Sepsis is an overwhelming blood infection, which when coupled with shock (such as that which may be experienced following a combat injury) has a mortality rate near 50 percent. Current methods to identify and treat sepsis may take 48 hours or longer – resulting in increased recovery time from combat wounds and hundreds of preventable deaths.
In fall 2011, DARPA began research to limit the impact of sepsis on the U.S. warfighter through the Dialysis-Like Therapeutics (DLT) program. The goal of DLT is to demonstrate a portable device capable of sensing and removing various targets in the blood (e.g. bacteria, viruses, toxins, and cytokines) on clinically relevant time scales. As pathogen load is strongly correlated with patient morbidity and mortality, early detection and rapid reduction is considered fundamental to program success and eventual clinical impact. Research to date has focused on advancing the components needed for such a device.
Today, DARPA announced a solicitation seeking integration of previously awarded DLT projects to develop sensors, complex fluid manipulation architectures, separation technologies and closed-loop control algorithms. After integration, DARPA hopes for a single device capable of removing at least 90 percent of sepsis-causing material from a patient within 24 hours. The DLT device sought by DARPA would differ from kidney dialysis devices by potentially enabling continuous, early sensing based on the entire blood volume, removing the need for anticoagulants, and facilitating label-free separation of multiple targets within the blood.
“DLT represents a revolutionary approach in the treatment of blood-borne illness,” said Tim Broderick, DARPA program manager. “If successful, this technology could be used to treat sepsis faster and more effectively, saving lives and reducing treatment costs. In 2009 alone, more than 1,500 active duty Service members were diagnosed with sepsis. DLT may eliminate the need for expensive culture-based identification methods and extended hospital stays. And, as the technology matures, we believe the device could be adapted to diagnose and treat a variety of illnesses.”
DLT is a technology demonstration and human trials will not be funded. However, proposers are encouraged to submit plans for testing that would result in an investigational device exemption approval from the Food and Drug Administration (FDA). The FDA will be engaged with the DLT team throughout the program lifecycle by reviewing proposals, participating in proposers’ day meetings and participating in Government review boards.
DARPA Press Release: http://www.darpa.mil/NewsEvents/Releases/2012/05/08.aspx
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