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In Treating Sepsis, Questions About Timing and Mandates.

In 2012, Rory Staunton, a 12-year-old boy from Queens, New York, died from sepsis after his pediatrician and an emergency department (ED) physician reportedly misinterpreted warning signs—a high fever and vomiting, but also a cut on his arm, and severe leg pain—as an intestinal illness and dehydration. He was discharged from the ED, but his condition deteriorated. He was readmitted the next day. However, he died in the hospital’s intensive care unit (ICU) 2 days later. Staunton’s story, although tragic, is not necessarily surprising to physicians. “Sepsis in its early throes, even if dire under the surface, can masquerade as a far milder problem,” said Derek Angus, MD, MPH, chair of the department of critical care medicine at the University of Pittsburgh Medical Center, who was not involved with Staunton’s care. “The trick is helping physicians to raise their index of suspicion in the ‘right’ cases—no easy task.” Staunton’s death inspired the passage of Rory’s Regulations in New York state the following year. The initiative requires New York hospitals to have evidence-based protocols for the early recognition and treatment of sepsis, now defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. The regulations stipulate that hospitals collect sepsis data and report it to the state annually. Now, investigators have mined the data to see how much timing really matters in sepsis care. Researchers led by Christopher Seymour, MD, of the University of Pittsburgh’s Clinical Research, Investigation, and Systems Modeling of Acute Illnesses (CRISMA) Center, recently published a report based on data from more than 49 000 adult patients with sepsis and septic shock treated at 149 New York hospitals from April 2014 to June 2016, after the state adopted Rory’s Regulations. Under the regulations, hospital sepsis protocols must contain a 3-hour bundle of care that includes serum lactate testing and administration of broad-spectrum antibiotics after obtaining a blood culture. A mandated 6-hour bundle includes fluid resuscitation—the administration of intravenous fluids to increase blood volume—for patients with low blood pressure (hypotension) or elevated lactate levels, which indirectly indicate low oxygen levels in the body’s tissues and organs. The data revealed that administering antibiotics and completing the 3-hour bundle of care more quickly appeared to save lives—but rapid completion of an intravenous fluid bolus did not. The mixed findings highlight the ongoing uncertainty around sepsis management at a time when additional states are moving to mandate hospital protocols for the challenging condition. Some experts caution that regulating sepsis care, although well-intentioned, could have unintended consequences. “The idea that we should be paying attention to this disease that kills hundreds of thousands of people per year— absolutely we should,” said Michael Howell, MD, an associate professor of medicine and chief quality officer at the University of Chicago Medicine, who was not involved with the new study. “Regulation and legislation helps with that, but there can be a downside to it if the regulation or legislation mandates the wrong thing.”