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


Journal Article

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.To state our analysis plan for trial data.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.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.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

  • 24289512

International Standard Serial Number (ISSN)

  • 1441-2772


  • eng