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

Crit Care Resusc. 2013 Dec;15(4):301-10.


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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acute Kidney Injury / therapy
  • Clinical Protocols*
  • Critical Care Nursing
  • Data Interpretation, Statistical
  • Hospital Mortality*
  • Humans
  • Multicenter Studies as Topic
  • Outcome Assessment, Health Care
  • Prospective Studies
  • Renal Replacement Therapy
  • Resuscitation*
  • Shock, Septic / mortality*
  • Shock, Septic / nursing
  • Shock, Septic / therapy*