The Survival of The Surviving Sepsis Campaign

T h e Su r v i v a l o f th e S u r v i v i n g
S e p s is C a mp ai g n
Rory Spiegel, MDa,b,*, Max Hockstein, MD
a,b
, Jessica Waters, MD
a
,
Munish Goyal, MDa
KEYWORDS
Sepsis Treatment bundles Surviving sepsis campaign
KEY POINTS
Care of the patient with sepsis should be individualized to the patient’s needs and guided
by the treating clinician.
Volume resuscitation in patients with sepsis should be undertaken with caution.
Lactic acid provides minimal insight into resuscitation progress.
INTRODUCTION
Even well-intentioned policies have great potential to cause harm. This statement is
vividly illustrated by the influential, yet controversial, Surviving Sepsis Campaign
(SSC) guidelines and subsequent CMS benchmarks. Despite low-quality evidence,
tendentious industry ties, and rebuke from the Infectious Disease Society of America
(IDSA), these benchmarks continue to eschew therapy driven by clinician expertise
and individual patient needs in favor of mandating an arbitrary, one-size-fits-all
approach that suspends clinical judgment and promotes indiscriminate use of treat-
ments that have the potential to cause great harm.1
HISTORICAL PERSPECTIVE OF THE SURVIVING SEPSIS CAMPAIGN
The creation of current SSC guidelines and treatment bundles has been surrounded
by controversy regarding both industry influence and the validity of their now-
mandated recommendations. The campaign published its first guidelines in 2004 in
Critical Care Medicine.2 The original sepsis guidelines were underpinned by the prin-
ciples of Early Goal-Directed Therapy (EGDT). EDGT was supported by a then-
landmark, though subsequently nonreproducible, study by Rivers and colleagues, a
small, single-center study that found mortality benefit in patients who received a
a
Department of Emergency Medicine, Medstar Washington Hospital Center, 110 Irving St,
Washington, DC 20010, USA; b Department of Critical Care Medicine, Medstar Washington
Hospital Center, Washington, DC 20010, USA
* Corresponding author. Department of Emergency Medicine, Medstar Washington Hospital
Center, Washington, DC 20010.
E-mail address: rory.j.spiegel@medstar.net
Med Clin N Am 106 (2022) 1109–1117

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reservados.
1110 Spiegel et al
protocol of therapies targeting measured goals for central venous pressure (CVP),
mean arterial pressure, and ScvO2.3–6
Beyond its shaky evidential foundation, controversy regarding industry funding
influencing committee recommendations plagued the SSC from its inception. The
SSC guidelines were initially developed by Eli Lilly as part of a commercial marketing
strategy for its product, Xigris (recombinant human activated protein C).7 Although the
touted benefits of Xigris were later disproved and subsequently removed from the
SCC’s recommendations, early ties to pharmaceutical companies continue to tarnish
the guidelines’ legitimacy.8
The first SSC care bundles were released as guidelines for clinicians in 2005 and
have been repeatedly updated when evidence supporting individual interventions
were refuted.5,8,9 The Severe Sepsis and Septic Shock Performance Measure Bundle,
known as SEP-1, is a performance measure (PM) initially developed by a number of
SCCM members, modeled closely after the SSC guidelines and was similarly muddied
by industry ties.10 In 2008, Henry Ford Hospital initially submitted its PM to the Na-
tional Quality Forum (NQF), which evaluates performance metrics for CMS. It was
not endorsed in its entirety until 2012, when it was approved despite both Henry
Ford Hospital and one of the PM investigators holding the patent to a CVP and
ScvO2 catheter that would allow for implementation of a measure requiring CVP
and ScvO2-guided hemodynamic support, an intervention later found to have no
benefit over usual care and that was subsequently dropped.4,10,11
After endorsement by the NQF, SEP-1 was formally adopted by CMS in 2015, tying
hospital reimbursement to implementation of 3-hour and 6-hour target bundles. By
2017, this required reporting of up to 7 unproven hemodynamic interventions and po-
tential completion of up to 141 tasks within 3 hours for one patient.12 An examination
of the evidence supporting the hemodynamic interventions mandated by SEP-1 found
that the CMS guidelines relied on low-quality studies without proven mortality
benefit.11 In 2018, the SCC updated their recommendations, dissolving the 3- and
6-hour bundles that many hospitals have struggled to implement in favor of a 1-
hour bundle.13,14 The evolution of the SCC bundles can be seen in Table 1.
THE SURVIVING SEPSIS CAMPAIGN: A PROBLEMATIC PROTOCOL
The first unproven assumption is whether treatment bundles similar to those promoted by
the SSC are beneficial. It is important to note that protocolized care has never been defin-
itively demonstrated to be superior to individualized treatment guided by the bedside
clinician. Arguments for the use of protocolized care have their roots in early goal-
directed therapy, citing its overwhelming superiority compared with standard care. But
the benefits seen in this small, single-center study were not replicated in any of the 3 sub-
sequent large, high-quality, multicenter randomized controlled trials (RCTs). All of those
studies demonstrated no benefit to protocolized hemodynamic resuscitation when
compared with the unstructured judgment of the treating physician.3–6
Second, the SCC guidelines and similar bundles assume that earlier treatment is
universally better. Support of such beliefs can be attributed to a number of datasets
reporting a temporal benefit associated with earlier completion of the sepsis
bundle.15–19 The common finding of these studies is a statistically significant increase
in mortality for every hour delay. Unfortunately, due to the methodological shortcom-
ings and concomitant bias inherent to these studies, we are incapable of reaching the
conclusion that early care is universally better care. To illustrate these flaws, the au-
thors examine the largest and most well-done study used to support bundled care,
reservados.
The Surviving Sepsis Campaign 1111
Table 1
The historical evolution of the Surviving Sepsis Campaign treatment bundles
20042 200834 201235 201814

