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New sedative trial aims to cut delirium and save lives in elderly ICU patients

NCT ID NCT06251375

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

65 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

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