NCT07212686

Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension

An Open-Label, Single-Center Study of Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension Despite Receiving Fluid Therapy and Vasoactive Therapy

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Todd Sweberg · Academic / Other
• Sex: All
• Age: 0 Days – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine the safety and efficacy of Angiotensin-II in the treatment of pediatric patients in fluid refractory vasodilatory shock. The main questions it aims to answer are: * To evaluate the change in blood pressure or reduction of vasoactive requirements (norepinephrine equivalent dosing) after initiating Angiotensin II * To establish the safety and tolerability of Angiotensin-II in pediatric patients Participants will receive Angiotensin-II in addition to standard of care therapy for vasodilatory shock. * The study team will then monitor the patient's vital signs, blood work, and for any potential side effects from the drug. * An ultrasound will be performed to look at blood flow through the kidney in the setting of vasodilatory shock. * A follow up phone call to check in with the patient will be performed 28 days after enrollment.

Conditions

• Vasodilatory Shock

Interventions

Type	Name	Description
DRUG	Angiotensin-II	Angiotensin-II will be given per the titration protocol.

Timeline

• Start date: 2025-09-09
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2025-10-08
• Last updated: 2025-10-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study