Sepsis is probably the deadliest illness you’ve never heard about.
It is a condition that kills about half the people who contract it. It occurs when the body’s immune system overreacts to an infection by releasing chemicals that trigger inflammation throughout the body. Blood clots and leaky blood vessels can follow. In the worst cases, a patient’s blood pressure drops, the heart weakens, and multiple organs fail.
Sepsis Is a Problem for U.S. Military
The illness has become a problem for the military. Soldiers who are injured by explosions or other traumatic events are particularly prone to sepsis. Lost limbs often lead to infection and sepsis. As many as 10% of combat wounds lead to life-threatening infections and sepsis.
Now the military has announced the awarding of some very large contracts to develop a device to combat sepsis, according to a MarketWatch press release. The U.S. government has agreed to give up to $22.83 million over the next four years to companies that can create a medical device to treat the sepsis in the field, reports The Columbus Dispatch.
If the device works for the armed forces, it could also help the approximately 775,000 civilians who contract sepsis each year. The technology will be shared with the public once it is developed and field-tested by the military.
DARPA Funds Battelle and Two Others
Battelle has been chosen as the contractor on the project. Based in Columbus, Ohio, Battelle researches, designs, and manufacturers products for the medical, energy and environmental industries. The key subcontractors are: NxStage Medical, based in Lawrence, Mass., which develops, manufactures, and markets systems to treat renal disease and acute kidney failure; and Aethlon Medical, based in San Diego, which develops medical devices that address unmet needs in cancer and infectious diseases.
The funding is coming from the Defense Advanced Research Projects Agency (commonly known as DARPA), which is responsible for researching and developing new technologies for use by the military. Created by President Eisenhower in 1958, DARPA has funded research that has developed projects that range from creating an unmanned anti-submarine warfare vessel, to an earthworm-like robot, to a prosthetic arm.
The Standard Treatment for Sepsis
Doctors traditionally start treating sepsis with a broad array of antibiotics, and then infection-specific antibiotics once they learn which specific bacteria they are fighting. Sometimes patients also require ventilation, kidney dialysis, and surgery. However, there are no specific treatments for sepsis itself.
“The traditional and current state-of-the-art (practice) is to stabilize the patients as much as possible and let them get better,” says Herb Bresler, senior research leader at Battelle and principal investigator on the project. “The approach we’re taking is really a much more active intervention to try to remove the bacteria and remove the source of inflammation in a much more active way.”
Developing a Portable Blood-Cleaning Device
The idea behind the new treatment is that a device can remove blood from the body, filter out “dirty” agents from the blood, then return “cleaned” blood to the patient, much like how kidney dialysis machines work today. Those “dirty” agents include bacteria, immune-system messengers, and components that trigger increased inflammation in the body. DARPA created the Dialysis-Like Therapeutics (DLT) program to facilitate the creation of a portable device for holistic treatment of sepsis.
The contract calls for the three companies “to design, develop, test and validate an advanced, portable medical device that exhibits the technical innovation for which DARPA projects are known, and to coordinate integration of key technologies developed during the overall DLT program,” says the MarketWatch news release. The funding does not include expenses for human clinical trials that could be required before the device is used in the field. The U.S. Food and Drug Administration may require human trials as well before the device is cleared for sepsis treatment in the civilian population.
“Even if we could have a 20% change in mortality due to sepsis, we could save tens of thousands of lives,” says Bresler. The three contractors hope to have the new medical device ready for tests in patients in four years.
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Dale McGeehon is the head journalist for the Polymer Solutions Newsblog, published by Polymer Solutions Incorporated (PSI), an independent materials testing lab that specializes in medical device testing. Dale has been a science journalist for more than 25 years.