Ondansetron for the Prevention of Patient Self-Inflicted Lung Injury in Patients With ARDS - Pilot RCT
This study is exploring a new way to help people with Acute Respiratory Distress Syndrome (ARDS), a serious condition where the lungs are severely inflamed. When ARDS patients are on breathing machines, they often need strong sedation, which can cause other problems. While allowing them to breathe more on their own could be good, it can also lead to them overworking their lungs and causing more damage, called P-SILI. Our research suggests that ondansetron, a drug normally used for nausea, might help reduce this strong breathing effort. This pilot study aims to see if ondansetron is safe and helps improve breathing in ARDS patients, potentially leading to better outcomes and less need for heavy sedation.
At a glance
What is this study about?
When someone has Acute Respiratory Distress Syndrome (ARDS), their lungs are very inflamed and have trouble working properly. This is a very serious condition that often requires a breathing machine to help. Doctors try to protect the lungs while on the machine, but this often means giving strong medications to keep the patient very sleepy or even temporarily unable to move their muscles. While helpful for the lungs, these medications can lead to other issues like confusion, muscle weakness, and longer hospital stays.
Researchers are looking for ways to reduce the need for such heavy sedation. One idea is to allow patients to breathe more on their own. However, many ARDS patients have a very strong urge to breathe, and this can actually cause them to strain their lungs too much, leading to more damage. This is called 'patient self-inflicted lung injury' (P-SILI). Early studies suggest that a medication called ondansetron, which is usually given to prevent feeling sick, might help calm this strong breathing drive in ARDS patients.
This study, called OSIRIS-1, is a small, first step to find out if ondansetron can protect ARDS patients from P-SILI and ultimately improve their chances of getting better. We want to see if the treatment is safe, if patients can stick to the study plan, and if it helps reduce breathing effort. If this pilot study is successful, it could pave the way for bigger studies and new ways to treat ARDS, possibly reducing the need for heavy sedation and making a real difference for critically ill patients.
Key takeaways
- The study aims to see if an existing anti-sickness drug, ondansetron, can help ARDS patients.
- It could potentially protect lungs and reduce the need for heavy sedation.
- This is an early-stage pilot study to check safety and feasibility.
- Participants will receive either ondansetron or a placebo.
- Close monitoring, especially of heart rhythm, will be part of the care.
Who may be eligible?
This study is looking for adults aged 18 to 75 who have moderate-to-severe ARDS. This means you would be in an intensive care unit (ICU) and already on a breathing machine for less than four days, and doctors don't expect you to be taken off the machine within the next day.
There are also some reasons why you wouldn't be able to join. For example, if you have certain heart conditions, a very slow heart rate, or serious liver problems. We also can't include pregnant women or patients who are already taking certain medications that could interact with ondansetron, particularly those affecting heart rhythm or serotonin levels.
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 between 18 and 75 years old?
- Do you have moderate-to-severe ARDS and are currently on a breathing machine?
- Have you been on the breathing machine for less than 4 days?
- Do you not have certain heart conditions (like a very slow heartbeat or known heart rhythm problems)?
- Are you not pregnant or taking certain medications that might interact with the study drug?
What does participation involve?
If you are eligible and choose to take part, you would be randomly assigned to receive either ondansetron or a dummy treatment (placebo) through an IV drip. This would happen four times a day. We would closely monitor your heart rhythm for safety. Researchers would also collect information on how your lungs are doing, how much sedation you need, and other details about your recovery. We are also interested in how well you stick to the study treatment. The total duration of your participation would depend on your hospital stay and course of treatment, but the medication would be given while you are on the breathing machine in the ICU.
Potential risks and benefits
Locations (1)
- Hopital du Sacré-Coeur de MontréalVerified postcodeMontreal, Canada
Common questions
What is ARDS?
ARDS stands for Acute Respiratory Distress Syndrome. It's a severe lung condition where the lungs become inflamed, leading to serious breathing problems and requiring help from a breathing machine.
What is ondansetron?
Ondansetron is a medicine commonly used to prevent and treat nausea and vomiting, often given after surgery or chemotherapy.
Why are you using ondansetron for ARDS?
Our early research suggests ondansetron might help calm the strong urge to breathe that some ARDS patients experience, which could prevent further lung damage and potentially reduce the need for strong sedatives.
Will I definitely get ondansetron?
No, this is a 'randomised' study. You will have an equal chance of receiving either ondansetron or a dummy treatment (placebo). Neither you nor your doctors will know which one you are getting.
Are there any side effects?
Like all medicines, ondansetron can have side effects. We will be carefully monitoring your heart rhythm for any changes, as this is a known potential side effect, among others.
How to find out more
Virginie Williams, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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