Harmonizing international trials of early goal-directed resuscitation for severe sepsis and septic shock: methodology of ProCESS, ARISE, and ProMISe
ProCESS/ARISE/ProMISe Methodology Writing Committee, David T Huang, Derek C Angus, Amber Barnato, Scott R Gunn, John A Kellum, Diana K Stapleton, Lisa A Weissfeld, Donald M Yealy, Sandra L Peake, Anthony Delaney, Rinaldo Bellomo, Peter Cameron, Alisa Higgins, Anna Holdgate, Belinda Howe, Steven A Webb, Patricia Williams, Tiffany M Osborn, Paul R Mouncey, David A Harrison, Sheila E Harvey, Kathryn M Rowan, ProCESS/ARISE/ProMISe Methodology Writing Committee, David T Huang, Derek C Angus, Amber Barnato, Scott R Gunn, John A Kellum, Diana K Stapleton, Lisa A Weissfeld, Donald M Yealy, Sandra L Peake, Anthony Delaney, Rinaldo Bellomo, Peter Cameron, Alisa Higgins, Anna Holdgate, Belinda Howe, Steven A Webb, Patricia Williams, Tiffany M Osborn, Paul R Mouncey, David A Harrison, Sheila E Harvey, Kathryn M Rowan
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.
Source: PubMed