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

The ProCESS/ARISE/ ProMISe Methodology Writing Committee

Research output: Contribution to journalArticle

44 Scopus citations

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 design elements. Each trial is a patient-level, equal-randomized, parallel-group superiority trial that seeks to enroll emergency department patients with inclusion criteria that are consistent with the original early goal-directed therapy (EGDT) trial (suspected or confirmed infection, two or more systemic inflammatory response syndrome criteria, and refractory hypotension or elevated lactate), is powered to detect a 6-8 % absolute mortality reduction (hospital or 90-day), and uses trained teams to deliver EGDT. Design differences appear to primarily be driven by between-country variation in health care context. The main difference between the trials is the inclusion of a third, alternative resuscitation strategy arm in ProCESS. Conclusions: Harmonization of study design and methods between severe sepsis trials is feasible and may facilitate pooling of data on completion of the trials.

Original languageEnglish
Pages (from-to)1760-1775
Number of pages16
JournalIntensive care medicine
Volume39
Issue number10
DOIs
StatePublished - Oct 1 2013
Externally publishedYes

Keywords

  • Clinical trial
  • Early goal-directed therapy
  • Methodology
  • Septic shock
  • Severe sepsis
  • Study design

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