A novel device for improving sepsis outcomes through hemodynamic optimization

Information

  • Research Project
  • 8592498
  • ApplicationId
    8592498
  • Core Project Number
    R43GM108320
  • Full Project Number
    1R43GM108320-01
  • Serial Number
    108320
  • FOA Number
    PA-12-088
  • Sub Project Id
  • Project Start Date
    9/20/2013 - 11 years ago
  • Project End Date
    3/18/2014 - 10 years ago
  • Program Officer Name
    DUNSMORE, SARAH
  • Budget Start Date
    9/20/2013 - 11 years ago
  • Budget End Date
    3/18/2014 - 10 years ago
  • Fiscal Year
    2013
  • Support Year
    01
  • Suffix
  • Award Notice Date
    9/20/2013 - 11 years ago
Organizations

A novel device for improving sepsis outcomes through hemodynamic optimization

DESCRIPTION (provided by applicant): Sepsis occurs frequently among critically ill patients hospitalized in intensive care units (ICUs). A key goal in treating patients 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 OmniSense catheter. Its innovative design combines fast pressure sensing functionality within the structure of a standard urinary drainage catheter. The sensitivity and bandwidth of our pressure measurement enables the monitoring of changes in cardiac output (from the relative amplitude of cardiovascular pressure waves transmitting into the bladder) and intra-abdominal pressure, both of which can be critical pieces of information for clinicians making treatment decisions during sepsis management. Use of the OmniSense 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 OmniSense device has the potential to directly track changes in cardiac output and detect 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 OmniSense 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 porcine model to test the capacity of the OmniSense to deliver accurate readings of changes in cardiac output in response to pharmacological manipulations of cardiac function. In addition we will experimentally induce fluid overload and test the ability of the OmniSense to detect the development of this condition early based on measurements of intra-abdominal pressure. This work is a crucial first step to lay the groundwork for future clinical studies with he ultimate goal of improving outcomes for critically ill patients suffering from septic shock and other forms of hemodynamic insult.

IC Name
NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
  • Activity
    R43
  • Administering IC
    GM
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    224666
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    859
  • Ed Inst. Type
  • Funding ICs
    NIGMS:224666\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    THERANOVA, LLC
  • Organization Department
  • Organization DUNS
    621187249
  • Organization City
    SAN FRANCISCO
  • Organization State
    CA
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    941072523
  • Organization District
    UNITED STATES