Status:
ENROLLING_BY_INVITATION
Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension
Lead Sponsor:
Todd Sweberg
Collaborating Sponsors:
Innoviva Specialty Therapeutics
Conditions:
Vasodilatory Shock
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief 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 a...
Eligibility Criteria
Inclusion
- Pediatric patients less than 18 years of age who have received at least 40 mL/kg of crystalloid or colloid equivalent fluid resuscitation for vasodilatory shock
- Titration of standard of care vasoactive medications for a minimum of 2 hours with persistent refractory hypotension for age, and who require a total sum NE equivalent dose of \> 0.1 μg/kg/min for a minimum of 1 hours and a maximum of 24 hours prior to initiation of Angiotensin-II.
- Indwelling arterial and central venous lines.
- Parent or legal guardian is willing and able to provide informed consent and assist the patient in complying with all protocol requirements.
Exclusion
- Standing DNR/DNI order
- Alternative shock diagnosis i.e. cardiogenic shock or post cardiac surgery
- Cannulated to extracorporeal membrane oxygenation
- Pre-existing condition confounding outcome determination such as terminal illness
- Patients diagnosed with acute occlusive coronary syndrome requiring pending intervention.
- Patients who have a history of asthma or are currently experiencing bronchospasm requiring the use of inhaled bronchodilators and who are not mechanically ventilated.
- Patients with acute mesenteric ischemia or a history of mesenteric ischemia.
- Patients with active bleeding AND an anticipated need of multiple transfusions (within 48 hours of Screening).
- Patients with active bleeding, hemoglobin \< 7 g/dL, or any other condition that would contraindicate serial blood sampling.
- Patients requiring more than 5 mg/kg daily of hydrocortisone or equivalent glucocorticoid medication as a standing dose.
- Patients with an expected lifespan of \< 12 hours or withdrawal of life support within 24 hours of screening.
- Patients currently using an angiotensin converting enzyme inhibitor or angiotensin receptor blocker.
- Patients with a known allergy to mannitol.
- Patients who are currently participating in another investigational clinical trial.
- Patients of childbearing potential who are known to be pregnant at the time of screening.
- Prisoners
- Patient's with Raynaud phenomenon, systemic sclerosis, or vasospastic disease.
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07212686
Start Date
September 9 2025
End Date
June 1 2030
Last Update
October 8 2025
Active Locations (2)
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1
Cohen Children's Medical Center of Northwell Health
New Hyde Park, New York, United States, 11040
2
Cohen Children's Medical Center
Queens, New York, United States, 11101