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The Hour-1 Bundle
14 Plays6 years ago
In this episode of Critical Matters, we discuss the Hour-1 Bundle for sepsis. The Surviving Sepsis Campaign has been working on improving outcomes for patients with sepsis for well over a decade. Today we are fortunate to have one of its leaders as a guest to discuss the 2018 update: The Hour-1 Bundle. Our guest is Mitchell Levy, MD, MCCM. Dr. Levy is Professor of Medicine and Division Chief, Pulmonary and Critical Care Medicine at the Alpert Medical School of Brown University in Providence, Rhode Island.
Additional Resources:
The Surviving Sepsis Campaign website. A wealth of resources for clinicians interested in improving outcomes for patients with sepsis and septic shock. http://www.survivingsepsis.org/Pages/default.aspx
The Surviving Sepsis Campaign Bundle: 2018 Update (The Hour-1-Bundle) http://www.survivingsepsis.org/SiteCollectionDocuments/Surviving-Sepsis-Campaign-Hour-1-Bundle-2018.pdf
Books Mentioned in This Episode:
Shambhala: The Sacred Path of the Warrior: https://www.amazon.com/Shambhala-Sacred-Warrior-Chogyam-Trungpa/dp/1611802326/ref=tmm_pap_swatch_0?_encoding=UTF8&qid=1528317558&sr=8-1
Recommended
Transcript
Introduction to Critical Matters Podcast
00:00:09
Speaker
Welcome to Critical Matters, a sound critical care podcast covering a broad range of topics related to the practice of intensive care medicine.
00:00:17
Speaker
And now, your host, Dr. Sergio Zanotti.
Understanding Sepsis: Impact and Costs
00:00:22
Speaker
Sepsis is a leading cause of morbidity and mortality in hospitalized patients and is the most expensive disease to treat in hospitals across the United States.
00:00:30
Speaker
The Surviving Sepsis Campaign has been working on improving outcomes for patients with sepsis for well over a decade.
Surviving Sepsis Campaign: Insights with Dr. Levy
00:00:36
Speaker
Today, we are fortunate to have one of its leaders as a guest to discuss the 2018 update, the Hour One Bundle.
00:00:44
Speaker
Our guest is Dr. Mitchell Levy, Professor of Medicine and Division Chief of Pulmonary and Critical Care Medicine at the Alpert Medical School of Brown University.
00:00:53
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Dr. Levy is also the Medical Director of the MICU at Rhode Island Hospital in Providence, Rhode Island.
00:00:58
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Dr. Levy is a world-class investigator, clinician, and teacher.
00:01:02
Speaker
He's a past president of the Society of Critical Care Medicine, a master of the College of Critical Care Medicine, and currently is a member of the Surviving Sepsis Campaign Executive Committee and is a Surviving Sepsis Campaign Guidelines author.
00:01:15
Speaker
Dr. Levy has published an impressive number of original studies within the field of critical care, including studies in ARDS, ethics, and sepsis.
00:01:24
Speaker
Most recently, Dr. Levy published the Surviving Sepsis Campaign Bundle 2018 update, which will be the topic of our conversation today.
00:01:32
Speaker
Mitchell, welcome to Critical Matters.
00:01:35
Speaker
Thanks, Sergio, and it's a pleasure to be here.
00:01:38
Speaker
and thanks for the invitation.
00:01:39
Speaker
Absolutely.
Origins and Goals of the Sepsis Initiative
00:01:40
Speaker
So I would like to start for our listeners who may be new to critical care or those of whom may have been living under a rock, if you could tell us a little bit about the Surviving Sepsis Campaign and its history.
00:01:53
Speaker
I'd be happy to.
00:01:54
Speaker
The Surviving Sepsis Campaign has, I think it's a remarkable example in medicine of an initiative that really has been based on grassroots
00:02:07
Speaker
That is that there were over started.
00:02:10
Speaker
The surviving steps campaign started in 2002.
00:02:14
Speaker
It was a sponsorship between the Society of Critical Care Medicine, the European Society of Intensive Care Medicine, and at that time, the International Sepsis Forum.
00:02:25
Speaker
Over time, the International Sepsis Forum dropped off and it was just the two critical care societies.
00:02:32
Speaker
So in 2002, we all came together with a group of
00:02:36
Speaker
with sepsis experts and committed to a 25% reduction in mortality over a five-year period globally and the development of evidence-based guidelines.
Evolution and Implementation of Sepsis Bundles
00:02:49
Speaker
And so over the next 10 years, it took us a little longer than five years, but over the next 10 years, we have now produced four iterations of the surviving sepsis campaign guidelines, which have become the gold standard for
00:03:04
Speaker
management of sepsis across the globe.
00:03:07
Speaker
We developed the initial sepsis bundles in partnership with the Institute for Healthcare Improvement, the IHI, which is probably the premier quality improvement institute in the United States founded by Don Berwick.
00:03:23
Speaker
And we partnered to develop the sepsis bundles, which we implemented starting in 2005 and then published two separate publications
00:03:34
Speaker
in 2010 and then again in 2015, which demonstrated over a seven and a half year period a 25% reduction, relative risk reduction, in sepsis mortality associated with increasing compliance with the sepsis bundle.
00:03:53
Speaker
And it was out of that, out of those data, and by the way, there are now over 60 manuscripts in the peer-reviewed literature using
00:04:03
Speaker
the sepsis bundles or some variation of our bundles that have demonstrated an associated reduction in mortality with improved compliance with these bundles.
00:04:13
Speaker
And it was all of that that led to the initiatives out of New York State and now the UK and the US looking at using bundles to improve outcomes in sepsis.
