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Acute Effects of the Prostaglandin (Alprostadil) on Cerebral and Pulmonary Flow (Alprostadil Trial)
Phase 1
Waitlist Available
Led By Rajiv Chaturvedi, MD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be measured 30 minutes to 40 minutes after infusion of alprostadil
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial investigates the effects of Alprostadil on children who have had heart surgery. Alprostadil helps widen blood vessels, which can improve blood flow to the lungs. This is important for children with low lung blood flow and poor oxygen levels after their surgery. Alprostadil is a naturally occurring substance used to help infants with heart issues until further surgery can be performed.
Eligible Conditions
- Congenital Heart Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ will be measured 30 minutes to 40 minutes after infusion of alprostadil
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be measured 30 minutes to 40 minutes after infusion of alprostadil
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cerebral blood flow
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
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).
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
711 Previous Clinical Trials
6,958,270 Total Patients Enrolled
Rajiv Chaturvedi, MDPrincipal InvestigatorThe Hospital for Sick Children