In this corner, the Surviving Sepsis Campaign (SSC), a Society of Critical Care Medicine and European Society of Intensive Care Medicine collaboration “committed to reducing mortality and morbidity from sepsis and septic shock worldwide.” See http://bit.ly/survive-sepsis.

And in this corner, thousands petitioning the 2018 Surviving Sepsis Campaign Bundle, asking SSC not be used for hospital-specific guidelines/protocols, government interventions, or mandated care. See http://bit.ly/SSC-petition.

I don’t need to tell you how big a deal sepsis is. It accounts for ~15% of in-hospital deaths (JAMA).

Supporters say, “The most important change is… the 3-hour and 6-hour bundles have been combined into a single “hour-1 bundle” with the explicit intention of beginning resuscitation and management immediately… [so] clinicians begin treatment immediately, especially in patients with hypotension, rather than waiting or extending resuscitation measures over a longer period.”

Dissenters say the guidelines are “arbitrary, dangerous… unsupported… and infantilize clinicians by prescribing a rigid set of bundles which mandate specific interventions within fixed time frames. Nonetheless, the guidelines have been adopted by the Centers for Medicare & Medicaid Services as a core measure (SEP-1). This pressures physicians to administer treatments despite their best medical judgment (e.g. fluid bolus for a patient with clinically obvious volume overload).”

I don’t know the right answer but think this is an important topic for your consideration.

If you are knowledgeable on the topic, please weigh in and educate us.

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Joe Hage
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Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Scott Seidewitz, I believe the petition is largely about the standard one hour. If the standard were “within three hours,” there might be less commotion.

Having said this (and I am far, far, far from an expert here), I’m somewhat familiar with the notion of fluid overload. My medical device marketing client ImaCor has technology that helps clinicians avoid it.

In its simplest terms, if you give fluid to someone whose heart can’t use it, the extra fluid goes into the lungs which almost invariably leads to complications.

So to say in a blanket statement, “if sepsis, give fluid” sounds, to my under-educated ear, a bad idea.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
I had a conversation with Marty Kohn. I love this guy despite his reluctance to join LinkedIn Groups. Grr. 😕 https://www.linkedin.com/in/marty-kohn-90a68a4/
Here’s our exchange:
Marty: Sepsis is a clinical issue where predictive analytics and early (before overt clinical manifestations) is essential. By the time sepsis established itself options are limited and prognosis poor. Starting treatment even a couple of hours earlier means a big difference in outcome. As with other clinical issues, acquiring and analyzing types of data beyond the conventional will be necessary to develop sufficient predictive power.

Your link is 15-20 year old information and no longer a game-changer. What is needed is the ability to anticipate sepsis and intervene earlier to reduce that likelihood that full-blown sepsis ever develops. (1 of 2)

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
My reply: I understood the guidelines were updated for 2018 and, for the first time, it was mandating fluids within 60 minutes. That’s what I gleaned from this story and associated petition: http://bit.ly/SSC-petition.

Marty: Perhaps, but I think it more a reflection of the limitation of guidelines. It takes years before proven interventions make it into the guidelines.

Guidelines are among the least valuable resources for making personalized healthcare decisions. They are usually developed through a majority vote of a committee, influence by very subjective criteria and plagued with delays.

Guidelines are also diagnosis-focused rather than patient-focused.

For example, do you give the same fluid treatment to a patient who is pulmonary edema as well as sepsis?

Personally, I consider the guideline process (as it is typically developed) as an obstacle to personalized healthcare.

Graham Nichol
Resuscitation Clinician and Researcher
Second, a challenge is that there is universally-accepted gold standard for the diagnosis of sepsis. Previously, clinicians used SOFA criteria, which is at least one of 4 of:
Body temperature >38.0 °C or <36.0 °C Heart rate >90 beats/min
Tachypnea >20 breaths/min or hyperventilation with PaCO2 <32 mm Hg White blood cell (WBC) count >12,000 cells/mm3; or <4,000 cells/mm3 In 2016, the SEPSIS3 group, which included some individuals who were part of the Surviving Sepsis Campaign, proposed changing the definition of sepsis to SOFA or qSOFA. SOFA is a composite score calculated from objective values for respiration [P/F or arterial oxygenation/inspired oxygen ratio]; coagulation [platelets]; liver [bilirubin]; cardiovascular [mean arterial pressure]; neurologic status [ Glasgow Coma Score]; and renal function [creatinine or urine output.] The PROCESS trial did not detect a significant mortality difference between protocol-based early goal directed therapy vs. protocol-based standard care vs. usual care in adults with suspected sepsis and refractory low blood pressure http://bit.ly/ProCESS-trial

But provider adherence was less in the early goal directed therapy group than in the standard care group.

It is unclear if the lack of mortality difference was 2/2 good recognition and response to sepsis, lack of effect of intervention, or other factors e.g. timing of prognosis assessment and withdrawal of care.

Graham Nichol
Resuscitation Clinician and Researcher
qSOFA was proposed as new clinical prediction rule to identify patients with high risk of adverse outcomes associated with sepsis. This includes the presence of 2 or more of 3 clinical criteria: altered mentation, respiratory rate ≥22 breaths/min, and systolic blood pressure ≤100 mm Hg.

