SPICE III RCT

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SPICE III RCT: Sedation Practices in Intensive Care Evaluation: SPICE III: A Prospective Multicentre Randomised Controlled Trial of Early Goal-Directed Sedation Compared with Standard Care in Mechanically Ventilated Patients in Intensive Care

The SPICE III Study is a prospective, un-blinded, randomised controlled trial of Early Goal-Directed Sedation (EGDS) compared with standard care. The study will recruit patients who are intubated and ventilated in a participating ICU, are expected to remain intubated the day after enrolment and need immediate and ongoing sedation. A total of 4,000 patients will be recruited from approximately 50 ANZ and international ICUs.

Goal: The primary aim of this study is to determine whether Early Goal-Directed Sedation, compared to standard care sedation, reduces 90-day mortality in critically ill patients who are expected to require mechanical ventilation for longer than 24 hours.

Rationale: Current sedation management in intensive care may have unacceptable short and long-term consequences on tens of thousands of patients per year in Australia and millions of patients worldwide. The human and societal cost associated with these problems are enormous. Providing high-level evidence to guide clinicians towards a safer paradigm of innovative and targeted sedation is an urgent clinical and economic imperative. EGDS is an attractive candidate intervention to improve outcome, and its feasibility has been proven in representative ICUs in Australia and New Zealand.

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Study Progress: Patient recruitment commenced in late 2013 in ANZ and is expected to expand to recruit internationally late in 2014.

Endorsement: The SPICE III RCT is endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS-CTG).

Contact: For further information about this study, please contact the ANZIC-RC SPICE Project Manager, Belinda Howe by email.