Time is critical when it comes to treating sepsis, Pitt study finds
A new University of Pittsburgh study could bolster efforts in Pennsylvania to require hospitals to react quickly to sepsis, a deadly and common complication that can occur when the body’s immune system overreacts to an infection.
The study looked at time-based sepsis protocols in New York, which required hospitals to establish them after a 12-year-old boy named Rory Staunton died from sepsis after cutting his arm in a gym class in 2012.
Sepsis contributes to as many as half of all hospital deaths, making it a target for improved treatment, but high-quality evidence is lacking on whether speed makes a difference, according to the study, published this week by the New England Journal of Medicine.
The study, which involved about 49,000 patients at 149 hospitals, found that each hour of delay in treatment was associated with an increased risk of death of up to 4 percent.
“Our study moves the needle a little bit … suggesting that timeliness is associated with an improved outcome,” said Dr. Christopher Seymour, the study’s lead author and an assistant professor in Pitt’s Department of Critical Care Medicine.
Pennsylvania’s Health Department is planning to require hospitals to put in place sepsis protocols based on the best practices supported by data, Health Secretary Karen Murphy said.
The department is planning to include the protocols in a general update to the state’s hospital regulations that it plans to undertake in September, Murphy said. She estimated the process, which involves a public comment period, legislative hearings and review by an independent regulatory authority, would take 18 to 24 months.
In the meantime, the department is encouraging hospitals to adopt their own protocols, a step many have already taken, Murphy said. Murphy arranged an October conference on sepsis and has posted the protocols of several large health systems on the department’s website.
“It’s very prevalent in academic medical centers and larger facilities,” she said. “What we want to do is offer those tools to smaller hospitals and community hospitals so they have access to the best practices in how they implement the protocol.”
Dr. Mark Mikkelsen, chief of the Section of Medical Critical Care for the University of Pennsylvania Health System, likened sepsis to major public health threats that hospitals have made progress against in recent decades.
“It’s not a story anymore about heart attacks,” he said. “It’s not about stroke. Millions of patients are arriving to our hospitals with sepsis; many are dying.”
Like heart attacks and strokes, time seems to be critical in treating sepsis, he said. The immune systems of people with sepsis flood the body with chemicals meant to fight infection, clotting blood and weakening vessels. Blood flow is impaired, damaging organs in ways that can cause them to quickly fail, causing death, according to the Centers for Disease Control and Prevention.
Rory Staunton’s sepsis went untreated for days as doctors mistook it for the flu, his parents wrote on a website for a foundation they named after him. He died five days after scraping his arm. They wrote that they had never heard of sepsis before their son’s death.
New York’s protocols, called “Rory’s Regulations,” are based on 3-hour “bundles” of steps doctors must take after identifying sepsis in patients. The protocol includes taking blood cultures to help tailor treatment, analyzing lactate levels that can signify septic shock and administering antibiotics.
Seymour’s study compared mortality rates among people who received the bundle within up to 12 hours, finding the increased association with death in patients with the slower implementation.
The study relies on an analysis of data reported by the hospitals, and doesn’t take into account all of the differences in individual patients that may have contributed to whether they lived or died, although the study authors adjusted those variables to try to isolate the effects of treatment times.
The Centers for Medicare & Medicaid Services established guidelines in 2015 for hospitals treating sepsis, outlining what hospitals should do within 3 and 6 hours of diagnosis, but they do not go as far as New York’s regulations.
Partly through a CMS-funded innovation program, Pennsylvania’s hospitals have reduced sepsis-related deaths by 29 percent since 2010, Robert Shipp III, vice president, population health strategies for the Hospital and Healthsystem Association of Pennsylvania, said in a statement.
Other states, including New Jersey, Ohio and Illinois are weighing or have introduced sepsis protocols, doctors said.