ISRCTN37114000
Active, Not Recruiting
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cardiff and Vale University Health Board
- Enrollment
- 3500
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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 (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
Outcomes
Primary Outcomes
Not specified
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