New sedative trial aims to cut delirium and save lives in elderly ICU patients
NCT ID NCT06251375
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests whether dexmedetomidine, a sedative that keeps patients more awake and has fewer side effects, can improve survival and reduce confusion in older adults (65+) on breathing machines in the ICU. Researchers will compare it to a placebo (salt water) in 300 patients across multiple hospitals. The goal is to find a safer way to sedate critically ill elderly patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dexmedetomidine
- What this could lead to
- If it works, this could point toward a safer sedation method for older ICU patients, potentially reducing delirium and improving survival.
- What could go wrong
- This is a Phase 4 trial with 300 participants, so results may not apply to all ICU patients. The benefit over standard care is uncertain, and sedation risks like low blood pressure or slow heart rate remain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 65 years 2. Intubated and receiving invasive mechanical ventilation in an intensive care unit 3. The treating clinicians believe that the patient will remain intubated and ventilated until the day after tomorrow (i.e. unlikely to be extubated the following day) 4. The patient requires immediate ongoing sedative medication for comfort, safety and to facilitate the delivery of life support measures. Exclusion Criteria: 1. Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 12 hours, with an additional 6-hour grace period, a total of 18 hours, in an intensive care unit 2. Proven or suspected acute primary brain lesion such as traumatic brain injury, haemorrhage, stroke, or hypoxic brain injury 3. Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness 4. Admission as a consequence of a suspected or proven drug overdose or burns 5. Administration of or need for ongoing neuromuscular blockade 6. A mean arterial blood (MAP) pressure that is less than 50 mmHg, despite adequate resuscitation and vasopressor support at time of randomization 7. Heart rate less than 55 beats per minute or a high grade atrio-ventricular block in the absence of a functioning pacemaker 8. Known sensitivity to dexmedetomidine 9. Acute fulminant hepatic failure with EITHER 1. hepatic encephalopathy OR 2. bilirubin (\>300 µmol/l) and INR (\>3.5), or both, without prior hepatic dysfunction. 10. Receiving full time residential nursing care 11. Death is deemed both imminent and inevitable and either the attending physician, patient or substitute decision maker is not committed to active treatment 12. Underlying disease that makes survival to 90 days unlikely 13. Previously enrolled in the SPICE IV study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
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