Early sedation with dexmedetomidine vs. placebo in older ventilated critically ill patients

Phase 4

• Conditions: Critically ill patients who are 65 years of age and older, and expected to be ventilated for more than 24 hours in an intensive care unit and are dependent on high level medical care including vasopressors, and sedative agents.; Not Applicable

• Registration Number: ISRCTN37114000
• Lead Sponsor: Cardiff and Vale University Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-10
• Last Update Posted: 27 May 2024
• Study Completion: 2026-12-29

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 3500

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 (unlikely to be extubated next 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 hours 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, intracranial 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 with a suspected or proven drug overdose or burns.
5. Administration of ongoing neuromuscular blockade
6. Mean arterial blood (MAP) pressure that is less than 50 mmHg despite adequate resuscitation and vasopressor therapy at time of randomization
7. Heart rate less than 55 beats per minute unless the patient is being treated with a betablocker 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. Death is deemed to be imminent or inevitable during this admission and either the attending physician, patient or substitute decision maker is not committed to active treatment
11. Patient has an underlying disease that makes survival to 90 days unlikely
12. Previously enrolled in the SPICE IV study

Study & Design

• Study Type: Interventional
• Study Design: Not specified