Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan.

Journal Article (Journal Article)

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 cost-effectiveness) 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.

Full Text

Duke Authors

Cited Authors

  • Pike, F; Yealy, DM; Kellum, JA; Huang, DT; Barnato, AE; Eaton, TL; Angus, DC; Weissfeld, LA; ProCESS Investigators,

Published Date

  • December 2013

Published In

Volume / Issue

  • 15 / 4

Start / End Page

  • 301 - 310

PubMed ID

  • 24289512

Pubmed Central ID

  • PMC4081520

International Standard Serial Number (ISSN)

  • 1441-2772


  • eng

Conference Location

  • Australia