The Surviving Sepsis
Campaign has focused for several years on reducing the morbidity and
mortality from sepsis. Early recognition and aggressive treatment of sepsis are
key to survival in patients with sepsis. But recognizing patients at risk for
sepsis and septic shock earlier has always been challenging.
Now researchers at Johns Hopkins (Henry 2015) used 27 routinely available physiological and
laboratory data from intensive care unit patients to develop the TREWScore (Targeted Real-time Early Warning Score), an early warning score that predicts which
patients are at risk for septic shock. The TREWScore
identified patients before the onset of septic shock with a sensitivity of 0.85
and specificity of 0.67 and identified patients a median of 28.2 hours before
onset of septic shock. Of those identified, two-thirds were identified before
any sepsis-related organ dysfunction. Compared to using the MEWS (modified
early warning score), the TREWScore demonstrated a 58.6%
increase in the number of patients identified before sepsis-related organ
failure. The authors conclude that continuous
sampling of data from the electronic health records and calculation of TREWScore may allow clinicians to identify patients at risk
for septic shock and provide earlier interventions that would prevent or
mitigate the associated morbidity and mortality.
This is not the
first effort to use information technology to help identify sepsis earlier. In
our March 15, 2011 Patient Safety Tip of the Week “Early
Warnings for Sepsis” we noted that investigators at Barnes-Jewish Hospital
in St. Louis had published preliminary results of a system of real-time computerized alerts for possible
sepsis in non-ICU patients (Sawyer
2011). Through review of prior cases the same group of investigators had
derived and validated a real-time computerized prediction tool (Thiel 2010).
That tool contains both information from vital signs monitoring and a variety
of laboratory parameters. When the prediction tool identified a patient on the
medicine ward with possible sepsis, an alert
was sent automatically (via text page) to the charge nurse on that ward.
That nurse would then assess the patient and notify the covering physician, who
would decide on any further course of action. Their results showed that
patients in the intervention group were more likely to have an increased rate
of interventions (such as antibiotic escalation, fluid therapy, oxygen,
cultures and other diagnostic tests, etc.) within 12 hours than the nonintervention
group. Though both groups had the same rate of transfer to the ICU, those in
the intervention group were transferred earlier on average. However, there was
no difference in mortality or total hospital length of stay between the two
groups, though this pilot study was underpowered to show any such difference.
And earlier this year we noted a study by Umsheid and colleagues that demonstrated that an early
warning and response system for sepsis resulted in a significant increase in
early sepsis care, ICU transfer, and sepsis documentation (Umscheid
2014). There was also a trend toward decreased sepsis mortality and
increased discharge to home that did not reach statistical significance. The
system was based on laboratory values and vital signs from the electronic
health record monitored in real time. If a patient had ≥4 predefined
abnormalities at any single time, the provider, nurse, and rapid response
coordinator were notified and performed an immediate bedside patient
evaluation.
And two studies presented in abstract form at specialty
society meetings this year also demonstrated encouraging results with IT-based
systems for early sepsis detection.
One was presented at the HIMSS annual meeting in April (Terry 2015) and discussed
an electronic alerting system, POC Advisor, developed by Huntsville Hospital
(in Alabama) in conjunction with Wolters-Kluwer. The system collects data from
the EMR, lab, nursing notes, and patient monitors and generates alerts for
nurses. The nurses then contact the responsible physician and a sepsis protocol
is begun. Sensitivity of the tool was 94-98% and specificity 96-99%. During use
of the tool mortality fell from 9% to 4.2%. However, in addition to use of the
tool, the hospital developed staff education, sepsis protocols, standardized
order sets, and sepsis teams. They did note, however, that sepsis deaths did
not fall on other floors involved in the study that did not use the alert tool.
