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. Other
Conditions
Interventions
Intravenous infusion of dexmedetomidine or saline as placebo will be started shortly after randomisation, at a recommended dose equivalent to 1 mcg/kg/h without a loading dose. The infusion will be ad
Sponsors
Cardiff and Vale University Health Board
Eligibility
Sex/Gender
All
Age
65 Years to 120 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day all-cause mortality measured using phone follow-up by the sites research support staff at 90-days following randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of days alive and free of coma and delirium at 28 days collected through medical records and direct patient assessment for delirium, coma at 28 days following randomisation 2. Number of days alive and ventilator free at 28 days collected directly from medical records and entered into study database at 28 days following randomisation 3. Major Adverse Kidney Events at 28 days (Mortality + Acute Kidney Injury > stage II, defined by Kidney Disease Improving Global Outcome (KDIGO) definition) collected directly from medical records and entered into study database at 28 days following randomisation 4. Duration of mechanical ventilation in survivors collected directly from medical records and entered into study database at ICU discharge 5. Hospital length of stay in survivors collected directly from medical records and entered into study database at Hospital discharge | — |
Countries
Brazil, Canada, England, Ireland, Kuwait, Malaysia, Netherlands, New Zealand, Northern Ireland, Saudi Arabia, Switzerland, Taiwan, United Kingdom, Wales
Contacts
Public ContactMatt Wise
Outcome results
None listed