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Statistical analysis plan for early goal-directed therapy using a physiological holistic view - the ANDROMEDA-SHOCK:
Glenn Hernández1, Alexandre Biasi Cavalcanti2, Gustavo Ospina-Tascón3
1Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile - Santiago, Chile.
Revista Brasileira De Terapia Intensiva
|August 2, 2018
Summary
The ANDROMEDA-SHOCK trial is a study comparing two resuscitation strategies for septic shock. The statistical analysis plan ensures unbiased reporting of results to determine the best treatment approach.
Area of Science:
- Critical Care Medicine
- Clinical Trials
- Septic Shock Pathophysiology
Background:
- ANDROMEDA-SHOCK is an international, multicenter randomized controlled trial.
- It compares peripheral perfusion-targeted resuscitation with lactate-targeted resuscitation in septic shock patients.
Purpose of the Study:
- To report the detailed statistical analysis plan for the ANDROMEDA-SHOCK trial.
- This plan aims to ensure methodological rigor and prevent analysis bias.
Main Methods:
- The plan outlines the trial design, patient population, randomization, interventions, and outcome measures.
- Statistical analyses for primary, secondary, and tertiary outcomes are detailed.
- Subgroup, sensitivity analyses, and results presentation methods are described.
Main Results:
- This abstract reports the statistical analysis plan, not the trial results.
- Mock tables are included to illustrate planned result presentations.
Conclusions:
- Reporting the statistical analysis plan before data analysis adheres to best trial practices.
- This transparency enhances the reliability and utility of the trial's findings on septic shock resuscitation.
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