Sepsis Protocol Update

Sam.

For years, since the sepsis guidelines have been developed in 1991, there have been three international meetings to tweak them, to change what sepsis is and how to manage it. Up until this point, sepsis has always been defined as sirs. And the problem with that always has been it's very overly sensitive and nonspecific for infection. So many people who may have had trauma or burns or some other condition may develop some of those four criteria, of which you need two to say you have sirs, but sepsis was SIRS and proven or suspected infection. And the problem with that is infection is only proven about one third of the time. So many people are being treated via SIRS for sepsis that don't have sepsis. So as of February 2016, at the third international meeting of the Sepsis Guideline Committee, they've actually defined what sepsis is. And SIRS is no longer in as of February 2016. So over 30 different organizations have bought into this and have agreed with the new guidelines and the new definition. And the new definition is a life threatening organ failure secondary to a dysregulated host response to presumed or proven infection. So what's wrong with that? Well, when does a host response become dysregulated? You want your response to be regulated to fight the infection. That's one problem. Number two is what actually defines infection. And as we know, only one out of three people, you actually isolate an organism most times because you can't get into the tissue that's necessarily infected.

Alright, so we're going to be talking about our new septic shock protocol. And you'll see that we have our new antibiotics, the ceftriaxone and the gentamicin in this protocol. The first thing you'll notice is that we don't have the SIRS criteria listed anymore. We have something called heat. The reason why we changed to something called heat is because the surge criteria is really very broad. It catches too many different people. It's not specific enough to sepsis or septic shock specifically. But actually, when you look at the heat criteria, if you have two or more of these criteria, the odds in association with a suspect or documented infection that you're dealing with septic shock is quite high. So our heat criteria are the following. Number one is H for hypotension. Anyone less than 100 is considered hypotension by the heat criteria. E is end tidal CO2. End tidal CO2 less than 25 is documented to correlate very well with high lactic Acid level. Now remember, if you're in shock of any type, your lactic acid level goes up. Your body responds by blowing off CO2. So you have low CO2 or end tidal CO2 less than 25. For somebody in shock, A is for altered mental status. Now be cautious on that because what we're looking for is new altered mental status or a change in the mental status. So for example, let's say you've got somebody who normally has mild dementia and now they're unconscious. Well, that would be altered mental status for that person. But just if they're confused and they're normally confused, that is not altered mental status. What we're looking for is a change from their baseline status for the altered mental status. And the last one, T is for tachypnea. And again, this goes along with shock of any cause. As your lactic acid level rises because the tissues are not getting enough oxygen and glucose to metabolize, acid level goes up. Your body compensates by breathing fast, which is tachypnea. Greater than 22 is what we're looking for there.

The reason why temperature has been taken away is because even somebody who's the most overwhelmingly septic patient in the hospital, they may have a temperature elevation twice in all the measurements. So it's not as reliable. First of all, you know, how do you take the temperature in a lot of patients? You know, you can't get an accurate temperature. Number two, when people are infected and they have fever, I always look at the maximum temperature in the 24 hour period, not the temperature that's going on right now. Often I'll get to a chart and the patient and the doctor has been afebrile. Yeah, at that moment you're looking at it. But eight hours ago they were 102 and they're looking at this moment because the body's going to regulate that temperature rapidly up and down.

So if you have two of the heat criteria, plus if you either documented infection or a suspected infection, keep in mind our folks that we suspect infection, high risk are folks that recently had an operation, that have indwelling catheters of any sort, those from nursing homes, elderly rundown to begin with. And of course anybody has a documented infection already being treated for pneumonia, already being treated for cellulitis, etc.

History, both from the patient, if they can provide it, or the family members of prior infections or what led up to them. Calling the EMS is going to be very, very important. You know, the history and physical. I've always said to medical residents, listen to the patient, they will tell you what's wrong. You have to hear it.

Those are examples of the people that we're looking for. Plus they have two of the heat criteria. Now we move into the antibiotics and our fluids.

So what actually changes the outcome of sepsis, which is the number one cause of death in hospitals? It causes one third of death in hospitals, more than myocardial infarction, more than stroke. And so we really need to know what makes a difference. If early goal directed therapy really doesn't make a difference, what does make a difference? Two things. Recognition that somebody may be septic, and secondly, appropriate antibiotics given within the first few hours. Why? Because if you think that the host is responding to an infection causing organ system failure, you need to do something to the infection to stop the whole cascade. And that's the best antibiotic given as quickly as possible. And that's the concept of giving antibiotics in the field, because we gain some.

