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Contact Information:

Dr Nicholas Richards
+44 7960854118
n.d.richards1@leeds.ac.uk


Dr Nicholas Richards
+44 7960854118
nicholas.richards5@nhs.net


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Be Part of Research - Trial Details - Feasibility and effects of using ketamine sedation for patients on the Intensive Care Unit.
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Feasibility and effects of using ketamine sedation for patients on the Intensive Care Unit.

Recruiting

Open to: All Genders

Age: Adult

Leeds

Medical Conditions

Intensive care patients requiring sedation in order to facilitate mechanical ventilation

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Around half of patients needing ICU require breathing support on a ventilator. Most patients need a combination of painkiller (analgesics) and sleep-inducing (sedatives) drugs to allow this to happen.
A side effect of sedative drugs currently used is an inability to maintain blood pressure adequately. Potentially, this can mean other organs (such as the heart, liver, kidneys, and brain) may be affected. Low blood pressure can cause increased mortality (risk of dying) and increased length of time in ICU.
ICU can also be an unpleasant experience for patients. Hallucinations (seeing or hearing things that aren’t real), delirium (severe confusion), depression, and post-traumatic stress disorder (PTSD) in survivors is common, and it's widely accepted that traditional sedative medications put patients at higher risk of these occurring.
Ketamine is a sleep-inducing and pain-relieving drug that has been used safely for over 50 years to produce anaesthesia (sleep) for surgery. Recent studies using ketamine as a sedative in intensive care show it does not significantly reduce blood pressure compared to current sedatives, whilst being similar in terms of overall safety.
Early studies show that ketamine sedation may have potential patient benefits, such as: maintained blood pressure, less delirium, better sedation, and reduced pain.
More recently it has been discovered that ketamine is a strong and quick-acting anti-depressant. This has not been investigated in ICU patients, but there is potential that it could reduce or prevent depression and PTSD following ICU admission.
Ketamine is not currently used as part of routine practice in ICU due to gaps in the evidence, however, further investigation is needed. This study aims to test initial feasibility of using ketamine sedation through a single-arm, prospective cohort study, helping refine study designs, identify key clinical and patient-centre outcomes, and identify barriers to implementation.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

24 Jan 2025 01 Sep 2026

When patients start on the breathing machine (ventilator) in ICU, the majority will start on a sedative called propofol and a painkiller called alfentanil, this is what we call ‘standard care’. Once enrolled to the study, participants will change over to ketamine sedation. In this crossover period they will be receive both Propofol and ketamine so that the change is more gradual. They will continue to receive additional painkillers (alfentanil).
During the study we will monitor at participant progress by assessing their sedation level and comfort, monitoring for side-effects, as well as all the observations that would usually occur. There will not be any specialist tests performed beyond what is normally carried out in ICU, nor will any additional blood or DNA samples be taken or stored.
Data will be collected at several points: at the start (after determining eligibility and enrolling), daily while the patient is receiving the treatment, at ICU discharge, and 90 days later. This will include collecting routine data as well as questionnaires regarding their recovery, mood, feelings of anxiety and depression, and experiences on and since ICU, which is something we aim to do with most of our patients even if they are not enrolled in a study.


Adults over 18 years old requiring sedation and mechanical ventilation on ICU

You can take part if:



You may not be able to take part if:


