Sepsis (or septic shock) accounts for an estimated 13-19% of all hospital admissions and has an astonishing mortality rate in the range of 50-55%. Many readers may not be familiar with this deadly clinical cascade or the efforts that have been made on a national level to standardize our approach to sepsis.
Sepsis at its core is a dysregulation of the inflammatory response to infection – most typically to bacteria although fungal infections do occur. In over 50% of cases, the causative organism is never identified. Sepsis and the inflammatory response that ensues can lead to multiple organ dysfunction syndrome and death.
Any patient presenting to an Emergency Department meeting criteria for sepsis is treated by a 3 component clinical algorithm which includes: 1. Serial measurements of lactate in the blood; 2. Copious intravenous fluids; and 3. The early initiation of IV antibiotics. These are performed uniformly without consideration for one’s age, past medical history, concurrent illnesses (such as diabetes, heart failure or hypertension) or even prior history of sepsis. IV fluids are given at a pre-defined amount of 30cc/kg. To illustrate, a 130 pound patient will receive nearly 4 Liters (2 large soda bottles) of intravenous fluids.
This clinical algorithm is called the SEP-1 protocol and Centers for Medicare and Medicaid Services requires hospitals to report compliance with their SEP-1 sepsis bundle. However, a comprehensive study published recently in Critical Care Medicine by Pepper and colleagues found no evidence to support three components of the SEP-1 bundle requirements. This systematic review of 17 published studies (termed a ‘meta analysis’) concluded “the SEP-1 bundle is not based on evidence” and that “these bundle elements should not be mandated unless there is evidence that proves their value.”
Nearly a year ago, a retrospective study by Dr. Chanu Rhee and colleagues Brigham and Women’s Hospital also showed that compliance with the Centers for Medicare and Medicaid Services’ (CMS) SEP-1 quality measure did not improve sepsis mortality rates.
The more recent meta-analysis by Pepper goes a step further than Rhee, however, in suggesting that “real harm can come from forcing clinicians to liberally administer broad-spectrum antibiotics and 30 mL/kg fluid boluses, and there is no evidence that serial lactate measurements have value.”
The bigger question here is how do we unwind a now mandated reporting measure that may not be in the individual patient’s best interest? Compliance with SEP-1 is mandated by Centers for Medicare and Medicaid Services who in turn provide reimbursement to the hospital who then compel practitioners in their hospital to follow the guideline. But what happens when the guideline and mandate have not been shown to have value?
To be clear, there is general consensus among clinicians that fluid resuscitation and early antibiotics are beneficial in sepsis. In fact, an analysis of 27 academic hospitals showed rates of septic shock mortality decreased from 55 to 51 percent between 2005 and 2014.
In August 2018, Dr. Rhee commented that their findings of no improvement in mortality rates with the SEP-1 bundle “should not be interpreted as timely sepsis recognition and care being unimportant, it likely reflects the overly rigid nature of the measure.”
Who is going to take the first step here to unwind this mandated reporting chain? Will it be Centers for Medicare and Medicaid Services? Will they reverse their position on mandated compliance reporting? Will it be individual hospitals who opt out thereby risking their reimbursement for care they have already provided? Or will it be individual physicians who would then risk the ire of hospital administration?