6 hours 3 hours 1 hour
CVP 8–12 mm Measure lactate level
Hg Obtain blood cultures before administration of antibiotics
MAP 65 mm Hg Administer broad spectrum antibiotics
UO 0.5 mL/kg1/h Administer 30 mL/kg crystalloid for hypotension or lactate
ScvO2 70% 4 mmol/L
If aforementioned 2018: apply vasopressors if patient is hypotensive during or after
goals are not fluid resuscitation to MAP 65 mm Hg
achieved,
transfuse
packed red
blood cells to
achieve a
hematocrit of
30% and/or
administer a
dobutamine
infusion to
achieve this
goal.
24 hours 6 hours
Low-dose Vasopressors (for hypotension that does not respond
steroids to initial fluid resuscitation) to maintain MAP
Human 65 mm Hg
activated In the event of persistent arterial hypotension despite
protein C volume resuscitation or initial lactate 4 mmol/L:
Glucose 70– Measure CVP
150 mg/dL Measure ScvO2
Median plateau Remeasure lactate if initial lactate was elevated
pressure <
30 cm H2O
Time to Treatment and Mortality during Mandated Emergency Care for Sepsis, pub-
lished in the NEJM in 2017 by Seymour and colleagues.17
The investigators performed a retrospective analysis of 185 hospitals involved in the
New York State Department of Health sepsis registry database. Patients were
included in this analysis if they were treated according to a prespecified 3-hour treat-
ment bundle within 6 hours of presentation to the Emergency Department. Although
the bundles varied from hospital to hospital, all participating centers were required
to obtain blood cultures before administering antibiotics, measure serum lactate level,
and administer broad-spectrum antibiotics. The investigators included patients older
than 17 years who had either severe sepsis or septic shock as defined by the 2001 In-
ternational Sepsis Definitions.20
Seymour and colleagues examined 49,331 patients seen at 149 Emergency Depart-
ments from April 2014 to June 2016. The median time to complete the 3-hour bundle
was 1.30 hours, to administer broad-spectrum antibiotics was 0.95 hours, and to com-
plete the initial fluid bolus (30 mL/kg) was 2.56 hours. Using an internally derived and
validated risk model using 10% of the cohort, the investigators performed a multivari-
able regression on the remaining 90% of the cohort and determined that each hour
reservados.
1112 Spiegel et al
required to complete the 3-hour bundle was associated with a statistically significant in-
crease in mortality (odds ratio of 1.04/h; 95% confidence interval [CI], 1.02–1.05;
P < 0.001). This same association was seen with the time to administration of broad-
spectrum antibiotics (odds ratio 1.04/h; 95% CI, 1.03–1.06; P < 0.001), time to comple-
tion of blood cultures (odds ratio 1.04/h; 95% CI, 1.02–1.06; P < 0.001), and time to
obtaining serum lactate (odds ratio of 1.04/h; 95% CI, 1.02–1.06; P < 0.001), the latter
two presumably serving as surrogates for the prior. Notably, this association was not
demonstrated when the time to completion of fluid bolus was examined in isolation
(odds ratio for mortality 1.01/h; 95% CI, 0.99–1.02; P 5 0.21).
Despite rigorous design, such retrospective analyses have inherent methodological
issues, limiting the conclusions one can draw from such data. All of these studies
