Sedation Practice in Intensive Care Evaluation-SPICE IV. Early Sedation with Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients. A Prospective, Multi-Centre, Double-Blind, Randomized, Controlled Trial

Cardiff and Vale University Health Board0 个研究点目标入组 3,500 人开始时间: 2024年4月10日最近更新: 2024年5月27日

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•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.

•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

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