Theranova LLC — Department of Health and Human Services SBIR Phase II: 300

Description

DESCRIPTION provided by applicant A key goal in treating patients suffering from septic shock is early detection as well as to normalize cardiac function while maintaining optimal fluid balance Intravenous fluid resuscitation and management is often critical to survival but can also lead to fluid overload and potentially fatal downstream consequences Currently there is a lack of adequate tools with which to monitor patient responses to fluid infusion particularly those that can safely and accurately measure cardiac output or detect the onset of fluid overload In response to this need we have developed the Canary Catheter a pivotal next generation technical enhancement to the current indwelling urinary catheter standard for patients admitted to the ICU The unique system enhances the current septic shock management profile through several key characteristics Simultaneous detection and isolation of multiple key physiological parameters Non invasive easily accessible relative CO monitoring Continuous accurate and real time detection of FO and Precise monitoring with limited associated cost or ER staff burden In the Phase stage of this SBIR we succeeded in demonstrating the feasibility of measuring useful clinical variables in real time by using the Canary Catheter in the bladder of a porcine model Specifically we targeted clinical variables related to the development and management of sepsis see table Additionally the clinicians we have worked with have been enthusiastic about the prospect that the CC may be able to also serve as an early detection system for patients in the ICU who are at risk for developing sepsis thus enabling earlier treatment and improvement of outcomes Our Phase feasibility data supports our current goal for this proposal which is to discover key physiologic patterns in the prediction of sepsis onset and fluid overload management in a clinical setting Aim Verification and Validation of the Canary Catheter for Clinical Trial In the first subtask we will manufacture the units necessary for a patient clinical study as well as for verificatio and validation testing In addition we will complete the training the health care staff at each of our three study sites in preparation for the study initiation The second subtask of this aim is t refine our methods of data analysis and begin development of a predictive model for sepsis based on the Canary Catheterandapos s measurement capabilities Aim Discover key physiologic patterns in the prediction of sepsis onset and fluid overload management in a clinical setting The design of the trial is a year observational multi center study using the Canary Catheter to collect data from patients Expected Outcomes Detection We expect that by providing high resolution measures of SIRS parameters into predictive models we will be able to more quickly detect the onset of sepsis Management This aim will be successful if a predictive score cutoff can be identified in any of the models using IAP and rCO either individually or in combination providing detection of FO with both sensitivity and specificity greater than PUBLIC HEALTH RELEVANCE Sepsis occurs in approximately one third of patients in the Intensive Care Unit where it is a leading cause of morbidity and mortality Among patients suffering from septic shock or other forms of hemodynamic insult fluid resuscitation treatment is critical to normalizing cardiac output and thus survival but clinicians are lacking good tools for assessing the effects of their ongoing management as well as tools for earlier detection Sepsis is a time sensitive emergency and every hour loss leads to an increase in mortality rate The Canary Catheter device is designed to aid clinicians in early detection of sepsis and hemodynamic optimization by providing accurate real time measurements of changes in cardiac output and intra abdominal pressure without introducing any additional risk to the patient