CompletedNot ApplicableInterventional

Evaluating the use of a lower blood pressure target to guide drug treatment in critically ill children with low blood pressure

When children become very unwell, their blood pressure can drop dangerously low. Doctors in paediatric intensive care units (PICUs) usually give fluids and strong medicines called vasoactive drugs to bring their blood pressure back up to an average level. While these medicines are vital, giving too much can cause harmful side effects, such as reduced blood flow to limbs or complications from intravenous drips. The PRESSURE trial is looking at whether aiming for a slightly lower, safe blood pressure target is better for children. Half of the children in the study will be treated to this lower target, meaning they may need less medication. The other half will receive standard care, where doctors use their usual targets. Researchers want to find out if this lower target helps children get better faster and reduces the risks linked with strong medications.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

1,900

Start

01 Nov 2021

Estimated completion

30 Apr 2026

Critically ill children with hypotension

What is this study about?

When a child is admitted to a paediatric intensive care unit (PICU) with a severe illness or infection, their blood pressure often drops. This is called hypotension. If blood pressure stays too low, vital organs like the brain, kidneys, and liver may not get enough oxygen. To treat this, doctors use intravenous fluids and powerful medicines called vasoactive drugs to pump up the blood pressure.

While these treatments save lives, they also carry risks. Giving high amounts of fluid can cause swelling and prolong recovery. Strong blood pressure medicines narrow the blood vessels and require deep lines placed in large veins, which can increase the risk of blood clots and infections. At the moment, guidelines suggest raising a child's blood pressure to an average level, but doctors are not entirely sure if this higher target is actually needed.

This clinical trial, called PRESSURE, compares two ways of managing blood pressure. One group of children will receive standard NHS care, where the medical team chooses the blood pressure target they normally use. The other group will be treated using a slightly lower, carefully monitored target. By aiming slightly lower, doctors hope children will need lower doses of strong medicines for shorter periods.

By comparing both approaches across NHS intensive care units, researchers hope to discover which method leads to safer, faster recoveries. The ultimate goal is to improve guidelines so that every critically ill child receives the safest balance of treatment.

Key takeaways

The PRESSURE trial investigates whether a lower blood pressure target is safe and helpful for critically ill children.
It aims to reduce the side effects caused by high doses of strong blood pressure medicines.
The study only involves children already receiving intensive care on a breathing machine.
No new or untested drugs are being used; doctors are only adjusting how standard medicines are given.
Taking part involves no extra procedures, and parents can withdraw their child at any time.

Who may be eligible?

This study is for children and young people aged from full-term newborn babies (over 37 weeks gestation) up to 16 years old who are admitted to a participating paediatric intensive care unit. To take part, the child must be on a breathing machine (ventilator) and must have recently started continuous treatment with blood pressure medicine that is expected to continue for at least six hours.

The trial is not suitable for children who have had heart surgery recently, those with known heart muscle problems, or babies with certain heart conditions. It also excludes children with severe, sudden brain injuries, high blood pressure in the lungs, or dangerously high blood pressure, as these conditions require very specific, tailored blood pressure targets.

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.

The child is between 37 weeks corrected age and under 16 years old.
The child is currently being cared for in a participating paediatric intensive care unit (PICU).
The child is on a breathing machine (invasive mechanical ventilation).
The child has started continuous intravenous medicine for low blood pressure in the last 6 hours.
The child has not had recent heart surgery or a severe, sudden brain injury.

Answer every question to see your result.

What does participation involve?

Because this study takes place in an intensive care unit during an emergency, children are enrolled while already receiving life-saving treatment. If your child is enrolled, a computer system will randomly place them into one of two groups. One group will be cared for using the slightly lower blood pressure target, while the other will receive standard blood pressure care.

Taking part does not require any extra hospital visits, blood tests, or needles beyond the standard intensive care routine. The doctors will adjust your child's usual blood pressure medications according to whichever group they are in. Once your child no longer needs blood pressure medicine, this part of the study ends. Researchers will follow your child's progress by looking at their routine hospital records until they leave hospital, and the whole study will run across the UK until April 2027.

Potential risks and benefits

There is no guarantee of direct personal benefit from taking part, but your child may receive lower doses of strong medications, which could reduce the risk of side effects like blood clots or reduced blood flow. The main risk is that allowing blood pressure to sit slightly lower might not suit every child, though the intensive care team will watch them constantly and can step in with extra treatment at any second. Taking part is completely voluntary. If your child is enrolled during an emergency, staff will talk to you as soon as possible, and you have the absolute right to withdraw them from the study at any time without their care being affected.

Locations (21)

St Mary's Hospital
Approximate
London, England
Leicester Royal Infirmary
Approximate
Leicester, England
King's College Hospital
Approximate
London, England
John Radcliffe Hospital
Approximate
Oxford, England
Bristol Royal Infirmary
Approximate
Bristol, England
St. James's University Hospital
Unverified
Leeds, England
Manchester Royal Infirmary
Unverified
Manchester, England
Addenbrooke's Hospital
Unverified
Cambridge, England
The Royal London Hospital
Unverified
London, England
Royal Stoke University Hospital
Unverified
Stoke-On-Trent, England
Sheffield Children's Hospital
Unverified
Sheffield, England
Queens Medical Centre
Unverified
Nottingham, England

Common questions

Why was my child entered into the study before I was asked?

Because low blood pressure is an immediate emergency in intensive care, treatment must start straight away. UK law allows researchers to begin the study under strict safety rules, but staff will speak to you at the earliest suitable moment to explain everything and ask for your consent.

Will my child still get all their normal intensive care medicines?

Yes. Your child will receive all standard intensive care treatments, including breathing support, antibiotics, and pain relief. Only the specific target used to adjust their blood pressure medicine is guided by the study.

Can the doctors override the study target if they are worried?

Yes, absolutely. The doctors and nurses caring for your child can change treatments or targets at any moment if they feel it is in your child's best interests.

Does this trial involve testing brand-new, experimental drugs?

No. The trial does not use any new or untested drugs. It only compares different ways of using standard, well-established blood pressure medicines.

What happens if I decide I don't want my child to take part?

You are free to say no or withdraw your child at any point. Your decision will not affect the high standard of care and dedication your child receives from the hospital team.

How to find out more

David Inwald

di260@cam.ac.uk +44 (0)7917 373689 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.