Pediatric sepsis is one of the leading causes of childhood mortality, responsible for over half a million deaths world-wide. A key goal in treating children suffering from septic shock is to normalize cardiac function while maintaining optimal fluid balance and tissue oxygenation levels. 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 PediaSense catheter? Its innovative design combines fast pressure sensing functionality within the structure of a standard 8F pediatric urinary drainage catheter. The sensitivity and frequency of our pressure measurement enables the monitoring of changes in cardiac output (from the relative amplitude of cardiovascular pressure waves transmitted to the bladder) and intra-abdominal pressure, both of which can be critical in guiding treatment decisions during sepsis management and the latter of which can be found in the "Surviving Sepsis" guidelines for catecholamine resistant septic shock in children. Use of the PediaSense catheter has clear advantages over other more invasive methods to measure cardiac output and detect fluid overload. Currently available tools to measure cardiac output (i.e. the Swan-Ganz catheter or Long Time Interval analysis based on arterial catheter measurements) have been shown to incur unacceptable infection risk for the patient and significantly increase the burden on nursing staff to administer and maintain. Moreover, methods to detect fluid overload often rely on observations during physical exam which are intermittent, subjective, and non-quantitative. The PediaSense device has the potential to directly track changes in cardiac output and to detect fluid responsiveness and fluid overload continuously, automatically, and quantitatively without any additional invasiveness or further burden on nursing staff. Our preliminary data support the feasibility of measuring relative cardiac output using the PediaSense and we have previously demonstrated the capacity of the device to provide clinically relevant readings of changes in intra-abdominal pressure. Here we propose to use a juvenile porcine model to test the capacity of the PediaSense to deliver accurate readings of changes in cardiac output in response to pharmacological manipulations of cardiac function. Additionally, we will induce fluid overload and test the ability of the PediaSense to achieve early detection of this condition based on measurements of relative cardiac output and intra-abdominal pressure. This work is a crucial first step to lay the groundwork for future clinical studies with the ultimate goal of improving outcomes for critically ill children suffering from septic shock and other forms of hemodynamic insult.

Public Health Relevance

Pediatric sepsis is one of the leading causes of childhood mortality, responsible for over half a million deaths world-wide. Among children suffering from septic shock, aggressive fluid resuscitation is critical to normalizing cardiac output and thus survival, but clinicians are lacking tools to allow them to determine when is enough and when is too much. The PediaSense device, which consists of a reusable monitor and a novel pressure sensing Foley catheter, aids clinicians in hemodynamic optimization by providing accurate real-time measurements of relative cardiac output and intra-abdominal pressure, both of which are markers of fluid responsiveness/fluid overload.

Agency
National Institute of Health (NIH)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HD080323-01
Application #
8715530
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Tamburro, Robert F
Project Start
Project End
Budget Start
Budget End
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Theranova, LLC
Department
Type
DUNS #
City
San Francisco
State
CA
Country
United States
Zip Code
94107