Study Finds Drop in Mortality, Hospital Stays with Sepsis Blood Test

By Matt Phillion

A new study out of Froedtert Hospital, Milwaukee’s only Adult Level 1 trauma center, has found that using an eight-minute sepsis blood test in the emergency department led to a 42% reduction in mortality and shortened hospital stays by nearly two days for patients suspected to have an infection.

Sepsis is the driver behind one in three hospital deaths—and we know it is hard to diagnose early. The study results, which align with previously published data, show an objective, rapid method to help guide decisions at triage.

Researchers evaluated 6,040 ED patients with suspected infection and found:

• Length of stay was shortened by roughly two days. Overall length of stay was 1.9 days shorter and septic patients’ length of stay 2.2 days shorter. Non-septic patient stays were 1.7 days shorter.
• Mortality rates were 42% lower among patients who were tested with IntelliSep, the blood test used in the study. Septic patients had a 35% decrease in mortality rates, while non-septic patients had a 43% decrease.

“The study was a matter of opportunity and timing,” says Thomas Carver, trauma surgeon, senior medical director for critical care services with Froedtert Hospital, and a professor of      surgery at the Medical College of Wisconsin.

The organization had a long relationship with Cytovale, the makers of IntelliSep, and an opportunity arose to look into ways to innovate on and advance clinical care.

“The timing was perfect: Cytovale had just gotten its FDA approval the year before and we were looking at this space for ways we could do better and thought we should take advantage of this,” says Carver.

The results of the study were very surprising, Carver says.

“When we launched the study, our thinking was, ‘What can we do with this test?’” he says. “’Can we improve on how we make our diagnoses? Can we improve our documentation?’ Instead, the surprising thing was our in-hospital mortality risk reduction was around 40%. I don’t think anybody expected that.”

It wasn’t a small sample size, either: Nine months of data and over 6,000 patients made for a compelling story.

“And our length of stay for these patients dropped by almost two days,” says Carver. “We couldn’t really explain it, but my guess is that we identified sepsis sooner, or something raised a concern that something was going on, and we could direct our resources to these patients.”

They had a control group, clinicians who preferred not to order the optional test, and the difference was stark.

“It was very eye opening to the group of us who championed this test in the ED. Certainly our hospital administrators were very interested in these results, and they were willing to give us funding to continue using it, says Carver.

Strong numbers, actionable results

The first step after seeing these results was to try to make the test standard practice, Carver says.

“We’re trying to eliminate the opt-in component. We want to make it so that if you are ordering certain tests because someone might be septic, that Intellisep is also included regardless of what the ordering provider believes is going on,” he says. “We don’t yet have 100% penetration there, but the interesting part of doing anything in medicine is you’ll have early adopters and late adopters. We recognize there’s something about this test that allows us to drive change. We’re trying to change the idea that you can order it later in certain people. It should be ordered in anyone we suspect has an infection.”

The next step is pushing the test out to smaller community sites now that they have proof of concept on their main campus.

“The results justify the investment in infrastructure to get it out to those smaller, community-based facilities,” says Carver.

For organizations looking to make a similar change, Carver stresses the need for champions in the emergency department who want to see the change.

“This is an innovative technology with a lot of potential for change in a hospital system, and that’s super hard. Not everyone is going to buy into it,” he says. “I’m not an ED physician but a lot of my colleagues and friends are. They are true leaders and are in that space every day. They know that even if we think we’re doing sepsis care well, we can always find ways to do it better, and we can highlight places where we can have a real impact.”

Carver believes that when people see these results and find it’s not hard to implement the additional test, they’ll recognize the value to patient care.

Change takes time and funding

As is often the case, the biggest barrier to innovation in medicine is time, effort, and financial viability. The culture shift is always a lift as well.

“The barriers are always daunting, and sometimes the biggest barrier is changing the mindset that what we’re doing now is fine. You’re never going to win over everybody,” he says.

Froedtert Hospital is a teaching facility, and the natural turnover in that environment can slow down a change in technology as well. Just as you begin to get folks onboard, they move on to their next role.

Meanwhile, no matter the organization, diagnosing sepsis is hard to do.

“We talk about medicine being an art and we talk about the clinical gestalt, but the clinical gestalt sometimes is wrong, and 50 percent of the time the diagnosis of sepsis is wrong. Even the definition and the current thinking around sepsis has changed. We’re lagging behind not only as physicians and practitioners in our understanding of what sepsis is, how to diagnose it, and what the possible complications are,” says Carver. “IntelliSep isn’t perfect, but it’s better than some of the AI-driven or algorithmic tools that incorporate a lot of different variables.”

Many of those tests are either not sensitive enough or too sensitive and not specific for sepsis, Carver notes.

“Every human’s physiology is different and how our bodies handle an infection is different. The usual methods like vitals won’t give you that information, but your own cells are what says this is how you’ll respond to it. With Intellisep, we get a look at what the host cells are doing,” he says.

Change needs to come from a variety of sources, but one group Carver would like to see step to the forefront are academic medical societies who can offer guidance.

“Ninety-nine percent of people who arrive septic are going to arrive in the ED because that’s their point of entry. I think the sepsis studies need to be championed on the emergency medicine side and through their national societies. Our study and other studies out there are showing potential improvements and places where patient-based outcomes can be better,” he says. “I think the emergency medicine societies have a prime opportunity to compare sepsis technologies through multi-center randomized trials.”

This is what will really move the needle, Carver explains.

“These things take a lot of time and effort,” says Carver. “But I think these early adopters and innovators can latch onto these results and bring them forward so you can build a case around getting this into your own institution.”

It’s important to not think about the test itself in isolation, he notes.

“It is a component of a treatment algorithm or triage algorithm of how sepsis is cared for. What I like about this test, or any of these types of tests, is that you don’t just use it in isolation,” Carver says. “These tests can lead you down a different pathway. If I could snap my fingers, I’d love every institution to incorporate an early test into their sepsis management process and help with the diagnosis very early as opposed to late in that person’s care. That changes resource utilization, costs, and identifies people who have more life-threatening conditions sooner.”

Matt Phillion is a freelance writer covering healthcare, cybersecurity, and more. He can be reached at matthew.phillion@gmail.com.