Clinicians continue to disagree on the relative utility of SIRS vs SOFA vs qSOFA

Graham Nichol
Resuscitation Clinician and Researcher
The ARISE trial did not detect a significant mortality difference between protocol-based early goal directed therapy for 6 h vs. usual care for 6 h in adults with suspected or confirmed infection, at least one SIRS criteria, and refractory low blood pressure.
http://bit.ly/ARISE-trial

But it is unclear if the lack of mortality difference is due to good recognition and response to sepsis, lack of effect of the intervention, or its brief duration (i.e., 6 h of a multiday hospital stay).

Scott Seidewitz
Market Research Leader, Innovator and Contrarian
Finish to post: I personally support establishing best practice protocols as much as possible and limiting physician discretion to when it’s really needed: a novel situation that requires creative problem solving and treatment.

Robert Christensen
Medical Consultant
Hello Joe’ not sure if this fits, but I have had multiple excisions so far of an ear sq cell cancer over last 8 months with sepsis of staphlococcus remaining despite vigorous IV and other antibiotic therapy. No end in sight for this 93 year old WWII and Korean War surgeon . Am I on a different path?

Scott Seidewitz
Market Research Leader, Innovator and Contrarian
Very interesting post, Joe. It brings up the broader issue of whether doctors should be able to use discretion to treat as they see fit, or if they should be constrained by specific protocols: “the guidelines…infantilize clinicians by prescribing a rigid set of bundles which mandate specific interventions within fixed time frames.” Two points : 1) As a market researcher, I have personally interviewed thousands of physicians. Many are not well informed on the latest data on care and/or cling to old habits. There is incredible variability in how different physicians treat the same situation, and in some cases the physician’s habits are not only sub-optimal but downright dangerous. 2) Studies consistently show that standardizing medical care, i.e. taking discretion away from physicians, leads to improved outcomes, sometimes dramatically so.

Graham Nichol
Resuscitation Clinician and Researcher
The PROMISE trial failed to detect a significant difference in mortality between protocol-based early goal directed therapy vs usual care for 6 h in adults with known or confirmed infection, at least 1 SIRS criteria and refractory low blood pressure or elevated lactate.
http://bit.ly/PROMISE-trial

Graham Nichol
Resuscitation Clinician and Researcher
Multiple trials have evaluated the impact of early identification and treatment of patients with sepsis in the emergency department and early hospital setting.

They have yielded conflicting results. The first trial was a single center trial conducted at Detroit Receiving Hospital. http://bit.ly/Rivers-NEJM-GDT
This study reported a large and significant difference in outcomes. But effects reported in single-center trials are often larger than those in multi-center trials. http://bit.ly/AlexanderJClinEpi2015SinglevsMulti

Graham Nichol
Resuscitation Clinician and Researcher
I will provide a multi-part response on this query about sepsis care…apologies in advance to those who regard what follows as spam.

First, the marked escalation in the reported incidence likely reflects better recognition and reporting, which is due in part to increase knowledge of providers about the need to recognize sepsis, as well as targetted reimbursement of sepsis by Medicare.

Luiz S.
Diretor, Scrimin Medical
I am just a distributor of medical devices here in Brazil, one of my biggest customers is clinical Hospital from the medicene university. They have almost 1200 thousand beds. And it is terrible the damage caused by what they call MR ( multi resistence?) Bacterias. Probably the main reason is the wrong prescription of antibiotics. Manly in the ortopedia sector, because of intensive trauma, it is a real bad situation. People don’t pass away by trauma they got sepsis because open wounds.

Ronda Cobb, BSME
★Mortgage Success★Debt Eliminator★$$ Educator★Wealth Builder★Radio Show Host★Money Bunny™★Speaker★Coach★Author★
As a sepsis survivor, I can attest to the fleet of people it took to save my life and limb. I was very fortunate that it was ‘back in the day’ when some employers were self-insured.
That being said, as a money person/profit consultant and not a doctor, I would suggest the CMS guidelines be carefully studied so that you can apply the proper PRIMARY code (edema or ?) and secondary code (possible sepsis) and choose your plan of care appropriately without eliminating your need for your skill, wisdom, and on-site situational observations. This way you get paid, you get results, you dot all your i’s and you don’t comply yourself out of business. Hopefully….

Ann Farrell
Principal Farrell Associates, LLC a boutique HIT consulting firm
What happened to idea we’d have evidence based standards of care aka best practices that would be adjusted at point of care based on individual patient and situation.

I can’t imagine clinicians being forced to implement guidelines that are contraindicated for a specific patient. I also don’t believe that every physician is aware of best practices.Is there a middle ground here?

Rush E. Simonson
Chairman & CEO at Juvent
Any discussion on Sepsis must include Dr. Marik’s work. This protocol is a game changer. https://www.ncbi.nlm.nih.gov/pubmed/27940189

Lisa Ann Wade
Sales Professional
Sepsis is an absolute Epidemic in this country let us continue to strive ahead to end this and save lives!

Rodney Chin, PhD, BSC, MA
Systems-minded in biomedical, physical chemistry, & physics. Concept, manufacturing, & commercialization
Having done high-end engineering & science in cleanrooms/etc, I’ve been appalled when I see lax procedures even in the ICU & other high-risk venues. Simple but disciplined behavior needs to be instilled and enforced through monitoring. It’s the people in most contact with the patient and the patient environment. There’s a lack of (personal) accountability. Sepsis causes are multi-modal & infections across the board are on the rise.