Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 Dec;15(4):301-10.

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

Francis Pike  1 , Donald M Yealy, John A Kellum, David T Huang, Amber E Barnato, Tammy L Eaton, Derek C Angus, Lisa A Weissfeld; ProCESS Investigators
Collaborators, Affiliations
Randomized Controlled Trial

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

Francis Pike et al. Crit Care Resusc. 2013 Dec.

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.

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.

PubMed Disclaimer

References

    1. Rivers E, Nguyen B, Havstad S, et al. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001;345:1368–77. - PubMed
    1. Reade MC, Huang DT, Bell D, et al. Variability in management of early severe sepsis. Emerg Med J. 2010;27:110–5. - PubMed
    1. ProCESS/ARISE/ProMISe Methodology Writing Committee Harmonizing international trials of early goal-directed resuscitation for severe sepsis and septic shock: methodology of ProCESS, ARISE, and ProMISe. Intensive Care Med. 2013 Aug 20; Epub ahead of print. - PMC - PubMed
    1. Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001;344:699–709. - PubMed
    1. Abraham E, Reinhart K, Opal S, et al. Efficacy and safety of tifacogin (recombinant tissue factor pathway inhibitor) in severe sepsis: a randomized controlled trial. JAMA. 2003;290:238–47. - PubMed

Publication types

LinkOut - more resources