NEPHROCHECK. Know earlier. Intervene sooner. Avoid the danger and damage of Acute Kidney Injury.

Transcription

1 Know earlier. Intervene sooner. Avoid the danger and damage of Acute Kidney Injury. 42% of critically ill patients with Sepsis develop AKI 1

2 2 SEPSIS AND ACUTE KIDNEY INJURY (AKI) ARE OFTEN CO-MORBIDITIES. 3 SEPSIS Sepsis a life-threatening organ dysfunction caused by a dysregulated host response to infection 1 is a serious medical threat. 2 AKI AKI a rapid loss of kidney function that includes, but is not limited to, acute renal failure is a serious medical threat. 5 Sepsis threatens more than 1.6 million patients in U.S. hospitals each year approximately 254,000 who do not survive 3 AKI threatens more than 3.2 million patients in U.S. hospitals each year approximately 1.1 million who do not survive 6 Sepsis is Common AKI is Common #4 clinically in addressable potential inpatient complications (PIC) 4 Length of stay for sepsis more than doubled between Sepsis is Dangerous Sepsis is complex and deadly Delays in giving patients antibiotics decrease survival rates This leads to early use of broad-spectrum antibiotics #1 clinically in addressable potential inpatient complications (PIC) 4 Length of stay for AKI more than doubled between AKI is Dangerous Patient outcomes are significantly compromised with AKI AKI is a complication of sepsis Antibiotic exposure can be nephrotoxic

3 NEPHROCHECK 4 THIS CAN HAVE SIGNIFICANT ECONOMIC AND CLINICAL IMPLICATIONS. SEPSIS IS COSTLY AKI IS COSTLY $17B Estimated spending per year on sepsis in the U.S.3 $10B Estimated spending per year on AKI in the U.S.8 AKI IS DEADLY SEPSIS IS DEADLY 14.7% 16% 8x Overall mortality rate (2009) 3 In-hospital mortality rate (2009)3 Higher than overall inpatient rate3 25% 20-25% 10x Overall mortality rate (2015)9 In-hospital mortality rate (2013)10, 11 Higher than overall inpatient rate12 5

4 6 FOR AKI ALONE, THE RAMIFICATIONS ARE SERIOUS. 7 LENGTH OF STAY HOSPITAL COSTS RE-ADMISSIONS CHRONIC KIDNEY HOSPITAL 2-3 times worse times worse 12 (in less than 30 days) DISEASE MORTALITY 2-3 times worse times worse times worse 12 For patients with Sepsis & AKI, mortality doubles. HOSPITAL MORTALITY 15 28% 57% SEPSIS SEPSIS + AKI

5 8 CURRENT DIAGNOSTIC TOOLS ARE INADEQUATE FOR ASSESSING THE RISK OF AKI. 9 Serum Creatinine Lagging indicator only elevates after 50% of function loss 16 Nondiagnostic for 48% of mod/severe AKI 17 Inconsistencies due to muscle mass, hydration, etc hours for serum creatinine to rise 19 Urine Output Lagging indicator 17 Not consistently measured 17 Compromised by HAI initiatives (e.g., early foley removal) 20 6 hours required for changes in urine output 21 KIDNEY STRESS DECREASED FUNCTION COMPLICATIONS NORMAL INCREASED RISK DAMAGE DECREASED GFR KIDNEY FAILURE DEATH SYMPTOMATIC (DIAGNOSIS) Functional Biomarkers Serum Creatinine, Urine Output²²

6 NEPHROCHECK 10 BIOMARKERS ARE PRODUCED DURING KIDNEY STRESS BEFORE SIGNIFICANT DAMAGE OCCURS. IGFBP7 & TIMP-2 Expressed in tubular cells in response to stress/damage Results in G1 cell cycle arrest, presumably to prevent cells with possible damage from dividing Injured cells spread the alarm to nearby cells via IGFBP7 and TIMP-2 A cellular alarm prior to actual damage when intervention can still make a difference. 11