00:04:24
Speaker
So overall, I think, and I should say that the surviving sepsis campaign implementation phase
00:04:33
Speaker
was on three continents in Europe, North America, and Latin America and involved over 225 hospitals.
00:04:41
Speaker
And as I said at the beginning, one of the things that most impressed me is the amount of academic institutions was relatively small in the campaign.
00:04:51
Speaker
It was an
Global Impact and Increased Awareness
00:04:52
Speaker
unfunded initiative in which clinicians stepped up and decided that they could do better at managing patients with sepsis and they wanted to do the right thing.
00:05:02
Speaker
and they were committed, even without funding, to taking part in the campaign and changing care for the better for these patients who are critically ill with severe sepsis and septic shock.
00:05:12
Speaker
No, and I think that from the perspective of a practicing clinician, I think tremendous utility and good has been done with not only providing these several iterations of the guidelines, but also just bringing sepsis to the forefront of our discussion, not only among clinicians, but among different specialties and the lay public.
00:05:32
Speaker
And I think for a disease that kills and affects so many of our patients, that was something that clearly was lacking 15 years ago.
00:05:41
Speaker
Yeah, I think that's exactly right.
00:05:42
Speaker
And I do feel that one of the things that I take most pride in on behalf of the campaign is that you could say that we put sepsis on the map.
00:05:53
Speaker
When we started and you asked participants in any given talk, how many of you have a sepsis initiative in your hospital or your hospital network, there would be very few hands raised.
00:06:07
Speaker
And now any talk you give,
00:06:10
Speaker
there is almost no one who doesn't raise their hand because sepsis initiatives, hospital-wide sepsis initiatives are so underpresent right now.
Adapting Sepsis Treatment to New Knowledge
00:06:20
Speaker
And I think that one of the aspects that has always fascinated me about sepsis, Mitchell, is that obviously it's a syndrome and our knowledge about it, like everything in medicine, but I think particularly in sepsis, is very fluid.
00:06:33
Speaker
So this is not by any means things that are set in stone.
00:06:37
Speaker
And like you mentioned, the first iteration of the bundles included things at 24 hours that we don't do maybe today.
00:06:43
Speaker
But even then, it showed that improving compliance with a set of standards does drive performance and does improve mortality.
00:06:51
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And that continues to evolve.
00:06:53
Speaker
And I guess we're going to hear the latest evolution of the bundles a little bit later.
00:06:58
Speaker
Yeah, that's a very good point, Sergio.
00:07:00
Speaker
And I think one worth emphasizing.
00:07:03
Speaker
There has been a lot of controversy, as we all know,
00:07:06
Speaker
with the rapid adoption of some of the initiatives for which we advocated in the Surviving Sepsis Campaign.
00:07:16
Speaker
And many of the trials that looked positive initially later turned out to be negative.
00:07:21
Speaker
But I think that's very important.
00:07:23
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They were negative.
00:07:24
Speaker
They never demonstrated any evidence of harm.
00:07:27
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So the fact that we advocated for rapid adoption
00:07:33
Speaker
of research to the bedside, I think turned out to be accurate in that when we had to drop things from the bundle, like steroids or even drotrichogen alpha, it was because the subsequent trials were found to be negative, not that they caused harm.
Lean ICU Concept and Sepsis-3 Definitions
00:07:50
Speaker
And that's very important as we move forward in the future that we're comfortable advocating for adoption of research while at the same time acknowledging that we have to be flexible and be prepared to change.
00:08:02
Speaker
Absolutely.
00:08:03
Speaker
So one of the things that we talk about in our group within the concept, what we call the lean ICU is flexible regimentation, being regimented in terms of having a standard.
00:08:14
Speaker
And by that, we don't mean a cookbook, but basically these are the four or three essential elements that every patient with this disease must get or every process in the ICU must have.
00:08:24
Speaker
But then be very flexible that you're operating on best available evidence.
00:08:29
Speaker
So when there's better evidence that might indicate that we should do something different,
00:08:32
Speaker
you have to be able to change.
00:08:35
Speaker
That's exactly right.
00:08:37
Speaker
So let's talk about two topics that I think are often confused and might be source of some controversy among clinicians, but I really think it's important to just defining and differentiating what they mean in relation to the Surviving Sepsis Campaign.
00:08:52
Speaker
The first one is sepsis definitions.
00:08:54
Speaker
As I mentioned earlier, it's a syndrome.
00:08:56
Speaker
When you say this patient looks septic, I think it might mean something different for an ED physician, for an ICU physician, for a chart abstractor.
00:09:06
Speaker
But also with recent publications of sepsis-3 definitions, I think there's a lot of people who are still confused.
00:09:12
Speaker
Any comments you can make on that front, Mitchell?
00:09:16
Speaker
Yes.
00:09:18
Speaker
The sepsis-3 definition has...
00:09:24
Speaker
First of all, I should say that the committee that determined the definitions, the consensus group, was, although it was from the European Society of Intensive Care Medicine and the Society of Critical Care Medicine and a host of other supporting critical care societies, it was completely separate from the Surviving Sepsis Campaign.
00:09:44
Speaker
So although we adopted for the last iteration of the campaign guidelines the Sepsis III definitions,
00:09:52
Speaker
The campaign itself really was not involved in any official way.
00:09:57
Speaker
Some of us who are, of course, involved in both.
00:10:01
Speaker
Myself, for instance, is on the Executive and Steering Committee of the Surviving Sepsis Campaign and was on the task force for the new definition, but they're really separate entities.
00:10:11
Speaker
More importantly, our attempt at clarification with the sepsis-free definitions, in many ways you could say backfired.
00:10:19
Speaker
And you actually alluded to it, although I think unwittingly.
