New hope for children in shock: experimental drug targets low blood pressure
NCT ID NCT07212686
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called Angiotensin II in children under 18 with life-threatening low blood pressure (vasodilatory shock) that hasn't improved with fluids or standard medicines. The goal is to see if the drug can safely raise blood pressure and reduce the need for other strong blood pressure medications. Researchers will monitor vital signs, blood work, and kidney blood flow, with a follow-up call at 28 days.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 days to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cohen Children's Medical Center
Queens, New York, 11101, United States
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Cohen Children's Medical Center of Northwell Health
New Hyde Park, New York, 11040, United States
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