7 12 IDENTIFY KIDNEY STRESS BEFORE DAMAGE OCCURS WITH NEPHROCHECK. 13 NEPHROCHECK is specific to AKI NEPHROCHECK outperforms all AKI biomarkers 24 NEPHROCHECK is elevated only under acute kidney stress and AKI 24 Know earlier. Intervene sooner. Avoid AKI. KIDNEY STRESS DECREASED FUNCTION COMPLICATIONS NORMAL INCREASED RISK DAMAGE DECREASED GFR KIDNEY FAILURE DEATH ASYMPTOMATIC NEPHROCHECK TIMP-2 IGFBP7 SYMPTOMATIC (DIAGNOSIS) Functional Biomarkers Serum Creatinine, Urine Output 3

8 14 NEPHROCHECK CREATES AN OPPORTUNITY TO INTERVENE PROACTIVELY. 15 Clinical Studies have demonstrated the impact of reducing AKI by only one severity level in the ICU: 350 bed hospital * *Calculated using assumptions published in AHA Database (ICU beds per hospital bed), Wunsch et al (ICU LOS, % cardiovascular/respiratory compromised), and Hobson et al (% moderate/severe AKI, incremental LOS/cost) Where and when to use NEPHROCHECK. NEPHROCHECK is useful for but not limited to Critical Care patients at risk or hospitalized for a variety of reasons. ICU patients with heart failure, diagnosed with cardio-renal syndrome with suspicion or confirmation of sepsis and/or moved from ED to ICU with decreased urinary output with respiratory compromise 143 DAYS 286 DAYS When a presumptive infectious disease diagnosis is made and a change in therapy is considered 428 DAYS $0.4M $0.9M NEPHROCHECK is a multipurpose tool that can aid in decision-making at multiple points on the care pathway. $1.3M NEPHROCHECK assists in improving short- and long-term outcomes for patients and hospitals. Enhance individual patient care Improve care for patient population Align with Triple Aim & QI priorities LOS Re-Admission Population Health Cost of Care Delivery For example: Dose and/or frequency modification of nephrotoxic drugs Close monitoring of urine output and serum creatinine Hemodynamic management/modification (perfusion, diuresis, vasopressors) How to act on a presumptive organism identification How to act on a definitive organism identification Whether to call for a renal consult Whether to order high-contrast imaging scan for ICU patient

9 16 KNOW EARLIER. INTERVENE SOONER WITH NEPHROCHECK. 17 Specific to AKI 27 Fast & Simple: 20-minute urine test 27 Commercially Available in USA 27 Peer-reviewed evidence 27 Easy, cost-effective to implement Low capital expense No investment in personnel biomérieux is a leader in supporting sepsis care management and the management of patients with blood stream infections. VIDAS B R A H M S PCT (procalcitonin) is considered an early biomarker of host response to a severe bacterial infection, 28 providing critical biomarker information that can help with: Increasing the accuracy of early sepsis diagnosis and assess host response to bacterial infection PCT-guided antibiotic therapy for sepsis Enhancing patient care Improving antibiotic stewardship Use NEPHROCHECK as an adjunct to your PCT assessment for sepsis and gauge the risk of AKI before damage occurs. Intended Use: The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK Test System is intended to be used in patients 21 years of age or older.

