What are systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis, and septic shock? If you are reading this — and you haven't been living in a cave — your and our definitions for these entities probably line up closely, thanks to early goal-directed therapy (EGDT) and the trove of research that followed, most notably the recent triumvirate of sepsis trials, ProCESS, ProMISE, and ARISE. (N Engl J Med 2001;345:1368; N Engl J Med 2014;370:1683; N Engl J Med 2015;372:1301; N Engl J Med 2014;371:1496.)
We also more or less agree on what to do about these conditions, which is recognize potential sepsis cases early, follow them closely, and give fluids and administer antibiotics as early as possible for patients in severe sepsis and septic shock.
We can quibble about the finer points about the diagnosis and management of these entities. We argue about it on blogs, in journals, and during conferences. The goal of these debates is to squeeze out just a few more saved lives. And if we disagree on the finer points? No big deal. Except now it might be.
For the first time, there is a real chance that your hospital might lose a significant portion of its funding in the not-so-distant future just because one or some of the debatable details of these definitions may be adopted into the guidelines of a veritable alphabet soup of quality watchdogs. The trouble is, these new definitions are neither evidence-based nor patient-centered. What's worse is that because adherence to some of the guidelines is compulsory under punishment of substantial financial penalties, the power simply to do what you think is best for your patients may be slipping away.
The way things look, the institutional bean counters won't care about outcomes or patient-tailored treatment. Instead, the difference between your hospital's survival — though not necessarily your patients' — will be determined by whether you checked the right boxes, no matter how right or wrong they may be. To understand what changes are coming down the pipeline, we first need to decode the alphabet soup and its hierarchy.
A Bad Idea
As far as sepsis is concerned, the Surviving Sepsis Campaign (SSC) is at the start of it all. As an independent organization, it wields no governmental power; its influence depends upon more powerful bodies adopting its ideas. One such body is the National Quality Forum (NQF), which similarly has no direct power to implement its quality recommendations. But many hospitals, governing bodies, and local and state organizations choose to adopt its recommendations when making policies. Activism at the hospital level makes it possible to alter which policies go into effect in our individual workplaces.
The NQF recommendations, however, frequently serve as the basis (if not the entirety) of the guidelines of the Centers for Medicare and Medicaid Services (CMS). These folks can really bring the hurt. Once CMS mandates a policy, failure to comply with its requirements can lead to your hospital losing reimbursement for the care it provides. The new NQF sepsis policies, despite being generated by doctors and then shepherded up the chain to CMS, are problematic. Let's take a look at what has happened.
The fun started in 2012 with the revision of the SSC guidelines pertaining to severe sepsis. (Crit Care Med 2013;41:580.) These new criteria were seemingly derived from a table in a 2003 paper with the only supporting evidence being a consensus panel from 2001. (Crit Care Med 2003;31:1250.) Interestingly, a seemingly small but, as we will see, important nugget was included: The observed features of severe sepsis must be “thought to be due to the infection.” Seems like a small detail. It isn't.
We all joke about the patient who got dizzy while hurrying to dialysis. He has SIRS, but he wouldn't be considered severe sepsis because of his measured creatinine of 4.5. That's his baseline. Because, you reason, the severe sepsis-defining features are not from any infection, so you would not be obligated to treat him as severe sepsis just because of his creatinine. The same does not hold true for the next set of guidelines.
The NQF has also reimagined septic shock. (http://bit.ly/1HJpVBH.) Suddenly, a lactate ≥4 now defines septic shock. That's quite a jump for lactate! Both during the EGDT era and today (triumvirate era), a lactate of ≥4 can diagnose severe sepsis, not shock. Someone decided to concatenate the existing definitions of severe sepsis and septic shock and then redefine severe sepsis as a new entity. And that's a bad idea.
Mountains of evidence demonstrate that the old definitions of severe sepsis and septic shock resulted in a cohort where aggressive treatment resulted in mortality benefit. Only associations and guesses are linked to this new definition of severe sepsis. Treating all of the definitions as equals benefits nobody. And where does a MAP <70 come from? Every shred of sepsis evidence uses a MAP <65. It seems like they just made it up. It is untenable to hold every U.S. hospital accountable to arbitrary definitions that lack rigorous evidentiary support. And this support cannot simply be associated with mortality. It must be evidence that treating these newly defined patients aggressively results in more good than harm.
What does the NQF want us to do?
- A. Measure lactate level.
- B. Obtain blood cultures prior to antibiotics.
- C. Administer broad-spectrum antibiotics.
- D .Administer 30 ml/kg crystalloid for hypotension or lactate = 4 mmol/L.
- E. Apply vasopressors for hypotension that does not respond to initial fluid resuscitation to maintain a mean arterial pressure >=65.
- F. In the event of persistent hypotension after initial fluid administration (MAP <65 mm Hg) or if initial lactate was equal to 4 mmol/L, reassess volume status and tissue perfusion and document findings. A focused exam, including vital signs, cardiopulmonary, capillary refill, pulse, and skin findings, by a licensed independent practitioner or any other two items are required to meet the requirements:
- Measure CVP.
- Measure ScvO2.
- Bedside cardiovascular ultrasound.
- Dynamic assessment of fluid responsiveness with passive leg raise or fluid challenge.
- G. Remeasure lactate if initial lactate is elevated.
After item A, we run into problems. Let's run through them. B: When possible, get the cultures first, but the SSC addressed this correctly, recommending “obtaining appropriate cultures before antimicrobial therapy is initiated if such cultures do not cause significant delay (>45 minutes) in the start of antimicrobial(s) administration.”
