Sepsis, one of the most common complications patients experience across the globe, is the result of an untreated bacterial infection that can often spiral out of control, leading to life-altering consequences, organ failure or even death1. Diagnosing the condition as early as possible is the best way to stop the condition from spreading. This can be done through the use of several tools that are available to help clinicians diagnose and monitor sepsis closely, including assays that aid in sepsis risk assessment for patients already in, or headed to, the intensive care unit.
Sepsis is the body’s overwhelming and life-threatening response to an infection. Common in medical facilities, the condition is the result of a natural inflammation exhibited in an effort to fight off a bacterial infection. Despite its good intentions, the inflammation may sometimes spread beyond the infection site to the entire body, making it critical to monitor for sepsis to avoid its onset or worsening. This will ensure the proper antibiotic therapies are administered to stop the condition from spreading further.
In 2013, sepsis accounted for over $23.6 billion in hospital costs2 making it the most expensive hospital-acquired condition that year. In addition to the costs associated with sepsis in an emergency room environment, patients who have been released and then readmitted due to complications during the outpatient stage can potentially result in further financial penalties from Medicare and Medicaid programs.
The probability of severe complications and health risks such as death from the condition, as well as astronomical medical costs, are driving greater awareness of sepsis. In an effort to curb sepsis and its affiliated issues, the Center of Medicaid and Medicare Services (CMS) released a new sepsis bundle in an attempt to reduce instances of the condition across U.S. hospitals. Because of these new CMS guidelines, it is increasingly important for hospitals and providers to recognize septic patients early and prevent those patients from progressing into severe sepsis or septic shock.
Included in the sepsis bundle is lactate, a marker of malprofusion that helps measure the end organ tissue profusion of a patient. It can help a provider identify sepsis and gauge whether the condition is improving or worsening in a patient, making lactate measurement one of the more crucial elements of the CMS sepsis bundle. After the initial three hours, (CMS requires < 6 hour repeat) providers should continue to monitor lactate levels to ensure the patient’s condition is not worsening. Decreased lactate levels may suggest that the patient is becoming less septic and experiencing better tissue perfusion.
Though not included in the most recent CMS sepsis bundle, procalcitonin (PCT) has proven to be another valuable biomarker that can assist providers in the early identification of sepsis. Used in conjunction with lactate, PCT is another resource clinicians can use to determine whether or not a patient has a bacterial infection, as well as the level of severity of the infection(s), and is highly regarded as a sensitive and specific biomarker of the inflammatory response to bacterial infections3 due to its kinetics. When PCT is measured prior to hospital admittance, emergency departments and hospital wards can use the information to determine the severity of the illness and adequacy of source control4. While lactate and PCT help identify different aspects of a patient’s condition, it is important to focus on both. Specifically, lactate levels may indicate a patient’s condition is not critical while PCT may indicate a patient’s condition is worsening. Together, these biomarkers give providers more informed insight into whether a patient’s condition is progressing into severe sepsis or septic shock.
The bundle developed by CMS is based on research from the Surviving Sepsis Campaign and outlines the actions hospitals and emergency departments should take to reduce the risk of a patient’s condition developing and/or worsening throughout a hospital stay. When sepsis is first presented in a medical setting, providers should assess the signs the patient presents and monitor for its possibility. As soon as sepsis is identified, providers should take the following actions within the first three hours:
1. Measure lactate level
2. Obtain blood cultures prior to administration of antibiotics
3. Administer broad spectrum antibiotics
4. Administer 30ml/kg crystalloid for hypotension or lactate ≥4mmol/L
Within the first six hours that sepsis presents itself, providers must:
5. Apply vasopressors (for hypotension that does not respond to initial fluid resuscitation) to maintain a mean arterial pressure (MAP) ≥65mmHg
6. In the event of persistent hypotension after initial fluid administration (MAP < 65 mm Hg) or if initial lactate was ≥4 mmol/L, re-assess volume status and tissue perfusion and document findings according to Table 1
7. Re-measure lactate if initial lactate elevated5
Adhering to the CMS sepsis bundle will help providers ensure that patients are receiving the quality of care they need to improve patient outcomes. Assessing the risk of sepsis early through the use of biomarkers can better determine the risk of the condition and help inform which therapies should be administered. In having access to these new tools and following the updated guidelines, providers are now better armed in fighting this deadly condition.
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1 Worldwide Market for Infectious Disease Diagnostic Tests. Kalorama, 2015. Page 119.
2 Celeste M. Torio, Ph.D., M.P.H., and Brian J. Moore, Ph.D. “National Inpatient Hospital Costs: The Most Expensive Conditions by Payer, 2013.” Agency for Healthcare Research and Quality, May 2016.
3 Brunkhorst FM et al: Kinetics of procalcitonin in iatrogenic sepsis. Intensive Care Med 1998;24(8):888-889.
4 Hausfater P et al: Serum procalcitonin measurement as diagnostic and prognostic marker in febrile adult patients presenting to the emergency department. Crit Care 2007;11(3):R60. doi:10.1186/cc5926.
5 Updated Bundles in Response to New Evidence. Surviving Sepsis Campaign. April, 2015.
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