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Enrolling By Invitation
NCT07212686
Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension
Conditions: Vasodilatory Shock
Sex: All
Ages: 0 Days – 18 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 30
Sponsor: Northwell Health
Location: Cohen Children's Medical Center of Northwell Health New Hyde Park New York
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.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07212686). StuddyBuddy aggregates publicly available trial information.