A real-time monitoring and predictive device for cardiovascular surgeries and sepsis - Abstract Sepsis is a life-threatening condition that occurs when the body's response to an infection damages its tissues and organs. It can quickly progress to septic shock, leading to multiple organ failure (heart, lung, kidney) and death. Sepsis is often difficult to recognize in emergency departments and intensive care units because it is a milieu of nonspecific symptoms, and a rapid diagnosis enabling earlier intervention could save many lives and preserve heart and lung function as myocardial depression occurs in 50% of patients with sepsis. The current diagnosis of sepsis requires a complex evaluation of signs and symptoms, identification of the infection source, and laboratory tests to assess systemic inflammation and organ dysfunction. The team has performed sepsis- animal studies and probed the diagnostic accuracy of sepsis through urine biomarkers of hypoxia. Other biomarkers in blood, such as arterial blood gas pH and lactate, can be used to monitor a patient's sepsis response to treatment. However, due to the invasive nature of blood sampling and associated safety requirements, sepsis diagnosis typically occurs in hospital laboratories. Urine analysis is a non-invasive method for diagnosing various diseases and is suitable for sepsis detection. A timely sepsis diagnosis without a blood test would represent a significant breakthrough in the medical field. Due to the invasive nature of blood analysis, arterial blood gas pH or lactate clearance is typically assessed over hours to a day rather than minutes. Continuously monitoring of urine sepsis biomarkers enables the patient's sepsis early diagnosis within minutes (less than 200 minutes), not several hours to a day. The team will develop a continuous, real-time, automated Smart Catheter Analyzer for early identification of sepsis through urine biomarkers to enable clinicians to respond quickly to support heart and lung function. It is envisioned that the device will be used by minimally trained personnel in emergency departments, urgent care, rural emergency services, intensive care units, and out-of-hospital settings. The team, comprised of sensors, engineering, computer science, medical and clinical research, and medical device industry/manufacturing expertise, will work to design and develop the Smart Catheter Analyzer for sepsis-related urine biomarkers in a 2-year R61 (Phase I) and to further develop and refine the Smart Catheter’s Algorithm for Sepsis in a 1-year R33 (Phase II). The device prototype developed in Phase I at Arizona State University will be used in a study during Phase II at Mayo Clinic Arizona, comparing noninvasive biomarker patterns in septic and non-septic cases. Industrial partner, Sequitur Health Corp., will contribute to the acceleration of the technology towards practice. This project will enhance medical personnel's technical capabilities for the diagnosis and treatment of sepsis and enable gains of scientific knowledge for heart and lung-related functions.
