This document summarizes a 2001 study that compared three approaches to treating early septic shock: 1) protocol-based early goal directed therapy (EGDT) using invasive hemodynamic monitoring to guide treatment; 2) protocol-based standard care using less invasive monitoring; and 3) usual care without protocols. The study found that 60-day mortality did not significantly differ between the three groups. While EGDT had been widely used, the study showed that invasive hemodynamic monitoring does not improve outcomes compared to less invasive approaches. Early recognition of sepsis and timely treatments like antibiotics and fluids may be more important than invasive monitoring for managing septic shock.

1. Protocolized Care for Early Septic Shock

6.  The physicians say it happens in hectic fever, that in the beginning of
the malady it is easy to cure but difficult to detect, but in the course of
time, not having been either detected or treated in the beginning, it
becomes easy to detect but difficult to cure.”
Machiavelli – The Prince Chapter 3

7.  Early Goal Directed Therapy (EGDT),
 6 hour protocol
 invasive measurements of hemodynamics to guide resuscitation
 New era of sepsis management
Rivers et al (2001)

10.  Protocol-based approach in treating sepsis
 1341 patients in suspected septic shock
 31 centers,
 Randomized in a 1:1:1 ratio
 Protocol-based EGDT,
 Protocol-based standard care
 Usual care
 within 2 hours of recognition of shock and within 12 hours of arrival to the ED
Process-trial

11.  Central venous catheter placement
 Treated based on targets in Rivers’ algorithm:
◦ central venous pressure,
◦ mean arterial pressure, and
◦ mixed venous oxygen saturation.
 The amount and timing of volume resuscitation
was specifically dictated in this treatment group.
EGDT

12.  Through a review of the literature
 Input of expert physicians,
 Targets requiring less invasive measurement
techniques,
◦ systolic blood pressure
◦ clinical and laboratory signs of hypoperfusion.
Protocol-based standard therapy

13.  Care without any direction from study coordinators
Usual care group
•Early treatment with antimicrobial agents,
•conservative transfusion thresholds,
•low tidal-volume ventilation
•moderate glycemic control.

16.  60-day mortality did not differ among the three
groups
◦ 21% in EGDT,
◦ 18% in protocol-based standard care,
◦ 19% in usual care;
95% confidence interval [CI], 0.82 to 1.31; p=0.83), with
comparably insignificant differences in 90-day and 1-year
mortality rates.
Primary outcome

17.  despite its widespread use,
a protocol based on invasive hemodynamic
monitoring does not significantly improve
outcomes in septic shock
compared to less invasive approaches.
Relevance

18.  ... is similar to research that found the use of pulmonary artery
catheters did not improve mortality,
 ... suggests invasive hemodynamic monitoring is not a requirement
for the management of septic shock.
 ... Can change current standards of care and management?
This study...

19.  Early recognition of sepsis,
as well as cornerstone interventions –
◦ the rapid infusion of intravenous fluids,
◦ early broad spectrum antibiotics,
◦ prompt source control
 have a greater impact on survival than the use of invasive monitoring
to guide such therapies.
Bottom line

21.  the early or facilitated
◦ recognition of septic shock,
◦ administration of intravenous antibiotics
(76% after 3 hours, 97% after 6)
 were associated with rates of survival that were higher than
projected and higher than predicted on the basis of scores on the
Acute Physiology and Chronic Health Evaluation (APACHE) II

22.  "A designer knows he has achieved perfection not when there is
nothing left to add, but when there is nothing left to take away."
- Antoine de Saint-Exupry

31.  PAC is a diagnostic and haemodynamic monitoring tool but not a
therapeutic intervention. Our review concluded that use of a PAC did
not alter the mortality, general ICU or hospital LOS, or cost for
adult patients in intensive care.
Pulmonary artery catheters for adult patients
in intensive care