RecruitingNAINTERVENTIONAL

Early Versus Late Initiation of ECMO (Extracorporal Membrane Oxygenation) Trial (ELIEO-Trial)

This study is for people with a serious lung condition called Acute Respiratory Distress Syndrome (ARDS). ARDS means your lungs are very sick and can't get enough oxygen into your blood, often needing a breathing machine. Doctors are studying a treatment called ECMO (Extracorporeal Membrane Oxygenation), which is a machine that does the work of your lungs while they heal. The trial wants to find out if starting ECMO soon after you arrive at the intensive care unit is more effective than trying other standard treatments first, and only using ECMO later if those don't work. The main goal is to see if early ECMO helps more people survive.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Tuebingen

Enrolment target

508

Start

01 Mar 2025

Estimated completion

01 Dec 2028

Acute Respiratory Distress Syndrome

What is this study about?

When someone has Acute Respiratory Distress Syndrome (ARDS), their lungs are severely damaged and struggle to provide enough oxygen to the body. This is a very serious condition, and patients often need a breathing machine (ventilator) to help them breathe. Sometimes, even with a ventilator, the lungs can't recover quickly enough.

Doctors are interested in a treatment called ECMO (Extracorporeal Membrane Oxygenation). This is a special machine that acts like an artificial lung and heart outside the body. It takes over the job of adding oxygen to your blood and removing carbon dioxide, giving your own lungs a chance to rest and heal. This study aims to compare two approaches to using ECMO for ARDS. One group of patients will start ECMO shortly after arriving at the intensive care unit. The other group will first receive standard treatments, and only start ECMO later if those treatments aren't working well enough.

The main purpose of this study is to discover if starting ECMO earlier can improve survival for people with severe ARDS. The study will also look at other important details, such as how long people need to stay on a breathing machine, how long they stay in intensive care, and how well their organs are functioning overall. Understanding the best time to use ECMO could help many patients with this life-threatening lung condition.

Key takeaways

The study compares starting ECMO early versus later for severe lung failure (ARDS).
ECMO is a machine that helps your lungs and heart work.
Participation involves being randomly assigned to an early ECMO or standard treatment group.
The main goal is to see if early ECMO improves survival.
The study will follow patients for up to 90 days after joining.
Your medical care will always be a priority, whether or not you participate.

Who may be eligible?

This study is for adults aged 18 or older who have severe Acute Respiratory Distress Syndrome (ARDS).

To be considered for the study, you must have started to experience ARDS symptoms fairly recently, typically within about four days, and you must have started on a breathing machine (ventilator) no more than seven days ago. You also need to have certain patterns on your chest X-ray and specific oxygen levels that indicate severe ARDS. Importantly, you, or your family if you're unable, and your doctor must agree to receive full intensive care support.

Some people cannot join the study. This includes anyone under 18 years old, pregnant individuals, or those who have been on a breathing machine for more than seven days. If more than four days have passed since you met all the study criteria, you also wouldn't be able to join.

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?
Have you been diagnosed with severe Acute Respiratory Distress Syndrome (ARDS)?
Did your ARDS symptoms start within the last four days?
Have you been on a breathing machine for seven days or less?
Are you, or your family, comfortable with full intensive care support?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups, like flipping a coin. One group will start ECMO treatment very soon after coming into the intensive care unit for ARDS. The other group will receive standard treatments first, and if your condition doesn't improve, you might then be given ECMO as a 'rescue' treatment. You won't be able to choose which group you are in. Researchers will monitor your health very closely while you are in the intensive care unit, including your breathing machine settings, organ function, and overall recovery.

After you are well enough to leave the intensive care unit, the study will continue to follow your health for about 90 days (roughly three months) from when you first joined. This follow-up will involve checking in on your general health and recovery, but will not involve additional treatments specifically for the study. The doctors and nurses looking after you will continue to provide the best possible care throughout, regardless of which group you are in.

Potential risks and benefits

Participating in this study might offer potential benefits, as it could help doctors understand the best way to treat severe ARDS, possibly leading to better outcomes for patients. However, there are also potential risks associated with ECMO treatment, including bleeding, infection, or other complications, which your medical team will discuss with you. You should know that you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University hospital Tübingen
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is ARDS?

ARDS (Acute Respiratory Distress Syndrome) is a severe lung condition where your lungs are very inflamed and can't get enough oxygen into your blood, often requiring a breathing machine.

What is ECMO?

ECMO is a life support machine that works like an artificial lung (and sometimes heart) outside your body, taking over their functions to give your own organs time to rest and heal.

Will I get to choose if I have early ECMO?

No, if you join the study, you'll be randomly assigned to either receive ECMO early or receive standard care first, with ECMO as a backup.

How long will the study follow me?

The study will follow your health for about 90 days (roughly three months) from the time you joined.

What if I change my mind about participating?

You are free to withdraw from the study at any time, and your decision will not affect the medical care you receive.

How to find out more

Peter Rosenberger, Prof.

peter.rosenberger@med.uni-tuebingen.de +49707129 Official trial record

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