Early goal-directed therapy in severe sepsis and septic shock: insights and comparisons to ProCESS, ProMISe, and ARISE

H Bryant Nguyen^{1

2}, Anja Kathrin Jaehne^{3

4}, Namita Jayaprakash⁵, Matthew W Semler⁶, Sara Hegab⁷, Angel Coz Yataco⁸, Geneva Tatem⁷, Dhafer Salem⁹, Steven Moore³, Kamran Boka¹⁰, Jasreen Kaur Gill³, Jayna Gardner-Gray^{3

7}, Jacqueline Pflaum^{3

7}, Juan Pablo Domecq^{11

12}, Gina Hurst^{3

7}, Justin B Belsky¹³, Raymond Fowkes³, Ronald B Elkin¹⁴, Steven Q Simpson¹⁵, Jay L Falk^{16

17

18

19

20}, Daniel J Singer²¹, Emanuel P Rivers^{22

23}

Affiliations

¹ Department of Medicine, Pulmonary and Critical Care Medicine, Loma Linda University, Loma Linda, CA, USA.
² Department of Emergency Medicine, Loma Linda University, Loma Linda, CA, USA.
³ Department of Emergency Medicine, Henry Ford Hospital, Wayne State University, Detroit, MI, USA.
⁴ Department of Quality Assurance, Aspirus Hospital, Iron River, MI, USA.
⁵ Division of Pulmonary and Critical Care Medicine, Mayo Clinic Rochester, Rochester, MN, USA.
⁶ Department of Medicine, Pulmonary and Critical Care Medicine, Vanderbilt University, Nashville, TN, USA.
⁷ Department of Medicine, Pulmonary and Critical Care Medicine, Henry Ford Hospital, Wayne State University, Detroit, MI, USA.
⁸ Department of Medicine, Pulmonary and Critical Care Medicine, University of Kentucky, Lexington, KY, USA.
⁹ Department of Internal Medicine, Mercy Hospital Medical Center, Chicago, IL, USA.
¹⁰ Department of Internal Medicine, Division of Critical Care Medicine, University of Texas Health Science Center at Houston, Houston, TX, USA.
¹¹ Department of Internal Medicine, Henry Ford Hospital, Wayne State University, Detroit, MI, USA.
¹² CONEVID, Conocimiento y Evidencia Research Unit, Universidad Peruana Cayetano Heredia, Lima, PERU.
¹³ Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
¹⁴ Pulmonary and Critical Care Medicine, California Pacific Medical Center, San Francisco, CA, USA.
¹⁵ Pulmonary and Critical Care Medicine, University of Kansas, Kansas City, Kansas, USA.
¹⁶ Department of Emergency Medicine, Orlando Regional Medical Center, Orlando, Florida, USA.
¹⁷ University of Central Florida College of Medicine, Orlando, Florida, USA.
¹⁸ University of Florida College of Medicine, Orlando, Florida, USA.
¹⁹ University of South Florida College of Medicine, Orlando, Florida, USA.
²⁰ Florida State University College of Medicine, Orlando, Florida, USA.
²¹ Department of Surgery, Division of Surgical Critical Care, Icahn School of Medicine, Mount Sinai Hospital,, New York, NY, USA.
²² Department of Emergency Medicine, Henry Ford Hospital, Wayne State University, Detroit, MI, USA. erivers1@hfhs.org.
²³ Department of Surgery, Henry Ford Hospital, Wayne State University, Detroit, MI, USA. erivers1@hfhs.org.

PMID: 27364620
PMCID: PMC4929762
DOI: 10.1186/s13054-016-1288-3

Review

Early goal-directed therapy in severe sepsis and septic shock: insights and comparisons to ProCESS, ProMISe, and ARISE

H Bryant Nguyen et al. Crit Care. 2016.

. 2016 Jul 1;20(1):160.

doi: 10.1186/s13054-016-1288-3.

