Early Sedation with Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients - V1.0

Monash University0 sites3,100 target enrollmentJune 11, 2023

Overview

No summary available.

Registry

who.int

Start Date

June 11, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Age \= 65 years, 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), Intubated and receiving invasive mechanical ventilation in an intensive care unit, The patient requires immediate ongoing sedative medication for comfort, safety and to facilitate the delivery of life support measures.

•Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 18 hours in an intensive care unit, Receiving full time residential nursing care, Death is deemed both imminent and inevitable and either the attending physician, patient or substitute decision maker is not committed to active treatment, Underlying disease that makes survival to 90 days unlikely, Previously enrolled in the SPICE IV study, Proven or suspected acute primary brain lesion such as traumatic brain injury, haemorrhage, stroke, or hypoxic brain injury, Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness, Admission as a consequence of a suspected or proven drug overdose or burns, Administration of or need for ongoing neuromuscular blockade, A mean arterial blood (MAP) pressure that is less than 50 mmHg, despite adequate resuscitation and vasopressor support at time of randomization, 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, Known sensitivity to dexmedetomidine, Acute fulminant hepatic failure