NCT07212686
Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension
Enrolling by Invitation
PHASE4Ages 0–18InterventionalTreatmentTodd SwebergInvestigator-initiated
~30 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:Angiotensin-II
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over From enrollment to Hour 2
Conditions
Where it's being run
2 sites across 1 statesNew York2
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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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.
What this trial measures
- 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-IIFrom enrollment to Hour 2
Percentage (%) of patients who have improvement in mean arterial pressure (MAP, mmHg) or reduction in sum norepinephrine (NE) equivalent at Hour 2 after the start of Synthetic Angiotensin-II