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

February 3, 2023 updated by: Rajiv Chaturvedi, The Hospital for Sick Children

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, L4K4x6
        • Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral blood flow
Time Frame: will be measured 30 minutes to 40 minutes after infusion of alprostadil
Cerebral blood flow
will be measured 30 minutes to 40 minutes after infusion of alprostadil

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 23, 2019

Primary Completion (ACTUAL)

February 24, 2021

Study Completion (ACTUAL)

November 9, 2022

Study Registration Dates

First Submitted

August 9, 2019

First Submitted That Met QC Criteria

August 12, 2019

First Posted (ACTUAL)

August 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000060394

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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