Sphingotest bio-ADM Biomarker for Guidance of Vasopressor Administration in Acute Diseases
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sphingotec’s Acute Disease Biomarkers sphingotec offers biomarkers for use in acute diseases. These biomarkers are used to help guide urgent clinical decisions in the emergency depart ment and in intensive care units in hospitals. Acute diseases such as sepsis or acute myocardial infarction are often accompanied by shock that is initiated by systemic vasodilation and organ failure. In most cases this results in kidney failure. It is therefore an unmet medical need to identify and predict systemic vasodilation that may lead to shock and also to speedily identify and predict kidney failure in patients with sepsis or acute myocardial infarction. sphingotec’s acute disease biomarkers bio-ADM and penKid do just that by enabling early intervention Acute MI or Stroke in these acute diseases. The clinical use of these biomarkers has been validated by sphingotec in the following settings: Most patients sepsis, Acute Kidney Injury ... are killed short term/midterm survive > 1 day, by comorbidities like but ... (AKI) and acute myocardial infarction (AMI). Micro- Kidney Infection circulatory Dysfunction Dysfunction Biomarkers Procalcitonin bio-ADM penKid for diagnosis
About the bio-ADM Assay The sphingotec bio-ADM assay (sphingotest® however waiting too long may lead to a drop in bio-ADM) is the only IVD method measuring the blood pressure resulting in organs becoming level of bioactive adrenomedullin by using a insufficiently perfused at this stage. It is an unmet sandwich of a C-terminal antibody specific for medical need and of immense urgency to quickly amide-terminus and an antibody avoiding the identify patients with acute diseases in need of N-terminal epitope leading to increased analyte vasopressors so that vasopressors/catecholamines stability. can be administrated in emergency departments and intensive care units at the right point of time. The need for guidance of vasopressor administration in acute diseases According to standard care procedures in hos- pitals, vasopressors are administered to a patient sphingotest® after the mean arterial pressure has dropped to 65mm Hg or below. Administrating vasopressors to patients not needing them might be harmful, bio-ADM
Prediction and diagnosis of circulation dysfunction bio-ADM (bioactive adrenomedullin) is a soluble peptide hormone with a molecular weight of approximately 6kDa. Mainly released by endothelial cells, its biological function is to control vasodilation, an important regulator of blood pressure and organ perfusion1, 2. This marker predicts and provides a diagnosis for circulation dysfunction. The level of bio-ADM in blood samples of patients in acute condition may be used as an early indicator for the need to administrator vasopressors/ catecholamines before the blood pressure of the patient drops to levels that endanger the life of the patient. Healthy SEPSIS SEVERE SEPSIS SEPTIC SHOCK Normal Systemic Organ Death blood flow Vasodilation Failure Adrenomedullin 1 Kitamura K et al. , Biochem Biophys Res Commun., 192:553–60, 1993 2 Ishimitsu T et al., Pharmacol Ther. 2006 Sep;111(3):909-27
Evidence for the use of bio-ADM in acute myocardial infarction (AMI)3 STEMI (ST-Elevated Myocardial Infarction) and NSTEMI bio-ADM Multivariate P value (Non-ST-Elevated Myocardial Infarction) patients MACE 1 year 1.32 (1.09-1.59) 0.004 admitted to the University Hospitals of Leicester NHS MACE 30 days 1.37 (1.04-1.79) 0.023 Trust between August 2004 and April 2007 were MACE 90 days 1.39 (1.10-1.75) 0.005 included in a study conducted to investigate the prognostic value of bio-ADM for MACE after MI 1 years 1.34 (1.03-1.75) 0.029 6 months or 2 years. MACE is defined as composite Dead 1 year 1.52 (1.12-2.05) 0.007 endpoint of all-cause mortality, heart failure (HF) Dead/MI 1 year 1.48 (1.20-1.82)
Prediction and diagnosis of circulation dysfunction The association of bio-ADM with sepsis severity and outcome (28 day mortality) in baseline and serial measurements has been investigated in a Rome-based study where 101 consecutive patients (61 males and 40 females) with median (IQR) age 78 (72 to 83 years) admitted to the emergency department with suspected sepsis (at least two systemic inflammatory response syndrome criteria plus clinical suspicion of infection) were enrolled. Plasma samples for bio-ADM measurement were taken and over the following four days and 28-day mortality rate was recorded. bio-ADM was negatively correlated with mean arterial pressure (r = −0.39; P
Evidence for the use of bio-ADM in sepsis4 In addition the potential value of serial bio-ADM above 70 pg/mL every day until 4 days after measurement has been shown for prediction admission. A 100% survival rate has been observed of 28-day mortality. At admission patients with a for those patients with decreased bio-ADM bio-ADM concentration above 70 pg/mL had a concentrations below 70 pg/mL within 4 days after 28-day survival rate of 55% which decreased to admission. 36% if the bio-ADM concentration had remained 100 100 Proportion of patients surviving (%) Proportion of patients surviving (%) 0 0 0 7 14 21 28 0 7 14 21 28 ADM, 0 < 70, n = 61, events = 11 ADM, 0 > 70, ADM, 4 < 70, n = 12, events = 0 ADM, 0 < 70, n = 40, events = 18 ADM, 0 > 70, ADM, 4 > 70, n = 28, events = 18 p = 0.00341 p = 0.00052 Illustration of added value of serial bio-ADM measurement. Kaplan-Meier Plots for survival are shown for patients with bio-ADM values above or below 70 pg/mL on admission (left) and for the subgroup of patients, who were above 70 pg/mL on admission and spread into those with bio-ADM values above or below 70 pg/mL 4 days later (right). 4 Marino R et al. Critical Care 2014, 18:R34
sphingotec GmbH aims to develop diagnostic methods for prediction, prevention, intervention strategies and early treatment of diseases in the fields of cancer, cardiovascular diseases and kidney function. In order to realize this mission we provide biomarkers indicating susceptibility for a specific disease which enables the monitoring of prevention and intervention strategies. The company was established in 2002 by Dr. Andreas Bergmann who is one of the founders and managers of BRAHMS Aktiengesellschaft where, in addition to several other biomarkers, the sepsis marker Procalcitonin (B.R.A.H.M.S PCT®: www.procalcitonin.com) was developed in his role as Chief Research Officer. This biomarker Procalcitonin created a new diagnostic standard of care supporting patient management in sepsis. sphingotec is located in Hennigsdorf, northwest of Berlin, Germany, with its facilities in the Technology Campus one of the largest industrial parks in Berlin and Brandenburg with several companies of the biotechnology branch located there. Images: Thinkstockphoto, sphingotec | WE-EN-ADM_R001 Further information can be obtained here: sphingotec GmbH Neuendorfstrasse 15A, 16761 Hennigsdorf Germany Phone +49 33 02/2 05 65-0 info@sphingotec.com, www.sphingotec.com
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