C: Antibiotics? Sure. But a three-hour time limit from ED triage on administration? We've already dealt with the debacle of demanding early antibiotics for pneumonia. Outcomes were negative for patients, physicians, and hospitals. This is why it is crucial not to conflate sepsis with severe sepsis and septic shock. Let's get evidence-y for a second. Early antibiotics are associated with decreased mortality in patients with septic shock (i.e., EGDT/triumvirate definition) while delays do not affect mortality in nonseptic shock patients (even severe sepsis patients). (Crit Care 2015;19:194; Crit Care Med 2010;38:1045; Crit Care Med 2006;34:1589; Crit Care Med 2011;39:2066.)
Despite this evidence, giving antibiotics within three hours for patients with an initial lactate >/=4 makes intuitive sense, and this was done in each of the triumvirate studies. On the other hand, no evidence supports this practice for the NQF-redefined severe sepsis group. This portion of the measure should be rewritten.
D: Yes, but only using the EGDT/triumvirate definitions. E: Apparently, the NQF prefers cookie-cutter medicine over individualized medicine. What about a 50-kg 20-year-old woman whose baseline MAP is 60? F: An apparently desperate grab to keep big-brother ownership of what the triumvirate studies rendered unnecessary.
And now, tying the pain to the money. CMS's proposed Sepsis Bundle Project introduces yet another definition of severe sepsis. (http://bit.ly/1egPD5G.) Three criteria must be met within six hours of each other for severe sepsis for CMS:
- Documentation of suspected (or “possible”) source of clinical infection in provider progress notes
- ≥2 SIRS manifestations
- Organ dysfunction, evidenced by any one of the following:
- Systolic blood pressure (SBP) <90 or MAP <65 or an SBP decrease ≥40 mm Hg from the last previously recorded baseline for that specific patient
- Creatinine >2.0 or urine output < 0.5 mL/kg/hour for two hours
- Bilirubin >2 mg/dL (34.2 mmol/L)
- Platelet count <100,000
- INR >1.5 or aPTT >60 sec
- Lactate >2 mmol/L (18.0 mg/dL)
The bar for organ dysfunction is remarkably low. A single drop in BP, a lactate ≥2, or even an INR of 1.6, and, poof! Diagnosis: severe sepsis. Worse, the term sepsis-induced is absent. Here's hoping none of your patients has baseline creatinine of 2.1.
What would CMS have you do with the patients who meet their severe sepsis definition and guarantee measure compliance? Well, a whole bunch of things actually, only a couple of which are evidence-based.
Received within three hours of presentation of severe sepsis:
- Initial lactate level measurement
- Broad-spectrum or other antibiotics administered
- Blood cultures drawn prior to antibiotics
- And received within six hours of presentation of severe sepsis:
- Repeat lactate level measurement only if initial lactate level is elevated.
- And only if septic shock is present:
- Received within three hours of presentation of septic shock:
- Resuscitation with 30 ml/kg crystalloid fluids
- And only if hypotension persists after fluid administration, received within six hours of presentation of septic shock:
- And only if hypotension persists after fluid administration or initial lactate >=4 mmol/L, received within six hours of presentation of septic shock:
- Repeat volume status and tissue perfusion assessment consisting of either:
A focused exam including vital signs, cardiopulmonary exam, capillary refill evaluation, peripheral pulse evaluation, and skin examination OR any two of the following four: central venous pressure measurement, central venous oxygen measurement, bedside cardiovascular ultrasound, and passive leg raise or fluid challenge.
To understand this, we need to know how they are defining septic shock. There must be documentation of severe sepsis present and tissue hypoperfusion must persist in the hour after crystalloid fluid administration, evidenced by:
- Systolic blood pressure <90 or
- Mean arterial pressure <65 or
- A decrease in systolic blood pressure by >40 mm Hg from the last previously recorded SBP considered normal for that specific patient or
- Lactate level of >= 4 mmol/L
Back to a mixed up vision of septic shock.
So how do we fix the CMS measure?
- Keep the initial lactate.
- Limit the antibiotic requirement within three hours to the new definition of septic shock (not their new vision of severe sepsis).
- Eliminate the blood culture rule.
- Keep the 30 ml/kg of fluid for the septic shock patients (CMS definition), but allow clinicians to document why particular patients should not get this volume.
- Keep the vasopressors.
- Eliminate the focused exam.
Alternatively, everything could be fixed simply by limiting the inclusion criteria to patients with persistent hypotension after fluids or initial lactate ≥4. You know, the only definition that has actually been studied.
If the drafted CMS measure goes into effect, we are hosed. Because data will be collected retrospectively, hundreds of patients will be deemed severe sepsis who were never actually sick.
Government organizations do not invent this stuff. Behind every measure there is, somewhere, a group of physicians that made it happen. Just as medical malpractice would not exist without plaintiff witnesses, these measures would not exist without us. Let's fight back before it is too late.
This article began as a blog post on the EMCrit Blog athttp://emcrit.org. Expansion of some of the issues can be found athttp://emcrit.org/blogpost/current-state-of-severe-sepsis-quality-measures/.
Defining Severe Sepsis
Sepsis-induced tissue hypoperfusion or organ dysfunction (any of the following thought to be due to the infection):
- Sepsis-induced hypotension
- Lactate above upper limits laboratory normal
- Urine output <0.5mL/kg/hr for more than two hours despite adequate fluid resuscitation
- Acute lung injury with PaO2/FiO2 <250 in the absence of pneumonia as infection source
- Acute lung injury with PaO2/FiO2 <200 in the absence of pneumonia as infection source
- Creatinine >2 mg/dL (176.8 μmol/L)
- Bilirubin >2 mg/dL (34.2 μmol/L)
- Platelet count <100,000 μL
- Coagulopathy (international normalized ration >1.5)
Adapted from Levy MM, Fink MP, et al; 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med 2003;31(4):1250.
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