RecruitingOBSERVATIONAL

Early Detection of At-risk Septic Patients

This study aims to find quicker ways to identify patients with a serious infection called sepsis when they arrive at the Emergency Department. Doctors want to see if using some extra tests, already used in other medical areas, can help them spot very sick patients more rapidly. This research involves looking at things like tissue oxygen levels, new blood tests, and special pictures of tiny blood vessels under the tongue. The goal is to see if gathering this extra information helps doctors decide more quickly who needs urgent, advanced hospital care. If successful, this could mean patients with severe sepsis get the right treatments, which are sometimes only available in intensive care, much sooner, potentially saving lives.

At a glance

Status

Recruiting

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

Start

12 Jan 2024

Estimated completion

06 Aug 2025

Sepsis

What is this study about?

Sepsis is a very serious condition where your body has an extreme reaction to an infection. It can be life-threatening if not treated quickly. When you come into the Emergency Department (A&E) feeling very unwell, doctors need to figure out as fast as possible if you have sepsis and how severe it is so they can give you the right treatment.

This study is looking for better and faster ways to identify people who are seriously ill with sepsis. The research team wants to see if using some special tools and tests, which are already used in other areas of healthcare, can help them spot these patients more quickly than the usual methods. If they can discover who needs urgent care sooner, it means those patients can start getting advanced treatments right away, which could make a big difference to their recovery.

The main aim is to understand if these extra tests can improve how doctors make decisions about care in the crucial first few hours. The results could help them start life-saving treatments, normally found in the Intensive Care Unit (ICU), much earlier for those who need them most.

Key takeaways

This study aims to find faster ways to spot severe infection (sepsis) in A&E.
It involves gentle, additional tests alongside your usual care.
The goal is to help patients get vital treatments much sooner.
You can agree to take part only when you feel well enough to do so.
Your decision to take part or withdraw will not affect your medical care.

Who may be eligible?

This study is looking for adults aged 18 or over who come to the Emergency Department with signs of an infection where doctors suspect sepsis. You might be considered if your initial health scores suggest you are quite unwell.

However, there are reasons why you might not be able to join. For example, if you have severe injuries from an accident, are already receiving intensive care before coming to the hospital, or if a doctor has previously decided that intensive care might not be the best option for your health. Also, if you have certain serious heart problems, a major active stomach bleed, or a large blood clot in your lungs, you wouldn't be able to take part.

The study also wouldn't include you if you've already had critical care before arrival, have signed a document refusing intensive care, or if you've been in another acute hospital very recently.

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.

Are you 18 years old or older?
Do doctors suspect you might have a serious infection (sepsis) and are you feeling quite unwell?
Do you not have active major bleeding or serious heart problems?
Are you coming directly to A&E, and have not been in another acute hospital very recently?
Have you not received intensive care treatment before arriving at the hospital?

Answer every question to see your result.

What does participation involve?

If you are well enough and agree to take part, the researchers will collect some extra information alongside your usual care. This involves using a device to check the oxygen levels in your body's tissues at the start, and again after a small cuff (like a blood pressure cuff) is gently applied to your arm for three minutes. You will also have some extra blood tests taken at the same time as your routine blood samples. Finally, they will use a special camera to take detailed pictures of the tiny blood vessels under your tongue to see how blood is flowing there. All these extra steps will happen early on during your time in the Emergency Department. The study team will then follow your progress to see if these extra measurements helped identify if you needed critical care. If at any point you decide you don't want to continue, you can withdraw, and it won't affect your medical care.

Potential risks and benefits

Participating in this study might help doctors learn more about identifying severe sepsis earlier, which could improve care for future patients. For you, the direct benefits are limited as the extra tests are for research purposes, but they are generally safe and non-invasive. The risks are very low; the extra tests are similar to procedures you might already experience in hospital. For example, the blood tests are taken when you already have routine samples, and the other tests are gentle and temporary. You have the right to withdraw from the study at any time without your medical care being affected.

Locations (1)

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

University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom· Recruiting

Common questions

What is sepsis?

Sepsis is a very serious and life-threatening reaction your body has to an infection. It's when your immune system overreacts and starts to damage your own tissues and organs.

Will taking part change my normal treatment?

No, taking part in this study will not change the medical care you receive for your condition. The extra tests are for research only and will not affect decisions about your treatment.

Do I have to consent right away?

The researchers understand you might be too unwell at first. They will only ask you to consent when you are more stable and able to understand and agree. If you say no, or if you change your mind later, you can withdraw without any impact on your care.

What kind of extra tests will be done?

You'll have a device briefly check oxygen in your tissues, some extra blood tests when you're already having routine ones, and a special camera will look at tiny blood vessels under your tongue.

What will happen with the results of these tests?

The information from these extra tests will be compared with your actual hospital journey to see if they helped identify how sick you were, or who needed critical care, more quickly than usual methods.

How to find out more

James N Ward, BM

wardj@doctors.org.uk +447881967336 Official trial record

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