Following the tragic and widely publicized death of Rory Staunton, 12, from undiagnosed sepsis in 2012, New York became the first state to require that hospitals follow a protocol to quickly identify and treat the condition.

Now, five years after the boy’s death, a University of Pittsburgh School of Medicine–led study covering nearly 50,000 patients from 149 New York hospitals is the first to offer scientific evidence that “Rory’s Regulations” work. The announcement – which gives fuel to other states pursuing rapid sepsis care initiatives – was made at the American Thoracic Society’s International Conference and simultaneously published in the New England Journal of Medicine (NEJM).

“There is considerable controversy about how rapidly sepsis must be treated,” said lead author Christopher W. Seymour, MD, MSc, assistant professor in Pitt’s departments of Critical Care Medicine and Emergency Medicine, and member of Pitt’s Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center. “Some question the benefit of rapid treatment with protocols, saying they can have unintended side effects and be a distraction in busy emergency departments. After reviewing the data, we can finally say that faster is better when it comes to sepsis care.”

Rory’s Regulations require hospitals to follow protocols for early identification and treatment of sepsis, and submit data on compliance and outcomes. The hospitals can tailor how they implement the protocols, but must include a blood culture to test for infection, measurement of blood lactate and administration of antibiotics within three hours of diagnosis – collectively known as the “three–hour bundle.”

Seymour and his team found that 83 percent of the hospitals completed the bundle within the required three hours, overall averaging 1.3 hours for completion. For every hour that it took clinicians to complete the bundle, the odds of the patient dying increased by 4 percent.

“With the implementation of Rory’s Regulations, New York State has been a leader in the fight against sepsis. Thanks to Governor Cuomo for recognizing the need for statewide evidence–based protocols and the work of the New York State Sepsis Advisory Workgroup, we have a system in place that quickly identifies sepsis cases, collects data and allows for ongoing communication with hospitals to improve care of their septic patients,” said Marcus Friedrich, MD, MBA, FACP, medical director, New York State Department of Health Office of Quality and Patient Safety. “It is my hope that with this study, combined with the efforts of the New York State Health Department, other states will see that this is a model for combating and improving sepsis–related outcomes and reducing mortality rates.”

The results come on the heels of an international analysis of several clinical trials, one led by physicians in Pitt’s School of Medicine, none of which found a benefit from a standardized approach to treating sepsis when compared to good physician judgment.

Senior author Mitchell Levy, MD, professor of medicine in the Warren Alpert Medical School of Brown University, explains that those clinical trials picked up after the initial urgent resuscitation period was over, and that more than 3 out of 4 sepsis patients in those trials had received elements of the three–hour bundle before they went on to the intensive care unit for further evaluation.