Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension

Conditions

• Vasodilatory Shock

Eligibility Criteria

Sex

ALL

Age

0 Days - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Angiotensin-II — DRUG
  Angiotensin-II will be given per the titration protocol.

Study Details

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.

Key Dates

Start date

Sep 9, 2025

Status verified

Oct 2025

Primary completion

Jun 30, 2030

Completion

Jun 30, 2030

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pediatric patients in vasodilatory shock
  Patients enrolled in the study who meet inclusion criteria will receive Angiotensin-II per the titration protocol.

Primary Outcome Measure

Percentage of patients who have improvement in mean arterial pressure or reduction in sum norepinephrine equivalent at Hour 2 after the start of Synthetic Angiotensin-II [ Time Frame: From enrollment to Hour 2 ]

Locations (2)

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