title: Protocolized Care for Early Septic Shock (ProCESS) statistical analysis plan.
abstract: 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.
  
  
  CONCLUSIONS
  By using measures to maintain study conduct and analysis rigour, we hope to improve understanding of early septic shock resuscitation and care of patients.
authors.affiliation: Department of Biostatistics, Pitt Public Health, University of Pittsburgh, Pittsburgh, Pa, United States. lweis@pitt.edu.
authors.forename: Francis
authors.initials: F
authors.lastname: Pike
authors.forename: Donald M
authors.initials: DM
authors.lastname: Yealy
authors.forename: John A
authors.initials: JA
authors.lastname: Kellum
authors.forename: David T
authors.initials: DT
authors.lastname: Huang
authors.forename: Amber E
authors.initials: AE
authors.lastname: Barnato
authors.forename: Tammy L
authors.initials: TL
authors.lastname: Eaton
authors.forename: Derek C
authors.initials: DC
authors.lastname: Angus
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Weissfeld
mesh_terms: D058186:Acute Kidney Injury / Q000628:therapy; D002985:Clinical Protocols; D064648:Critical Care Nursing; D003627:Data Interpretation, Statistical; D017052:Hospital Mortality; D006801:Humans; D015337:Multicenter Studies as Topic; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D017582:Renal Replacement Therapy; D012151:Resuscitation; D012772:Shock, Septic / Q000401:mortality* / Q000451:nursing / Q000628:therapy*