ProCESS Trial

NEJM

May 1, 2014

A Randomized Trial of Protocol-Based Care for Early Septic Shock.

What was the research question?

  • Is 60-day mortality better comparing protocol-based EGDT, protocol-based standard therapy, and usual care in adult patients with septic shock?


How did they do it?

  • A pragmatic randomized trial in 31 emergency department in the United States.

  • 1341 patients with septic shock were randomly assigned in a 1:1:1 ratio to protocol-based EGDT (439), protocol-based standard therapy (446), or usual care (456) for 6 hours of resuscitation.

  • Protocol-based EGDT was the Rivers 2001 protocol, which included a central line with SCvO2 monitoring, fluids, vasopressors, dobutamine, and pRBCs. Protocol-based standard therapy did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions in contrast to EGDT. Usual care did not prompt he physician for any treatment.

  • The primary end point was 60-day in-hospital mortality and whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy.

  • Secondary outcomes included longer-term mortality and the need for organ support.


What did they find?

  • 60-day in-hospital mortality was not different for the protocol-based EGDT group (21%), protocol-based standard-therapy group (18.2%), or usual care group (18.9%).

  • There was no difference in primary endpoint between the combined protocolized patients and usual care (19.5 vs 18.9, p=0.83).

  • Relative risk with protocol-based therapy vs. usual care is1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83. Relative risk with protocol-based EGDT vs. protocol-based standard therapy is 1.15; 95% CI, 0.88 to 1.51; P=0.31.

  • There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support.

  • Subgroup analysis, specifically related to severity of illness, was unrevealing for any differences among the groups.


Are there any limitations?

  • Not powered to detect any benefit in subgroups.

  • In-hospital mortality is affected by different physician’s approaches to end of life.


What does it mean?

  • Protocol-based resuscitation septic shock patients is not associated with a better 60-day mortality compared to usual care.

  • Usual care has improved over the years since EGDT in providing adequate fluid resuscitation and early antibiotic therapy.

  • The trial offers a less invasive and equally effective approach to septic shock patients.

ProCESS Trial