including the one highlighted earlier by Seymour and colleagues are observational co-
horts that separate patients by time to intervention. As patients were not randomized
to receive treatment at a certain time threshold, causative statements cannot be
made. Hershey and colleagues21 illustrate a progressive decrease in sepsis-related
mortality, describing that sepsis-related mortality has been falling over time nation-
wide, with or without mandatory bundled care.
Further, even if one is to disregard their methodology, the effect sizes reported in
these trials are minimal and driven by those patients with septic shock. The analysis
by Seymour and colleagues17 published in the NEJM reports a 1.04 (95% CI, 1.03–
1.06) increase in the odds of death for every hour delay to completion of the 3-hour
sepsis bundle. Essentially, for every 148 patients in whom the completion of the sepsis
bundle is delayed by 1 hour, one additional person will die. These temporal benefits for
early treatment were only present in the sickest subset of patients, suggesting that
when applied to a general ED population, any benefit that may exist in this selected
cohort will be diluted out.
In fact, the only prospective RCT evaluating early antibiotic administration in an un-
differentiated cohort of patients with suspected infection found no benefit. The PHAN-
TASi trial, published by Alam and colleagues22 in the Lancet, examined the effects of
prehospital antibiotics in a cohort of patients with suspected infection. The investiga-
tors randomized patients with a diagnosed or suspected infection, to either usual care
(typically intravenous (IV) fluid resuscitation and supplemental O2) or traditional care
plus open-label IV ceftriaxone.
Between June 2014 and June 2016, the investigators enrolled 2698 patients, of
whom 1548 were assigned to the intervention and 1150 to the usual care group.
The prehospital administration of antibiotics reduced the time to antibiotic administra-
tion by 96 minutes. Despite this temporal benefit, the investigators reported no differ-
ence in their primary outcome, 28-day mortality, between the prehospital antibiotic
group and standard care (8% in both groups). Nor did they observe a difference in
90-day mortality (12% in both groups), the rate of intensive care unit (ICU) admissions
(10% vs 9%), and hospital or ICU length of stay. Notably, less than 4% of study par-
ticipants had septic shock limiting extrapolation of this finding to the sickest subset of
septic patients.
A third flawed assumption is that all components of the bundle are equally effica-
cious and Should be applied with uniform zeal. Although early appropriate antibiotic
administration is paramount to the management of septic shock, the remainder of
the current bundle has very little evidence supporting its use. When Seymour and col-
leagues examined the individual components of the sepsis bundle, they noted that
time to antibiotic administration showed similar temporal benefits to completion of
the entire sepsis bundle, whereas the time to fluid bolus administration did not.
Andrews and colleagues further question the benefit of early protocolized care in their
reservados.
RCT of a 6-hour hemodynamic resuscitation protocol versus usual, clinician-directed

