Early Sedation With Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients

Launched by ST. JOSEPH'S HEALTHCARE HAMILTON · Feb 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called dexmedetomidine for sedation in older patients who are critically ill and on mechanical ventilation, which means they need help breathing through a machine. The goal is to see if dexmedetomidine can help make patients more comfortable and reduce anxiety while they are receiving life-saving treatments. The trial will focus on patients aged 65 and older who are expected to stay on ventilation for at least another day and require sedation for their comfort and safety.

To participate in the trial, patients must be intubated, meaning they have a tube inserted in their airway, and they cannot have certain medical conditions that might complicate their treatment. Interested participants will be monitored closely and receive either dexmedetomidine or a placebo (a treatment that looks like the real medication but has no active ingredients). This research is important because it aims to find the best practices for sedation in critically ill patients, which can improve their overall care and recovery.

Gender

ALL

Eligibility criteria

• 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 unless the patient is being treated with a beta- blocker, or a high grade atrio-ventricular block in the absence of a functioning pacemaker
• • 8. Known sensitivity to dexmedetomidine
• • 9. Acute fulminant hepatic failure
• • 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