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

Congenital Heart Disease Clinical Trial

— Alprostadil  

Official title:

The Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow After the Bidirectional Cavopulmonary Connection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04054115
• Other study ID #: 1000060394
• Status: Terminated
• Phase: Phase 1
• Start date: July 23, 2019
• Est. completion date: November 9, 2022

Study information

• Verified date: February 2023
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 9, 2022
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Drug:
• Alprostadil 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.

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral blood flow	Cerebral blood flow	will be measured 30 minutes to 40 minutes after infusion of alprostadil