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

Phase 1

Terminated

• Conditions: Congenital Heart Disease
• Interventions: Drug: Alprostadil 5 MCG Injection

• Registration Number: NCT04054115
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-23
• Study First Submitted: 2019-08-09
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-13
• Primary Completion: 2021-02-24
• Study Completion: 2022-11-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Alprostadil 5 MCG Injection	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).

Primary Outcome Measures

Name	Time	Method
Cerebral blood flow	will be measured 30 minutes to 40 minutes after infusion of alprostadil	Cerebral blood flow

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada