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: (1) Simultaneous detection and isolation of multiple key physiological parameters, (2) Non-invasive, easily accessible relative CO monitoring, (3) Continuous, accurate and real-time detection of FO, and (4) Precise monitoring with limited associated cost or ER staff burden. In the Phase 1 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 1 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 1 - Verification and Validation of the Canary Catheter for Clinical Trial. In the first subtask we will manufacture the units necessary for a 100-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 Catheter's measurement capabilities.
Aim 2 - 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 2-year, observational, multi-center study using the Canary Catheter to collect data from 100 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 80%.
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.
| Kramer, George C; Luxon, Evan; Wolf, Jordan et al. (2017) Inaccuracy of Urine Output Measurements due to Urinary Retention in Catheterized Patients in the Burn ICU. J Burn Care Res 38:e409-e417 |
