Congenital Heart Disease
Conditions
Brief summary
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.
Interventions
DRUGAlprostadil 5 MCG Injection
During the MRI, Alprostadil infusion will be started and titrated to the target dose, ensuring there is a less than 20% drop in blood pressure from baseline. Repeat pressure and MRI flow measurements once Alprostadil reaches 0.1mcg/kg/min.
Sponsors
The Hospital for Sick Children
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with a bidirectional Glenn in their Pre-Fontan evaluation.
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
• 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral blood flow | will be measured 30 minutes to 40 minutes after infusion of alprostadil | Cerebral blood flow |
Countries
Canada
Outcome results
None listed