The Surviving Sepsis Campaign recently released an update to the bundles of care it recommends for “sepsis” patients. (We'll get into that sepsis-in-quotes in a minute.) You may have heard of the three-hour bundle, which essentially means that you do a bunch of stuff (lactate, cultures, antibiotics, fluids) within three hours of the patient declaring himself as having severe sepsis. If you don't do all the stuff—say, for example, the patient got antibiotics prior to blood cultures—you get an F even if you did everything else.
The campaign made a dramatic change to how we define sepsis and how we risk-stratify patients in 2016. (JAMA 2016;315:801; http://bit.ly/2MYmXBo.) You undoubtedly have heard of the SOFA score or the qSOFA score and that our traditional SIRS criteria were unfortunately not sensitive enough (and have never been very specific) for sepsis, which they called Sepsis-3.
Definitions in medicine and in research are critically important for the same reason researchers often jump right to the methodology section of a paper. If your definitions are lacking, your research can't be good. Garbage definitions in, garbage outcomes out. So Sepsis-3 redefined everything.
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. SIRS was bad, so you'll note no vital signs are in this definition of sepsis. Next, organ dysfunction can be identified as an acute change in total SOFA score ≥2 points consequent to the infection. (Assume the baseline SOFA score is zero in patients without known baseline organ dysfunction.) OK, you think to yourself, an objective score to tell me who is septic. Great! And then you see the components of the score: PaO2, FiO2, platelet count, GCS, bilirubin, blood pressure or use of pressors, and creatinine or urine output per day.
Here's where you probably should start to get a little worried because the diagnosis of sepsis, according to Sepsis-3, requires an ABG, CBC, chemistry panel, and LFTs to rule it out. Granted, you're septic if you're hypotensive or super-altered and the suspicion is that your hypotension or altered mental status is due to infection. Sounds reasonable. But throw in the rest of the items, and, oof, you start to scratch your head. (The SOFA score, as you might imagine, was developed by the European Society of Intensive Care Medicine, and is really well validated—in ICU patients.)
Sick patients are obviously much easier to define and agree upon: Patients with septic shock can be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP of ≥65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation.
One Short Hour
I'm not getting into defining adequate volume resuscitation; that's another article. And you'll note I never defined severe sepsis because Sepsis-3 retired it as a redundant term that didn't fit with the new “sepsis” and “septic shock” definitions.
Those are the new definitions, and the new bundle, finally upgraded this year, is pretty different. At first glance, it actually looks similar:
- Measure a lactate and measure again if it is more than 2.
- Do blood cultures before antibiotics.
- Give broad-spectrum antibiotics.
- Give 30 mL/kg of IV fluids rapidly for patients who are hypotensive or have a lactate of 4 or more.
- The last recommendation is a little more interesting: Give pressors during or after fluid resuscitation for a target MAP of at least 65. Of course, do this within an hour of arrival to the emergency department.
I'll say that again to emphasize the point and because of my penchant for the dramatic: The new Sepsis-3 bundle requires all of five of those to be started within one hour of triage, unless the patient comes from another care venue. Then time zero (or time of presentation) is from the earliest chart annotation consistent with all elements of sepsis (formerly severe sepsis) or septic shock ascertained through chart review.
See the problem?
The initial three- and six-hour bundles required a bunch of stuff within three or six hours of the patient being declared as having severe sepsis (a high lactate, the first episode of hypotension, etc.). The new bundle requires a bunch of stuff within one hour of ED arrival, regardless of when the patient is said to have severe sepsis (now called just sepsis).
If the patient is sent back to the waiting room because he had normal vital signs and a cough and is seen at minute 61, you fail. If he is seen immediately and becomes septic five hours into his ED stay, you fail. If he has the flu and you don't give antibiotics within an hour, you fail. If the patient is a difficult IV stick or requires immediate intubation and keeps coding for an hour, you fail. Feel free to think of your own examples.
Listen, I am all for aggressive, immediate resuscitation in the critically ill. I can't think of an emergency physician who is not. Pick your etiology: STEMI, GI bleed, sepsis, acute pulmonary edema; these are the cases we love. You come in and you're sick as all get-out? I will resuscitate the heck out of you. I'll even follow some arbitrary, arguably somewhat-evidence-based bundle recommendations and get blood cultures, give broad-spectrum antibiotics, and measure a lactate. I'll give pressors while I'm volume resuscitating (something new to my practice). I don't need an hour. We'll get it all started in five minutes and be done in 30.
But how in the world am I supposed to follow the bundle when I don't even know who I'm supposed to apply it to, and then need to do it all in 60 minutes? I talked to two of the authors of the bundle, and will bring you their responses in next month's column.
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