AuthorisedPhase II and Phase III (Integrated)Interventional

KARMA - INtenSive care TreAtmeNT with adjuvant KetAmine and Recovery after Mechanical ventilAtion: a multicenter doubleblind randomized controlled trial

The KARMA study is investigating a new way to help critically ill patients in intensive care (ICU) who need a breathing machine. Researchers are testing if adding a drug called ketamine to their regular treatment can improve their recovery. They want to find out if patients treated with ketamine spend more days alive and at home 60 days after starting treatment, compared to those who receive a dummy drug (placebo). The study also looks at other important things like how long patients stay on the breathing machine, if they experience confusion, and their overall health and well-being after leaving the hospital. This research aims to find better ways to help patients recover from severe illness.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

640

Start

20 Apr 2026

Adult patients admitted to the ICU and receiving unplanned invasive mechanical ventilation

What is this study about?

When someone is extremely unwell and needs a breathing machine in intensive care, it can be a very challenging time. This study, called KARMA, is looking into whether a medicine called ketamine could help these patients recover better. Ketamine is a powerful drug that can be used for pain relief and to help people relax. In this study, doctors want to see if giving a small amount of ketamine, alongside the usual care, might lead to a quicker and more complete recovery for patients.

The main thing the researchers want to find out is how many days people spend alive and at home in the 60 days after starting the treatment. This is a really important measure because it tells us if the treatment helps people not only survive but also get back to their normal lives sooner. To make sure the results are fair, some patients will receive ketamine, and others will receive a dummy drug (placebo).

Beyond simply going home, the study will also look at many other aspects of recovery. This includes how long patients need the breathing machine, whether they experience confusion or problems with their memory, and if they suffer from anxiety or depression after their illness. By looking at all these different things, the study hopes to give a clearer picture of whether ketamine can genuinely improve the overall recovery and quality of life for these very sick patients.

Key takeaways

This study is for very sick adult patients in intensive care needing a breathing machine.
It tests if ketamine helps speed up recovery and allows patients to spend more time at home.
Patients receive either ketamine or a dummy drug, and neither they nor their doctors know which one.
The main goal is to measure how many days patients are alive and at home within 60 days.
The study also looks at other health aspects like confusion, breathing machine time, and mood.
Participation is voluntary, and you can withdraw at any time without affecting your care.

Who may be eligible?

This study is looking for adult patients who have been admitted to intensive care. They must unexpectedly need a breathing machine to help them breathe.

To be considered for this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

The doctors running the study will carefully check if an individual patient meets all the specific requirements to ensure it's safe and appropriate for them to 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.

Are you an adult (18 years or older)?
Are you currently in intensive care?
Do you need a breathing machine unexpectedly?
Are you suffering from a serious illness requiring this care?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part in this study, you would receive either the study drug, ketamine, or a dummy drug (placebo), in addition to your usual intensive care treatment. Neither you, nor your doctors, would know which one you are receiving – this is known as a 'double-blind' study to keep the results fair. During your hospital stay, the medical team will closely monitor your health, how you're recovering, and any side effects you might experience.

After you leave the hospital, there will be follow-up checks. An independent research assistant will contact you to ask about how many days you've been home and alive during the 60 days after you started the treatment in the ICU. They will also look at how you're feeling emotionally at 90 days after your treatment started, checking for things like anxiety, depression, and any memories of your time in the ICU. The total duration of your participation, including follow-up, would be around 90 days from the start of your treatment in the ICU.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit of an improved recovery from your severe illness, though this is not guaranteed, and the treatment might not help everyone. As with any medication, there can be potential risks or side effects from ketamine, which will be monitored closely. However, you will receive the highest standard of care regardless of whether you are in the study or not. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is ketamine?

Ketamine is a medicine that can be used for pain relief and to help people relax, often used in hospitals.

Why are doctors doing this study?

They want to find out if adding ketamine to regular care can help very sick patients on breathing machines recover better and return home sooner.

Will I know if I'm getting ketamine or a dummy drug?

No, neither you nor your doctors will know. This helps make the study results as accurate and fair as possible.

What does 'days alive and at home' mean?

It means the total number of days you are alive and have spent back at your own home within 60 days of starting the study treatment.

What happens after I leave the hospital?

You'll have some follow-up checks over the phone or similar, specifically at 60 and 90 days, to see how you're doing and feeling.