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RecruitingOBSERVATIONAL

Recovery From ICUAW Following Severe Respiratory and Cardiac Failure

This study, called CLEVERER, is exploring why some very sick patients develop muscle weakness after spending time in intensive care for severe heart and lung failure requiring special life support (ECMO). This weakness, known as 'ICU-acquired weakness' (ICUAW), can make it hard for patients to recover fully and can impact their daily activities and overall quality of life. Even though it's a known issue, we still need to learn more about how it happens and its long-term effects. This observational study aims to follow these patients to see what factors influence their recovery and how this weakness affects their physical abilities and well-being once they leave the hospital.

At a glance

Status
Recruiting
Sponsor
Barts & The London NHS Trust
Enrolment target
100
Start
09 Apr 2019
Estimated completion
26 Sep 2026

What is this study about?

When people are very seriously ill and need to be in intensive care, especially if they have severe heart and lung failure requiring a special machine called ECMO (Extra-Corporeal Membrane Oxygenation) to help them breathe and circulate blood, they can sometimes develop a condition called 'ICU-acquired weakness' (ICUAW). This weakness isn't just from staying in bed; it's a specific problem where muscles and nerves can stop working as well. While we know it's a significant issue that can make recovery much harder, we don't fully understand why it happens in some people more than others, or how much it impacts their ability to get back to normal life.

This study, called CLEVERER, is an observational pilot study. This means we will be carefully watching and collecting information from patients who have experienced very severe heart and lung failure and needed ECMO. We want to identify specific things that might lead to this weakness and, importantly, see how it affects their daily physical activities and their overall quality of life once they're out of intensive care. For example, previous research has shown that even after less complicated surgeries, patients can lose significant muscle mass, which suggests it's not just about lying still.

By observing patients in a real-life setting, especially those with such severe conditions, we hope to gain a better understanding of ICUAW. This knowledge is crucial because this weakness can have a big impact on a patient's recovery, how long they stay in hospital, and how well they can live their lives afterwards. We also want to understand the link between having severe heart and lung failure and how well patients do in their recovery, including their ability to function physically and their general well-being.

Key takeaways

  • This study looks at why patients stay weak after severe critical illness needing life support.
  • It's an observational study, meaning no new treatments are given.
  • The focus is on understanding ICU-acquired weakness (ICUAW) and its long-term effects.
  • Information gathered will help improve care for future critically ill patients.
  • Participation involves painless scans and answering questions about your recovery.
  • Your medical care will not be affected by taking part, and you can withdraw anytime.

Who may be eligible?

This study is looking for adults who are aged 18 or over. You might be considered if you have experienced very severe heart and lung failure that required support from a special machine called ECMO (Extra-Corporeal Membrane Oxygenation).

Because of the nature of the critical illness, we understand that patients might not be able to agree to take part themselves initially. Therefore, if you are being considered, a close family member or someone who knows you well, along with a healthcare professional, would need to agree for you to be included in the study.

However, some conditions would mean you couldn't take part. These include if you have previously had a stroke, or if you have certain existing conditions related to muscles or nerves (neuromuscular diseases), or if you are currently being treated for cancer. The study is also only for adults, so children cannot participate.

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.

  1. Are you 18 years old or older?
  2. Did you experience severe heart and lung failure requiring ECMO life support?
  3. Do you (or a family member/professional consultee) agree to take part?
  4. Have you not had a stroke before, or a diagnosed nerve/muscle disease?
  5. Are you not currently receiving treatment for cancer?
Answer every question to see your result.

What does participation involve?

As this is an observational study, it means we will be gathering information about your recovery. You won't be given any new medications or treatments. We will measure the size of a thigh muscle (called the rectus femoris) using a safe and painless ultrasound scan. This will happen during your first week in the hospital and at specific times later on. We'll also ask you about your physical abilities and how you feel about your health and quality of life at different points during your recovery. The total duration of your participation will depend on your recovery journey, but our main interest is in observing you over time to understand how you recover.

Potential risks and benefits

Participating in this study will help us learn more about recovery after severe critical illness, especially why some people experience ongoing weakness. This knowledge could help improve care for future patients. There are minimal risks involved as no new treatments are being given; the study mainly involves observations and answering questionnaires, plus a non-invasive ultrasound scan. You are free 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)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • St Bartholomew's hospital (Barts NHS trust)
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is ICU-acquired weakness (ICUAW)?

It's a specific type of muscle or nerve weakness that can develop in people who have been very ill in intensive care, making recovery harder.

What is ECMO?

ECMO (Extra-Corporeal Membrane Oxygenation) is a life-support machine that helps very sick patients whose heart and lungs aren't working properly.

Will I be given new medicine or treatment?

No, this is an observational study, meaning we are just collecting information; you won't receive any new medications or treatments.

How will you measure my muscle strength?

We will use a safe and painless ultrasound scan to measure the size of a muscle in your thigh, which is a way to track muscle changes.

Can I leave the study at any time?

Yes, your participation is voluntary, and you can withdraw from the study at any point without it affecting your medical care.

How to find out more

Mark Griffiths, PhD FRCP

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

Interested in taking part?

Register your interest

Share your details and the research team for "Recovery From ICUAW Following Severe Respiratory and Cardiac…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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