The other was presented at the Society of Critical Care
Medicine Critical Care Conference in January (Melville 2015) and was
used to identify sepsis in trauma patients. It used 4 readily available
measures to create a predictive score. Twice-daily measures of the WBC count,
heart rate, respiratory rate, and temperature were each given a score of 0 to
4. A score of 4 or higher led to a nurse alerting the clinician, who
subsequently identified whether infection was present and initiated therapies.
The tool had a sensitivity of 92.5%, specificity of 97.4%, positive
predictive value of 73.5% and negative predictive value of 99.4%. Furthermore,
the researchers found that use of the tool was associated with a reduction in
the 30-day ICU mortality rate (from 13% down to 8%).
It’s not clear how
the latter 2 tools compare to the Hopkins-developed tool in terms of how soon
at-risk patients are identified. And it is quite likely that components of the
sepsis programs in addition to use of the early detection tools played a role
in the sepsis mortality improvements. Nevertheless, the ability of these new
sepsis prediction tools to identify likely cases earlier is very encouraging.
And there are
commercially available surveillance programs. The Cerner Sepsis Biosurveillance Program was recently implemented at Dignity
Health Sierra Nevada Memorial Hospital (Cooke
2015).
These sepsis early warning systems are arriving just in
time. CMS (The Centers for Medicare & Medicaid Services) has notified
hospitals participating in the inpatient quality reporting program that data
collection of the Severe Sepsis and Septic Shock: Management Bundle measure (NQF
#0500) will begin with discharges on or after Oct. 1, 2015 (QualityNet
2015). Key elements are as follows, with the timeframe for the first
three elements being within 3 hours, and the latter four elements (septic
shock) within 6 hours:
In our April 1, 2014
Patient Safety Tip of the Week “Expensive
Aspects of Sepsis Protocol Debunked” we discussed the results of the
ProCESS trial (The ProCESS Investigators 2014). The ProCESS
trial involved 31 medical centers and over 1300 patients with sepsis. The
patients were randomized to one of 3 treatment arms. One arm received the full
early goal-directed therapy (EGDT) protocol, which included the invasive
monitoring plus guidelines for vasopressors and blood transfusions. The second
arm also received management by a protocol but it did not require the invasive
monitoring, vasopressors/inotropes, or blood transfusions. The third arm was
the “usual care” group where the clinicians basically decided how to manage the
patient. The primary end-point of the trial, mortality at 60 days, did not
differ across the 3 trial arms. There were also no differences in secondary
outcomes such as 90-day mortality, one-year mortality, and need for organ
support.
In the accompanying editorial (Lilly 2014) Craig
Lilly, MD noted that guidelines such as those included in state legislation and
those endorsed by the National Quality Forum (NQF) needed to be updated now to
remove the requirement for central hemodynamic monitoring. It’s pretty clear
now that the expense and potential unintended consequences of such monitoring
are no longer necessary.
And, indeed, the Surviving
Sepsis Campaign has responded “With publication of 3 trials that do
not demonstrate superiority of required use of a central venous catheter (CVC)
to monitor central venous pressure (CVP) and central venous oxygen saturation
(ScvO2) in all patients with septic shock who have received timely antibiotics
and fluid resuscitation compared with controls or in all patients with lactate
>4 mmol/L, the SSC Executive Committee has revised
the improvement bundles.”
Also timely was a
review in the New England Journal of Medicine about what’s new in management of
septic shock, what is evidence-based and what is uncertain (Seymour 2015).
Seymour and Rosengart discuss in detail the studies
that led to removal of the need for protocolized
invasive early goal-directed therapy (EGDT) from management guidelines. They
provide a good discussion on use of focused ultrasound for assessing central
hemodynamics, markers of tissue injury, the types of fluids used in
resuscitation, the colloid vs. crystalloid issue, and which vasopressors are
recommended. They also noted that fluid overload is common in management of
septic shock and note uncertainty about the best ways to handle that. They also
note that, while measurement of serum lactate is universally recommended in
sepsis management, questions remain regarding lactate thresholds and frequency
of determination.
