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

NCT ID: NCT04054115

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-23
• Study Completion Date: 2022-11-09

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.

Conditions

Congenital Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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).

Group Type: EXPERIMENTAL

Alprostadil 5 MCG Injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Rajiv Chaturvedi

Staff Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajiv Chaturvedi, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000060394

Identifier Type: -

Identifier Source: org_study_id