Early goal-directed therapy (EGDT) is a six-hour protocol for the hemodynamic management of septic shock that requires the insertion of a central venous catheter to aid in the administration of IV fluids, vasopressors, and dobutamine and in red-cell transfusion. In a 2001 study the practice was found to significantly reduce mortality. A new study, the Protocolized Care for Early Septic Shock study, sought to determine whether EGDT measures were still superior to either a less-invasive protocol or usual care for the treatment of septic shock.

Thirty-one academic hospitals across the United States participated in the randomized trial over a five-year period (2008 to 2013). Patients were enrolled while in the ED after presenting with suspected sepsis into one of three treatment arms: an EGDT arm, a standard-protocol arm, and a usual-care arm. The standard protocol was also a six-hour set of directives on the hemodynamic management of sepsis but was less aggressive: placement of a central catheter wasn't required, and limits were placed on when red-cell transfusions should be performed. Usual care was care provided by a hospital clinician using medical judgment instead of a prescribed protocol.

A total of 1,341 patients were analyzed: 439 in the EGDT group, 446 in the standard-protocol group, and 456 in the usual-care group. How resuscitation was carried out varied among the three groups. Patients in the standard-protocol arm received the most fluid (a mean of 3.3 liters) during the initial six hours of their treatment course and overall, followed by the EGDT arm (2.8 liters) and the usual-care arm (2.3 liters). Patients in both protocol groups were more often given vasopressors than those receiving usual care (54.9% in the EGDT arm, 52.2% in the standard-protocol arm, and 44.1% in the usual care arm). Dobutamine administration and red-cell transfusion were more frequent in the EGDT group (8%) than in either the standard-protocol group (1.1%) or the usual-care group (0.9%).

Despite the significant differences in treatment management, the investigators found that in-hospital mortality at day 60 was similar in all three groups-21% in the EGDT group, 18.2% in the standard-protocol group, and 18.9% in the usual-care group-which led them to conclude that there was no observed benefit to protocol-driven care in sepsis management.

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