ANZICS CTG Endorsed Study

SPICE IV

Early Sedation with Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients: A Prospective, Multi-centre, Double-Blind, Randomized Controlled Trial.

Study Description

The SPICE VI RCT, a follow up to the SPICE III study, is an exciting project which has received $4.9 million dollars in funding from the National Health & Medical Research Council.

The study hypothesis is that early sedation with dexmedetomidine as the primary sedative agent in ventilated critically ill patients who are ≥ 65 years old, reduces 90-day all-cause mortality.

Eligible patients will be randomly assigned to receive a blinded study infusion of either dexmedetomidine or placebo to achieve a RASS score of -1 to +1. The blinded study infusion will continue until sedation is no longer required, ICU discharge or day 28, whichever occurs first. In addition to the blinded study infusion of dexmedetomidine or placebo, all patients will receive standard sedation at minimum required rates to achieve RASS and all other standard care treatments.

Management Committee

Yahya Shehabi, Rinaldo Bellomo, Belinda Howe, Carol Hodgson,  Michael Reade, Jeffrey Presneill, Steve Webb, Ian Seppelt, Lewis Campbell, Colin McArthur, Rebecca Gresham, Rima Song, Anna Hunt, Zahra Thompson

Administering Institution

Monash University

Sample Size

3500 patients

Funding

tba

Reference

CTG2021-02

Contact

Yahya Shehabi (email)

Zahra Thompson (email)