A Retrospective Comparison of the Efficacy and Safety of Celsior® in Pediatric Cardiac Surgery for Transposition of the Great Vessels
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Death at 30 days after surgery
研究概览
简要总结
Celsior® is an organ preservation solution used for the harvesting and the preservation of solid organs. Its use as a crystalloid cardioplegia solution has been established recently. Its main advantage is the long duration of myocardial protection. Compared to the other cardioplegia solutions, it allows a reduced amount of solution administered during the surgery and fewer interruptions during the intervention for the administration of supplemental doses of cardioplegia for long and complex operations.
The objective of this register is to compare the safety and the efficacy of Celsior® to the old cardioplegia solution Saint-Thomas used as cardioplegia solution in surgery of the transposition of great vessels, the arterial switch operation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient of neonatal age at the time of the intervention
- •Patients with a transposition of the great vessels with intact septum and with the arterial switch operation performed as a corrective procedure
- •CELSIOR® used as cardioplegia solution between 2012 and 2019
- •Saint-Thomas used as cardioplegia solution (control group) between 2005 and 2011
排除标准
- •Major cardiovascular malformations needing correction during the surgery for the transposition of great vessels including : interventricular communication, coarctation of the aorta, interruption of the aortic arch
- •Significant anomalies of coronary arteries origin or paths including : intramural course, single coronary ostium
- •Opposition to participate in this retrospective research
研究组 & 干预措施
CELSIOR® group
Patient who received Celsior® during their transposition of the great vessels surgery
干预措施: CELSIOR® group (Drug)
Saint-Thomas group
Patient who received Saint-Thomas during their transposition of the great vessels surgery
干预措施: Saint-Thomas group (Drug)
结局指标
主要结局
Death at 30 days after surgery
时间窗: 30 days
Death at 30 days after surgery
次要结局
- Post-operative troponin levels(48 hours)
- Cardiac rhythm assessment(24 hours)
- Variation of pre- and post-operative creatinine levels(24 hours)
- Intensive care unit length of stay(30 days)