Time once we recognize sepsis. There are two recommended treatments. The first is what we've been doing for years, which is to give the patient a fluid bolus. And that is still current guideline recommendation. But then most importantly, we give antibiotics because we want to deal with the root cause of the sepsis. And earlier is better.

The only thing that's ever really been proven is an antibiotic given as quickly as possible when it's recognized. Even greater information has come out about that than has come out about intravenous flu, which are goal directed therapy, then we need to supply the antibiotic. And if we look at people who are found in the home or in the workplace right now, or on the street, and by our criteria are felt to possibly be septic, then giving the antibiotics can make a big difference in their outcome. Because if you can turn off that dysregulated the response by fighting the offending organism faster, then it will make a difference. In fact, if you look at every study on sepsis throughout the last 25 years, the one thing that's withstood the test of time is the best antibiotic given as quickly as possible. So the idea of the medication, the only purpose of an antibiotic is to kill the bacteria as quickly as possible. It has no other effect. And the concept being that if you can kill the offending agent, then the war that's going on in our body and we become the collateral damage, the renal failure, the heart failure, the change in mental status, the hypotension, we're the collateral damage of that war. So if our antibiotic can eliminate what we're fighting quickly, then the war doesn't have to go on as vigorously and the collateral damage hopefully will cease or at least be suspended to some degree. So the purpose of the antibiotic is to kill the offending agent. Once when those bacteria invade a tissue, for whatever reason, they're more virulent, there's been some trauma, something else happens, then your body fights back, and that fight is the collateral damage that either causes a localized process, let's say a boil, or a systemic process, let's say sepsis. So if we can attack that bacteria, which is decided that day, to invade our body with an antibiotic and kill it before it does much damage and elicits a bad response, it's a win win. So the big risks in the field paramedics of giving the antibiotics we've chosen are a. Is there going to be an anaphylactic reaction? I'm not real concerned about a delayed rash as an allergic reaction. We're talking about an anaphylactic reaction. But the truth is, who's better to handle an anaphylactic reaction than the paramedics in the field? If somebody writes you a prescription in their office and you take it to the pharmacy and fill it and go home and take the antibiotic, you may have an anaphylactic reaction. The system doesn't know how the drug got into you, whether it's given to you intravenously, intramuscularly, or if you swallow it. So we don't seem to be concerned about that anaphylactic reaction, but we may be in the field. There's no difference. And who better can handle that? Secondly, the major concern that you'll hear is you're going to promote resistance. Well, we have strict criteria of who's going to meet sepsis criteria and may have an infection, as opposed to to the 78% of people who get an oral antibiotic when they go to their physician for a cold and the antibiotic is useless. So the concern for resistance, I think, is totally outweighed. The benefit of giving the antibiotic for sepsis totally outperforms the concern for developing resistance in the field.

Now, keep in mind, some of our hospital partners may be a little uncomfortable with this, and that's because we have something we call the CMS criteria. These are criteria that's set up from the Centers for Medicare and Medicaid Services that ties to hospital reimbursement. So if they don't follow their sepsis CMS criteria, then they could be dinged by Medicare and it could reduce their reimbursement. Keep in mind that you can reassure our hospital partners that we have already looked into these criteria. I've done this protocol in conjunction with an infectious disease specialist, and we are not impacting the hospital CMS criteria. If anything, we are helping them because we've already given the leaders of fluid, we've already identified the septic shock cases, the antibiotics. They get concerned because of this whole issue with blood cultures. So here's the thing.

With blood cultures, if the tissue's badly enough infected and most aren't, then you could get bacteria in the blood. But if it's badly enough infected, you still may get a positive blood culture, even after you gave them the antibiotic. Why? Because your one dose of antibiotic did not cure this tissue. If that was the case, why would I treat your pyelonephritis for 14 days? Why not just one dose? Right. You still have pyelonephritis, so you may still capture the blood culture. But as I said, the positive blood cultures, in fact, the pneumonia guidelines, our blood cultures are useless. The chance of getting a positive blood culture with pneumonia is almost nil. They basically said, don't wait for blood cultures to give antibiotics because they're useless.

But let's look at it from a clinical standpoint. The results don't come back for 24 to 48 hours. Well, by that time, your patient has either gotten better or they haven't gotten better. If they've gotten better, you've given them the right antibiotics. If they haven't gotten better, you're going to have to switch antibiotics anyway. So from a clinician standpoint, it's never really been tremendously useful to have blood cultures. So again, our focus always what's in the patient's best interest? Well, clearly, what's in the patient's best interest is to give antibiotics as soon as possible. So let's reassure our hospital partners that, you know what, the patients come first. We're not going to be dinging your CMS core measures, and we're going to be increasing, hopefully, the survival rate from septic shock.