ARISE Trial

NEJM

October 16, 2014

Goal-Directed Resuscitation for Patients with Early Septic Shock.

What was the research question?

  • Does EGDT result in a better mortality outcome compared to usual care in patients with septic shock?



How did they do it?

  • A pragmatic randomized trial in 51 centers mostly in Australia or New Zealand.

  • 1600 patients with septic shock were randomly assigned in a 1:1 ratio to EGDT (796) or usual care (804).

  • The primary outcome was all-cause mortality within 90 days after randomization.


What did they find?

· EGDT was associated with larger volume of fluid in the first 6 hours (1964 ml vs. 1713 ml, p<0.001), higher vasopressor infusions (66.6% vs. 57.8%, p<0.001), more red-cell transfusions (13.6% vs. 7.0%, p<0.001), and more dobutamine (15.4% vs. 2.6%, p<0.001) compared to the usual care group.

· 90-day mortality rates were not significantly different between the EGDT group and the usual care group (18.6% vs. 18.8%; P=0.90).

· Lower ICU admission rate was observed in the usual care group compared to EGDT (87% vs. 76.9%, p<0.001). Central venous placement observed I 61.9% of the usual care group compared to 90% in the EGDT group.

· There was no significant difference in survival time, in-hospital mortality, duration of organ support, or length of hospital stay.

Are there any limitations?

  • The study is underpowered with high risk of type II      error.

What does it mean?

· EGDT did not reduce 90-day mortality in patients presenting to the emergency department with septic shock.

· 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.

ARISE Trial