Monash leads largest ever randomised controlled trial on ICU sedation



The largest RCT on ICU sedation study, led by Monash University, recruited its 4000th and final patient this week.

The largest RCT on ICU sedation study, led by Monash University, recruited its 4000th and final patient this week.

The clinical trial known as Sedation Practice in Intensive Care Evaluation (SPICE III) is led by Chief Investigator Professor Yahya Shehabi from the School of Clinical Sciences at Monash Health (SCS). SPICE III is funded by a NHMRC project grant.

Professor Shehabi reported that the final patient was recruited at Nepean Hospital in Sydney on February 7 at 2.23pm.

The SPICE III trial is investigating the use of dexmedetomidine as a light sedation in critically ill, ventilated ICU patients, using an innovative approach called Early Goal Directed Sedation.

“This approach has the potential to improve 90 day survival of critically ill patients who are ventilated for more than 24 hours,” Professor Shehabi said.

“The study also aims to evaluate institutional dependency and quality of life six months after discharge from ICU.”

Professor Shehabi said the delivery of early light sedation is likely to reduce ICU delirium and dependency on mechanical ventilation whilst in ICU.

“These outcomes are all patient-centred and have enormous implications for the quality of life for patients and their families. Improvements in these outcomes could translate to significant reduction in the societal burden of post ICU care syndromes with huge positive resource implication.

The SPICE III trial has been conducted in 76 ICUs in nine countries including Australia, New Zealand, Malaysia, Saudi Arabia, United Kingdom, Scotland, Ireland, Italy and Switzerland.  It is managed by the Monash University Australian and New Zealand Intensive Care Research Centre.

“SPICE III will change the landscape of how critically ill patients are sedated in ICUs worldwide and will provide the highest level of evidence to inform future practice,” Professor Shehabi said.

The final results of SPICE III will be available at the end of 2018.