Protocolized care for early septic shock (ProCESS) statistical analysis plan

Background: The Protocolized Care for Early Septic Shock study is a randomised, multicentre, prospective, three-arm, parallel-group trial of alternative resuscitation strategies for early septic shock. Objective: To state our analysis plan for trial data. Methods: Our plan is to guide data collection and analysis using pre-existing definitions and testing, with local consensus-based efforts where needed. We examine protocolised care (two experimental approaches) and compare this to usual "wild type" care. Results: Our plan is to address three aims (clinical efficacy, biology of illness and recovery, and costs and costeffectiveness) and four hypotheses, and we specify rules for handling data and determining outcomes. Conclusion: By using measures to maintain study conduct and analysis rigour, we hope to improve understanding of early septic shock resuscitation and care of patients.