Not yet recruitingPHASE4INTERVENTIONAL

Early Sedation With Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients

This research study is about helping older patients (65 years and above) who are seriously ill and need a machine called a ventilator to help them breathe. When patients are on a ventilator, they often need medicine to keep them calm and comfortable. This study is testing a specific medicine called dexmedetomidine against a dummy treatment (placebo) to see if it's better at helping these patients. The main goal is to find out if using dexmedetomidine early can help these patients survive for at least 90 days. Researchers also want to see if it helps them get off the ventilator sooner, avoids confusion, and reduces the time they spend in hospital.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

St. Joseph's Healthcare Hamilton

Enrolment target

300

Start

07 Sep 2025

Estimated completion

31 Jan 2028

Respiratory Insufficiency

What is this study about?

When people become very unwell and need to go into intensive care, sometimes their lungs struggle, and they need a machine called a ventilator to help them breathe. While on this machine, patients are often given medicines to keep them calm, comfortable, and to help them tolerate the breathing tube. Deciding which calming medicine is best is a really important choice for their comfort, safety, and recovery.

Over the years, doctors have tried different approaches to help patients on ventilators, but there isn't always a clear answer on the very best way to give these calming medicines, especially for older patients. Older adults tend to have more complex health issues and unfortunately, often have a higher risk of not surviving. This study focuses on people aged 65 and over because previous research hinted that a medicine called dexmedetomidine might be particularly helpful for them.

Dexmedetomidine is a type of calming medicine. This study is designed to see if giving dexmedetomidine early, as the main calming medicine, helps older patients on ventilators survive longer (specifically, for at least 90 days). It's a follow-up to previous research that suggested this medicine could be beneficial for this age group. By carefully comparing dexmedetomidine to a fake treatment called a placebo, the researchers hope to get clear answers and improve care for seriously ill older patients.

Key takeaways

This study is for critically ill patients aged 65 and over who need a breathing machine.
It compares a calming medicine (dexmedetomidine) with a dummy treatment (placebo).
The main aim is to see if dexmedetomidine improves survival over 90 days.
It also checks if the medicine helps patients get off the ventilator sooner and reduces confusion.
Participation involves receiving one of the treatments and close monitoring in intensive care.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

This study is looking for volunteers who are 65 years old or older. You would need to be in intensive care and connected to a breathing machine (ventilator) because of breathing difficulties. The doctors would also need to think that you'll likely stay on the ventilator for at least another full day, and you need calming medicine to be comfortable and safe with the life support.

There are several reasons why someone might not be able to join the study. For example, if you've already been on a ventilator for more than 18 hours in intensive care, or if you have certain serious brain or spinal cord injuries. People admitted due to drug overdose, severe burns, or those needing a specific muscle-relaxing medicine (neuromuscular blockade) cannot take part. Also, if your blood pressure or heart rate is very low despite treatment, or if you have severe liver failure, you wouldn't be able to join.

Other reasons for not being suitable include if you're already in full-time residential nursing care, if your doctors believe your death is very close and unavoidable, if you have a life-limiting illness that makes living for 90 days unlikely, or if you've already been part of this specific study before.

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.

I am 65 years old or older.
I am currently in intensive care and using a breathing machine (ventilator).
My doctors expect I will need the breathing machine for at least another day.
I need calming medicine to be comfortable with the life support treatment.
I haven't been on a breathing machine in intensive care for more than 18 hours already.
I don't have severe brain or spinal cord injuries, or severe liver problems.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be in intensive care and receive either the study medicine, dexmedetomidine, or a dummy treatment (placebo) through a drip. You won't know which one you're getting, and neither will your doctors or nurses, which helps make the results fair. During your time in hospital, the medical team will continue to closely monitor your health, treat your illness, and record important information about your progress, like how long you stay on the ventilator and if you experience confusion.

After you leave the hospital, the researchers will check in on you to see how you are doing, particularly whether you have survived for at least 90 days since joining the study. There are no extra visits directly linked to the study, as most of the information will be gathered from your hospital records and routine follow-up. The entire study duration, for the purpose of primary results, is 90 days after you start receiving the study treatment.

Potential risks and benefits

Taking part in a study like this might have potential benefits, such as receiving a focused approach to your calming medication that healthcare professionals believe could improve your recovery and survival. However, there are also potential risks; for example, dexmedetomidine can sometimes lower blood pressure or heart rate, which will be closely monitored. Because it's a study, there's a chance the treatment might not work as expected, or you might receive the dummy treatment. You have the 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)

Mount Sinai Hospital
Verified postcode
Toronto, Canada

Common questions

What is a 'ventilator'?

A ventilator is a machine that helps you breathe when your lungs are too weak to do it on their own, often by supplying oxygen through a tube in your windpipe.

What is 'sedation'?

Sedation is when doctors give you medicine to make you calm, relaxed, or even sleep, especially when you're going through a stressful medical procedure or treatment like being on a ventilator.

What is 'dexmedetomidine'?

Dexmedetomidine is a medicine used to keep patients calm and comfortable in intensive care, particularly when they are on a breathing machine.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but doesn't contain any active drug. It helps ensure that any effects seen are truly due to the medicine being tested.

Will I know if I'm getting the drug or the placebo?

No, neither you nor your doctors and nurses will know if you are receiving the real drug or the placebo. This is called 'double-blind' and helps make the study results fair and accurate.

How to find out more

Jose Estrada

jestrada@stjosham.on.ca 905-522-1155 Official trial record

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