November 8, 2001
Early Goal-Directed Therapy in the Treatment of Severe Sepsis and Septic Shock.
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.