Authors

Affiliations

¹ Department of Medicine, Pulmonary and Critical Care Medicine, Loma Linda University, Loma Linda, CA, USA.
² Department of Emergency Medicine, Loma Linda University, Loma Linda, CA, USA.
³ Department of Emergency Medicine, Henry Ford Hospital, Wayne State University, Detroit, MI, USA.
⁴ Department of Quality Assurance, Aspirus Hospital, Iron River, MI, USA.
⁵ Division of Pulmonary and Critical Care Medicine, Mayo Clinic Rochester, Rochester, MN, USA.
⁶ Department of Medicine, Pulmonary and Critical Care Medicine, Vanderbilt University, Nashville, TN, USA.
⁷ Department of Medicine, Pulmonary and Critical Care Medicine, Henry Ford Hospital, Wayne State University, Detroit, MI, USA.
⁸ Department of Medicine, Pulmonary and Critical Care Medicine, University of Kentucky, Lexington, KY, USA.
⁹ Department of Internal Medicine, Mercy Hospital Medical Center, Chicago, IL, USA.
¹⁰ Department of Internal Medicine, Division of Critical Care Medicine, University of Texas Health Science Center at Houston, Houston, TX, USA.
¹¹ Department of Internal Medicine, Henry Ford Hospital, Wayne State University, Detroit, MI, USA.
¹² CONEVID, Conocimiento y Evidencia Research Unit, Universidad Peruana Cayetano Heredia, Lima, PERU.
¹³ Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
¹⁴ Pulmonary and Critical Care Medicine, California Pacific Medical Center, San Francisco, CA, USA.
¹⁵ Pulmonary and Critical Care Medicine, University of Kansas, Kansas City, Kansas, USA.
¹⁶ Department of Emergency Medicine, Orlando Regional Medical Center, Orlando, Florida, USA.
¹⁷ University of Central Florida College of Medicine, Orlando, Florida, USA.
¹⁸ University of Florida College of Medicine, Orlando, Florida, USA.
¹⁹ University of South Florida College of Medicine, Orlando, Florida, USA.
²⁰ Florida State University College of Medicine, Orlando, Florida, USA.
²¹ Department of Surgery, Division of Surgical Critical Care, Icahn School of Medicine, Mount Sinai Hospital,, New York, NY, USA.
²² Department of Emergency Medicine, Henry Ford Hospital, Wayne State University, Detroit, MI, USA. erivers1@hfhs.org.
²³ Department of Surgery, Henry Ford Hospital, Wayne State University, Detroit, MI, USA. erivers1@hfhs.org.

PMID: 27364620
PMCID: PMC4929762
DOI: 10.1186/s13054-016-1288-3

Abstract

Prior to 2001 there was no standard for early management of severe sepsis and septic shock in the emergency department. In the presence of standard or usual care, the prevailing mortality was over 40-50 %. In response, a systems-based approach, similar to that in acute myocardial infarction, stroke and trauma, called early goal-directed therapy was compared to standard care and this clinical trial resulted in a significant mortality reduction. Since the publication of that trial, similar outcome benefits have been reported in over 70 observational and randomized controlled studies comprising over 70,000 patients. As a result, early goal-directed therapy was largely incorporated into the first 6 hours of sepsis management (resuscitation bundle) adopted by the Surviving Sepsis Campaign and disseminated internationally as the standard of care for early sepsis management. Recently a trio of trials (ProCESS, ARISE, and ProMISe), while reporting an all-time low sepsis mortality, question the continued need for all of the elements of early goal-directed therapy or the need for protocolized care for patients with severe and septic shock. A review of the early hemodynamic pathogenesis, historical development, and definition of early goal-directed therapy, comparing trial conduction methodology and the changing landscape of sepsis mortality, are essential for an appropriate interpretation of these trials and their conclusions.

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Figures

**Fig. 1**
A systems-based approach. The origin and components of EGDT. *Hct* hematocrit [–132]

**Fig. 2**
Comparing baseline lactate to ScvO₂ and APACHE II scores. *APACHE II* Acute Physiology and Chronic Health Evaluation II, *ARISE* Australasian Resuscitation in Sepsis Evaluation, *EGDT* Early Goal-Directed Therapy, *ProCESS* Protocolized Care for Early Septic Shock, *ProMISe* Protocolized Management in Sepsis, *ScvO* ₂ mixed central venous oxygen saturation

See this image and copyright information in PMC

Comment in

Work of breathing, not dysoxia, as the cause of low central venous blood O2 saturation in sepsis.
Gutierrez G. Gutierrez G. Crit Care. 2016 Sep 19;20:291. doi: 10.1186/s13054-016-1476-1. Crit Care. 2016. PMID: 27640526 Free PMC article. No abstract available.

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Early goal-directed therapy in severe sepsis and septic shock: insights and comparisons to ProCESS, ProMISe, and ARISE

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Early goal-directed therapy in severe sepsis and septic shock: insights and comparisons to ProCESS, ProMISe, and ARISE

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Abstract

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