President's Message - So, What’s Up with Sepsis Bundles Anyway?

2014 - 3 June - 43rd Critical Care Congress Review
J. Christopher Farmer, MD, FCCM
SCCM President J. Christopher Farmer, MD, FCCM, discusses the debate and controversy surrounding the ProCESS trial.

The Protocolized Care for Early Septic Shock (ProCESS) trial has caused some confusion and even consternation. Does the trial change our perspectives regarding the use of the current sepsis bundles? Is there a rationale to change (now) the sepsis bundle elements?
Assembling this month’s message, we thought about the conversations surrounding the ProCESS trial, some more constructive than others. We wrote a one-act vignette to help bring clarity and a human face to a confusing issue.
Ready, action...
Fade In:
During a Society of Critical Care Medicine (SCCM) meeting, two intensivist attending physicians wait outside a meeting room, waiting for the educational session to start.
“Are you going to change your initial management
approach for severe sepsis? How is that discussion
happening at your institution? Does the (ProCESS) trial
change your ICU protocols?”
“Good questions. We’ve been having these same
conversations at our place, too. It’s not really surprising.
People are lining up on both sides of the issue, and there is
“Yeah, the National Quality Forum raised concerns about
some of the #0500 sepsis measures. Central lines and
CVP(1) tracing are areas of discussion. There are two more
relevant studies yet to be published. So, the Surviving
Sepsis Campaign advocates waiting for these data before
we make big changes. Others vocally disagree with this
‘wait-and-see’ approach. Some of these interactions were a
little negative and even seemed personal in their tone.”
“Ouch. That’s not constructive and adds to everyone’s
confusion. Everyone is trying to do the right thing. People
need to remember that. I think what we’re witnessing is a
natural evolution of existing clinical practices. It happens.
Things change. We certainly don’t use the same antibiotics
now that we did when we were in training.”
“You know, the other thing that makes this difficult is
prompt and accurate identification of patients with severe
sepsis. These patients are easily missed in intensive care
units (ICUs) and elsewhere. Our sepsis definitions and our
early warning systems are not sufficiently precise. Failure to
recognize is still a big issue.”
“I agree. And SIRS(2) criteria can flag patients with
pulmonary embolisms, gastrointestinal bleeding and other
things. This has been recognized for a long time. We need
more clarity and precision. We need to be able to identify
sepsis patients sooner and more accurately.”
“Ha. As they say, that’s why I don’t take the stairs! If
someone evaluated me after I climbed two or three flights,
my SIRS criteria might be positive!”
“Yep, that’s basically how and why these bundles came
into being in the first place: to overcome these very sorts of
issues. Helping people avoid a too-little, too-late approach
has been the goal and the central theme. Specific details
will, and always have been, dependent on local expertise
and resources.”
“Exactly. Getting people on the same page is still a
dominant theme and focus in most circumstances. The
ProCESS trial doesn’t change that. Timely recognition
of sepsis. Appropriate and accurate resuscitation: not too
little, not too much. Early administration of antibiotics and
source control by other means when antibiotics are not
enough. Go fast.”
“I agree with that, too. The impact of sepsis-related
immune dysregulation amplifies explosively when that
cycle is not promptly recognized and broken. Longer
time unchecked equals more badness. None of that really
changes either.”
“You know what’s really interesting: how we measure shock
resuscitation endpoints in the ICU. Now that has changed.”
“Yeah, when the Rivers paper first came out, bedside
ultrasound was not nearly as common. Gosh, I didn’t even
have any grey hair then! Now, basically every fellow in
critical care training is taught how to use serial ultrasound
as a resuscitation measurement tool. I’m not saying that
ultrasound is the gold standard, but its use is much more
widespread than it was 12 or 14 years ago.”
“Well, at least you still have hair! I wonder if that practice
change could skew the results of some of these trials?
It hasn’t really been assessed; our focus has been on
resuscitation parameters like lactate, central lines and
“Good point. I’ve wondered the same thing. The other
change is PICC(3) lines: their use is increasing a lot,
including their placement for the initial resuscitation of
ICU patients.”
“Yeah, our reference point is usually what happens in
academic medical centers …and maybe that’s OK? But
a huge component of important critical care happens in
community hospital ICUs. By necessity, things like PICC
lines are an integral part of many practices. We are not
considering that either.”
“Yeah, these lines are not used exclusively for
chemotherapy and long-term antibiotics anymore. That’s
probably OK? And, actually, we are using them more and
more in my teaching hospital as an acute intervention
device. It is not just a community hospital phenomenon. It
may already be impacting what we do for sepsis patients in
an increasing number of settings?”
“Great, so where does all of this conversation leave us?
What about sepsis bundles? What changes now?”
“Well, I believe we should focus on basic ‘blocking-and tackling’
skills: early recognition, prompt and accurate
resuscitation and timely antibiotic administration. The
exact assessment methodology regarding how we measure
restoration of perfusion status should not distract us from
getting things done.”
“Pragmatism is a good thing. For now, maybe we focus
on a basic amalgam of assessment methods and not the
superiority of one individual thing versus another? Avoid
potential harm whenever possible, like invasive procedures.
Ultrasound, for instance, does not require any big needles.”
“Yeah, we should also not be distracted by whether bundles
help or not. That’s obviously important, but it’s a different
discussion. What is important for our sepsis patients is
consistency: predictable and reliable clinical response, solid
team behaviors and excellent communications. This is
where we need to be.”
“Exactly. And I do think that collectively we are doing
better. That recent JAMA paper from the Australian and
New Zealand Intensive Care Society was encouraging. I
know some wonder if we’re counting less sick patients as
‘severe sepsis,’ which, the argument goes, has given the
appearance of improving mortality. But I’m an optimist,
and I believe that overall we are doing a better job with
sepsis patients at an increased risk of death.”
“Keep the faith. We can do better. That is the message.”
“Make sure that we all do an impeccable job with the
basics. Teamwork matters. So does education, which
cannot be limited to just ICU personnel. The early
recognition of sepsis needs to be on everyone’s RADAR.”
“Excellent discussion. Now, do you want to tackle world
hunger after this session is over?”

1. CVP = central venous pressure
2. SIRS = systemic inflammatory response syndrome
3. PICC = peripherally inserted central catheter