ANZICS CTG Endorsed Study

SPICE RCT

Sedation practice in intensive care evaluation randomised controlled trial

Study Description

Each year, more than 3 million patients in intensive care worldwide receive sedative drugs to facilitate mechanical ventilation and life-saving therapies, however, they are also associated with significant harm. Unfortunately, despite their widespread use, there is no high quality evidence to guide clinical practice. In a recent multicentre observational study, we found that current practice is commonly associated with deep sedation and a high incidence of delirium. Both are modifiable and can be targeted to improve outcomes. Currently used sedative drugs have many side-effects that may be attenuated by use of a new approach to sedation that uses the alpha-2 agonist dexmedetomidine (DXMD) instead. DXMD has been shown in multiple phase II trials to shorten ventilation time, reduce delirium, provide analgesia and deliver lighter sedation with minimal respiratory depression. We believe that, in mechanically ventilated patients, early use of a sedative algorithm based on DXMD will result in safe but lighter sedation, higher delirium free days, less time on mechanical ventilation, in ICU and in hospital, and increased survival. Accordingly, we have designed a multicentre randomised controlled trial of 4000 patients. This study will compare Early Goal-Directed Sedation delivered within hours of initiation of ventilation, using DXMD as a primary sedative drug, targeting light sedation and minimising use of other sedative drugs, with best current care. The primary outcome will be 90 day all-cause mortality. Other outcomes include institutional dependency at 90 days, cognitive function at 6 months, ventilation time, incidence and duration of delirium. This is the largest sedation trial ever conducted. It is crucial to the advancement of intensive care medicine and is the first to tackle all key aspects of sedation that need improvement. Once completed, this landmark trial will provide definitive evidence to transform sedation practice in Australia and worldwide.

Management Committee

Yahya Shehabi (Chair), Yaseen Arabi, Frances Bass, Rinaldo Bellomo, Simon Erickson, Belinda Howe (Project Manager), Suhaini Kadiman, Colin McArthur, Lynne Murray, Michael Reade, Ian Seppelt, Jukka Takala,  Steve Webb and Matthew Wise.

Administering Institution

ANZIC Research Centre

Collaborators

Pfizer
Orion Pharma

Sample Size

4000 patients

Funding

NHMRC Project Grant $2,752,725.01
Health Research Council of New Zealand NZ$1,118,620.90
National Heart Institute of Malaysia,  Institut Jantung Negara 600,000 MR (200,000 AUD)

Project Status as of June 2018

The study completed recruitment on the 8th February 2018. Last follow up is due August 2018. The results are anticipated late 2018.

Reference

CTG12-003
NCT01728558 clinicaltrails.gov

Contact

Belinda Howe (email)