Potrero Medical, Inc. — Department of Health and Human Services SBIR Phase II: 300

Description

Abstract Septic shock is a severe condition resulting in a critical reduction of organ perfusion with consequential and common stageandacute kidney injuryAKIoccurring in as many asof patients and with an alarmingly high in hospital co morbid mortality rate of up toCurrent Surviving Sepsis Guidelines recommend early aggressive fluid resuscitation targeting mean arterial pressureMAPmmHghowever aggressive resuscitation commonly results in hypervolemiaElevated intra abdominal pressureIAPwhich occurs frequently in critically ill patientsis recognized as a vital parameter reflecting venous outflow that has wide ranging physiologic effects including an association with AKIThusabdominal perfusion pressureAPP MAP IAPmay provide the optimal target to guide hemodynamic support as it reflects both inflowMAPand outflowIAPperfusionHowevercurrent methods of IAP measurement limit the validation of APP as a hemodynamic target as they are prone tohuman errorlimiting the reproducibility of measurements andcontamination resulting in catheter associated urinary tract infectionsPotrero MedicalInchas developed the Accuryn Monitoring Systemwhich accuratelyautomatically and digitally extracts physiological data in real time from the bladderwithout the need for external equipment or manual manipulationAccuryn received formalkclearance from the FDA for measurement of IAPurine output and core temperature in April ofIn combination with MAP acquired through standard of careAccuryn will enable APP targeted hemodynamic resuscitation in septic shock patientsIn this grantthe use of Accuryn to improve clinical outcomes in septic shock patients via both IAP monitoring and APP targeted hemodynamic resuscitation will be validatedWe plan to conduct amonth clinical trial withseptic shock patients divided among three groupsMonitoringnormal IAP receiving MAP targeted resuscitationStandard of Care MAP groupelevated IAP receiving MAP targeted resuscitationandAPP groupelevated IAP receiving APPmmHg targeted resuscitationThe primary endpoint for comparison will be incidence or progressiondefined by peak severity in creatinine and UO compared to baseline levelsof stageandAKISecondary endpoints include ICUand hospital mortalityfrequency and duration of RRTurinary biomarker datadays on mechanical ventilationmean duration of vasopressor supportand adverse eventsIndependent comparisons between these groups willverify that elevated IAP during fluid resuscitation is correlated with AKI in septic shock patients andvalidate that APP guided fluid resuscitation reduces the incidence or progression of stageandAKI in septic shock patients compared to MAP guided resuscitationWith this clinical studywe will validate the need for the Accuryn device to continuously measure IAP and target APP during resuscitationThe data collected from this grant will enable the design of a pivotal phase III clinical study defining APPtargeted hemodynamic support as the new standard of care for septic shock