New York's required sepsis protocol appears to be helping in pediatrics, study finds

The death of 12-year-old Rory Staunton from septic shock six years ago sparked a series of changes, including the passage of New York regulations in 201e requiring hospitals to complete certain clinical protocols within one hour of identifying a patient suspected of having sepsis.

In a study of about 1,200 patients from the New York Department of Health data, researchers say they found the one-hour bundle protocol appeared to be linked to improved outcomes for patients. This is the largest study of pediatric patients to date on the topic. 

The study was published today in the Journal of the American Medical Association.

Lead author Idris Evans, M.D., an assistant professor at University of Pittsburgh's Critical Care Medicine Department, told FierceHealthcare the study showed promising results with completion of the protocol within one hour associated with a 40% decrease in hospital mortality. 

"It's encouraging and always good to see what you suspect could be helpful demonstrated on such a large scale," Evans said. 

​​​​​​RELATED: Sepsis treatment: Earlier action in hospitals can mean the difference between life and death

But, he cautioned, more study was needed. When researchers looked at the entire bundle, they saw improvement. When they teased out the data to examine each individual element of the bundle of care, they saw the difference was no longer statistically significant. 

He said researchers have to examine whether they just need a larger study size to see a more significant difference or if there is something else causing the difference when all the elements of the bundle are at play. "Is the completion of the bundle within one hour a marker for something else, such as greater awareness by the doctors and nurses on the care team?" Evans said.

What's next? Evans said he is interested in continuing to look at how timely sepsis care such as fluids and antibiotics can impact outcomes, and in looking at questions raised by this study, such as what parts of the bundle actually contributed to the improved outcome, as well as doing more causal analysis. 

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