Vasodilatory ShockPhase 4NCT07212686
Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension
A Phase 4 study testing Angiotensin-II in people with Vasodilatory Shock, run by Northwell Health at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- Vasodilatory Shock
- What is being tested?
- Angiotensin-II
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2025to Jun 2030
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Cohen Children's Medical Center of Northwell Health
New Hyde Park, New York, 11040
Cohen Children's Medical Center
Queens, New York, 11101
About this study
Official title: An Open-Label, Single-Center Study of Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension Despite Receiving Fluid Therapy and Vasoactive Therapy
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.
- Conditions
- Vasodilatory Shock
- Being tested
- Angiotensin-II
- Keywords
- Vasodilatory shock, Angiotensin II, Pediatric Critical Care Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin-IIDrug
Angiotensin-II will be given per the titration protocol.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients in vasodilatory shock | Experimental | Patients enrolled in the study who meet inclusion criteria will receive Angiotensin-II per the titration protocol. Receives: Drug: Angiotensin-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Measured: From enrollment to Hour 2
Secondary outcomes (8)
Change in MAP
Change in mean arterial pressure (mmHg) from baseline to 24 hours
Measured: From enrollment to 24 hours
Change in systolic blood pressure
Change in systolic blood pressure (mmHg) from baseline to 24 hours
Measured: From enrollment to 24 hours
Change in diastolic blood pressure
Change in diastolic blood pressure (mmHg) from baseline to 24 hours
Measured: From enrollment to 24 hours
Change in concentration of serum lactate
Change in concentration of serum lactate (mmol/L) from baseline to 2 hours
Measured: From enrollment to 24 hours
Change in pSOFA score
Change in pSOFA score from screening to 24 hours (%)
Measured: From enrollment to 24 hours
Change in PRSIM-III score
Change in PRSIM-III score from screening to 24 hours (%)
Measured: From enrollment to 24 hours
Change in total neutrophil count
Change in total neutrophil count (cells/µL) from the start of Synthetic Angiotensin-II to 24 hours
Measured: From enrollment to 24 hours
Change in renal resistive index (%)
Change in renal resistive index (%) from the start of Synthetic Angiotensin-II to 24 hours after the start of Synthetic Angiotensin-II
Measured: From enrollment to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start28 Oct 2025
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vasodilatory ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Innoviva Specialty Therapeutics
- Responsible party
- Principal investigator, Todd Sweberg, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212686
- Sponsor's protocol ID
- 24-0641-CCMC
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bailey DM, Chima RS, Tidmarsh GF, Williams MD. Synthetic Human Angiotensin II in Pediatric Patients With Vasodilatory Shock: A Report on Two Patients. Crit Care Explor. 2019 Aug 15;1(8):e0036. doi: 10.1097/CCE.0000000000000036. eCollection 2019 Aug.
PubMed 32166277Tezel O, Hutson TK, Gist KM, Chima RS, Goldstein SL, Stanski NL. Utilization of Synthetic Human Angiotensin II for Catecholamine-Resistant Vasodilatory Shock in Critically Ill Children: A Single-Center Retrospective Case Series. Crit Care Explor. 2023 Sep 12;5(9):e0978. doi: 10.1097/CCE.0000000000000978. eCollection 2023 Sep.
PubMed 37711646Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.
PubMed 28528561