The Effect of Glucose-Insulin-Potassium Infusion on Myocardial Injuries and Cardiac Function in Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Postcardiotomy ventricular dysfunction
研究概览
简要总结
The purpose of this study is to evaluate the cardioprotective effects of a short term infusion of glucose-insulin-potassium (GIK) during heart surgery.
详细描述
Cardiac surgery with cardiopulmonary bypass and ischemic cardiac arrest is associated with a wide spectrum of perioperative myocardial ischemic-reperfusion injuries resulting in significant cardiac morbidity, namely contractile dysfunction, myocardial infarction, and low cardiac output syndrome requiring prolonged intensive care and hospital stay. The infusion of glucose-insulin-potassium (GIK) is one of the oldest cardioprotective interventions during cardiac surgery. Although experimental evidence is strong, clinical data remain conflicting. We will investigate the impact of short term GIK on the extent of myocardial injuries as well as on the left-ventricular systolic and diastolic function in 2 high-risk groups of cardiac surgical patients: Patients with cardiac dysfunction undergoing aortocoronary bypass surgery and patients with severe aortic stenosis.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic stenosis
- •Coronary artery disease associated with poor left ventricular function
- •Parsonnet score >7
排除标准
- •Dementia or inability to understand the study protocol
- •Off-pump and emergent cardiac surgery
- •Poorly controlled diabetes mellitus
- •Severe renal insufficiency
- •Abnormal liver function Child-Plugh - C
- •Body Mass Index < 18 and > 35
研究组 & 干预措施
1
Administration of glucose-insulin-potassium
干预措施: Glucose-insulin-potassium (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Postcardiotomy ventricular dysfunction
时间窗: 48h postoperative
次要结局
- Serious cardiovascular adverse events (myocardial infarction, cardiac arrhythmia, low cardiac output, stroke)(48 postoperative)
- Serum troponin and creatinine kinase(Intraoperative - 48 h postoperative)
- Systolic and diastolic cardiac function using transoesophageal echocardiography(intraoperative)
- Hypo-/hyperglycemia Hypo-/hyperkaliemia(intraoperative)
研究者
Christoph Ellenberger
Médecin Adjoint
University Hospital, Geneva
