Synthetic Angiotensin II/Giapreza in Pediatric Patients With Refractory Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-09

Study Completion Date

2030-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Vasodilatory Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pediatric patients in vasodilatory shock

Patients enrolled in the study who meet inclusion criteria will receive Angiotensin-II per the titration protocol.

Group Type EXPERIMENTAL

Angiotensin-II

Intervention Type DRUG

Angiotensin-II will be given per the titration protocol.

Interventions

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Angiotensin-II

Angiotensin-II will be given per the titration protocol.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

0 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No