00:10:23
Speaker
So for years, two iterations, in fact, from 1991 and then again in 2001, the definitions were sepsis, severe sepsis, and septic shock.
00:10:36
Speaker
And as we all know, severe sepsis was infection, evidence of inflammation, and organ dysfunction.
00:10:44
Speaker
But the truth is, and therefore sepsis was only
00:10:48
Speaker
evidence of infection and inflammation.
00:10:51
Speaker
But the truth is clinicians, just as you said, Sergio, when they thought someone was getting sicker, they said, oh, Mrs. Jones looks like she's getting septic.
00:11:03
Speaker
We never said, Mrs. Jones looks like she's getting severely septic.
00:11:09
Speaker
And so the vernacular, if you will, at the bedside was sepsis was bad.
00:11:16
Speaker
But in fact,
00:11:17
Speaker
For the definition, sepsis was not bad.
00:11:20
Speaker
Sepsis just was the body's inflammatory response to infection, not necessarily bad.
00:11:26
Speaker
It didn't become bad until organ dysfunction became manifest, and therefore a patient met the criteria for severe sepsis.
00:11:35
Speaker
In the sepsis 3 group, we felt that it was really time to align the consensus definitions that were in use
00:11:46
Speaker
with the way we as clinicians use them at the bedside.
00:11:50
Speaker
That is, when someone has a simple pneumonia without organ dysfunction, we say this patient has pneumonia.
00:11:58
Speaker
If you send someone home from your office or even the emergency department without organ dysfunction but with a, quote, walking pneumonia, close quote, you don't say this patient was septic.
00:12:10
Speaker
But when someone then develops severe ARDS or renal failure,
00:12:16
Speaker
or hypotension because of their pneumonia, we say that patient's not septic and we admit them.
00:12:21
Speaker
So that's exactly what the change was with the new sepsis-3 definitions.
00:12:25
Speaker
We went from sepsis, severe sepsis, septic shock, to what we all felt on the task force was a more accurate way in which we all use it, which is infection, that is UTI or pneumonia, sepsis, which is pneumonia and evidence of organ dysfunction, and then, of course, septic shock.
00:12:46
Speaker
So I still feel that change in definition was the right way to go.
00:12:50
Speaker
The problem is, of course, for coding, especially in the United States, the coding now in the U.S. does not match the new definitions.
00:13:00
Speaker
And therefore, the uptake of the new definitions nationally have been very slow in the United States.
00:13:06
Speaker
And I think it causes a lot of confusion with providers that are not necessarily in the ICU, but are nurses and abstractors, because what it does ultimately is it lumps a whole bunch of patients who just have uncomplicated infections within these categories that we're trying to target and creates these big denominators that make our patients
00:13:30
Speaker
metrics look bad, but also make the mortality probably look better than it should.
00:13:35
Speaker
And I think that without definitions, just to clarify, Mitchell, moving forward, when we talk about the bundles, we're really talking about applying them to patients who have a suspected or documented infection with acute organ failure or who have progressed to
Regulatory and Campaign Bundles: SEP1 Measures
00:13:51
Speaker
a state of shock.
00:13:51
Speaker
Is that correct?
00:13:53
Speaker
That's absolutely correct.
00:13:55
Speaker
And you're 100% right.
00:13:56
Speaker
We wound up causing much more confusion than help
00:13:59
Speaker
And that's why in the United States, certainly for New York State and at the federal government level, they have specifically not adopted the sepsis three definitions so that the coding can be clear and clinicians can be clear.
00:14:13
Speaker
And as you said, most importantly about the appropriate denominator, because when you add the old sepsis term, which is no organ dysfunction, when you add those patients and their mortality rate,
00:14:26
Speaker
to the denominator of patients with organ dysfunction, everybody's mortality rate looks better.
00:14:32
Speaker
So the other topic that I wanted to ask you about was the SEP1 CMS bundles, which obviously are regulatory in every hospital that I know of is working and to some extent struggling with.
00:14:45
Speaker
Can you just make the distinction between that and the Surrounding Cephasis Campaign bundles and recommendations?
00:14:51
Speaker
Yes, and this is very important.
00:14:53
Speaker
Now, because...
00:14:55
Speaker
The two bundles have been conflated, not just in the mind of the public, but a lot of the controversy now that has been directed in the literature towards the surviving sepsis campaign conflates the SEP1 bundle with the surviving sepsis campaign bundle.
00:15:12
Speaker
Having said that, there's no question, and I take pride in this, that the data from the surviving sepsis campaign that demonstrated association between improved survival
00:15:24
Speaker
and the surviving sepsis campaign bundles are what drove the New York State government and the federal government to develop their own bundle so that they could drive change in clinical behavior to be more consistent with evidence-based practice.
00:15:43
Speaker
But the SEP1 bundle is truly a CMS measure.
00:15:48
Speaker
Now, a lot of the individual elements are similar
00:15:53
Speaker
to what we developed in the surviving sepsis campaign.
00:15:56
Speaker
However, the way of identifying the patients, the time zero that they use in SEP1 are very different than the surviving sepsis campaign.
00:16:07
Speaker
And the SEP1 bundle is not the surviving sepsis campaign bundle.
00:16:12
Speaker
So let's dive into the bundles now.
00:16:14
Speaker
And I guess we could start by defining for everybody just to make sure we're on the same page.
00:16:19
Speaker
What is a bundle?
00:16:22
Speaker
Yeah, that's a great question, Sergio.
Effectiveness of Sepsis Bundles: Evidence and Practice
00:16:24
Speaker
The bundle concept was really developed by the Institute for Healthcare Improvement.
00:16:31
Speaker
And the first bundles that were in use with IHI were the ventilator-associated pneumonia bundle and the central line-associated bloodstream infection bundle, the CLABSI bundle.
