Ketamine for Intensive Care Unit Patients
(KANINE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants will be receiving non-ketamine continuous sedative infusions, so you may continue with those if applicable.
What data supports the effectiveness of the drug ketamine for ICU patients?
Research suggests that ketamine can help reduce the need for other sedatives in ICU patients on mechanical ventilation, potentially making it a useful option for managing sedation. However, the evidence is limited and of low quality, and more high-quality studies are needed to confirm its effectiveness and safety.12345
Is ketamine safe for use in ICU patients?
Research shows that ketamine has been used safely in critically ill adults, including those on mechanical ventilation in ICUs. It is important to note that while ketamine is generally considered safe, its use can vary across hospitals, and further research is needed to fully understand its safety in these settings.15678
How is the drug ketamine unique for ICU patients?
Ketamine is unique for ICU patients because it can be used as a low-dose continuous infusion to help with sedation and pain management, especially in those who are mechanically ventilated. It is particularly beneficial for patients with respiratory and hemodynamic instability, and it may reduce the need for other sedatives and painkillers, although its use is still being studied due to potential side effects.134910
What is the purpose of this trial?
Sedation is given to intensive care unit (ICU) patients to treat discomfort, anxiety, agitation, and to help facilitate care, particularly when they require a breathing tube. Sedation is very commonly used in the ICU with North American data showing almost 40% of ICU patients get sedation to help when they are requiring a breathing machine. Various medications can be given intravenously to provide sedation in the ICU but there are side-effects associated with each such as decreasing a patient's own drive to breathe, and delirium or acute confusion, both of which are associated with worse outcomes. Also, most drugs used for sedation don't treat pain. As a result, many ICU patients are also given narcotics for pain control which can result in tolerance, dependence, and withdrawal. Ketamine is a sedating medication that also treats pain and is often used in the Emergency Department and in the Operating Room but for whatever reason is not commonly used in the ICU.The investigators are proposing a study to examine the usefulness and safety of adding an intravenous infusion of ketamine to usual care in adult patients that are on a breathing machine in the ICU.Study Methods The KANINE study is being done at hospitals across Ontario, Canada. It is a randomized controlled trial which means patients will be randomized (akin to a coin flip) to receive ketamine or usual care without ketamine. The study will be blinded which means that neither patients or the doctors will know if the patient is getting ketamine or not, those that get randomized to usual care without ketamine will get an intravenous solution that looks the same as the ketamine infusion. This is important to make sure the results aren't biased in any way. The investigators will include adult ICU patients on a breathing machine who are early in their ICU admission. As most patients will be unconscious, the investigators will ask substitute decision makers (families or caregivers) of patients for informed consent prior to the study commencing. Regardless of whether patients get randomized to ketamine or not, the investigators will make sure that all patients will be adequately sedated and have their pain managed as per usual care.Setting This study will be performed in adult ICUs across Canada.Population The investigators will include adults admitted to the ICU on a breathing machine for at least 24 hours (and fewer than 3 days). The investigators will exclude patients if: (i) they were admitted with a brain bleed, traumatic brain injury, or stroke; (ii) Admitted with uncontrolled high blood pressure; (iii) if they have a history of schizophrenia; (iv) if they have very bad liver failure; (v) if they are palliative or only for comfort care; (vi) if they are receiving a medication that causes paralysis, sometimes used in patients with very bad lung disease; (vii) if they have a tracheostomy which means a whole in their neck that they breathe through; (viii) if they are allergic to ketamine; (ix) if they've had a liver transplant in the last month; (x) if they are pregnant or breast-feeding.Outcomes The investigators will follow all the study patients to see if their outcomes are different depending on whether they get randomized to ketamine or not. The investigators will capture how much time they are on the breathing machine, whether they survive or die, how long they stay in the ICU and whether they require a tracheostomy which is a procedure often done on patients who require the breathing machine over a prolonged period of time.The investigators will also capture how often they get delirious and for those that get delirious how long it lasts for. The investigators will capture how much of other sedating medications study patients use such as antipsychotics and benzodiazepines. The investigators will capture outcomes such as how often study patients get post-traumatic stress disorder after leaving the ICU and how well their pain relief is addressed during their ICU stay. Finally, the investigators will capture side effects related to ketamine or other sedating drug use.
Eligibility Criteria
This trial is for adult ICU patients on ventilators early in their stay, excluding those with brain injuries, uncontrolled high blood pressure, schizophrenia, severe liver failure, palliative care status, paralysis medication use, tracheostomy breathing through the neck, ketamine allergy, recent liver transplant or who are pregnant/breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either adjunctive ketamine infusion or placebo while on a breathing machine in the ICU
Follow-up
Participants are monitored for outcomes such as delirium, sedative use, and PTSD symptoms post-ICU discharge
Treatment Details
Interventions
- Ketamine
Find a Clinic Near You
Who Is Running the Clinical Trial?
McMaster University
Lead Sponsor