search
Back to results

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

Primary Purpose

Congenital Heart Disease

Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Alprostadil 5 MCG Injection
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease

Eligibility Criteria

1 Year - 6 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Arm

Arm Description

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).

Outcomes

Primary Outcome Measures

Cerebral blood flow
Cerebral blood flow

Secondary Outcome Measures

Full Information

First Posted
August 9, 2019
Last Updated
February 3, 2023
Sponsor
The Hospital for Sick Children
search

1. Study Identification

Unique Protocol Identification Number
NCT04054115
Brief Title
Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow
Acronym
Alprostadil
Official Title
The Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow After the Bidirectional Cavopulmonary Connection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Covid 19 and difficulty with recruitment
Study Start Date
July 23, 2019 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
November 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Patients with a bidirectional Glenn in their Pre-Fontan evaluation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Alprostadil 5 MCG Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cerebral blood flow
Description
Cerebral blood flow
Time Frame
will be measured 30 minutes to 40 minutes after infusion of alprostadil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajiv Chaturvedi, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
L4K4x6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs