Nitroglycerin Infusion During Rewarming in Cardiac Surgery and Its Effects on Tissue Perfusion and Coagulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Plasma Lactate Level, Before Incision
研究概览
简要总结
Hypothermic cardiopulmonary bypass results in peripheral vasoconstriction and heparin trapping. Hypoperfusion and ischemic-reperfusion injury are associated with systemic inflammatory response, while insufficient and delayed neutralization of heparin by protamine may contribute to more blood loss during rewarming stage.
Nitroglycerin infusion, an NO-related vasodilator, is an established and effective treatment for unstable angina, myocardial infarction, congestive heart failure, and perioperative hemodynamic management for cardiac surgery. Therefore, we hypothesize that nitroglycerin infusion during rewarming corrects systemic ischemic stress and facilitates heparin neutralization in cardiac surgery.
详细描述
A randomized clinical trial in a tertiary academic center in patients with cardiac surgery, to receive either nitroglycerin infusion dose of 0-0.1 mcg/kg/min, or 1-5 mcg/kg/min during rewarming in cardiopulmonary bypass.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective cardiac surgery
排除标准
- •heart failure, respiratory failure, asthma attack, uremia, normothermic bypass.
研究组 & 干预措施
High-dose NTG
Nitroglycerin infusion 1-5 mcg/kg/min
干预措施: Nitroglycerin infusion (Drug)
Low-dose NTG
Nitroglycerin infusion 0-0.1 mcg/kg/min
干预措施: Nitroglycerin infusion (Drug)
结局指标
主要结局
Plasma Lactate Level, Before Incision
时间窗: Before Incision
Plasma Lactate Level, mmol/L, Before Incision
Plasma Glucose Level, Release of Aortic Clamp
时间窗: Release of Aortic Clamp
Plasma Glucose Level, mg/dL, Release of Aortic Clamp
Plasma Lactate Level, Before Start of CPB
时间窗: Before Start of CPB
Plasma Lactate Level, mmol/L, Before Start of CPB
Plasma Lactate Level, Release of Aortic Clamp
时间窗: Release of Aortic Clamp
Plasma Lactate Level, mmol/L, Release of Aortic Clamp
Plasma Glucose Level, Before Incision
时间窗: Before Incision
Plasma Glucose Level, mg/dL, Before Incision
Plasma Lactate Level, Upon Arrival at ICU
时间窗: Upon Arrival at ICU
Plasma Lactate Level, mmol/L, Upon Arrival at ICU
Plasma Lactate Level, After Protamine Administration
时间窗: After Protamine Administration
Plasma Lactate Level, mmol/L, After Cessation of CPB and Protamine Administration
Plasma Glucose Level, Before Start of CPB
时间窗: Before Start of CPB
Plasma Glucose Level, mg/dL, Before Start of CPB
Plasma Glucose Level, After Protamine Administration
时间窗: After Protamine Administration
Plasma Glucose Level, mg/dL, After Cessation of CPB and Protamine Administration
Plasma Glucose Level, Upon Arrival at ICU
时间窗: Upon Arrival at ICU
Plasma Glucose Level, mg/dL, Upon Arrival at ICU
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion
时间窗: After Initiation of NTG infusion During Rewarming
Mean Arterial Blood Pressure ≤ 40 mmHg After Initiation of NTG Infusion During Rewarming of Cardiopulmonary Bypass
次要结局
- Activated Coagulation Time, Before Start of CPB(Before Start of CPB)
- Post-op Dopamine Infusion(Upon Arrival at ICU)
- Activated Coagulation Time, After Protamine Administration(After Protamine Administration)
- Length of ICU Stay(Arrival at ICU and Leaving ICU)
- Time to Extubation(Arrival at ICU and Extubation)
研究者
Tso-Chou Lin, MD
Assistant Professor
Tri-Service General Hospital