00:16:45
Speaker
And many of that work was, as we know, done by Peter Pronovost when he worked for the Institute for Healthcare Improvement.
00:16:52
Speaker
and people like Terry Clemmer from Latter-day Saints and Intermountain Healthcare in Salt Lake City, and Roger Resar, who worked with IHI, were really pioneers in developing bundles.
00:17:07
Speaker
The idea of a bundle is you define a set of interventions that are evidence-based and founded on recent literature, and that are not being adopted widely at the bedside currently.
00:17:22
Speaker
And the key to a bundle is that they're grouped together in time and easy to measure.
00:17:28
Speaker
So any element like, let's say blood cultures, should be able to be easily chart-abstracted and answered yes or no.
00:17:37
Speaker
Lactate, was it measured or not?
00:17:39
Speaker
If so, what was it?
00:17:41
Speaker
And so easy to measure, yes, no is one important key to a bundle.
00:17:46
Speaker
And the second is that they're grouped in time closely.
00:17:50
Speaker
So in other words,
00:17:52
Speaker
If you did a bundle where you measured it every Tuesday and Thursday of the second week in a month, clearly that's gonna be a very difficult bundle to monitor and measure.
00:18:04
Speaker
But therefore, many of the bundles are what happens in the first three hours, what happens in the first six hours, what happens in the first 24 hours.
00:18:13
Speaker
So easy to measure and grouped together in an easily identifiable time period
00:18:21
Speaker
are the two key aspects of bundle technology that makes it work.
00:18:26
Speaker
So, Mitchell, do bundles make a difference in patient outcomes?
00:18:29
Speaker
That's a great question, Sergio, and one that I'm amazed at.
00:18:35
Speaker
We still ask in 2018.
00:18:37
Speaker
I understand that for many years, the detractors of quality improvement and in particular the Surviving Sepsis Campaign repeatedly would say, well, there's no evidence that bundles work.
00:18:48
Speaker
I think that
00:18:50
Speaker
I think one has to acknowledge doing a review in the literature.
00:18:54
Speaker
And by the way, there are several published meta-analyses now.
00:18:58
Speaker
As I said earlier in this podcast, there are over 60 manuscripts in the peer-reviewed literature that demonstrate an association between improved compliance and decreased mortality with the use of sepsis bundles.
00:19:14
Speaker
And it's, by the way, not just sepsis bundles.
00:19:17
Speaker
But even if we just stick with the sepsis bundles,
00:19:20
Speaker
we've published two manuscripts one with 15,000 and the other with a total of 30,000 patients in critical care medicine and intensive care medicine showing a statistically significant increase over time in compliance that was associated with a statistically significant decrease in mortality we published recently in the New England Journal of Medicine Chris Seymour was the lead author and
00:19:50
Speaker
A demonstration of the time to completion of the three-hour bundle was every hour delay in the completion of the six-hour bundle was associated with about a 5% increase in the odds ratio of mortality, and that was in almost 70,000 patients.
00:20:10
Speaker
So for me, I think we have to put to rest this question of do bundles work in the face of this overwhelming
00:20:19
Speaker
amount of data in the literature that demonstrate a clear association between compliance and decreased mortality for using the sepsis bundles.
00:20:29
Speaker
And I think it's very important also in terms of distinguishing between some refer as cookbook medicine and implementing a bundle with some key elements that all we're saying is every patient should get this within this timeframe.
00:20:43
Speaker
And all that happens after that really is very complex and is going to depend on the clinician and each individual patient.
00:20:49
Speaker
But it's just assuring the basis of what we think is critical in terms of we'll talk about the elements in a second for every patient.
00:20:57
Speaker
Is that correct?
00:20:59
Speaker
I think that's exactly right.
00:21:00
Speaker
And I think I hear the objections quite frequently that this removes the art of medicine and inhibits our ability to teach young clinicians to trust their understanding of their own patient population.
00:21:14
Speaker
And I appreciate that.
00:21:16
Speaker
At the same time, as we all know, medicine has gotten so complex and our lives as caregivers has become so busy that it becomes easy, honestly, to just simply
00:21:28
Speaker
lose track of what we're doing at the bedside and to get to do the right thing.
00:21:32
Speaker
So the literature is clear that prompts, electronic medical record prompts, change care for the better and so does quality improvement using standardized care.
00:21:47
Speaker
So I feel that I understand the feelings of loss of autonomy and what that brings to a lot of physicians and at the same time
00:21:56
Speaker
If my relative comes in the hospital, I want to know that he or she is being treated with standardized approach to care.
00:22:06
Speaker
And I think that it also speaks, Mitchell, to basic human behavior.
00:22:10
Speaker
What we say we will do and what we do are always two different things, no matter what the topic is, how I treat a septic patient or when I will start my diet to lose some weight.
00:22:21
Speaker
It's exactly the same, and I think that we need to find ways to
00:22:25
Speaker
overcome that inertia, overcome those heuristics and all those biases that we have in human behavior to really make sure that our patients do the best they can.
00:22:34
Speaker
Yeah, I think that's a very good point.
00:22:37
Speaker
We published a number of pieces as part of the campaign with the difference between what we think we do at the bedside and what we do do at the bedside, and I think we all experience this.
00:22:47
Speaker
We leave as an attending physician with a patient on a certain settings, let's say,
00:22:53
Speaker
ventilator settings and ARDS and we come in in the morning and you realize that for the last 12 hours their care has not at all been consistent what we would like to think
00:23:02
Speaker
is the best care possible for these folks.
00:23:04
Speaker
Absolutely.
00:23:05
Speaker
So let's talk about the hour one bundle.
