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

NCT04054115 | Terminated Phase 1 DMC

• 1 other identifier: 1000060394
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cerebral blood flow

  Cerebral blood flow

  will be measured 30 minutes to 40 minutes after infusion of alprostadil

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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).

Drug: Alprostadil 5 MCG Injection

Interventions

Alprostadil 5 MCG Injection 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.

Treatment Arm

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients between the ages of 1 and 6 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, L4K4x6, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Alprostadil; Injections

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Rajiv Chaturvedi, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Model Details: Patients with a bidirectional Glenn in their Pre-Fontan evaluation.

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: July 23, 2019
• Primary Completion: February 24, 2021
• Study Completion: November 9, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

CA (1)