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2015 ; 19
(1
): 260
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Management of septic shock: a protocol-less approach
#MMPMID26088759
Cabrera JL
; Pinsky MR
Crit Care
2015[Jun]; 19
(1
): 260
PMID26088759
show ga
BACKGROUND: In a single-center study published more than a decade ago involving
patients presenting to the emergency department with severe sepsis and septic
shock, mortality was markedly lower among those who were treated according to a
6-h protocol of early goal-directed therapy (EGDT), in which intravenous fluids,
vasopressors, inotropes, and blood transfusions were adjusted to reach central
hemodynamic targets including central venous pressure, central venous oxygen
saturation, and indirect estimates of cardiac output, than among those receiving
usual care. OBJECTIVE: The objective was to determine whether these EGDT findings
were generalizable and whether all aspects of the EGDT protocol were necessary to
achieve those outcomes. DESIGN: A multicenter randomized three-arm controlled
trial. SETTING: Thirty-one academic emergency departments in the United States.
SUBJECTS: Patients older than 18 years of age presenting to the emergency
department with septic shock. INTERVENTION: Patients were assigned to one of
three groups for 6 h of resuscitation: protocol-based EGDT as defined by River
and colleagues; protocol-based standard therapy that did not require the
placement of a central venous catheter, administration of inotropes, or blood
transfusions; and usual care which mandated no specific monitoring or management
approaches. OUTCOMES: The primary end point was 60-day in-hospital mortality.
Also tested sequentially was 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. RESULTS: A total of 1,351
patients were enrolled, of whom 1,341 were evaluable due to patient/family
request: 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based
standard therapy, and 456 to usual care. Resuscitation strategies differed
significantly with respect to the monitoring of central venous pressure and
central venous oxygen and the use of intravenous fluids, vasopressors, inotropes,
and blood transfusions. By 60 days, there were 92 deaths in the protocol-based
EGDT group (21.0 %), 81 in the protocol-based standard therapy group (18.2 %),
and 86 in the usual care group (18.9 %) (relative risk with protocol-based
therapy versus usual care, 1.04; 95 % confidence interval, 0.82 to 1.31; P =
0.83; relative risk with protocol-based EGDT versus protocol-based standard
therapy, 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.
CONCLUSIONS: In a multicenter trial conducted in the tertiary care setting,
protocol-based resuscitation of patients in whom septic shock was diagnosed in
the emergency department did not improve outcomes.
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