Effect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- perioperative blood lactate level
研究概览
简要总结
Hyperlactatemia, occuring 10-20% in patients undergoing valvular heart surgery, is known to be associated with hemodynamic instability, organ dysfunction and increased postoperative morbidity and mortality. Glucose-Insulin-Potassium(GIK) has been constantly used as an adjuvant therapy in patients with myocardial infarction or in the patients undergoing valvular heart surgery to reduce the low cardiac output syndrome and mortality. GIK is known to prevent excretion of lactate and to increase the extraction of lactate after reperfusion with various mechanism. In addition, it is also known to decrease ischemic-reperfusion injury of myocardium after CPB, to improve myocardial contractility, insulin resistance and hyperglucemia. As a result, it brings hemodynamic stability and sufficient oxygen supply to the tissue, which might reduce the incidence of hyperlactatemia after valvular heart surgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients(20 yr or older) undergoing elective valvular heart surgery under cardiopulmonary bypass(CPB) with more than 2 of following features:
- •congestive heart failure
- •infective endocarditis
- •redo valvular surgery
- •surgery combined with coronary bypass graft
- •multiple valvular surgery
- •expected CPB duration longer than 2 hr 7> preoperative serum creatinine over 1.4 mg/dl 8> preoperative hemoglobin level less than 12 mg/dl 9> left ventricular ejection fraction less than 40%
排除标准
- •emergency surgery
- •hemodynamic instability before surgery (mean arterial pressure < 60 mmHg, heart rate >100 /min
- •need for pharmacological or mechanical assist for hemodynamic stability before surgery
- •baseline blood lactate level more than 2 mmol/l
- •on steroid or NSAID
- •hepatic dysfunction
研究组 & 干预措施
(Glucose-Insulin-Potassium)GIK group
infusion of 0.1 IU/kg/hr of insulin and mixture of 30% dextrose water with 80 mmol/l of potassium in the rate of 0.5 ml/kg/hr through out the surgery
干预措施: (Glucose-Insulin-Potassium)GIK group (Drug)
normal saline group
same rate of normal saline
干预措施: normal saline group (Drug)
结局指标
主要结局
perioperative blood lactate level
时间窗: change of blood lactate level for 10 time points (before induction of anesthesia, immediately after induction of anesthesia, pre-CPB, 15 min after CPB, ACC off, post-CPB, sternum closure, ICU admission, 3 h after ICU admission, POD 1)
Measuring blood lactate level at each time point to compare the efficacy of GIK solution between control and Gik group
次要结局
未报告次要终点