Australasian Resuscitation In Sepsis Evaluation trial statistical analysis plan

Area of Science:

• Critical Care Medicine
• Clinical Trials Methodology
• Epidemiology

Background:

• The Australasian Resuscitation In Sepsis Evaluation (ARISE) is an international, multicenter, randomized controlled trial.
• The trial evaluates early goal-directed therapy (EGDT) against standard care for severe sepsis patients in the emergency department (ED).

Purpose of the Study:

• To outline principles and methods for analyzing and reporting ARISE trial results.
• To ensure adherence to current practices for non-pharmacologic intervention trials.
• To prepare for analysis and reporting before trial completion and unblinding.

Main Methods:

• A statistical analysis plan was designed by ARISE chief investigators and approved by the steering committee.
• Data collected per the study protocol and case report form were reviewed.
• Baseline characteristics, intervention delivery, resuscitation details, and outcomes were defined for planned statistical analyses.

Main Results:

• A statistical analysis plan was developed, including a trial profile, mock tables, and figures.
• Plans for presenting baseline data, therapies, interventions, care processes, and adverse events were established.
• Primary, secondary, and tertiary outcomes, including subgroup analyses, were defined.

Conclusions:

• A statistical analysis plan for the ARISE study has been publicly released before recruitment completion.
• This proactive approach minimizes analytic bias.
• The plan aligns with current best practices for clinical trial conduct and reporting.