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Early Sedation with Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients
EU CTIS ID: 2022-501157-36-00
What this study is testing
1. To evaluate mortality among patients ≥ 65 years of age given early DEX as a primary sedative agent to verify the findings of the sub-group analysis in SPICE III trial (Early sedation with dexmedetomidine vs usual care in critically ill patients).
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 65 years
- 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)
- Intubated and receiving invasive mechanical ventilation in an intensive care unit
- The patient requires immediate ongoing sedative medication for comfort, safety and to facilitate the delivery of life support measures.
You likely can't join if
- Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 18 hours in an intensive care unit
- Receiving full time residential nursing care
- Death is deemed both imminent and inevitable and either the attending physician, patient or substitute decision maker is not committed to active treatment
- Underlying disease that makes survival to 90 days unlikely
- Previously enrolled in the SPICE IV study
- Proven or suspected acute primary brain lesion such as traumatic brain injury, haemorrhage, stroke, or hypoxic brain injury
See the full eligibility criteria
- Age ≥ 65 years
- 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)
- Intubated and receiving invasive mechanical ventilation in an intensive care unit
- The patient requires immediate ongoing sedative medication for comfort, safety and to facilitate the delivery of life support measures.
- Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 18 hours in an intensive care unit
- Receiving full time residential nursing care
- Death is deemed both imminent and inevitable and either the attending physician, patient or substitute decision maker is not committed to active treatment
- Underlying disease that makes survival to 90 days unlikely
- Previously enrolled in the SPICE IV study
- Proven or suspected acute primary brain lesion such as traumatic brain injury, haemorrhage, stroke, or hypoxic brain injury
- Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness
- Admission as a consequence of a suspected or proven drug overdose or burns
- Administration of or need for ongoing neuromuscular blockade
- A mean arterial blood (MAP) pressure that is less than 50 mmHg, despite adequate resuscitation and vasopressor support at time of randomization
- Heart rate less than 55 beats per minute unless the patient is being treated with a beta-blocker, or a high grade atrio-ventricular block in the absence of a functioning pacemaker
- Known sensitivity to dexmedetomidine
- Acute fulminant hepatic failure
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- New Zealand
- Malaysia
- Saudi Arabia
- Brazil
- Australia
- Switzerland
- Canada
- Kuwait
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; New Zealand; Malaysia; Saudi Arabia; Brazil; Australia and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.