Statistical Analysis Plan for ANDROMEDA-SHOCK 2 Clinical Trial
Background: The ANDROMEDA-SHOCK 2 trial is an international study comparing targeted resuscitation based on hemodynamic phenotype and capillary refill time to standard care in patients with early septic shock. The goal is to see if this targeted approach leads to lower complications and deaths.
Objective:
To outline the statistical plan for the ANDROMEDA-SHOCK 2 trial.
Methods:
We will describe:
- The trial design and patient selection
- How randomization and interventions are carried out
- The outcomes we are measuring and our sample size
We will explain our planned statistical methods for analyzing the main outcome, along with additional analyses for secondary and tertiary outcomes. We’ll also cover subgroup and sensitivity analyses, and how we will present our results, including sample tables and treatment effects.
Conclusion:
We are sharing our statistical analysis and data management plan before we finalize the database and begin analysis. This approach aims to avoid bias in our results and enhance the usefulness of the study findings.
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