Randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with Acute Respiratory Distress Syndrome (ARDS).
This study is looking at whether a medicine called metoprolol, given directly into the bloodstream, can help adults with a serious lung condition called Acute Respiratory Distress Syndrome (ARDS). ARDS makes it very hard to breathe, often requiring a machine to help. Researchers want to see if metoprolol can help patients come off these breathing machines sooner and stay alive. They are comparing metoprolol to a 'dummy' treatment (placebo) in a large group of patients to ensure reliable results. The main goal is to find out if patients treated with metoprolol have more days alive and breathing without a machine during the first 28 days of treatment. They will also look at survival rates, time spent in intensive care, and quality of life later on.
At a glance
What is this study about?
This study aims to discover if a medication named metoprolol, which is usually used for heart conditions, could be beneficial for individuals suffering from a severe lung illness called Acute Respiratory Distress Syndrome, or ARDS. ARDS is a life-threatening condition where fluid builds up in the air sacs of the lungs, making it extremely difficult to get enough oxygen. Patients with ARDS often need a machine, called a ventilator, to help them breathe. Giving metoprolol through a drip means the medicine goes straight into the bloodstream.
The researchers want to compare metoprolol with a 'dummy' treatment, called a placebo, to see if it helps patients breathe on their own more quickly. This is important because spending less time on a breathing machine can help reduce complications and improve recovery. The study is designed to be 'double-blind,' which means neither the patients nor their doctors will know whether they are receiving the actual medicine or the placebo. This helps ensure the results are fair and unbiased.
The main thing the doctors will be watching is how many days people are alive and breathing without the help of a machine within the first 28 days of the study. They will also be looking at other important things like how many people survive, how long patients stay in intensive care, and their overall quality of life a few months after being treated. The hope is that metoprolol could offer a new way to help people with ARDS recover better and faster.
Key takeaways
- This study investigates if metoprolol can help patients with severe lung failure (ARDS).
- It aims to reduce time spent on a breathing machine and improve survival.
- Patients will receive either metoprolol or a dummy treatment through a drip.
- The study measures recovery speed and overall health for up to three months.
- It's exploring a new use for a common heart medicine in lung conditions.
Who may be eligible?
This study is designed for adults aged 18 and over, and both men and women can take part. To be considered, you would need to be diagnosed with Acute Respiratory Distress Syndrome (ARDS), which is a serious lung condition that makes breathing very difficult.
- Are you 18 years old or older?
- Have you been diagnosed with Acute Respiratory Distress Syndrome (ARDS)?
- Are you currently in hospital for this condition?
- Are you prepared for closely monitored treatment and follow-up for up to 3 months?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would receive the study medication (either metoprolol or a placebo) through a drip directly into your veins. Doctors and nurses will closely monitor your condition, particularly your breathing and how well your lungs are working, over the first 28 days. They will keep track of how many days you are able to breathe without a machine. You will also have follow-up assessments, including checks on your general health and probably a questionnaire about your quality of life, up to about three months after starting the treatment. The total time you would be actively involved in the study's follow-up goes up to three months.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
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.
What is metoprolol?
Metoprolol is a medicine commonly used to treat heart conditions, like high blood pressure or irregular heartbeats. In this study, it's being tested for a new use in lung disease.
What does 'double-blind' mean?
Double-blind means that neither you nor your doctors will know if you're receiving the actual metoprolol medicine or a dummy treatment (placebo). This helps make the study results fair.
What is a 'placebo'?
A placebo is a substance that looks exactly like the real medicine but doesn't contain any active drug ingredients. It's used to compare against the actual medicine to see if the medicine really works.
Will this study affect my usual hospital care?
No, your regular hospital care will continue. This study is an additional treatment you might receive, and your medical team will ensure it fits with your ongoing care. You can also leave the study at any time without it affecting your care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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