1. Acute brain injury (hypoxic, traumatic, ischaemic, haemorrhagic) at time of screening2. Acute central nervous system infection (including meningitis and encephalitis) at time of screening3. Acute liver failure (Hyper-acute, acute, or sub-acute liver failure as defined by O’Grady et al33*) at time of screening4. Acute liver injury (ALT >400iu/L ± INR>1.5 in absence of other causes)** at time of screening5. Acute myocardial infarction or known severe coronary or myocardial disease at time of screening6. Allergy to ketamine or any of its formulation excipients, or allergy to alfentanil7. Continuous neuromuscular paralysis at time of screening8. Decision to provide only palliative or end-of-life care by clinical team at time of screening9. Drug induced / malignant hyperpyrexia at time of screening10. Enrolled in another CTIMP or any ICU study at time of screening11. Home ventilation (including overnight non-invasive ventilation / CPAP)12. Liver transplant recipient at any point in participant’s medical history13. Long-term medical condition resulting in the participant lacking capacity prior to current illness, and who is not expected to ever regain capacity to provide consent to participate after cessation of sedation 14. Neuromuscular junction disorder as admitting or contributing diagnosis (e.g. Guillain-Barre, myasthenia gravis etc.) at time of screening15. Patient not expected to survive >24 hours at time of screening16. Patient known to be taking / prescribed ergometrine or memantine (severe interaction with IMP)17. Post cardiac arrest where there is clinical concern of acute hypoxic brain injury at time of screening18. Pregnancy***, up to 6 weeks post-partum (following delivery), suspected eclampsia / pre-eclampsia, or breast feeding / expressing milk19. Previously enrolled into SHOCK-ICU20. Psychosis or any mental health illness requiring treatment at time of screening21. Raised intra-ocular pressure (suspected, confirmed, or history of****)22. Severe hypertension (systolic blood pressure >180mmHg) at time of screening23. Tachyarrhythmia (ventricular and supraventricular) at time of screening excluding atrial fibrillation with rapid ventricular response or sinus tachycardia in the context of a precipitating cause e.g. sepsis24. Transferred from another ICU in which MV occurred for >6 hours 25. Prisoner or detained in police custody prior to admission

* O’Grady jaundice to encephalopathy time intervals: Hyper-acute = <7 days, acute = 8-28 days, sub-acute = 5-12 weeks.33 **These tests should be performed and recorded in the medical notes as part of the standard of care for ICU patients. Any potential participants in this category without liver function tests from the previous 7 days at the time of eligibility screening will be excluded from participation.*** Any woman of childbearing potential (as defined by Clinical Trials Facilitation and Coordination Group34 i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation includes hysterectomy, bilateral salpingectomy and bilateral oophorectomy) lacking capacity with a possibility of being pregnant should have a pregnancy test performed and recorded in the medical notes as part of the standard of care for ICU patients. Any potential participants in this category without a valid negative pregnancy test at the time of eligibility screening will be excluded from participation. **** It is not a requirement to measure intraocular pressure specifically (beyond any clinical reason to outside of the study). Any patient with a documented history of raised intra-ocular pressure or on long-term treatment will be excluded.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Leeds Teaching Hospitals NHS Trust (LTHT)
    J54 Intensive Care Unit Lincoln Wing St James’s University Hospital Beckett Street
    Leeds
    LS9 7TF

Benefits:
The study is aimed at improving the treatment for critically unwell patients admitted to ICU as well as improving their experience of ICU. Participation in the study could help shape the future of intensive care by helping identify ways to improve outcomes for patients requiring ventilator support. There is not necessarily a direct benefit in taking part at this stage.
Risks:
The medicines used in this study, like all medicines, have side effects. Common side-effects associated with ketamine include hallucinations, abnormal dreams, confusion, nausea and vomiting, rashes, abnormal eye or limb movements. These are minor but can occur between 1-10% of the time. Rarely participants may experience more serious side-effects such as allergic reactions, or abnormal heart rhythms though these are rare and approximately occur around 0.1-0.01% of the time.
The occurrence of all side-effects will be carefully monitored and recorded during the study.
Ketamine and propofol have been used in medical practice for over 30 years. The nursing and medical staff are well trained in identifying and managing these side effects as well as the risks associated with sedating medicines in general. They are able to reduce or stop the medicines as necessary. We anticipate ketamine to not be any higher risk than other sedation medicines currently used.
As with any research study, there is a risk that confidential identifiable data may be disclosed though every precaution will be taken to try to prevent this happening.
Administering the IMP (ketamine) poses no additional burden to standard practice as participants will receive the same number of infusions, via the same route, for the same indication, that will be titrated and weaned as would occur in standard practice. They will continue to receive additional pain relief (alfentanil) the help ensure comfort, as would occur in standard practice.
Although currently not commonly used in ICU for primary sedation, safety profiles reported in recent studies of ketamine show it is at least as safe as other more common sedatives, with lower or similar rates of adverse events compared to standard of care.

Dr Nicholas Richards
+44 7960854118
nicholas.richards5@nhs.net


Dr Nicholas Richards
+44 7960854118
n.d.richards1@leeds.ac.uk



The study is sponsored by Leeds Teaching Hospitals NHS Trust and funded by Leeds Teaching Hospitals NHS Trust.



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Read full details for Trial ID: ISRCTN13274002
Last updated 10 February 2025

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