Ketamine Sedation in the ICU (KANINE) RCT
The KANINE study is testing if a drug called ketamine can help very sick patients in intensive care (ICU) who are on a breathing machine. Doctors often give medicines to these patients to keep them calm and comfortable, but these drugs can have side effects. Ketamine is different because it also helps with pain and might have fewer negative side effects. Researchers want to see if adding low-dose ketamine to a patient's treatment helps them recover better, for example, by reducing the time they spend on a breathing machine or how often they become confused. The study will compare patients who receive ketamine with those who receive a dummy drug, and neither the patients nor the doctors will know who is getting which. This helps ensure fair and accurate results.
At a glance
What is this study about?
When people are so unwell that they need to go to the intensive care unit (ICU) and use a breathing machine, they often receive medicine to help them stay calm and comfortable. This is very important, but sometimes these medicines can cause problems like confusion or make it harder for patients to breathe on their own later. Many of the usual medicines don't help with pain, so patients often need strong painkillers too, which can lead to other issues like dependence.
Ketamine is a medicine that helps people stay calm and also works as a painkiller. It's often used in emergency rooms and during operations, but it's not commonly used in the ICU. The KANINE study wants to find out if adding a small, continuous dose of ketamine to the usual care for ICU patients on a breathing machine is a good idea. The study hopes ketamine might help patients recover better, perhaps by reducing how long they need the breathing machine and improving their overall experience in the ICU.
This study is a "randomised controlled trial," which means some patients will receive ketamine and others will receive a dummy medicine that looks the same. Which one a patient gets is decided by chance, like flipping a coin. Neither the patient nor their doctors will know who is getting ketamine, which helps make sure the study results are fair and reliable. The study will carefully watch all patients to see if ketamine has any different effects on things like how long they are on the breathing machine, their confusion levels, and their general recovery after leaving the ICU.
Key takeaways
- Tests if ketamine can help sick patients on breathing machines in ICU.
- Compares ketamine to a dummy medicine to see if it improves recovery.
- Aims to reduce time on breathing machines and prevent confusion.
- Neither patients nor doctors know who gets ketamine for fair results.
- Participation will not involve extra tests beyond standard ICU care.
Who may be eligible?
This study is looking for adults (18 years or older) who have recently been admitted to the intensive care unit and are on a breathing machine. They need to be expected to stay on the breathing machine for at least another day after joining the study.
However, some conditions might mean you can't join. For example, if you were admitted to the hospital because of a stroke, a serious head injury, or a brain bleed. You also can't join if you have very high blood pressure that isn't under control, or if you have severe asthma. Other reasons for not being able to join include certain serious burns, a history of schizophrenia, very bad liver failure, or if you are receiving care just for comfort rather than active treatment.
Also, if you need very strong medication to keep your blood pressure up, are on muscle-relaxing drugs, already have a breathing tube through your neck (a tracheostomy), are allergic to ketamine, have had a liver transplant recently, or are pregnant or breastfeeding, you won't be able to take part in this study.
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 18 years or older?
- Are you currently in intensive care and on a breathing machine?
- Were you admitted due to a severe head injury, stroke, or brain bleed? (If yes, you may not be eligible)
- Do you have uncontrolled very high blood pressure or severe asthma? (If yes, you may not be eligible)
- Are you allergic to ketamine? (If yes, you are not eligible)
- Are you pregnant or breastfeeding? (If yes, you are not eligible)
What does participation involve?
If you are eligible and agree to take part (or your family/caregiver agrees for you), you will be assigned by chance to either receive an infusion of ketamine or a matching dummy medicine, alongside your usual care. This infusion will be given continuously. The study team will closely monitor your condition throughout your ICU stay, including how long you are on the breathing machine, how long you stay in the ICU, and if you experience confusion (delirium) or pain. They will also track if you develop any side effects. There are no extra visits or assessments beyond what would be part of your normal ICU care. The study will follow your progress during your time in the ICU and track your long-term recovery, including things like memory problems or post-traumatic stress after leaving the ICU.
Potential risks and benefits
Locations (3)
- St. Joseph's Healthcare HamiltonVerified postcodeHamilton, Canada
- Hamilton Health SciencesVerified postcodeHamilton, Canada
- Mount Sinai HospitalVerified postcodeToronto, Canada
Common questions
What is the main goal of this study?
The study aims to see if adding ketamine to routine care for critically ill patients on breathing machines in the ICU is safe and helps improve their recovery.
What is a 'breathing machine'?
A breathing machine, also called a ventilator, helps you breathe when you are too sick to do it properly on your own.
Will I know if I'm getting ketamine or the dummy medicine?
No, neither you nor your doctors will know. This is a common way to make sure the study results are fair and unbiased.
Are there any extra tests if I join the study?
No, all monitoring and assessments are part of the standard care you would receive in the ICU.
Can I leave the study if I change my mind?
Yes, you or your family can withdraw from the study at any time, and it will not affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.