In our April 1, 2014
Patient Safety Tip of the Week “Expensive
Aspects of Sepsis Protocol Debunked” we did get on our soapbox to express
our opinion that some of the perceived improvements in sepsis morbidity and
mortality over the last decade may actually have been artifacts of changes in
hospital coding practices. The pneumonia patient happily walking up and down
the ward hallway pushing his IV pole might now be labelled as having sepsis
because he also happens to meet 2 of the 4 SIRS criteria. Hardly what we would
have envisioned as a septic patient years ago!
Nevertheless, we
still recognize the importance of early recognition, timely antibiotics and
adequate fluid resuscitation to reduce morbidity and mortality from sepsis.
Hopefully, as more hospitals develop and adopt these computerized tools to
identify sepsis earlier we will further reduce the morbidity and mortality from
sepsis.
References:
Surviving Sepsis Campaign. Website.
http://www.survivingsepsis.org/Pages/default.aspx
Henry KE, Hager DN, Pronovost PJ, Saria S. A targeted real-time early warning score (TREWScore) for septic shock. Science Translational Medicine 2015; 299(7): 299ra122; 05
Aug 2015
http://stm.sciencemag.org/content/7/299/299ra122
Sawyer AM., Deal EN, Labelle AJ, et al. Implementation of a
real-time computerized sepsis alert in nonintensive
care unit patients. Critical Care Medicine 2011; 39(3): 469-473
Thiel SW, Rosini JM, Shannon W, et
al. Early prediction of septic shock in hospitalized patients. J Hosp Med 2010; 5(1): 19-25
http://onlinelibrary.wiley.com/doi/10.1002/jhm.530/abstract
Umscheid CA, Betesh
J, VanZandbergen C, et al. Development,
implementation, and impact of an automated early warning and response system
for sepsis. J Hosp Med 2014; Article first published
online: 26 SEP 2014
http://onlinelibrary.wiley.com/doi/10.1002/jhm.2259/abstract
Terry K. Clinical Decision Support May Help Reduce Sepsis
Mortality. Medscape Conference News 2015; May 20, 2015
http://www.medscape.com/viewarticle/845051
Healthcare Information and Management Systems Society
(HIMSS) Annual Conference and Exhibition: Presentation 109. Presented April 14,
2015
Melville N. Sepsis Screening Tool Spots Subtle Signs, Saves
Lives. Medscape Medical News January 23, 2015
http://www.medscape.com/viewarticle/838645
Society of Critical Care Medicine (SCCM) 44th Critical Care
Congress: Abstract 8. Presented January 18, 2015
Cooke G. New tool at SNMH alerts doctors to potential sepsis
cases. The Union (Western Nevada County, CA) 2015; September 1, 2015
http://www.theunion.com/news/17971351-113/new-tool-at-snmh-alerts-doctors-to-potential
QualityNet. Specifications Manual,
Version 5.0a. Discharges 10/01/2015 to 06/30/2016. Sepsis Bundle Project (Sep)
National Hospital Inpatient Quality Measures (updated 5/29/2015)
The ProCESS Investigators. A
Randomized Trial of Protocol-Based Care for Early Septic Shock. N Engl J Med 2014; 370(18): 1683-93 published online March
18, 2014
http://www.nejm.org/doi/pdf/10.1056/NEJMoa1401602
Lilly CM. The ProCESS Trial - A
New Era of Sepsis Management. N Engl J Med 2014; 370(18):
1750-1751 published online March 18, 2014
http://www.nejm.org/doi/pdf/10.1056/NEJMe1402564
Surviving Sepsis Campaign. SSC Six-Hour Bundle Revised.
http://www.survivingsepsis.org/News/Pages/SSC-Six-Hour-Bundle-Revised.aspx
Seymour CW, Rosengart MR. Septic
Shock. Advances in Diagnosis and Treatment. JAMA 2015; 314(7): 708-717
http://jama.jamanetwork.com/article.aspx?articleid=2428960
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