Not yet recruitingNot ApplicableInterventional

Investigating the effects of intravenous fluids and imatinib in human volunteers with a sepsis-like state

Sepsis happens when the immune system overreacts to an infection. This damages blood vessels, making them 'leaky' and making it harder for oxygen to reach vital organs. Doctors routinely treat sepsis with fluids through a drip to improve blood flow. However, giving too much fluid might make vessel leakage and swelling worse. This study in Belfast tests how intravenous fluids affect blood vessels and whether a drug named imatinib can help protect them. Healthy volunteers aged 18 to 40 will receive a small, safe injection that creates a temporary, mild flu-like state for a few hours. Researchers will give some volunteers fluids and examine their blood flow and vessel health using blood tests and ultrasound scans. The findings could help doctors tailor fluid treatments and protect patients who develop life-threatening sepsis in NHS hospitals.

At a glance

Status

Not yet recruiting

Phase

Not Applicable

Sponsor

Belfast Health and Social Care Trust

Enrolment target

Start

04 Aug 2027

Estimated completion

07 Aug 2030

Sepsis

What is this study about?

Sepsis is a life-threatening medical emergency. It occurs when the body's natural response to an infection damages its own tissues and organs. A major feature of sepsis is damage to the cells lining the inside of blood vessels. When these cells are injured, fluid leaks out into surrounding body tissues, leading to swelling and making it difficult for oxygen to get where it is needed.

Currently, one of the main hospital treatments for sepsis is giving fluids straight into a vein through a drip. This is meant to keep blood pressure up and support blood flow. However, scientists are concerned that extra fluid might worsen the leaks in damaged vessels, potentially causing more harm than good in some people. Researchers also want to find out whether protective medicines, such as a drug called imatinib, can help seal blood vessels and calm the immune response.

In this study, doctors are investigating these questions by safely creating a short-lived 'sepsis-like' state in healthy volunteers. By using a harmless bacterial protein, the research team can observe the immune response and blood vessel changes in real time. This will help them understand whether standard fluid therapy helps or hinders, and whether new treatments can protect vulnerable patients in intensive care units.

Key takeaways

The study investigates how drip fluids and a drug called imatinib affect blood vessels during an immune reaction.
It aims to improve future hospital treatments for patients with life-threatening sepsis.
Open to healthy adults aged 18 to 40 who do not smoke.
Involves a single 10-hour monitoring visit at Belfast City Hospital.
Participants will experience brief, mild flu-like symptoms that settle on the same day under close medical care.

Who may be eligible?

This trial is open to healthy men and women aged between 18 and 40 years old who are willing to give informed consent to take part.

To keep everyone safe, you cannot take part if you are pregnant or breastfeeding, if you smoke, or if you regularly drink more than 21 units of alcohol per week. You must also be free from major underlying illnesses, have normal blood oxygen levels, and not have a history of frequent fainting.

Additionally, you cannot join if you are taking prescription or over-the-counter medicines (apart from paracetamol, hormone replacement therapy, or hormonal contraception) within seven days of the study, or if you have an allergy to the study drug, imatinib.

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.

I am a healthy adult aged between 18 and 40 years old.
I do not smoke or use tobacco products.
I drink 21 units of alcohol or less per week.
I am not pregnant and not currently breastfeeding.
I have not taken prescription medicines (other than contraception or HRT) in the last week.
I do not have a history of frequent fainting or an allergy to imatinib.

Answer every question to see your result.

What does participation involve?

If you take part, you will attend the Northern Ireland Clinical Research Facility at Belfast City Hospital for a single day of close observation lasting about 10 hours.

A trained healthcare professional will place a small plastic tube (cannula) into a vein in each arm. Through one tube, you will receive a small, safe dose of a bacterial protein called LPS. This briefly triggers mild, flu-like symptoms. Some participants will also be given fluids through the drip, while others may receive the medicine imatinib.

Doctors and nurses will check your heart rate, blood pressure, and temperature every 30 minutes at first, and then once an hour. They will take regular blood samples and use harmless ultrasound scans on your chest to check for any fluid build-up. You will be looked after on a hospital bed or reclining chair throughout the day. Before you go home, the team will ensure you feel well and provide written emergency contact details.

Potential risks and benefits

Taking part will not improve your own health directly, but your participation could help doctors develop safer, more effective treatments for critically ill patients with sepsis in the future. The main risk is experiencing temporary, flu-like symptoms after the injection, such as chills, headache, muscle aches, tiredness, and mild nausea. These usually peak after one to two hours and settle within six to eight hours, and doctors can give paracetamol if needed. There may also be mild bruising from the blood tests or drips. You are completely free to leave the study at any time without giving a reason, and this will never affect your normal medical care.

Locations (1)

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

Northern Ireland Clinical Research Facility
City only
Belfast, Northern Ireland

Common questions

Will I actually catch sepsis during this study?

No. You are not given a live infection. You receive a tiny, purified bacterial protein that triggers a safe, temporary immune reaction lasting only a few hours.

How unwell will I feel on the day?

Most people feel as though they have a mild case of the flu, with tiredness, headache, or muscle aches. These effects peak after an hour or two and fade within six to eight hours.

What happens if I feel faint or dizzy?

The study takes place in a fully equipped clinical research unit. You will be resting in a bed or reclining chair, and medical staff are on hand immediately if you feel lightheaded.

Is the medicine imatinib safe?

Imatinib is an established medicine used widely for blood disorders. In this study, it is given in a single short dose, making serious side effects extremely unlikely.

Can I leave the study early if I change my mind?

Yes. Taking part is completely voluntary. You can stop or withdraw your consent at any point without needing to give a reason.

How to find out more

Ross McMullan

rmcmullan07@qub.ac.uk +44 (0)2895 041096 Official trial record

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