care performed in a resource-limited setting in adults with sepsis and hypotension.
Although participants randomized to protocolized care received more fluid and were
more likely to receive vasopressors in the first 6 hours of their care, in-hospital mortal-
ity was 15% higher than those randomized to usual care.23 The investigators observed
that the rates of resolution of shock were equal between groups. In contrast, signs of
harm from fluid overload were far more prevalent in the protocolized care group; this
calls into question the hemodynamic utility of a fluid bolus and whether timely source
control is enough.
The use of serum lactate to guide ongoing resuscitation as recommended by the
SSC is not only not supported by evidence, given our current understanding of the
cause of hyperlactatemia in sepsis, but also it is nonsensical. Since William Hucka-
bee’s publications in 1958, lactate has been an understood byproduct of anaerobic
metabolism.24 For patients in states of hypoperfusion, delivery of oxygen to tissues
decreases, lowering its availability to act as the final electron acceptor in oxidative
phosphorylation. As such, cellular metabolism shifts to anaerobic from aerobic meta-
bolism resulting in type A lactic acidosis. The logical pathway that follows is that
elevated serum lactate levels in sepsis are due to shock, leading to end-organ hypo-
perfusion. IV fluid administration will increase venous return and cardiac output, thus
improving end-organ perfusion and subsequently clearing elevated lactate levels. Un-
fortunately, this physiological rationale falls apart at every step when examined
closely.
First, the mechanisms for elevated lactate values in sepsis are multifactorial. They
are primarily driven by circulating endogenous catecholamines and metabolic distur-
bances caused by sepsis-induced inflammatory mediators.25 As end-organ hypoper-
fusion is not the principal driver of lactate values in sepsis, the assumption that using
lactate as a therapeutic end point of fluid-resuscitation is misguided. Second, an
elevated lactate value neither defines shock type nor guides its management if shock
is present. Serum lactate levels can be elevated in all forms of shock, which have var-
ied responses to IV fluid administration. Third, even in patients with shock due to
sepsis, serum lactate levels do not differentiate patients who will augment their car-
diac output from patients who will not. Finally, among patients who improve their car-
diac output following IV fluid administration, these improvements are often transient, a
return to baseline levels shortly following the fluid administration.
These flaws in a lactate-guided resuscitation strategy were illustrated by the find-
ings of the ANDROMEDA-SHOCK investigation.26 The investigators found that pa-
tients randomized to the lactate-driven protocol did notably worse than their
counterparts randomized to a protocol driven by capillary refill. Lactate reduction at
fixed time points (eg, 6 h) is associated with improved mortality; however, a number
of confounders, for example, the initiation of concomitant vasoactive infusions, pre-
vent what may seem to be a straightforward interpretation.27 As such, although lactate
should be viewed as a prognostic marker of ongoing resuscitative efforts, it should be
detached from the ongoing decisions of IV fluid administration.
Finally, most of the studies examining the temporal benefit of various treatments in
sepsis approach this question from a very finite vantage. By examining only the pa-
tients retrospectively determined to have sepsis, investigators excluded patients
without sepsis who are exposed to all the risks associated with broad spectrum an-
tibiotics, large volume fluid resuscitation, and having blood cultures obtained without
any potential for benefit. As such, the harm they are exposed to from overtreatment
is purged from the subsequent analysis and unquantifiable. It is these unintended
and unmeasured consequences that are most concerning. Each of us has been
reservados.
1114 Spiegel et al
witness to the victims of overzealous sepsis care: in a patient presenting with sus-
pected pneumonia only after the CMS-mandated 30 mL/kg fluid challenge does it
become apparent their symptoms were not infectious but due to underlying cardiac
infirmity. How many patients receive broad-spectrum antibiotics and large volume
fluid resuscitation needlessly? And what about blood cultures? How many patients
experience the pain from multiple needle sticks let alone the added expense, antimi-
crobial exposure, and hospital length of stay associated with false positives? How
many patients do we screen in order to identify the few that may benefit from aggres-
sive care?
No one would argue against an aggressive and timely resuscitation in the face of a
patient presenting with septic shock, but this is not the mandate the SSC guideline
promotes. Achieving the 3-hour treatment bundle is challenging enough for most hos-
pitals; most centers increase sepsis-bundle compliance not by improving the quality
of care but by entering anyone with even the smallest sign of physiological derange-
ment into the sepsis pathway.28,29 Compressing the time required to complete these
quality measures will only heighten these “beat the clock strategies.” Filbin and col-
leagues30 report that despite implementation of a robust sepsis screening and treat-
ment protocol, 71% of the patients were unable to reach the 1-hour treatment
