Our product will monitor intravenous (IV) blood lactate levels (for >7 days) of critical ill patients with sepsis, organ failure, trauma, or acute inflammatory response in the ICU, and infant patients with congenital heart disease (CHD) recovering from cardiopulmonary bypass (CPB) surgery. This device will alert doctors or nurses at the ICU when dangerous lactate increase rates are present, allowing early intervention to reduce life-threatening complications. Our sensors possess our proprietary NO releasing coating that prevent infection, thrombosis, and blockages for >7days that would otherwise render IV sensors inoperable/ inaccurate within minutes.1-7 This device would enable discrimination between infants at high and low risk of morbidity and mortality after CHD surgery to prevent sudden infant death undergoing CPB surgery,11,12 and significantly reduce hospital mortality in patients with hyperlactatemia.13-15 The Meyerhoff lab has been working on various NO releasing technologies for >15 yrs, and the chemistries used to date have had significant limitations that have heretofore prevented translational efforts. The low cost and robustness of our newest IP-protected compounds have completely overcome prior issues and enabled rapid translation of this IV blood lactate sensing technology to clinical practice affordably. We are targeting the markets of pediatric interventional cardiology and adult patients with hyperlactatemia at ICU admission with sepsis, organ failure, trauma, or acute inflammatory response syndrome. The pediatric interventional cardiology market is estimated at $1,379 MM by 2018 with a CAGR of 9.0%,2 the blood and electrolyte testing market was $1.56 B in 2014 with a CAGR of 3.5% $1,852 MM by 2019, and the global sepsis therapeutics market is estimated to be $7.4 B by 2017 with a CAGR of 5.8. %.2,3
Public Health Relevance Statement: Public Health Relevance: Lactate levels and lactate-increase-rate monitoring are valuable parameters in the early resuscitation of critically ill patients with organ failure and sepsis, and infants with congenital heart disease requiring cardiopulmonary bypass. Monitoring blood lactate increase rate is a critical marker to distinguish high and low risk of patient morbidity in the ICU and indicate a shift from aerobic to anaerobic respiration. A device that can continuously quantitate blood lactate in real time will better predict blood lactate rate changes than 1-2 hour discrete measurements now conducted on benchtop blood analyzers to prevent sudden patient death.
NIH Spending Category: Bioengineering; Cardiovascular; Congenital Heart Disease; Congenital Structural Anomalies; Heart Disease; Hematology; Infant Mortality; Infectious Diseases; Networking and Information Technology R&D; Pediatric; Perinatal Period - Conditions Originating in Perinatal Period; Prevention; Rare Diseases; Septicemia; Sudden Infant Death Syndrome
Project Terms: Acute; Admission activity; Adult; Aerobic; Animal Experimentation; Animal Model; Anti-Bacterial Agents; bactericide; base; Biological Assay; Biosensor; Blood; Blood Platelets; Cardiac Surgery procedures; Cardiology; Cardiopulmonary Bypass; Carrying Capacities; Catheters; Cell Proliferation; Cessation of life; Chemicals; Chemistry; Childhood; clinical practice; Clinical Trials; Coagulation Process; congenital heart disorder; cost; Critical Illness; crosslink; design; Detection; Device Designs; Devices; Dialysis procedure; Discrimination; Early Diagnosis; Early Intervention; Electrolytes; enzyme immobilization; Enzymes; fetal bovine serum; Glucose; Glutaral; Health; Hemoglobin; Hospital Mortality; Hour; Hypoxemia; Implant; Infant; Infection prevention; Inflammatory Response; Intravenous; intravenous drip; Kinetics; Lead; Lesion; Life; Low Cardiac Output; Marketing; Measurement; Measures; Mediating; Medical; Michigan; Milrinone; Monitor; Morbidity - disease rate; mortality; Needles; Nitric Oxide; Nitric Oxide Donors; Nurses; Operative Surgical Procedures; Organ failure; Outcome; Oxidases; Packed Red Blood Cell Transfusion; Patient risk; Patients; Peripheral Resistance; Pharmaceutical Preparations; Phase; Phosphate Buffer; Polymers; Polyurethanes; Postoperative Period; prevent; Property; rate of change; Reading; Respiration; response; Resuscitation; Risk; S-nitro-N-acetylpenicillamine; Saline; sensor; Sepsis; Shunt Device; Silicones; Smooth Muscle Myocytes; Stenosis; Sterilization; Sudden infant death syndrome; Surface; Syndrome; Technology; technology development; Testing; Therapeutic; Thick; Thrombosis; Time; Translations; Trauma; Universities; Variant; Whole Blood; Wireless Technology; Work
