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Angiotensin II in Children and Adolescents With Refractory Hypotension in Distributive Shock

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying refractory hypotension in distributive shock, which means a very low blood pressure that does not improve easily, even after fluid treatment and medicines that help raise blood pressure. The study is testing angiotensin II, given as an infusion into a vein, compared with placebo, to see whether it can help reduce the amount of other blood pressure medicines needed in children and young people from 0 to 17 years of age.

Participants are placed by chance into one of the study groups and neither the study team nor the family knows which treatment is being given. The study medicine or placebo is added to the usual care already being used for this serious condition. The trial is designed to look at both the benefits and the safety of the treatment during the first hours and days after it is started.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of study treatment

    At the start of the trial, you receive either angiotensin ii or placebo through a vein as an intravenous infusion. The placebo is 0.9% sodium chloride solution, which is salt water.

    The study is randomised, which means the treatment is assigned by chance. It is double-blind, which means the treatment choice is not revealed during the study.

  2. Step 2

    Study medicine and dose

    If you receive the test medicine, you are given angiotensin ii at a dose of 80 nanograms by intravenous infusion.

    If you receive the placebo, you are given 0.9% sodium chloride solution at a dose of 0.11 milligrams per kilogram by intravenous infusion.

  3. Step 3

    First 6 hours after study medicine starts

    During the first 6 hours after the study medicine begins, the dose of your usual blood pressure medicines, called vasopressors, is measured for the main study result. Vasopressors are medicines that help raise blood pressure.

    Your blood pressure support continues during this period while the study records how much your usual medicine dose changes.

  4. Step 4

    First 3 hours, 3 to 6 hours, 6 to 12 hours, 12 to 24 hours, and 24 to 48 hours

    Your blood pressure is followed during the first 3 hours, then from 3 to 6 hours, 6 to 12 hours, 12 to 24 hours, and 24 to 48 hours after study medicine starts.

    The study also checks changes in the dose of your usual vasopressor medicines during each of these time periods.

  5. Step 5

    First maintenance dose period

    The study records the time from the start of the study medicine until you reach the first maintenance dose that stays at the same dose for at least 1 hour.

    The dose you are receiving at that time is also recorded.

  6. Step 6

    Checks during the first 48 hours

    Your condition is checked by looking at a score called PELOD-2, which is a score that shows how well different body organs are working. This score is measured from the start of the trial and again at 48 hours if you are still in the picu at that time.

    Your blood lactate is also measured from the start of the trial and again at 6 hours, 12 hours, 24 hours, and 48 hours. Lactate is a substance in the blood that can rise when the body is under stress.

  7. Step 7

    Reduction in usual blood pressure medicine

    The study checks whether your usual vasopressor dose is reduced by at least 25%, 50%, or 75% by 6 hours after study medicine starts.

    This check is only counted if you are alive, still blinded to treatment, and have not been withdrawn at 6 hours.

  8. Step 8

    Later follow-up to day 7

    Your PELOD-2 score is checked again at day 7 if you are still in the picu at that time.

Who can join the trial?

10 criteria

  • Be between 0 and 17 years old.
  • Be of any sex.
  • Have refractory hypotension in distributive shock, which means dangerously low blood pressure that does not improve easily, even with standard treatment, and is caused by the blood vessels being too relaxed and wide.
  • Have already received adequate fluid resuscitation, meaning enough IV fluids have been given to help raise blood pressure, based on the doctor’s judgment.
  • Be receiving a norepinephrine base equivalent dose greater than 0.2 micrograms per kilogram per minute when the study eligibility is checked. Norepinephrine is a medicine used to raise blood pressure, and the dose is measured by body weight.
  • Have written informed consent from a legal representative, and assent from the patient when required. Informed consent means permission to join the study after the information has been explained. Assent means the child or adolescent agrees if they are old enough and able to do so.
  • If legal representative(s) are not available in this emergency situation, the patient may still be enrolled if the investigator and an independent physician both agree and sign the emergency enrolment declaration.
  • If the patient is sedated, unconscious, or otherwise unable to sign assent, they may be enrolled without signed assent.
  • If the patient is of childbearing potential, meaning they have started having periods after puberty, they must have a negative pregnancy test at screening.
  • If venous thromboembolism prophylaxis is needed according to local guidelines, it must be given before starting the study medicine. Venous thromboembolism prophylaxis means treatment to help prevent blood clots in the veins.

Who cannot join the trial?

12 criteria

  • Infants born too early, meaning preterm babies born before 37 weeks of pregnancy, if they also weighed less than 3.0 kg at birth.
  • Known allergy or strong sensitivity to angiotensin II or any of the inactive ingredients in the study medicine.
  • Currently breastfeeding.
  • Already taking part in another clinical trial with an investigational medicine that is not approved in that country.
  • Expected to live less than 48 hours.
  • A standing Do Not Resuscitate order, meaning no efforts should be made to restart breathing or the heart if they stop.
  • Acute coronary syndrome, a serious problem caused by reduced blood flow to the heart.
  • Mesenteric ischaemia now or in the past, meaning poor blood flow to the intestines.
  • Major bleeding in a critical area or organ within the last 30 days.
  • Any current or past blood clot in a vein or artery, or a previous diagnosis of coagulopathy, which means a blood clotting problem.
  • Burns covering more than 20% of the body surface.
  • Use of an angiotensin receptor blocker within 48 hours before randomisation, meaning before being assigned to a study group.
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Investigated drugs

Angiotensin II is the study medicine being tested in this trial. It is given by intravenous infusion, meaning it goes directly into a vein. The goal is to see whether it can help raise blood pressure in children with very low blood pressure caused by distributive shock when fluids and the usual blood pressure medicines are not enough.

Standard-of-care vasopressors are the usual medicines already used in the hospital to help tighten blood vessels and support blood pressure. In this trial, they are given along with the study treatment, and the researchers are looking to see whether angiotensin II can reduce how much of these usual medicines are needed.

What is already known about the treatment

  • Angiotensin II

    Angiotensin II is given as a solution for intravenous infusion, which means it is delivered directly into a vein through a drip. It is an active medicine used in critical care to help raise blood pressure in people with very low blood pressure from distributive shock, and it is a recognized treatment in medical literature for severe cases that do not respond well to fluids and other blood pressure medicines. It works by binding to angiotensin receptors on blood vessel cells, causing the vessels to tighten and the blood pressure to rise, and it is classified as a vasopressor and a cardiovascular medicine.

  • Sodium chloride solution 0.9%

    Sodium chloride solution 0.9% is given as an intravenous infusion, so it is administered through a vein as a saltwater fluid. It is widely used in medicine as a placebo in clinical trials and also as a basic fluid for hydration and for carrying other medicines, but it does not have a direct blood pressure-raising effect like an active vasopressor. Its main role is to match the infusion process without providing the trial drug, and it is classified as an isotonic saline solution used for intravenous fluids.

Investigated diseases

Refractory distributive shock - A severe form of shock in which the blood vessels stay too relaxed and widened, causing dangerously low blood pressure even after fluid replacement and usual support. It develops when the body cannot keep enough pressure to supply blood to the organs, so the circulation remains weak and unstable. The condition often progresses with ongoing low blood pressure, poor blood flow, and increasing need for support to maintain circulation.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-523750-14-00Protocol codeCRH07Estimated enrolment143 patients

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