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

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Recruiting

CT.gov ID

NCT04054115

Collaborator

(none)

Enrollment

Location

Arm

65.3

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease	Drug: Alprostadil 5 MCG Injection	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 23, 2019

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treatment Arm

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

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.

Outcome Measures

Primary Outcome Measures

Cerebral blood flow [will be measured 30 minutes to 40 minutes after infusion of alprostadil]
Cerebral blood flow

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital for Sick Children	Toronto	Ontario	Canada	L4K4x6

Sponsors and Collaborators

The Hospital for Sick Children

Investigators

Principal Investigator: Rajiv Chaturvedi, MD, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rajiv Chaturvedi, Staff Cardiologist, The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT04054115

Other Study ID Numbers:

1000060394

First Posted:

Aug 13, 2019

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Heart Diseases

Heart Defects, Congenital

Alprostadil

Study Results

No Results Posted as of Sep 14, 2021