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A study testing the medicine angiotensin II in patients of 0–17 years with a life-threateningly low blood pressure
EU CTIS ID: 2025-523750-14-00
What this study is testing
To evaluate the effect of angiotensin II (AT2) versus placebo on the dose of standard-of-care (SOC) vasopressors, in paediatric patients with refractory hypotension in distributive shock receiving fluid resuscitation and SOC vasopressors
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient 0 to 17 years of age, any gender
- Diagnosis of refractory hypotension in distributive (= vasodilatory) shock
- Adequate fluid resuscitation at investigator’s discretion
- Norepinephrine base equivalent dose > 0.2 µg/kg/min when checking inclusion criteria
- Legal representative(s) signed informed consent and patient signed assent, per applicable regulatory requirement(s). If legal representative(s) are not available in this emergency situation, the investigator may still enrol the patient in the trial, in agreement with an independent physician. In this case, both the investigator and the independent physician need to sign a declaration of emergency enrolment. If the patient is sedated, unconscious, or unable to sign assent due to another cause, they can be enrolled without signed assent. In all cases, signed informed consent and/or signed assent must retrospectively be requested as soon as possible
- Negative pregnancy test at screening for participants of childbearing potential, i.e. after menarche
You likely can't join if
- At screening, preterm infants < 37 weeks of pregnancy and < 3.0 kg body weight at birth
- Hypersensitivity to angiotensin II or to its excipients
- Concurrent provision of breastfeeding
- Current participation in another clinical trial with an investigational medicinal product not approved in that country
- Expected survival duration < 48 hours
- Standing Do Not Resuscitate order
See the full eligibility criteria
- Patient 0 to 17 years of age, any gender
- Diagnosis of refractory hypotension in distributive (= vasodilatory) shock
- Adequate fluid resuscitation at investigator’s discretion
- Norepinephrine base equivalent dose > 0.2 µg/kg/min when checking inclusion criteria
- Legal representative(s) signed informed consent and patient signed assent, per applicable regulatory requirement(s). If legal representative(s) are not available in this emergency situation, the investigator may still enrol the patient in the trial, in agreement with an independent physician. In this case, both the investigator and the independent physician need to sign a declaration of emergency enrolment. If the patient is sedated, unconscious, or unable to sign assent due to another cause, they can be enrolled without signed assent. In all cases, signed informed consent and/or signed assent must retrospectively be requested as soon as possible
- Negative pregnancy test at screening for participants of childbearing potential, i.e. after menarche
- Venous thromboembolism prophylaxis before beginning IMP administration if indicated per local guidelines
- At screening, preterm infants < 37 weeks of pregnancy and < 3.0 kg body weight at birth
- Hypersensitivity to angiotensin II or to its excipients
- Concurrent provision of breastfeeding
- Current participation in another clinical trial with an investigational medicinal product not approved in that country
- Expected survival duration < 48 hours
- Standing Do Not Resuscitate order
- Acute coronary syndrome
- Acute or history of mesenteric ischaemia
- Acute or history of major bleeding in a critical area or organ within 30 days prior to randomisation
- Active or history of venous or arterial thrombotic or thromboembolic events or previously diagnosed coagulopathy
- Burns covering > 20% of total body surface area
- Use of angiotensin receptor blocker within 48 hours prior to randomisation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.