New treatment could drastically reduce sepsis death rate, researcher says
Kansas City doctor’s discovery is awaiting FDA approval after clinical trials showed improved survival rates
(InvestigateTV) — Sepsis kills more than 350,000 adults and 1,800 children in the United States each year, according to the CDC. One in three adults who die in the hospital have sepsis.
A doctor in Kansas City, Missouri, has made a discovery that could drastically reduce that statistic.
What is sepsis?
Sepsis happens when the body’s immune system starts harming healthy tissues and organs in response to an infection, according to the Cleveland Clinic.
That can trigger a chain reaction throughout the body.
Early sepsis signs can start with a fever, chills and rapid breathing. Those symptoms then progress to confusion and difficulty breathing until it reaches the final stage, septic shock, which can lead to organ failure and death in as little as 12 hours, according to Sepsis Alliance.
A mother’s story
Two years ago, Brie Morgan Bauer was pregnant with her third child and excited to welcome him to a growing family. Everything about the pregnancy was normal until she felt flu-like symptoms at 27 weeks.
She went to her obstetrician’s office and that’s when the real emergency began.
“When they hooked me up, we were showing back-to-back contractions and I didn’t feel anything,” Bauer said. “But little did I know I was actually going septic.”
Bauer’s son, Bo, was delivered by emergency C-section. Her flu-like symptoms were strep throat. She went from bringing new life into the world to fighting for her own.
“By the third day that’s when they started looking at my toes, looking at my fingers and that they were turning purple and black,” Bauer said. “My hands were almost like mummified. They were black. And then I unwrapped my legs, and the legs were so crazy to see. The feet were definitely black.”
In her mind, Bauer thought there was no going back. “There’s no option to get blood flow back to a foot that is obviously dead.”
In the end, there was nothing she could have done to prevent what happened to her. She would have to live life as a quadruple amputee.
The current treatment for sepsis is antibiotics and IV fluids, which is sometimes not enough.
Researcher’s discovery
Dr. Cuthbert Simpkins has worked to find a solution to sepsis. He is the founder of Vivacell Bio Inc., where he has worked to find a solution to septic shock.
“There are 11 million cases around the world, and its mortality rate’s about 30%, 40%,” Simpkins said. “Depends on what stage you’re at, but if you’re at an advanced stage, it becomes almost 100%.”
Simpkins said during sepsis, the body makes too much nitric oxide, which leads to organ failure. His product, VBI-S, absorbs the nitric oxide, something Simpkins said has never been done before.
“It will act quickly, very quickly. You’ll see the blood pressure come up. You don’t have to wait to see its effect.”
He said that within 24 to 48 hours, “you’ll see the lungs get better, you’ll see the kidneys get better.”
In clinical trials, 80% of participants were expected to die from sepsis. VBI-S lowered that to 50%.
“They have shown that a high degree of efficacy in reversing failure of multiple organs,” Simpkins said.
He said the mortality rate would be even lower when the substance is given to patients early in their diagnosis. The clinical trials have concluded, and the product is awaiting FDA approval.
Other experts watching closely
Dr. Steven Simpson, a pulmonary and critical care doctor, is board chairman of the Sepsis Alliance, a group dedicated to finding a solution to sepsis.
“I am pleased that it seems to work as it’s intended to work,” Simpson said. “[It’s a] small study. We need a lot more patients treated. But very promising.”
Simpson said he sees patients in septic shock every day in the ICU.
He hopes, someday soon, no more will have to die from it. “It’s the reason that I work with Sepsis Alliance, it’s the reason for my entire career. It’s been 40 years, we haven’t found that solution yet.”
While Simpson doesn’t know if this will be a solution for sepsis, he is encouraged by the results.
“I don’t stick my neck out on what’s going to be the cure for sepsis. I am hopeful. I do believe that this is going to play a role, and I think it’s exciting,” he said.
Finding a new normal
Bauer was stunned to hear about the major discovery that could mean the end of sepsis.
I think that’s very promising," she said. “And I’m excited. I wish it was approved a while ago.”
VBI-S was not available for Bauer’s case. She has since found she has an interest in art and remains active in her sons’ lives.
“It’s been chaos. We live minute by minute,” Bauer said. “But my husband, he does everything. And I’m trying to do my best to find that more independence, more partnership with him to help reduce the chaos.”
“But that’s kind of what I’m showing my kids is what resilience looks like and to learn how to adapt,” Bauer said.
Bauer started a website, BriesHope.org, to offer support to survivors and families.
Simpkins said that with FDA approval, VBI-S could be in hospitals as soon as 2027.
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