The Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow After the Bidirectional Cavopulmonary Connection
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cerebral blood flow
研究概览
简要总结
The second stage operation towards single ventricle palliation is 'bidirectional cavopulmonary connection' (BCPC). The superior vena cava is connected to the pulmonary artery, diverting 'blue' blood from the upper body (including the brain) to the lungs. A successful BCPC requires sufficient and easy blood flow through the lungs. Alprostadil is the synthetic form of prostaglandin (hormone that causes dilation of blood vessels) and has been shown to increase blood flow in the brain hence increasing blood flow to the lungs after BCPC, potentially useful in managing children post BCPC with low flow to the lungs and thus poor oxygenation. This study propose to investigate acute effects of Alprostadil on different blood vessels after BCPC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BCPC patients at time of routine pre-Fontan assessment: Cardiac catheterization and cardiac magnetic resonance imaging (CMR)
- •Patients between the ages of 1 and 6 years old.
排除标准
- •Patients who are hypersensitive to this product or to any ingredient in its formulation.
- •Patients with seizure disorders or coagulopathies.
- •Patients with abnormal kidney function.
研究组 & 干预措施
Treatment Arm
-
Baseline cardiac catheterization under GA. (Standard of Care, SOC)
-
Transfer patient to MRI unit
-
Baseline MRI
-
Obtain ABG for pCO2 from existing femoral arterial access.
-
Repeat pressure measurements with existing catheters at the SVC, RA and Aorta.
-
MRI phase contrast imaging for flow measurements(SOC).
-
During the MRI, Alprostadil infusion will be started and titrated to the target dose 0.1mcg/kg/min, provided there is a less than 20% drop in blood pressure from baseline.
-
Post alprostadil infusion
-
1ml blood sample taken from existing femoral venous access for prostaglandin level.
-
Repeat pressure measurements with existing catheters left at the SVC, RA and Aorta.
-
Repeat MRI flow measurements
7.Return to cath lab if further intervention required. 8.Recovery and monitoring for 4 to 6 hours prior to discharge(SOC).
干预措施: Alprostadil 5 MCG Injection (Drug)
结局指标
主要结局
Cerebral blood flow
时间窗: will be measured 30 minutes to 40 minutes after infusion of alprostadil
Cerebral blood flow
次要结局
未报告次要终点
研究者
Rajiv Chaturvedi
Staff Cardiologist
The Hospital for Sick Children