NCT07386990已完成4 期
The Type of Cardioplegia and Cardiometabolic Impact - a Prospective Randomized Trial in Patients Undergoing CABG
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- CKMB
研究概览
简要总结
This study seek to compare two different solutions used to protect the heart during cardiac surgery. 40 adult patients planned for coronary artery bypass surgery with cardiopulmonary bypass machine assistance will be included in the study. Blood samples from the first 48 hours after surgery will be analyzed together with physical data, x-ray-results, ecg and general outcome after 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for non urgent, single procedure coronary artery bypass grafting surgery at Skåne university hospital in Lund Sweden
排除标准
- •*Heart failure (=Left ventricular ejection fraction less than 40 %).
- •Moderate and severe aortic valve insufficiency.
- •Type 1 diabetes.
- •Renal insufficiency (=estimated glomerular filtration rate <60 mL/min/1,73m2)
- •Not communicating in Swedish language.
- •Previous cardiac surgery.
研究组 & 干预措施
Buckberg cardioplegia
Experimental
干预措施: Modified Buckberg cardioplegic solution (Drug)
St Thomas´ cardioplegia
Active Comparator
干预措施: Modified St Thomas´ cardioplegic solution (Drug)
结局指标
主要结局
CKMB
时间窗: 48 hours after surgery (cross clamp release)
Peak plasma levels of Creatin kinase muscle brain 0,18-300 µg/L
次要结局
- DC cardioversion(during the surgical procedure in the operating room)
- Cardiometabolic protein profile(2 hours after surgery)
- hs-cTnT(48 hours after surgery (cross clamp release))
- hs-cTnI(48 hours after surgery (cross clamp release))
- Pacemaker(two hours after aortic cross clamp release)
研究者
研究点 (1)
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