Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension

Todd Sweberg

Status and phase

Invitation-only

Phase 4

Conditions

Vasodilatory Shock

Treatments

Drug: Angiotensin-II

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07212686

24-0641-CCMC

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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.