FREDERICK, MD News (9/11/2024) – Researchers at Fort Detrick’s U.S. Army Medical Research and Development Command (MRDC) have made significant strides in combating sepsis in burn patients with a new invention called SeptiBurnAlert. Developed by Dr. Rasha Hammamieh and Nabarun Chakraborty of the Walter Reed Army Institute of Research, this device uses artificial intelligence and machine learning to predict whether burn patients are at risk of developing sepsis, a potentially life-threatening condition.
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The team recently submitted the device to the U.S. Food and Drug Administration (FDA) for a guidance review, an important step toward eventual commercial use. SeptiBurnAlert promises to significantly improve patient outcomes by identifying the risk of sepsis onset within the first 24 hours of intensive care unit (ICU) admission. This early detection allows clinicians to administer timely treatment, potentially saving lives.
Sepsis remains the leading cause of death among burn patients, even with advancements in medical care that have increased survival rates. Burn patients are especially vulnerable due to the loss of their skin, the body’s primary defense against infection. As wounds remain exposed, patients are at risk for harmful infections that can trigger sepsis, a condition marked by the body’s overwhelming response to infection, leading to inflammation and, often, organ failure.
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“Many of the symptoms of sepsis, such as fever, rapid breathing, and low blood pressure, are common in burn patients, making diagnosis challenging,” explained Chakraborty. “Our goal is to provide a tool that quickly and accurately identifies those at risk of sepsis so that treatment can begin as early as possible.”
SeptiBurnAlert uses a polymerase chain reaction (PCR) assay to analyze blood samples for the presence of six genes associated with sepsis. The results are processed by a machine learning algorithm trained on data from burn patients treated at MedStar Washington Hospital Center, a leading burn treatment facility. In early tests, the device accurately predicted sepsis onset in patients with a high degree of accuracy, offering faster results than traditional methods, which can take up to 100 hours to produce a diagnosis.
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MRDC’s Combat Casualty Care Research Program is conducting further studies to validate the effectiveness of the biomarkers used in the device. The FDA’s guidance review will assess the safety and efficacy of SeptiBurnAlert, determining whether further clinical trials or modifications are needed before it can be widely adopted in healthcare settings.
Dr. Hammamieh and Chakraborty believe that SeptiBurnAlert has the potential to revolutionize sepsis detection. They highlight that the assay required for the device can be used with standard PCR equipment, which is already available in most laboratories. This could allow for rapid adoption once the device is approved.
MRDC is also exploring options for developing a second-generation model of SeptiBurnAlert that would be fully automated and portable, potentially enabling earlier detection in field or emergency settings before patients even reach the ICU.
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The team has applied for a global patent on the biomarker assay and is working with MRDC’s Small Business Innovation Research and Small Business Technology Transfer programs to identify partners for commercial development.
As the review process progresses, the inventors are optimistic about SeptiBurnAlert’s potential to improve patient care. “We are excited to be at the forefront of this innovation,” said Hammamieh. “Our hope is that SeptiBurnAlert will soon be a standard tool in ICUs, helping to save the lives of both military personnel and civilians.”
Story by multiple RFHC contributors.
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