10 18 19 References 1. Bagshaw SM, et. al. Early acute kidney injury and sepsis: a multicentre evaluation. Critical Care, 2008, Volume 12, Number 2, Page Singer, M, Deutschman, CS, Seymour, CW, et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016;315(8): Elixhauser A, et al. Septicemia in U.S. Hospitals Agency for Healthcare Research and Quality Statistical Brief # Complications Research, a new Premier methodology for identifying hospital-wide harm associated with increased cost, length of stay and mortality in U.S. hospitals. Premier, Inc Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney Inter, Suppl. 2012; 2: Brown, JR, Rezaee, ME, Marshall, EJ, Matheny, ME. Hospital Mortality in the United States following Acute Kidney Injury. BioMed Research International, vol. 2016, Article ID , 6 pages, Dasta, JF, Kane-Gill, SL, Durtschi, AJ, et al. Costs and outcomes of AKI following cardiac surgery. Nephrology, dialysis, transplantation: official publication of the European Dialysis and Transplant Association - European Renal Association. (2008) Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J. Am. Soc. Nephrol. 2005;16: Hoste EAJ, Bagshaw SM, Bellomo R et al (2015) Epidemiology of acute kidney injury in critically ill patients: the multinational AKI- EPI study. Intensive Care Med. 41: Susantitaphong P, Cruz DN, Cerda J, et al. Acute Kidney Injury Advisory Group of the American Society of Nephrology. World incidence of AKI: a meta-analysis. Clin J Am Soc Nephrol. 2013;8: Selby NM, Kolhe NV, McIntyre CW, et al. Defining the cause of death in hospitalized patients with acute kidney injury. PLoS One. 2012;7:e Dasta JF, Kane-Gill SL, Durtschi AJ, Pathak DS, Kellum JA. Costs and outcomes of acute kidney injury (AKI) following cardiac surgery. Nephrol Dial Transplant. 2008;23(6): Brown JR, Parikh CR, Ross CS, et al, for the Northern New England, Cardiovascular Disease Study Group. Impact of perioperative acute kidney injury as a severity index for thirty-day readmission after cardiac surgery. Ann Thorac Surg. 2014;97(1): Heung M, Steffick DE, Zivin K, et al. Acute kidney injury recovery pattern and subsequent risk of CKD: an analysis of Veterans Health Administration data. Am J Kidney Dis. 2015;67(5): Hoste EAJ et al. Acute Renal Failure in Patients with Sepsis in a Surgical ICU: Predictive Factors, Incidence, Comorbidity, and Outcome. J Am Soc Nephrol. 2003;14: Martensson J et al. Novel Biomarkers of Acute Kidney Injury and Failure: Clinical Applicability. Brit J Anesth. 2012;109(6): Wlodzimirow KA, et al. A comparison of RIFLE with and without urine output criteria for acute kidney injury in critically ill patients. Critical Care. 2012;16:R Baxmann AC, et al. Influence of Muscle Mass and Physical Activity on Serum and Urinary Creatinine and Serum Cystatin C. Clin J Am Soc Nephrol Mar; 3(2): Ostermann, M, Joannidis, M. Acute kidney injury 2016: diagnosis and diagnostic workup. Critical Care. (2016) 20: Gould CV, et al. Guideline for Prevention of Catheter-Associated Urinary Tract Infections. HICPAC Legrand M, Payen D. Understanding urine output in critically ill patients. Ann Intensive Care. 2011;1: Lewington AJP, Certa J, Mehta RL. Raising awareness of acute kidney injury: a global perspective of a silent killer. Kidney Int. 2013;84(3): Kashani, K, Al-Khafaji, A, Ardiles, T, et al. Discovery and validation of cell cycle arrest biomarkers in human acute kidney injury. Crit Care. (2012) 17, R Hobson C, Ozrazgat-Baslanti T, Kuxhausen A, Thottakkara P, et al. Cost and mortality associated with postoperative acute kidney injury. Ann Surg. 2015;261: American Hospital Association Database. Accessed December Wunsch H, Angus DC, Harrison DA, Linde-Zwirble WT, Rowan KM. Comparison of medical admissions to intensive care units in the United States and United Kingdom. Am J Respir Crit Care Med. 2011;183(12): NEPHROCHECK Test Kit Package Insert. PN Rev E. 28. Muller B. et al. Calcitonin precursors are reliable markers of sepsis in medical intensive care unit. Crit. Care Med. 2000; 28(4):

11 2018 biomérieux, Inc. BIOMÉRIEUX, the BIOMÉRIEUX logo, and VIDAS are used, pending, and/or registered trademarks belonging to biomérieux, S.A. or one of its subsidiaries, or one of its companies. Patents: ASTUTE140, NEPHROCHECK and the NEPHROCHECK logo are registered trademarks of Astute Medical, Inc. in the United States. B R A H M S PCT is the property of Thermo Fisher Scientific, Inc. and its subsidiaries. PRN PRODUCT # DESCRIPTION ASTUTE140 Printer Paper Rolls ASTUTE140 Electronic Quality Control Device NEPHROCHECK Calibration Verification Kit NEPHROCHECK Test Kit NEPHROCHECK Liquid Controls Kit ASTUTE140 Meter Kit NEPHROCHECK VIRTUO VITEK MS The biomérieux Solution for Sepsis Care Management VIDAS B.R.A.H.M.S. PCT BACT/ALERT 3D VITEK 2 biomérieux, Inc. 100 Rodolphe Street Durham, NC U.S.A. Tel: (800) Fax: (800) VIDAS 3 FILMARRAY MYLA