mandate outlined by the 2018 SSC. This resource-heavy protocolized metric of care
is based on an overreaching interpretation of evidence, which when reviewed in total-
ity, suggests the futility of such bluntly applied endeavors.
WHAT LIES BEYOND THE SURVIVING SEPSIS CAMPAIGN TREATMENT BUNDLES?
Although the SSC experienced wide-spread support for many years, recently there
has been a growing dissent due to the guidelines’ lack of high-quality evidence sup-
porting most of their claims and the logistical burdens these guidelines have placed on
health care systems. The Infectious Disease Society of America (IDSA) and the Amer-
ican College of Emergency Physicians (ACEP) have published their own position arti-
cles on the management of patients with sepsis and septic shock.
Compared with the SSC, these guidelines limit their recommendations to what is
supported by the current evidence. For example, the SSC continues to recommend
an empiric 30 mL/kg initial fluid bolus and to guide ongoing resuscitative efforts using
serum lactate levels. The ACEP clinical policy does not endorse an empirical fluid
bolus but rather recommends individualized fluid resuscitation needs for each patient.
Nor do they recommend the use of serum lactate levels to guide ongoing IV fluid
resuscitation, as it has not been found to be an accurate marker of ongoing fluid
needs. The SSC continues to recommend the SIRS criteria as a tool to screen patients
with sepsis and septic shock despite evidence demonstrating its poor diagnostic ac-
curacy. In the IDSA’s position article, the investigators recommend against using the
SIRS criteria due to its poor specificity, recommending instead using the simple
criteria of suspected infection and signs of shock.
In the end, guidance documents published on the management of sepsis and septic
shock should discuss how best to identify patients who will truly benefit from timely
aggressive care and what interventions are supported by the current evidence. Policy
makers need to understand the interplay between sensitivity and specificity when rec-
ommending a screening tool. We will never be able to identify every patient who goes
on to develop sepsis at time zero, without broadening our catchment population so
large as to render the screening tool functionally useless. Rather, when selecting a
tool to aid clinicians in identifying patients with sepsis, it should focus on identifying
the subset of patients who truly do benefit from timely care.
reservados.
Moreover, future policies should embrace the concept that sepsis is not a monolith.
Rather it is a syndrome that originates from a multitude of sources, and the physiolog-
ical derangements observed in any one patient are a result of the interplay of the host’s
specific physiology, environmental factors, and infectious source. It is naive to think
such complexities can be addressed by blunt tools such as treatment bundles. Policy
makers should encourage early evaluation by a clinician experienced in the manage-
ment of sepsis and treatment individualized to each specific patient’s underlying phys-
iologic perturbations. Most importantly, they should avoid policies mandating care
bundles that do not have compelling evidence to support their implementation.
They must consider the inevitable burdens and opportunity costs mandates create
on clinicians and hospital systems alike.
SUMMARY
Although well intentioned, the Surviving Sepsis guidelines in all their iterations have
laid a heavy weight on already overstressed health care systems,31 all without any
evidence of benefit, nor knowledge of the logistical consequences such recommenda-
tions will cost.32,33 Consider the consequences of blindly adhering to these broad-
reaching, resource-laden protocols, not only for the patients with sepsis, but for those
without, needlessly exposed to these aggressive treatment bundles. Consider the
consequences for the hospitals charged with the task of differentiating the sick from
the well and applying radial traction to their already scarce resources. If we fail to
do so, there may come a time in the not-so-distant future when we look back upon
our marginal gains in sepsis care, only to discover we have quite literally drowned
an entire populace in our endeavors.
CLINICS CARE POINTS
In the care of patients with sepsis, protocolized care has never been definitively
demonstrated to be superior to individualized treatment guided by the bedside clinician.
Although it is assumed, earlier treatment is universally better in the care of patients with
sepsis; this too is not supported by the evidence.
Because end-organ hypoperfusion is not the principal driver of lactate values in sepsis, the
assumption that using lactate as a therapeutic end point of fluid-resuscitation is misguided.
DISCLOSURE
The authors have nothing to disclose.
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T h e Su r v i v a l o f th e S u r v i v i n g

HISTORICAL PERSPECTIVE OF THE SURVIVING SEPSIS CAMPAIGN

Med Clin N Am 106 (2022) 1109–1117

THE SURVIVING SEPSIS CAMPAIGN: A PROBLEMATIC PROTOCOL

20042 200834 201235 201814

RCT of a 6-hour hemodynamic resuscitation protocol versus usual, clinician-directed

WHAT LIES BEYOND THE SURVIVING SEPSIS CAMPAIGN TREATMENT BUNDLES?

CLINICS CARE POINTS

The authors have nothing to disclose.

Descargado para Anonymous User (n/a) en Cayetano Heredia Pervuvian University de

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