Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
研究概览
简要总结
The purpose of this study is to confirm if myocardial protection effect can be obtained by intravenous administration of glutamine in patients undergoing aortic valve replacement with severe aortic stenosis (who are at high risk for ischemia-reperfusion injury). As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the degree of myocardial damage(with CK-MB and Troponin T) and myocardial protection (through hsp 70 expression in atrial tissue), cardiovascular index, inflammatory reaction, and clinical manifestation.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Adult patients with between 20 and 80 years scheduled for aortic valve replacement alone or combined surgery including aortic valve replacement due to severe aortic valve stenosis
排除标准
- •Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less)
- •patients who are considering surgery for coronary artery disease or who have a stenosis> 70%
- •hemodynamically unstable patients undergoing emergency surgery or patients with intra-aortic balloon pump insertion
- •patients unable to make their own decisions, illiterate, foreigners
- •severe metabolic acidosis
- •pulmonary edema
- •history of myocardial infarction
- •elevation of total bilirubin or AST / ALT
- •Patients higher than normal, weighing more than 80 kg
- •with evidence of infection
- •pregnant and lactating women
研究组 & 干预措施
Glutamine
Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)
干预措施: N(2)-L-Alanine L-Glutamine dipeptide (Drug)
Placebo
干预措施: placebo (0.9% NaCl (normal saline)) (Drug)
结局指标
主要结局
degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)
时间窗: 48 hours after surgery
Troponin-T(Tn-T) level
时间窗: 24 hours after surgery
次要结局
- IL-6(10 minutes after ICU(intensive care unit) entrance)
- Free fatty acid(10 minutes after ICU(intensive care unit) entrance)
- CRP(24 hours after surgery)
- cardiovascular index(24 hours after surgery)
- occurrence of sternal infections(Within 30 days postoperatively)
- mortality(During hospitalization regardless of length of stay or within 30 days of surgery if discharged)
- occurrence of cardiovascular complications(up to 1 year)