SGEM#69: Cry Me A River (Early Goal Directed Therapy) ProCESS Trial
SGEM - Dr. Suneel Upahdye Suneel - April 2, 2014
"BEEM Comments: This was a well executed three arm randomized clinical trial looking at three likely resuscitation scenarios. Block randomization 1:1:1 to ensure adequate numbers in each group.
Blinding was not explicitly described in paper or Supp Appendix; but outcomes data locked until Dec 2013 so clinical investigators unaware of different arm outcomes. No industry sponsorship. Near perfect follow-up for outcomes.
They did change their sample size part way through the study. The initial sample size was 1950 and based on a power calculation on the difference seen in the Dr. River’s trial. Then they changed the sample size. Initial sample size calculation modified at first planned interim analysis due to less observed mortality in control arm (attributed to the changing trend in improved sepsis care over last decade); reduced from 1950 to 1350 patients with preserved power metrics. The limitations discussed are appropriate and likely irrelevant to the overall conclusions. Overall quality was super.
This landmark ED-based study further refines the revolutionary care pioneered in the original Rivers EGDT paper in 2001. It refutes the need for universal invasive monitoring, which will be welcome for most ED clinicians in smaller/rural settings who may not have the full technical support/expertise to fully execute the original EGDT protocol.
This study also reaffirms the importance of early antibiotics, IV crystalloid resuscitation, and following serial lactates to monitor resuscitation success. The options outlined here can likely be extrapolated easily to those patients with severe sepsis as well as septic shock.
Importantly, this article does NOT refute the value of bundled care, which has been proven in prior trials/metaanalyses to be of significant benefit to reduce patient mortality/morbidity, but does suggest that an all-or-nothing super-invasive strategy (a la EGDT) is not universally required. Furthermore, the emphasis on crystalloids for IV resuscitation is congruent with SSC guidelines (update 2013) and a 2013 Cochrane update on fluid resuscitation of critically patients.
Finally, although no vasopressor is specified, the results here again are congruent with use of norepinephrine (NE) vs. dopamine (DA) recommendations from the SSC 2013 update and a recent metaanalysis published supporting NE over DA (De Backer et al. Dopamine versus norepinephrine in the treatment of septic shock: a meta-analysis. Crit Care Med 2012)."
Additional Reviews of the ProCESS Trail:
- Academic Life in Emergency Medicine
- EM Crit
- Emergency Medicine Ireland
- Hippo EM Blog
- St. Emlyns
- Oxford Deanery Intensive Care Medicine Blog
http://thesgem.com/2014/04/sgem69-cry-me-a-river-early-goal-directed-therapy-process-trial/