I know from an unfortunate experience with a family member that sepsis is a helluva medical condition that can arise suddenly, cause enormous pain and, if not diagnosed quickly, can bring unexpected death within a day or two. About 20-35 percent of patients with severe sepsis and 40-60 percent of patients with septic shock die within 30 days. Others die within the ensuing 6 months, often after enduring multiple surgical attempts to identify and treat the source of the infection. According the Centers for Disease Control, sepsis in the United States is the second-leading cause of death in noncoronary ICU patients, and the tenth-most-common cause of death overall. Sepsis is common and also more dangerous in elderly populations.
Thus, I think it is great that DARPA is attempting to take on one of the grand challenges of the medical establishment. The agency describes sepsis as “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.”
Apparently, DARPA began to tackle sepsis beginning in fall 2011 through its Dialysis-Like Therapeutics program. The agency says the goal of the DLT is to demonstrate a portable device capable of quickly sensing and removing bacteria, viruses, toxins and cytokines from the bloodstream on clinically relevant time scales. It notes, “research to date has focused on advancing the components needed for such a device.”
Now it appears that DARPA is taking the next step and has issued a notice requesting “next step” proposals:
DARPA [is] 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 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.
If successful, the sepsis technology should prevent the deaths of thousands of people in military service and may open the door to novel detection and treatment approaches for other medical maladies. “DLT represents a revolutionary approach in the treatment of blood-borne illness,” says 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.”
Detailed information about the program and requirements for proposals can be found in the Broad Agency Announcement. The proposal due date is July 13, 2012, and DARPA expects that the awards will be issued in October. The manager for this program is Timothy Broderick.