Statistical analysis plan for hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: the ANDROMEDA-SHOCK-2 randomized clinical trial.

Summary

This pre-registered SAP for a multicenter RCT specifies a hierarchical primary endpoint analyzed via stratified win ratio, with detailed subgroup and sensitivity analyses for capillary refill time-targeted, phenotype-based resuscitation versus standard care in early septic shock. Publishing the SAP before database lock aims to minimize analysis bias and enhance transparency.

Key Findings

• Hierarchical primary outcome will be analyzed using a stratified win ratio to compare CRT-targeted, phenotype-based resuscitation versus standard care.
• Prespecified secondary/tertiary outcomes, subgroup analyses, and sensitivity analyses are detailed to minimize analytic flexibility.
• Comprehensive presentation plan includes mock tables, baseline characteristics, and treatment effect reporting prior to database lock.

Clinical Implications

While outcomes are pending, the SAP increases confidence that trial results will be interpretable and less prone to bias; if positive, CRT-targeted, phenotype-based resuscitation may be adopted and studied in implementation.

Limitations

• No clinical outcomes reported yet; impact depends on forthcoming trial results
• Sample size and operational nuances not detailed in the abstract

Future Directions

Execute the RCT per SAP, then assess generalizability and implementation of CRT-targeted, phenotype-based resuscitation; consider patient-centered outcomes within a hierarchical framework.