Unlike heart disease, which can be detected with an EKG, or stroke, which can be detected with a CT scan, sepsis has been more difficult and impossible to diagnose – until now.

According to the National Institute of General Medical Sciences, sepsis is the third leading cause of death in America, with 350,000 deaths annually and 1.7 million cases in adults each year.

What is sepsis?

Sepsis is an extreme overreaction of the body to an infection. Instead of fighting the infection, white blood cells in the body begin to attack important organs, which, if not treated early, can lead to tissue damage, organ failure and death.

The symptoms of sepsis are non-specific, which means that they can be the cause of many other conditions that brought the patient to the hospital – rapid heart rate, severe pain, fever, shortness of breath, etc.

“The problem is that we tend to treat more people with sepsis who don’t have it than we treat for sepsis in people who do,” said the LSU associate professor of medicine and medical director of research at Our Lady of theLakeHealthDr. Hollis “Bud” O’Neal. “And that’s because it’s extremely difficult to recognize and diagnose.”

Now, under O’Neal’s leadership as principal investigator of a nationwide study, a team of scientists has developed a new test to determine how likely a patient is to develop sepsis before he or she develops an infection.

The IntelliSep test was developed by Cytovale, a research company working to advance early detection technology, in collaboration with LSU, researchers at Our Lady of the Lake Regional Medical Center in Baton Rouge. Work on the project began in 2014.

“The technology was extremely new,” O’Neal said. “We really didn’t know exactly how we were going to do it.”

In December 2022, after more than eight years and numerous studies in Louisiana and nationally, the technology was approved by the U.S. Food and Drug Administration for use in hospitals to detect the likelihood of sepsis.

In August 2023, the OLOL healthcare system saw its first patient receive a sepsis test.

Bringing it to the people

Mortality rates from sepsis increase by as much as 8% for every hour of delay in treatment. As many as 80% of sepsis deaths could be prevented with prompt diagnosis and treatment, making early detection essential, according to a study published in the National Library of Medicine.

Dr. Christopher Thomas, vice president and chief quality officer of Franciscan Missionaries of Our Lady’s Health System, worked with the researchers throughout the project but became a leading force in the later stages of development.

Thomas’ primary role on the study was to design the test implementation for the health care system and create pathways for easy access to testing for patients.

According to Thomas, when a patient arrives at the emergency department, he or she is triaged, or sorted into “buckets” that trigger a series of tests – a patient with a high risk of heart attack will go to the cardiac route, a patient with a high risk of heart attack and a risk of stroke will go to the cardiac route, etc.

“We want to make sure the people getting tested are the ones who need them,” Thomas said.

How does it work?

The test involves examining blood samples taken from patients entering the emergency room.

In less than 10 minutes, the results will determine whether a patient falls into one of three categories:

• Band 1: Low probability of sepsis
• Band 2: Further research may be warranted
• Band 3: High probability of sepsis

Based on this, doctors will determine treatment.

O’Neal admits the test doesn’t mean everything will be settled.

He says it helps detect sepsis. The process of monitoring a patient’s health still requires judgment and medical expertise, but the examination provides important information that physicians would not otherwise obtain.

Since Our Lady of the Lake Health System began using IntelliSep screening, more than 7,500 patients have been classified as “high probability.”

According to Thomas, after 14 months of research and implementation of the new test, “for every 100 patients the healthcare system screens for sepsis, we save one life.”

Cost

According to the U.S. Department of Health and Human Services, more than $62 billion is spent annually in the United States on the diagnosis and treatment of sepsis.

Although no test is free, detecting the likelihood of contracting sepsis early can shorten a patient’s hospital stay and save money.

“We wanted to make sure that the total bill after the test would be less than the bill it would have been without the test,” Thomas said.

Thomas and his team looked at 200 patients who did not receive sepsis testing and 400 patients who received sepsis testing before the test was introduced across all hospital systems and found that patients who received screening saved an average of $1,400 .

“We live in a vulnerable area,” Thomas said. “We want to make sure that if you claim a $5,000 deductible, I’m really concerned about your money and how much you have to spend.”

Although IntelliSep screening is FDA approved, individual hospital systems require their own evaluation process. All six Our Lady of the Lake hospitals use the test, and the Froedtert Health Network & Medical College of Wisconsin has begun a pilot program to make the test available in emergency departments.