Management of septic shock: a protocol-less approach

Area of Science:

• Critical Care Medicine
• Emergency Medicine
• Sepsis Research

Background:

• A prior single-center study suggested early goal-directed therapy (EGDT) significantly reduced mortality in severe sepsis and septic shock.
• EGDT involved intensive hemodynamic monitoring and interventions to achieve specific targets.

Purpose of the Study:

• To determine if the positive findings of EGDT were generalizable to a broader patient population.
• To assess whether all components of the EGDT protocol were essential for achieving improved outcomes.

Main Methods:

• A multicenter, randomized, three-arm controlled trial involving 31 academic emergency departments.
• 1,351 adult patients with septic shock were randomized to either protocol-based EGDT, protocol-based standard therapy, or usual care for 6 hours.
• Outcomes included 60-day in-hospital mortality, with secondary analyses of longer-term mortality and organ support needs.

Main Results:

• No significant difference in 60-day mortality was observed between the EGDT group (21.0%), standard therapy group (18.2%), and usual care group (18.9%).
• Protocol-based care (EGDT and standard therapy combined) was not superior to usual care (RR 1.04; P=0.83).
• Protocol-based EGDT was not superior to protocol-based standard therapy (RR 1.15; P=0.31), and no differences were found in longer-term mortality or organ support.

Conclusions:

• In a tertiary care setting, protocol-based resuscitation for emergency department patients with septic shock did not improve outcomes.
• The generalizability of earlier EGDT findings was not supported in this large, multicenter trial.
• The study suggests that intensive, protocolized resuscitation may not be necessary for all patients with septic shock.