MedTrace Logo

Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension

NCT07212686 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-08

No results posted yet for this study

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

DRUG

Angiotensin-II

Angiotensin-II will be given per the titration protocol.

Sponsors & Collaborators

  • Innoviva Specialty Therapeutics

    collaborator INDUSTRY

  • Todd Sweberg

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2030-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07212686 on ClinicalTrials.gov