Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow

The Hospital for Sick Children

Status and phase: Terminated; Phase 1

Conditions: Congenital Heart Disease

Treatments: Drug: Alprostadil 5 MCG Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04054115

1000060394

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment Arm

Experimental group

Description:

1. Baseline cardiac catheterization under GA. (Standard of Care, SOC) 2. Transfer patient to MRI unit 3. Baseline MRI 1. Obtain ABG for pCO2 from existing femoral arterial access. 2. Repeat pressure measurements with existing catheters at the SVC, RA and Aorta. 3. MRI phase contrast imaging for flow measurements(SOC). 4. 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. 5. Post alprostadil infusion 1. 1ml blood sample taken from existing femoral venous access for prostaglandin level. 2. Repeat pressure measurements with existing catheters left at the SVC, RA and Aorta. 3. 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).

Treatment:

Drug: Alprostadil 5 MCG Injection