RecruitingOBSERVATIONAL

Early Severe Illness TrAnslational BioLogy InformaticS in Humans

The ESTABLISH study explores serious illnesses like sepsis and ARDS (a severe lung problem) that often affect people in intensive care. Many patients don't survive these conditions, and there are no specific cures. Researchers are observing patients newly admitted to the ICU to understand the body's early responses to these life-threatening situations. The goal is to find early signs that can help doctors diagnose these illnesses sooner, identify which treatments might work best for different people, and develop completely new ways to treat them. This could ultimately save lives and improve long-term recovery for critically ill patients.

At a glance

Status

Recruiting

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

1,000

Start

26 Apr 2024

Estimated completion

31 Dec 2034

Sepsis ARDS Critical Illness Neurocognitive Dysfunction Shock, Septic Ventilator Associated Pneumonia Immune Suppression Inflammation SIRS

What is this study about?

When people get very sick with serious infections or injuries, their bodies can struggle to keep important systems like blood pressure and breathing working properly. These situations are often called sepsis or ARDS (Acute Respiratory Distress Syndrome), and they are very common in the Intensive Care Unit (ICU). Currently, there aren't many specific treatments for these critical illnesses, and sadly, about a quarter of patients admitted to the ICU don't survive.

This study, called ESTABLISH, is an 'observational' study. This means doctors won't be giving new medicines or treatments; instead, they will be carefully watching and collecting information from patients who are already in the ICU. The main aim is to understand the very early stages of these illnesses. By looking at blood tests, lung fluid, and other samples, researchers hope to find early clues that tell them what's happening in the body. This could lead to faster diagnosis, help doctors choose the best existing treatments for each patient, and even pave the way for completely new treatments in the future.

The researchers are particularly interested in how the body's immune system reacts during these severe illnesses. They want to understand why some people get sicker than others and how the immune system's response affects recovery. By gathering this detailed information, they hope to unlock secrets about these complex conditions that have been a puzzle to doctors for a long time. This knowledge is crucial for improving care and saving more lives.

Key takeaways

This study aims to understand severe illnesses like sepsis and ARDS in the ICU.
It's an observational study, meaning no new treatments are given.
Researchers collect samples (blood, lung fluid, swabs) to find early clues about illness.
The goal is better diagnosis and new treatments for critical illness.
Participation is voluntary and will not change your medical care.
You can withdraw at any time without affecting your treatment.

Who may be eligible?

This study is looking for adults aged 18 or older who have been admitted to the Intensive Care Unit (ICU) fairly recently – within 48 hours of arriving there, and within 72 hours of first coming to the hospital's Emergency Department.

You might be eligible if doctors suspect you have a critical illness based on certain signs. These signs include changes in your alertness (like being very sleepy or confused), problems with your heart and blood pressure (like a very fast heart rate or low blood pressure needing support), or breathing difficulties (like rapid breathing or needing help to breathe).

You would not be able to join the study if you are under 18, if too much time has passed since your ICU admission, or if you were admitted to the ICU for reasons other than critical illness, such as simply because there was a spare bed elsewhere in the hospital.

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?
Were you admitted to the ICU within the last 48 hours?
Did you arrive at the hospital's Emergency Department within the last 72 hours?
Do doctors suspect you have a critical illness like severe infection, breathing problems, or blood pressure issues?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part in this study, you won't be given any new medications or treatments. Instead, the doctors will collect information from routine blood samples that are already being taken for your care. They might also collect additional small samples of blood, lung fluid (from a procedure called a bronchoalveolar lavage or tracheal aspirate, which checks fluid from your lungs), or a rectal swab. These collections will happen at different times during your ICU stay to see how your body changes as you recover. The study is observational, meaning it focuses on understanding what's happening to you, rather than testing a specific treatment. The total duration of your participation would depend on how long you are in the ICU.

Potential risks and benefits

Taking part in this study won't directly treat your illness, but the information gathered could help doctors understand critical illnesses better in the future, potentially leading to new treatments for others. The main risks involve the collection of additional small samples; however, these are generally safe procedures. You have the full right to withdraw from the study at any time without giving a reason, and this will not affect your medical care in any way.

Locations (1)

Aleks Leligdowicz
Verified postcode
London, Canada· Recruiting

Common questions

What is sepsis?

Sepsis is a life-threatening condition where the body's response to infection damages its own tissues and organs. It can lead to organ failure and death if not treated quickly.

What is ARDS?

ARDS stands for Acute Respiratory Distress Syndrome. It's a severe lung condition where fluid builds up in the lungs, making it very hard to breathe and get enough oxygen into the blood.

Will I get different treatment if I join the study?

No, this is an observational study. You will receive the same medical care from your doctors whether or not you decide to take part.

Why do you need samples like blood and lung fluid?

Researchers collect these samples to look for early signs and changes in your body that can help them understand how critical illnesses develop and how people respond to them. This information is key to finding better ways to diagnose and treat these conditions.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time without needing to give a reason, and your medical care will not be affected.

How to find out more

Aleks Leligdowicz, MD PhD

aleligdo@uwo.ca 519-661-2111 Official trial record

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