Adenosine Instead of Supranormal Potassium in Crystalloid Cardioplegia, a Randomized Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Release of cardiac enzymes (TnT and CKMB)
研究概览
简要总结
60 elective patients for CABG will be included to receive either standard hyperkalemic cardioplegia (St.Thomas Hospital Solution No I) or cardioplegia where supranormal potassium is replaced with 1.2 mM adenosine. Hypothesis as follows: 1. Adenosine instead of supranormal potassium in the cardioplegic solution give satisfactory cardiac arrest. 2. Adenosine instead of supranormal potassium in the cardioplegic solution gives equal cardioprotection. The patients will be followed with PiCCO-catheter to monitor cardiac function and repetitive blood samples to measure release of cardiac enzymes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective patients
- •Ejection fraction > 40%
- •Age 40-75
- •No release og TnT or CKMB within last week before CABG
- •Pure CABG
排除标准
- •Age >75 or < 40
- •EF < 40%
- •Emergency operations
- •Unstable angina
- •Release of TnT or CKMB within the week before operation
研究组 & 干预措施
Adenosine cardioplegia
Adenosine cardioplegia
干预措施: Adenosine (Drug)
Control
Standard hyperkalemic cardioplegia
干预措施: Adenosine (Drug)
结局指标
主要结局
Release of cardiac enzymes (TnT and CKMB)
时间窗: First 48 hour postoperatively
Repeatedly measured postoperatively.
次要结局
- PiCCO(First 24 hours postoperatively)
- Endothelial injury(Peroperatively (before crossclamping aorta and after 5 minutes of reperfusion))