Overview
The SPICE IV Trial follows on from its predecessor SPICE III. The SPICE III Trial highlighted a difference in the effect of Dexmedetomidine between younger and older adults – showing a lower mortality in the older adult group. Therefore, the SPICE IV Trial will focus on this patient group and build upon the work in SPICE III.
The primary aim is to determine whether early sedation with Dexmedetomidine will reduce
mortality at 90 days in mechanically ventilated patients >65 years old, as well as delirium and
ventilator free days.
Intervention
Patients will be randomized to receive an IV infusion of Dexmedetomidine or a matching blinded
placebo which will be administered until sedation is no longer required, ICU discharge or Day 28. At
target RASS of -1 to +1 will be maintained (unless clinically indicated) with the trial IMP –
supplementary sedatives may be given only if required, e.g. neuromuscular blockade.
Data, including RASS score, CAM-ICU, will collected until Day 28. Follow ups are conducted at Day 90
and 180.
