Journal article
The SPICE III study protocol and analysis plan: a randomised trial of early goal-directed sedation compared with standard care in mechanically ventilated patients
Y Shehabi, AB Forbes, Y Arabi, F Bass, R Bellomo, S Kadiman, BD Howe, C McArthur, MC Reade, I Seppelt, J Takala, S Webb, MP Wise
Critical Care and Resuscitation | AUSTRALASIAN MED PUBL CO LTD | Published : 2017
Abstract
Background: Sedation strategy in critically ill patients who are mechanically ventilated is infl uenced by patient-related factors, choice of sedative agent and the intensity or depth of sedation prescribed. The impact of sedation strategy on outcome, in particular when delivered early after initiation of mechanical ventilation, is uncertain. Objectives: To present the protocol and analysis plan of a large randomised clinical trial investigating the effect of a sedation strategy, in critically ill patients who are mechanically ventilated, based on a protocol targeting light sedation using dexmedetomidine as the primary sedative, termed “early goal-directed sedation”, compared with usual prac..
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Awarded by National Health and Medical Research Council
Funding Acknowledgements
SPICE III is conducted on behalf of and endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group, managed by the Australian and New Zealand Intensive Care Research Centre at Monash University, and funded by the National Health and Medical Research Council of Australia (project grant no. 1043938), the Health Research Council of New Zealand (project grant no. 14/115) and the National Heart Institute of Malaysia. This report presents the trial protocol and the statistical analysis plan. SPICE III is registered with clinicaltrials.gov (NCT01728558).