RecruitingOBSERVATIONAL

Septic Shock-induced Immunosuppression

This study is about a serious health issue called septic shock, which can lead to a weakened immune system, known as sepsis-induced immunosuppression. When the body fights a severe infection, it can sometimes become too weak to fight off other germs, making patients very ill and increasing their risk of death. We’re still learning how to best identify patients who develop this problem. This research aims to find better ways to recognise when someone's immune system is struggling after septic shock. It also explores new ways to help the immune system recover. The goal is to provide doctors with better tools to decide which patients might benefit most from special treatments that boost their immune system, ultimately improving their chances of recovery.

At a glance

Status

Recruiting

Sponsor

Hospices Civils de Lyon

Enrolment target

305

Start

21 Oct 2019

Estimated completion

21 Nov 2024

Septic Shock

What is this study about?

Sepsis is a very serious problem that happens when your body has an extreme and dangerous reaction to an infection. It's actually a major cause of death in intensive care units (ICUs) in hospitals. While we know that sepsis causes a huge amount of inflammation in the body, we're now learning that it's much more complicated than we first thought. Your body's response changes over time. After an initial powerful fight against the infection, many patients enter a phase where their immune system becomes very weak. We call this 'sepsis-induced immunosuppression'.

When your immune system is in this weakened state, it's like a shield has been lowered. This can allow other common viruses, like the ones that cause cold sores (Herpes Simplex) or glandular fever (Cytomegalovirus), to become active again. It can also make patients vulnerable to unusual infections, like fungal infections, which normally only affect people with very weak immune systems. These new infections and problems with the immune system can unfortunately make things much worse for patients who survived the initial septic shock, affecting their recovery and increasing their risk of complications.

Because of these important findings, new ways to help the immune system are being looked into. These include treatments that could 'reignite' the immune system, almost like giving it a jump-start. However, before doctors can use these treatments, they need to be able to tell which patients would benefit the most. Right now, there isn't an easy way to see if someone's immune system is severely weakened after sepsis. This study, called IMMUNOSEPSIS 4, has two main goals: firstly, to find the best ways (we call these 'biomarkers') to identify when someone's immune system is weakened by sepsis, and secondly, to test potential new treatments in the lab that could help the immune system get back to normal after septic shock.

Key takeaways

Sepsis is a serious infection that can weaken your immune system.
A weakened immune system after sepsis can lead to new infections.
This study aims to find better ways to spot a weakened immune system in septic patients.
It also looks for treatments that could help the immune system recover.
Participation involves providing blood samples during your hospital stay.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) and currently be in an intensive care unit (ICU) because of septic shock. Specifically, you must have been diagnosed with septic shock within the last 48 hours. This diagnosis means you have a suspected or confirmed infection, need medication to keep your blood pressure up, and have high levels of lactic acid in your blood despite receiving fluids.

You also need to have had a blood sample taken around three or four days after your septic shock diagnosis that can be used for the study. Importantly, either you or your next of kin (a close family member) must agree for your blood samples to be used for this research.

There are some reasons why you couldn't join the study. This includes if you are pregnant or breastfeeding, if you don't have social security insurance, or if there's a language barrier that prevents understanding. You also can't take part if you are involved in another medical study using a medicine that might affect the results of this research.

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?
Are you currently in intensive care with septic shock?
Was your septic shock diagnosed within the last 48 hours?
Is a blood sample available from around day 3-4 of your diagnosis?
Are you, or your next of kin, happy for your samples to be used?

Answer every question to see your result.

What does participation involve?

If you take part in this study, the main thing involved is providing blood samples. These samples will be taken at specific times during your stay in the intensive care unit. You won't be given any new medications or treatments as part of this study; it only involves collecting information from your blood. The doctors and researchers will use these blood samples to look for signs of a weakened immune system and to test potential treatments in the lab. There are no extra visits or follow-up appointments required beyond your standard medical care. The total duration of your participation would simply be while your blood samples are being collected during your ICU stay.

Potential risks and benefits

Taking part in this study won't directly improve your health during your current hospital stay, as it's an observational study focused on understanding septic shock. However, the information gathered could lead to better ways of diagnosing and treating future patients with this condition. The risks associated with participation are minimal, mainly those linked to routine blood draws, such as slight discomfort or bruising. You are free to decide not to participate or to withdraw at any time without affecting your medical care.

Locations (1)

Hôpital Edouard Herriot
Verified postcode
Lyon, France· Recruiting

Common questions

What is septic shock?

Septic shock is a life-threatening condition caused by your body's extreme reaction to an infection, leading to very low blood pressure and organ damage.

What does 'immunosuppression' mean?

Immunosuppression means your body's infection-fighting system (immune system) is weaker than usual, making it harder to fight off germs.

Will I receive new medicine in this study?

No, this study only involves taking blood samples and observing your condition; you won't receive any new medications as part of it.

Why is it important to identify immunosuppression early?

Spotting immunosuppression early could help doctors choose the right treatments to boost your immune system and improve your recovery.

Who benefits from this research?

While you won't get direct treatment from this study, the findings could help countless future patients who develop septic shock and weakened immune systems.

How to find out more

Fabienne VENET, PhD

fabienne.venet@chu-lyon.fr 04 72 11 97 46 Official trial record

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