RIVERS' Trial

NEJM

November 8, 2001

Early Goal-Directed Therapy in the Treatment of Severe Sepsis and Septic Shock.

Summarized by: 

Mazen Kherallah

What was the research question?

  • Does early goal-directed therapy (EGDT) reduce mortality in patients with severe sepsis?


How did they do it?

  • A randomized controlled trial in a single center in Detroit, Michigan.

  • Patients with severe sepsis were randomized to receive EGDT in the first 6 hours of their presentation (130 patients) or standard therapy (133 patients) prior to admission to the intensive care unit.

  • EGDT included arterial catheterization and central venous catheter capable of continuous ScvO2 measurement. Goals were to maintain MAP 65-90 mmHg with fluid and vasopressors, CVP of 8–12 mmHg with fluid boluses, and ScvO2 >70% with blood transfusion if hematocrit <30% or dobutamine.

  • Primary outcomes were in-hospital mortality and Acute Physiology and Chronic Health Evaluation (APACHE II) scores during the first 72 hours.


What did they find?

  • In-hospital mortality was significantly higher in the EGDT group compared to the standard care (30.5% vs 46.5% p = 0.009).

  • During the interval from 7 to 72 hours, mean APACHE II scores were significantly lower in EGDT group compared to standard therapy (13.0±6.3 vs. 15.9±6.4, P<0.001).


Are there any limitations?

  • Single center study.

  • The study included a bundle of care interventions, and it is difficult to ascertain the benefit of each intervention separately.

  • Higher mortality in the standard care than usual.

  • Primary outcome of in-hospital mortality has limitations as some patients may be discharge to home hospice and die outside the hospital.


What does it mean?

  • Early goal-directed therapy is associated with improved mortality and organ functions in patients with severe sepsis and septic shock.

  • As per ProCESS, ARISE, and ProMISE, there is no need to follow strict EGDT if adequate fluid resuscitation and early use of antimicrobial therapy were implemented.

RIVERS' Trial