Statistical analysis plan for the Australasian Resuscitation in sepsis evaluation: FLUid or vasopressors in emergency department sepsis (ARISE FLUIDS) trial

Background

The optimal approach to haemodynamic resuscitation in patients with septic shock is uncertain and will be evaluated in The Australasian Resuscitation In Sepsis Evaluation: FLUid or vasopressors In emergency Department Sepsis (ARISE FLUIDS) trial.

Objective

The objective of this study was to describe the prespecified ARISE FLUIDS statistical analysis plan (SAP).

Design, setting, participants, and interventions

The ARISE FLUIDS trial is a 1000-participant international multicentre randomised controlled trial comparing restricted intravenous fluid volume and earlier introduction of vasopressors (vasopressor strategy) to larger initial intravenous fluid volume and later introduction of vasopressors if required (fluids strategy) in adults with early septic shock presenting to the emergency department in participating sites in Australia, New Zealand and Ireland.

Main outcome measures

The primary outcome is days alive and out of hospital at 90 days post randomisation, and the difference in medians between the two treatment groups will be estimated using a linear quantile mixed-effect regression model. Secondary outcomes include duration of survival censored at day 90, ventilator-, vasopressor-, and acute renal replacement–free days censored at day 28 and death or disability at 6 and 12 months

Conclusion

ARISE FLUIDS will compare the effects of a vasopressor vs. fluids strategy on days alive and out of hospital at 90 days in adults with early septic shock. The prespecified SAP is reported here to mitigate analysis bias.