00:23:08
Speaker
And I guess words do matter.
00:23:11
Speaker
I did notice that it's called the hour one bundle as opposed to the one hour bundle, which would be what I think most people would think about it.
00:23:20
Speaker
But I suspect there's an important difference there.
00:23:22
Speaker
Can you explain that?
00:23:26
Speaker
Yeah.
00:23:26
Speaker
Yes.
00:23:27
Speaker
And I'm really happy you asked this because it is,
00:23:30
Speaker
one of the common misunderstandings from the publication last month.
00:23:36
Speaker
And what we tried to do is not dissimilar to what I described we tried to do with the new sepsis redefinition, sepsis-free.
00:23:44
Speaker
And that is, we remember we originally had six and 24-hour bundles.
00:23:49
Speaker
And then we had three and six-hour bundles.
00:23:51
Speaker
And we, as the, and by the way, the bundles for the Surviving Sepsis Campaign come from
00:23:58
Speaker
the evidence-based guidelines, and they're developed by a different panel than the guideline panel.
00:24:05
Speaker
They're developed by the Surviving Sepsis Campaign Steering Committee, which is made up of a group of experts from the European Society of Intensive Care Medicine and the Society of Critical Care Medicine in the US.
00:24:17
Speaker
So we felt when you think about it, and you have a critically ill patient with sepsis, and that's in the new definition, so someone with organ dysfunction,
00:24:27
Speaker
and or septic shock, we don't wait for three or six hours to give them fluids, to give them vasopressors, to give them antibiotics.
00:24:38
Speaker
In fact, when we see a patient in the emergency department, on the wards, or in the intensive care unit, and we say, this patient's septic, we don't go through these things sequentially.
00:24:51
Speaker
We do them all together.
00:24:52
Speaker
We order blood cultures.
00:24:54
Speaker
We order antibiotics.
00:24:56
Speaker
We start fluids.
00:24:57
Speaker
And honestly, if their main arterial pressure is low enough, while we're giving the fluids, we start vasopressors.
00:25:03
Speaker
So the idea is not that all of these things should be completed within an hour.
00:25:09
Speaker
Of course, we have the aspiration that you'll administer the antibiotics within an hour, but we never intended that two liters, let's say two liters, 30 cc per kilogram of fluid administration would be completed within an hour
00:25:25
Speaker
The idea behind hour one is as soon as you see this patient, but certainly within the hour that you see a patient, all these things should be started immediately.
00:25:35
Speaker
And I don't think this is revolutionary.
00:25:38
Speaker
And it's interesting to me that there's so much controversy around it, because in fact, I think that's the way we practice, which is you see someone and you treat them right away.
00:25:49
Speaker
I think that's an important distinction because I do think that right now in the current environment, a lot of people are measuring when the fluids are done, when the antibiotics are completed.
00:26:00
Speaker
And what you're really saying here is in the first hour of recognizing a patient with sepsis, which we have defined as somebody who has an infection, either suspected or documented, and acute organ failure, we should initiate these therapies.
00:26:15
Speaker
And I think that's really the directive.
00:26:19
Speaker
I think that's exactly right now there's also controversy about when recognized in the emergency department traditionally the surviving sepsis campaign has advocated for a time zero of triage time in the ED on the wards and in the intensive care unit it is through chart abstraction and it is when recognized and I think a lot of the objection in the from my ED colleagues is well-founded because I think there's a fear of
00:26:47
Speaker
that they will be held to a one-hour antibiotic administration within one hour of triage.
00:26:56
Speaker
And honestly, I think any of us, if our loved ones came in to the emergency department, we would like to think that that might be true.
00:27:06
Speaker
So that's why we call it aspirational.
00:27:09
Speaker
The hour one bundle, there's no intention that it's going to be adopted by CMS in the United States.
00:27:16
Speaker
We're seeing it as aspirational to get antibiotics started within an hour and completed as quickly as possible.
00:27:24
Speaker
And I think it speaks very strongly to what happens with mindsets.
00:27:31
Speaker
And there's a lot of literature on fixed mindsets, which are very prevalent in physicians, and growth mindsets.
00:27:37
Speaker
But I guess the quote that would summarize the intent from what I'm understanding, Mitchell, is that to become is better than being.
00:27:45
Speaker
And what we're trying to do is not attain perfection, but just improve what we're doing for our patients.
00:27:51
Speaker
I think that's exactly right.
00:27:53
Speaker
I think that's exactly right.
00:27:54
Speaker
And honestly, I think that the experience of the surviving sepsis campaign, the data that's emerged, support that assertion.
00:28:03
Speaker
So if I have a patient that I recognize as having a new infection and I recognize has acute organ failure, within that first hour, what should I do?
00:28:14
Speaker
What are the elements of the hour one bundle?
00:28:18
Speaker
I think that when you see a patient and you think that they have sepsis or septic shock,
00:28:23
Speaker
You should immediately get a blood culture and order a pain of lactate.
00:28:28
Speaker
You should immediately order a broad spectrum antibiotic.
00:28:31
Speaker
And if they're hypotensive or their lactate comes back that quickly, you should start 30 cc per kilogram.
00:28:39
Speaker
And then ultimately we measure the lactate at a time interval of whatever your local protocol is.
00:28:46
Speaker
And if the blood pressure does not respond to fluids or like you mentioned earlier, if it's still very low while I'm giving fluids, early administration of vasopressors to protect the MAP is important.
00:28:58
Speaker
Exactly.
00:28:58
Speaker
And I think that's a... Go ahead.
00:29:00
Speaker
Let me just clarify because I think this is very important.
00:29:03
Speaker
Again, I think that if someone's not severely hypotensive and their mean arterial pressure is in the 60 range, I would start the fluids right away.
