Harmonizing international trials of early goal-directed resuscitation for severe sepsis and septic shock: methodology of ProCESS, ARISE, and ProMISe.

ABSTRACT:

Purpose

To describe and compare the design of three independent but collaborating multicenter trials of early goal-directed resuscitation for severe sepsis and septic shock.

Methods

We reviewed the three current trials, one each in the USA (ProCESS: protocolized care for early septic shock), Australasia (ARISE: Australasian resuscitation in sepsis evaluation), and the UK (ProMISe: protocolised management in sepsis). We used the 2010 CONSORT (consolidated standards of reporting trials) statement and the 2008 CONSORT extension for trials assessing non-pharmacologic treatments to describe and compare the underlying rationale, commonalities, and differences.

Results

All three trials conform to CONSORT guidelines, address the same fundamental questions, and share key desig

SUBMITTER: ProCESS/ARISE/ProMISe Methodology Writing Committee 

PROVIDER: S-EPMC3864363 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature