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Related Experiment Video

Updated: May 5, 2026

Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies

Observational Study Protocol for Repeated Clinical Examination and Critical Care Ultrasonography Within the Simple Intensive Care Studies

Published on: January 16, 2019

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

Francis Pike¹, Donald M Yealy, John A Kellum

¹Department of Biostatistics, Pitt Public Health, University of Pittsburgh, Pittsburgh, Pa, United States. lweis@pitt.edu.

Critical Care and Resuscitation : Journal of the Australasian Academy of Critical Care Medicine

|December 3, 2013

Summary

This summary is machine-generated.

This study outlines the analysis plan for the Protocolized Care for Early Septic Shock trial, comparing new resuscitation strategies to usual care to improve patient outcomes.

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Area of Science:

Critical Care Medicine
Clinical Trial Design
Septic Shock Research

Background:

The Protocolized Care for Early Septic Shock study is a randomized, multicenter, prospective trial.
It investigates alternative resuscitation strategies for early septic shock.

Purpose of the Study:

To detail the analysis plan for the trial data.
To guide data collection and analysis for septic shock management.

Main Methods:

Examining protocolized care with two experimental approaches.
Comparing protocolized care to usual 'wild type' care.
Utilizing pre-existing definitions and local consensus for data analysis.

Main Results:

Addressing clinical efficacy, illness biology, recovery, and cost-effectiveness.
Specifying rules for data handling and outcome determination.
Testing four distinct hypotheses.

Conclusions:

Maintaining study conduct and analysis rigor is crucial.
Aims to enhance understanding of early septic shock resuscitation.
Improving care for patients with early septic shock.