00:29:15
Speaker
but I might wait on vasopressors.
00:29:16
Speaker
But again, I don't think any of us is faced with a patient whose map is 45 or 50.
00:29:25
Speaker
We wouldn't just start fluids and wait to see how they responded.
00:29:28
Speaker
We would start vasopressors and administer fluids at the same time.
00:29:33
Speaker
Absolutely.
00:29:33
Speaker
And I think it's worth, I mean, reemphasizing that this hour one bundle applies to patients who have infection or suspected infection with acute organ failure and not to anybody who has a uncomplicated infection.
Key Components of the Hour One Bundle
00:29:49
Speaker
So I think that some people do talk about this, but if you came in with unrelated symptoms and they find out you have a UTI, you do not need to do all these things.
00:29:58
Speaker
And I think that's a big distinction.
00:30:01
Speaker
And I also think, Mitchell, that it'd be worth exploring each one of these a little bit more before we wrap up.
00:30:08
Speaker
So let's talk about the lactate.
00:30:11
Speaker
What's the number that you should worry about?
00:30:14
Speaker
What are the triggers?
00:30:15
Speaker
And when should we remeasure it and why?
00:30:19
Speaker
Yes.
00:30:20
Speaker
So we kept, I think any lactate above your hospital laboratory's normal limits, which is usually 2.0 millimoles per liter,
00:30:32
Speaker
Identifies a patient at higher risk.
00:30:34
Speaker
We recently changed the definition of septic shock in February of 2016 to a lactate greater than 2.0 For the bundle we kept a lactate greater than 4.0 because we felt it identified a patient population that was at higher risk for death and we felt that
00:30:56
Speaker
comfortable especially because that's been the lactate level we've used up until now at keeping it at 4.0.
00:31:03
Speaker
So I think that's an important distinction.
00:31:05
Speaker
And I think the other thing that I would like you to comment on before we leave lactate behind is I see that a lot of clinicians have a hard time differentiating lactate as a diagnostic tool versus lactate as a risk assessment or prognosticator tool in terms that if you don't have infection, the lactate does not make you have sepsis.
00:31:29
Speaker
Can you explain that a little bit better?
00:31:30
Speaker
Yeah, I...
00:31:32
Speaker
I'm laughing only because you know, as well as I do, that we field an enormous amount of calls from clinicians who want to admit their patients to the intensive care unit because they have, quote, sepsis, close quote, as identified by a lactate.
00:31:49
Speaker
And I think it's really important to understand, obviously, lactate is metabolized through the liver.
00:31:55
Speaker
So anyone with chronic liver disease or liver dysfunction is going to have a
00:31:59
Speaker
chronically elevated lactate and be slow to clear an elevated lactate people with seizures obviously will have an elevated lactate there are a whole host of people with asthma can have a chronically can have an acutely elevated lactate from the acute asthmatic attack so there are a number of reasons apart from sepsis that can lead to elevated lactate and so it's very important for clinicians to understand that you start
00:32:27
Speaker
with a patient who you believe might have an infection, and then we obtain a lactate to determine whether this patient is either at higher risk or has evidence of severe hypoperfusion and therefore would benefit from fluid administration independent of hypotension.
00:32:46
Speaker
Absolutely.
00:32:47
Speaker
So let's talk a little bit about, I think with the blood cultures, it's self-evident in an age of resistance,
00:32:56
Speaker
If we can't de-escalate later, it's really difficult to manage antibiotics.
00:33:01
Speaker
And I think most people have no problem doing that.
00:33:04
Speaker
But let's talk a little bit about the antibiotics.
00:33:05
Speaker
What are your thoughts on antibiotics in terms of why we should give it early, how you would approach it?
00:33:11
Speaker
And also, you can comment a little bit of what you do as a clinician at 48 hours or later with your broad-spectrum antibiotics.
00:33:19
Speaker
Yes, Sergio, this is also an important question.
00:33:22
Speaker
As I said about bundles, I feel the same way about early antibiotics.
00:33:26
Speaker
I think now there are enough data in the literature, and Vinnie Liu from Kaiser Permanente in Northern California just published a really great manuscript in the American Journal of Respiratory and Critical Care Medicine.
00:33:40
Speaker
We've published some work out of the Surviving Sepsis Campaign, and obviously Anand Kumar published some of the original data, all of which pointed towards the fact
00:33:50
Speaker
that for every hour delay in the administration of appropriate broad-spectrum antibiotics, the odds ratio of mortality increases.
00:33:58
Speaker
Originally, the data were in only septic shock patients.
00:34:01
Speaker
Now they're in patients with severe sepsis or sepsis and septic shock.
00:34:05
Speaker
And I think the data are convincing to give antibiotics.
00:34:09
Speaker
I think what's important to remember is that in this era of antibiotic resistance, it's important to marry
00:34:19
Speaker
early antibiotic administration with antibiotic stewardship.
00:34:24
Speaker
And therefore, we should be administering antibiotics right away and then reevaluating right away whether or not the patient really is infected.
00:34:33
Speaker
So I always say to the house staff, start antibiotics right away.
00:34:38
Speaker
And then in the morning, let's reevaluate whether we think that patient really does have pneumonia or if it's simply congestive heart failure.
00:34:45
Speaker
And I feel if you marry de-escalation,
00:34:49
Speaker
as to rapid administration, I think that's the best combination for treating patients with suspected sepsis.
00:34:59
Speaker
And I think, again, we're emphasizing that this rapid administration of broad-spectrum antibiotics only applies to patients who are sick.
00:35:06
Speaker
Acute organ failure, suspected infection, maybe shock.
