• Glenn Hernández, Alexandre Biasi Cavalcanti, Gustavo Ospina-Tascón, Arnaldo Dubin, Francisco Javier Hurtado, Lucas Petri Damiani, Gilberto Friedman, Ricardo Castro, Leyla Alegría, Maurizio Cecconi, Jean-Louis Teboul, and Jan Bakker.
• Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile - Santiago, Chile.
• Rev Bras Ter Intensiva. 2018 Jul 1; 30 (3): 253-263.

BackgroundANDROMEDA-SHOCK is an international, multicenter, randomized controlled trial comparing peripheral perfusion-targeted resuscitation to lactate-targeted resuscitation in patients with septic shock in order to test the hypothesis that resuscitation targeting peripheral perfusion will be associated with lower morbidity and mortality.ObjectiveTo report the statistical analysis plan for the ANDROMEDA-SHOCK trial.MethodsWe describe the trial design, primary and secondary objectives, patients, methods of randomization, interventions, outcomes, and sample size. We describe our planned statistical analysis for the primary, secondary and tertiary outcomes. We also describe the subgroup and sensitivity analyses. Finally, we provide details for presenting our results, including mock tables showing baseline characteristics, the evolution of hemodynamic and perfusion variables, and the effects of treatments on outcomes.ConclusionAccording to the best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and initiating the analyses. We anticipate that this procedure will prevent analysis bias and enhance the utility of the reported results.

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