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

NCT04054115 — Phase 1, Terminated, 10 participants, The Hospital for Sick Children

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

Registry	NCT04054115, acronym Alprostadil
Status	Terminated - Covid 19 and difficulty with recruitment
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	10 (Actual)
Sponsor	The Hospital for Sick Children (Other)
Conditions	Congenital Heart Disease
Interventions	Alprostadil 5 MCG Injection (Drug)
Dates	start 2019-07-23, primary completion 2021-02-24, completion 2022-11-09, first posted 2019-08-13, last updated 2023-02-08
Locations	1 site in Canada

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Treatment Arm	Experimental	Drug: Alprostadil 5 MCG Injection	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).

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.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 1 Year to 6 Years

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.

+Locations (1)

Facility	City	Country	Status
Hospital for Sick Children	Toronto, Ontario	Canada

+Investigators

Rajiv Chaturvedi, MD, Principal investigator, The Hospital for Sick Children