00:35:10
Speaker
It's not for everybody who comes to the hospital that you're sending home in terms of other diagnosis.
00:35:18
Speaker
What about the fluids?
00:35:22
Speaker
Just tell us a little bit about that.
00:35:24
Speaker
I hear a lot of controversy that we're flooding patients, that we're harming patients.
00:35:29
Speaker
People quote studies that are unrelated to adults with sepsis.
00:35:33
Speaker
But what is your take on fluids and what we should be doing in these patients?
00:35:39
Speaker
Yes.
00:35:41
Speaker
The amount of fluids and fluid administration is probably one of the areas which is filled with the most emotion.
00:35:47
Speaker
of all the things we've ever done in the campaign.
00:35:50
Speaker
And you're right, Sergio, the data, first of all, I have to acknowledge, there are no good randomized controlled data that show any amount of fluids are good.
00:36:00
Speaker
In the same way, by the way, that there are no good randomized controlled data that antibiotics make a difference.
00:36:05
Speaker
It's not something that is gonna be subjected to a randomized controlled trial soon.
00:36:10
Speaker
And the data that people use to refute the administration of 30 cc per kilogram
00:36:16
Speaker
are often unrelated trials in children or in under-resourced environments that really don't apply to the way in which we were using the Surviving Sepsis Campaign.
00:36:27
Speaker
I think there are a couple of things.
00:36:28
Speaker
First of all, I want to remind us, 30 cc per kilogram, in a 70 kilogram person, that's two liters.
00:36:36
Speaker
That's not a lot of fluid.
00:36:38
Speaker
And I think that for most intensivists, by the time we see these folks come up from the emergency department, they've already received at least
00:36:46
Speaker
two liters of fluid.
00:36:47
Speaker
So we're not talking about an enormous amount of fluid.
00:36:50
Speaker
That's one.
00:36:51
Speaker
Two, in the recent early goal-directed therapy trials, process, promise, and arise, before randomization, the median amount of fluid received in each of those trials was close to or above 30 cc per kilogram.
00:37:08
Speaker
Those are the data that we used in the last 2016 campaign guidelines
00:37:15
Speaker
for reasserting the value of 30 cc per kilogram since it seems to have become the standard of care.
00:37:23
Speaker
And finally, there are several randomized control trials now underway that are addressing this question of what's an adequate amount of fluid.
00:37:33
Speaker
But in the meanwhile, I think the data in the literature support the fact that it is safe, even in patients.
00:37:41
Speaker
And these are data from, again, Vinnie Liu
00:37:45
Speaker
Northern California Kaiser Permanente published in the American Journal of Respiratory and Chronical Care Medicine in which he showed that in patients with immediate with a moderate lactate elevation two to three the populations that seemed to do the best with those patients with end-stage renal disease who are dialysis dependent and patients with congestive heart failure so the data there are no data in the literature
00:38:12
Speaker
prospective data that demonstrate harm in those two patient populations and so the only data available in the literature support the use of 30 cc's per kilogram there's a lot of emotion there are a lot of emotional pieces written out there about the evils of fluid overload but until there are better data out there to me you we will we will save more lives to adequate fluid resuscitation and
00:38:41
Speaker
than by withholding fluids.
00:38:43
Speaker
And I think that part of the discussion, I think, that becomes muddled is that we're talking about what to do in the first hours.
00:38:51
Speaker
There's no question that for some time we may have gone overboard at 24, 36, 48 hours with the amount of fluids, but that's another topic and I think another challenge in terms of when people are in persistent shock, how to best manage them.
00:39:06
Speaker
But that's not what we're recommending with these bundles, correct?
00:39:10
Speaker
I think that's so important.
00:39:13
Speaker
Most of the data that looks at total fluid balance are looking at 72 in 96 hours.
00:39:19
Speaker
And by the way, the median amount of fluids that were received in the three large early gold erected therapy trials were close to eight liters in 72 hours.
00:39:29
Speaker
That's a totally different conversation than what we're talking about in immediate fluid resuscitation, which is in the two liter range.
00:39:36
Speaker
And yet, because of the emotion around all of this,
00:39:39
Speaker
we conflate the 8-10 liters of fluid that patients receive with a positive fluid balance at the end of admission with the administration of 2 liters of fluid within the first resuscitation period in sepsis.
00:39:57
Speaker
Absolutely.
00:39:58
Speaker
So finally, the fifth element of the bundle is
00:40:01
Speaker
is vasopressors.
00:40:03
Speaker
And you mentioned a little bit earlier how you would approach it, but can you just recap on how you would approach a patient with severe sepsis, septic shock in the first hours in terms of vasopressors?
00:40:15
Speaker
Yes, of course.
00:40:16
Speaker
So two important points.
00:40:18
Speaker
One, I think that there's general agreement now, especially because of the French trial and some other data, that a mean arterial pressure target of 65 millimeters of mercury is more than adequate, and there's no reason...
00:40:31
Speaker
to push the mean arterial pressure higher than 65 millimeters of mercury.
00:40:37
Speaker
And so that's the first thing that targeting a MAPA 65 is appropriate.
00:40:42
Speaker
The second piece, and I think this is important, is if you have someone who you're seeing in front of you, whether it's in the emergency department, on the wards, or in the ICU, and I think this is how we all practice, if they have severely low blood pressure, life-threateningly low.
00:41:01
Speaker
What is that definition?
00:41:02
Speaker
It's hard to say.
00:41:03
Speaker
But someone whose pressure is in the 40s or 50s, not even MAP, a systolic pressure in the 40s, 50s, 60s, or a MAP in the 50s, that patient should be started on vasopressors immediately.
00:41:16
Speaker
And fluid resuscitation.
