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LSU and Our Lady of the Lake Health Pioneer New Sepsis Test, Saving Lives, Cost

In hospitals nationwide, more people die from sepsis than from anything else. It鈥檚 more deadly than opioid overdoses, breast cancer and prostate cancer combined, and is the leading cause of hospital admission and readmission. It鈥檚 also one of the most difficult diseases to diagnose. But since August, a new sepsis test based on LSU and Our Lady of the Lake Health research and advances in microfluidics is saving lives and cost at Our Lady of the Lake Health in Baton Rouge, Louisiana.

鈥淲e used to do the best we could,鈥� said Dr. Christopher Thomas, chief quality officer for Franciscan Missionaries of Our Lady Health System, which operates six major medical centers in Louisiana and Mississippi, including Our Lady of the Lake Health in Baton Rouge. 鈥淣ow, through translational research, we have a test that allows us to do personalized medicine that is improving our speed and efficacy. After six months, our results show that a higher percentage of patients are returning home to their families earlier, at lower cost for them and the hospital. Just our ability to improve patient flow has been revolutionary.鈥�

Time is the primary challenge in sepsis care. Every hour that passes before a patient with sepsis receives treatment makes it eight percent more likely they鈥檒l die. The life expectancy of people with untreated sepsis is three days or less. Meanwhile, early symptoms, such as chills, dizziness and a rapid heartbeat, could just as easily point to the flu or a panic attack.

鈥淵ou come in with chest pain, we do an EKG; you have some weakness on the right side of your body, you go straight into what we call a stroke landing zone and get a CT scan,鈥� said Dr. Thomas, who also serves as assistant professor of clinical medicine at LSU Health New Orleans. 鈥淏ut with sepsis, all we used to have鈥攚hat every hospital in America currently has, except for Our Lady of the Lake鈥攚as a combination of vital signs that predicted something. So, we could treat you, perhaps unnecessarily, without being clinically sure, or wait until more tests and labs returned, which could mean extended time in the waiting room. This made our sepsis care inefficient. Now, we鈥檙e using the IntelliSep test and patient-centered questions we鈥檝e learned from our research to triage efficiently and effectively. We鈥檙e getting to where we鈥檙e pulling people out of the waiting room 60 minutes faster.鈥�

Sepsis is an extreme overreaction to infection, where a person鈥檚 white blood cells start attacking vital organs. When LSU Health New Orleans physician Dr. Hollis 鈥淏ud鈥� O鈥橬eal, who also serves as medical director of research at Our Lady of the Lake Health, started work on a rapid test for sepsis in 2014, he didn鈥檛 know the now FDA-approved test would be in clinical practice just 10 years later. It took multiple research studies with thousands of patients enrolled across the country and a large, collaborative team effort to get there.

The sepsis test itself relies on research advances in microfluidics. 鈥淲hen the white blood cells become activated, they undergo structural changes,鈥� Dr. O鈥橬eal said. 鈥淭hey become squishy, for lack of a better word, and we use microfluidics鈥攖he study of fluids in very small volumes鈥攖o detect the change. That鈥檚 how the test works.鈥�

It only takes one or two drops of blood to run the sepsis test. The results come back in less than 10 minutes and indicate a high, intermediate, or low probability of sepsis.

鈥淎lmost everyone who comes into the emergency room has blood drawn, and we can get what we need for the sepsis test from the same tube of blood we run a CBC on,鈥� Dr. O鈥橬eal said.

CBC stands for complete blood count. It鈥檚 a routine blood test used to look at overall health and find a wide range of conditions, including at annual checkups and in emergency rooms. When a person starts having sepsis, the change in their white blood cells occurs before there is any sign of organ damage, making early detection critical.

While identifying patients with sepsis early is a big deal, identifying patients who don鈥檛 have sepsis is also important.

鈥淧atients can be very sick, but if it鈥檚 something else that鈥檚 causing their illness, you can鈥檛 stick with sepsis, or odds are you鈥檙e going to miss something,鈥� Dr. O鈥橬eal said. 鈥淥ur Lady of the Lake Health is now able to detect sepsis earlier in patients in whom it wasn鈥檛 really suspected, and get patients who don鈥檛 have sepsis quicker diagnosis and treatment. Overall, we鈥檙e saving patients more than a full day in the hospital.鈥�

Dr. O鈥橬eal hopes rural and critical access hospitals in Louisiana and elsewhere will be able to use the test soon.

鈥淚鈥檓 from a small town鈥擠eRidder, Louisiana鈥攁nd one of the things I鈥檓 most interested in is helping to deliver better care in rural areas and at smaller hospitals,鈥� Dr. O鈥橬eal said. 鈥淭hey tend to be underserved and understaffed, and this technology could really help improve their sepsis care.鈥�

Developing a test that receives FDA approval is one thing, while using that test in a hospital setting is entirely another, however, said Dr. Thomas:

鈥淭o deliver sepsis care at a world-class level, we need consistency and repeatability鈥攚e need process and continuous learning,鈥� he said. 鈥淲e鈥檝e already changed the nurses鈥� workflow and taken what鈥檚 traditionally called a passive best-practice advisory and turned it into an active screen that requires an answer. Essentially, we鈥檙e saying to our teams that sepsis is just as critical as trauma, stroke and heart attacks. We need everyone to start a standard process as early as possible using the test. If action isn鈥檛 taken when it looks like it should have been, we now go and ask that triage nurse expert鈥攚hat was it that made you dismiss the alert? All in order to learn and improve.鈥�

While we鈥檝e had the privilege of interacting with a number of universities, what鈥檚 been really special about the work with Dr. O鈥橬eal and LSU has been their continuous focus on making sure the collaborative research and development we did together was always focused on patient needs. They鈥檝e been the best partner we could have asked for.鈥�

Ajay Shah, CEO of Cytovale, a medical diagnostics company that worked in concert with the team at LSU during the clinical development of the test

To ease broader implementation and make the test more useful, Dr. O鈥橬eal鈥檚 team surveyed several hospitals and emergency departments.

鈥淲hile most places have a process or plan of care for patients with possible sepsis, every site is different,鈥� Dr. O鈥橬eal said. 鈥淪ome hospitals have a very nurse-driven process, while others have physician-driven processes. Some have processes they don鈥檛 follow, while others do, down to the comma. If we want our test to be used not just here at Our Lady of the Lake Health but at other hospitals, we have to help figure out how to integrate it into their workflows.鈥�

The sepsis test was created by Cytovale, a medical diagnostics company that worked in concert with the team at LSU and Our Lady of the Lake Health during the clinical development of the test. Data has shown that up to 80 percent of sepsis deaths could be prevented with rapid diagnosis and treatment.

鈥淲hile we鈥檝e had the privilege of interacting with a number of universities, what鈥檚 been really special about the work with Dr. O鈥橬eal and LSU has been their continuous focus on making sure the collaborative research and development we did together was always focused on patient needs,鈥� said Ajay Shah, CEO of Cytovale, who received his PhD from the Harvard-MIT Division of Health Sciences and Technology. 鈥淭hey challenged us to develop this technology with the needs of emergency room patients first and foremost in our minds. They鈥檝e been the best partner we could have asked for.鈥�

To date, the ongoing collaboration between LSU, Our Lady of the Lake Health and Cytovale has enabled over 3,000 patients to be tested for sepsis at Our Lady of the Lake Health since the test was implemented in August 2023.

鈥淲e鈥檙e humbled to be able to partner with LSU and Our Lady of the Lake Health as they continue to improve care delivery in their communities,鈥� Shah said.

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