AuthorisedTherapeutic confirmatory (Phase III)Interventional

A phase III randomised, double-blind, placebo-controlled, multicentre efficacy and safety clinical trial of angiotensin II in paediatric patients of 0 to 17 years of age with refractory hypotension in distributive shock receiving fluid resuscitation and standard-of-care vasopressors

This study is for children aged 0 to 17 years who are seriously ill with very low blood pressure, often due to severe infection or illness, a condition called 'distributive shock'. These children are already receiving standard treatments, including fluids and medicines to raise blood pressure (vasopressors), but their blood pressure remains dangerously low. The study is testing a new medicine called angiotensin II. Doctors want to see if adding angiotensin II to their current treatment can help stabilise their blood pressure and reduce the amount of other strong blood pressure medicines they need. This is a Phase III trial, meaning it's a large study designed to confirm the treatment's effectiveness and safety in a bigger group of patients.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Paion Pharma GmbH

Enrolment target

143

Start

30 Apr 2026

refractory hypotension in distributive shock

What is this study about?

When a child gets very sick, sometimes their body struggles to keep their blood pressure up, especially if they have a severe infection or illness. Doctors call this 'distributive shock'. When this happens, their blood pressure can become dangerously low, which means vital organs might not get enough blood. To help, doctors give fluids and powerful medicines called 'vasopressors' to help raise blood pressure. However, sometimes even these strong medicines aren't enough, and the child's blood pressure remains too low. This is called 'refractory hypotension'.

This study is looking into a new medicine, angiotensin II (which has the brand name Giapreza), as an additional treatment for these very sick children. Angiotensin II is a natural substance in the body that helps control blood pressure. The study wants to find out if giving extra angiotensin II can help children in this difficult situation. We hope it might help stabilise their blood pressure, potentially allowing doctors to use less of the other strong blood pressure medicines they are already on.

This is a carefully planned study where children will either receive the new medicine or a dummy medicine (a 'placebo') alongside their usual care. Neither the patient's family nor the medical team will know who is getting which, which helps ensure the results are as fair and accurate as possible. By doing this, we can properly assess if the new medicine is both effective and safe for children.

Key takeaways

The study is for very sick children (0-17 years) with critically low blood pressure.
It's testing a new medicine called angiotensin II alongside standard care.
The main goal is to see if it reduces the need for other strong blood pressure medicines.
Children will receive either the new medicine or a dummy treatment.
Participation involves close monitoring in the intensive care unit.
Families can withdraw their child from the study at any time.

Who may be eligible?

This study is designed for children and young people of all ages, from newborns up to 17 years old. Boys and girls are all welcome to take part if they meet the other study requirements.

The main requirement is that the child must be in a very serious condition. Specifically, they need to have very low blood pressure (what doctors call 'refractory hypotension') caused by a particular type of severe illness called 'distributive shock'. This means their body is struggling to maintain blood pressure even after getting fluids and other strong medicines to help.

Basically, if a child is seriously ill in hospital, has very low blood pressure that isn't fully responding to standard strong medications, and is aged 17 or under, they might be able to join this study. The medical team will check all specific criteria to see if it's suitable.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child aged 17 or younger?
Does my child have extremely low blood pressure that isn't responding fully to current treatments?
Is my child's low blood pressure due to a severe whole-body illness (distributive shock)?
Is my child currently receiving blood pressure raising medicines (vasopressors)?
Is my child in the intensive care unit?
Does their medical team think this study might be suitable for them?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive either the study medicine (angiotensin II) or a dummy medicine (placebo) through a drip, in addition to their usual hospital care. Neither you nor the doctors will know which treatment your child is receiving. The main part of the study will involve closely monitoring your child's blood pressure and how much of their other blood pressure medicines they need, especially during the first 6 hours of treatment.

Your child will be in the intensive care unit (PICU) for this study. The medical team will regularly take blood samples to check things like blood pressure, heart function, and how different organs are working, particularly at 3, 6, 12, 24, and 48 hours, and up to 7 days. They will also track their overall health using special scoring systems. The total duration your child is directly involved in receiving the study drug will be determined by their medical needs, but close monitoring and data collection will continue for several days.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. Your child might benefit if the new medicine helps stabilise their blood pressure better than current treatments alone. However, we don't know for sure if it will help, as that's what the study is trying to find out. There could also be side effects from the study medicine, or from having extra monitoring and blood tests. The medical team will explain all known risks. Remember, participation is always voluntary. If you decide that this study is not right for your child, or if you wish to withdraw them at any point, you are free to do so without affecting their medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Germany
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Unverified
France
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Unverified
Spain

Common questions

What is 'distributive shock'?

It's a severe medical condition where blood pressure drops very low, often because of a serious infection or illness affecting the whole body.

What are 'vasopressors'?

These are strong medicines given to seriously ill patients to help raise their blood pressure.

Will my child definitely get the new medicine?

No, your child will either receive the new medicine or a dummy medicine (placebo) alongside their usual care. It's decided by chance, like flipping a coin.

How long will my child be in the study?

Your child will be closely monitored for several days, especially in the first 48 hours to 7 days, while receiving treatment in the intensive care unit.

Can I take my child out of the study?

Yes, you can choose to withdraw your child from the study at any time, and this will not affect their medical care.