00:41:19
Speaker
And then after the 20, 30 cc per kilogram, if you can wean the pressors rapidly, of course, I would do so.
00:41:27
Speaker
But I wouldn't wait until fluid administration is administered
00:41:31
Speaker
before starting vasopressor therapy in the face of a life-threateningly low blood pressure.
00:41:36
Speaker
And I think that, obviously, the timing of vasopressor is always a great challenge.
00:41:41
Speaker
And when we talk about it theoretically, it's sequential to after fluid.
00:41:46
Speaker
But like you mentioned, in reality, I think the best guide is our patient.
00:41:50
Speaker
And if the blood pressure is very low, like you mentioned, we probably should be doing both at the same time with the intention of weaning off as soon as possible as they respond to fluids.
00:42:02
Speaker
Right, exactly.
00:42:03
Speaker
So I think that to recap and to summarize, the hour one bundle really recommends that we take the appropriate steps to treat patients who have an infection or suspected infection with acute organ failure or those who might be in a state of shock.
00:42:20
Speaker
And there's five elements to this hour one bundle that include measuring a lactate,
00:42:25
Speaker
obtaining blood cultures, starting broad-spectrum antibiotics, administering IV fluids, 30 cc per kilogram, for those who are hypotensive or have a lactate over 4, and in those patients who are still hypotensive or don't respond initially, to start the vasopressors as soon as possible.
00:42:44
Speaker
Is that correct?
00:42:45
Speaker
I agree.
00:42:46
Speaker
Absolutely.
00:42:47
Speaker
And I would add to remeasure lactate as well.
00:42:52
Speaker
as part of the management strategy for the resuscitation.
00:42:56
Speaker
Excellent.
00:42:57
Speaker
So this has been, I think, a very insightful conversation.
00:43:01
Speaker
I think it'd be of great value for our clinicians.
Philosophical Perspectives: Stoicism and Healthcare
00:43:04
Speaker
But one of the things that we also like to do at Critical Matters, Mitchell, is to tap into the wisdom of our guest and talk about some other topics that, whether they're related to the practice of critical care medicine in life, might not be related specifically to sepsis and the Hour 1 bundle.
00:43:20
Speaker
Would that be okay?
00:43:22
Speaker
Yes, it is.
00:43:24
Speaker
So the first question is, what book or books have influenced you the most, or what book have you gifted most often to others?
00:43:33
Speaker
There are so many, but for me, clearly, the book that has had the most impact for me and the one that I recommend the most is a book called The Sacred Path of the Warrior, and it's written by a Tibetan gentleman, C. Sivak.
00:43:51
Speaker
M-U-K-P-O, and that's the book.
00:43:54
Speaker
In fact, I just saw one of my physician colleagues today who I recommended that book strongly to.
00:44:01
Speaker
So we will definitely put that in the show notes and encourage our listeners to pick it up.
00:44:07
Speaker
The second question, Mitchell, is what do you believe to be true in medicine or in life that most other people don't believe?
00:44:17
Speaker
Well, I'm not sure I would say that this is something
00:44:19
Speaker
that most people other that don't believe, but I, I think we create the light life we lead.
00:44:27
Speaker
And I think that if we, if we reside in cynicism and skepticism, then we will lead a cynical skeptical life and be met with that.
00:44:41
Speaker
If we lead a life that believes in the goodness of other people and trusts,
00:44:47
Speaker
the profound goodness that is inherent in the human spirit.
00:44:51
Speaker
That's the kind of life we will lead.
00:44:53
Speaker
And that's the kind of environment we'll have around us.
00:44:56
Speaker
So we create the life that we lead by the way we live.
00:45:03
Speaker
And I think that that's a great point.
00:45:06
Speaker
I'm a big fan of the Stoic philosophy.
00:45:09
Speaker
And Marcos Aurelius was one that would often say that our life or our thoughts are our life.
00:45:16
Speaker
So what we think and what we act depends on that is ultimately how we live.
00:45:21
Speaker
And I think it really speaks to that as well.
00:45:25
Speaker
Yeah, that's right.
Essentials of ICU Collaboration
00:45:26
Speaker
The final question, Mitchell, as we close,
00:45:30
Speaker
would be what would you want every intensivist or every person who listens to this podcast to know yeah I like this question actually all three river I think the most important thing and something that I talk with my fellows about is the essential importance of collaboration in intensive care because the quality of the quality of care that patients receive the quality of the environment in the intensive care unit and the quality of life in
00:46:00
Speaker
for the clinicians in the intensive care unit is really based on our ability to collaborate together.
00:46:08
Speaker
And that's something that I have used to build intensive care units wherever I've gone and done that collaboratively with my nursing and respiratory and partners.
00:46:20
Speaker
And I feel that's the most important thing for intensives to remember.
00:46:25
Speaker
And I think it's not only important for intensive, it's probably for all of us in society these days.
00:46:30
Speaker
And perhaps the greatest enemy to collaboration is ego, which seems to be prevalent among our colleagues and in other sectors as well.
00:46:38
Speaker
So I think that those are very good words of advice, Mitchell, to finish.
00:46:43
Speaker
It was a great pleasure to have you on Critical Matters.
00:46:47
Speaker
I really enjoyed it.
00:46:48
Speaker
It's an honor to be here.
00:46:49
Speaker
Enjoyed our conversation and hope to have you back soon to talk about sepsis or many other topics.
00:46:55
Speaker
Thank you very much for your time and for sharing your knowledge with us.
00:46:59
Speaker
Thanks, Sergio.
00:47:00
Speaker
Pleasure to be here.
00:47:04
Speaker
Thanks again for listening to Critical Matters.
00:47:07
Speaker
Make sure to subscribe to this podcast on iTunes or Google Play.