is to evaluate the effects of modified glucose - insulin - potassium (GIK) therapy in cardiac surgery patients undergoing cardiopulmonary bypass (CPB).
详细描述
Cardiopulmonary bypass (CPB) is a necessary technique to maintain the circulation during cardiac surgery. But CPB itself is associated with a series of problems of organs, such as hyperglycemia induced by neuroendocrine stress. The research showed that hyperglycemia induced by stress would cause a worsened hospital outcome for patients undergoing cardiac surgery. Intraoperative and postoperative glucose control is beneficial for patients.
It has been for more than 40 year since the first application of glucose - insulin - potassium (GIK) in cardiac surgery but the clinical application of GIK shows controversial results. The beginning time of application and the ratio of glucose and insulin may be the key reasons for the controversy. In our pilot trial of 40 valve replacement cases, we found that perioperative treatment of GIK with an insulin-glucose ratio of 1:3 showed beneficial effects during heart surgery. Therefore, the investigators are planning to continue to test this modified GIK regimen for more heart surgery patients and determine whether GIK may have cardioprotective effects on patients undergoing CPB surgery.
Myocardial biopsies for biological mechanism analysis will be performed prior to CPB, 15 min after aortic cross clamp application and 15 min after reperfusion only in a small cohort. Myocardial biopsies will be snap frozen or fixed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 70 years of age
- •Elective cardiac surgery with first time cardiopulmonary bypass
- •Left ventricular ejection fraction(LVEF) ≥ 30%
- •Informed agreement signed
排除标准
- •Previous cardiac surgery
- •Emergent surgery
- •Cardiac surgery without the use of cardiopulmonary bypass
- •Diabetes mellitus
- •Severe renal insufficiency
- •Severe respiratory insufficiency
- •Serious preoperative illness (sepsis, active infection or active malignancy requiring treatment)
- •Pregnant woman or positive pregnancy test
- •History of drug abuse
- •Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion
- •Enrollment in another clinical study
- •Lack of informed consent
研究组 & 干预措施
GIK
glucose-insulin-potassium (GIK) consists of 20% glucose (200 g/L), 66.7 U/L regular insulin and 80 mmol/L potassium chloride (KCl).
干预措施: GIK (Drug)
Control
6.12 g/L sodium acetate, 5.85 g/L sodium chloride, 0.3 g/L potassium chloride and 0.33 g/L calcium chloride
干预措施: Control (Drug)
结局指标
主要结局
Number of participants of the major adverse cardiac events
时间窗: Stay in hospital
The composite of major adverse cardiac events included acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome, congestive heart failure, arrhythmia and all-cause death.
次要结局
- Number of patients of postoperative complications(Stay in hospital)
- Length of stay in intensive care unit and hospital(Stay in intensive care unit and hospital)
- mortality(until the study ends)