Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension (NCT07212686) | Clinical Trial Compass
By InvitationPhase 4
Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension
United States30 participantsStarted 2025-09-09
Plain-language 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.
Who can participate
Age range
0 Days – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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