Exploring the Impact of "Rory's Regulations" On Sepsis Patients

As the proper management of sepsis continues to be debated globally, recent research findings seem to support controversial state regulations in New York, which call for early intervention with antibiotic-based therapy, among other steps.

A study published in the New England Journal of Medicine on May 21, 2017, by researchers from multiple institutions—including, perhaps most notably, the Clinical Research, Investigation, and Systems Modeling of Acute Illness (CRISMA) Center at the University of Pittsburgh School of Medicine—attempted to assess the impact of “Rory’s Regulations,” a set of mandates for hospitals in New York State that establish protocols for the diagnosis and treatment of sepsis. Established in 2013, the sepsis guidelines are named for Rory Staunton, a 12-year-old New Yorker who died due to complications from the disease the year before. The Empire State was the first state to enact sepsis-related protocols.

“In all of my clinical practice in the ICU, sepsis is the most common problem that I see,” study coauthor Christopher W. Seymour, MD, MSc, Assistant Professor, in the Departments of Critical Care and Emergency Medicine at the University of Pittsburgh School of Medicine told Contagion^®. “So, there is a huge clinical imperative to focus on the disease in our clinical practice and in our research. At the time of Rory Staunton’s death, there was a groundswell of interest in change and learning about how we can do things better. Our study is part of that.”

To assess the effect of the regulations, Dr. Seymour and his colleagues analyzed New York State Department of Health data (publicly reported as part of Rory’s Regulations and released in March) from 49,331 patients (at 149 hospitals) diagnosed with sepsis and septic shock between April 1, 2014 and June 30, 2016. All of these patients underwent sepsis management, as established by the protocol, within 6 hours of admission to an emergency department (ED). Furthermore, all of the patients “had all items in a 3-hour bundle of care for patients with sepsis within 12 hours of admission; items included blood cultures, broad-spectrum antibiotics, and lactate measurement.

Among the cases included in the analysis, 40,696 (82.5%) received the 3-hour bundle within 3 hours of ED admission. Median time to completion of the 3-hour bundle was 1.30 hours, with a median time to antibiotic admission of 0.95 hours, and a median time to completion of fluid bolus of 2.56 hours.

For the 17.5% of patients who received the 3-hour bundle within 12 hours of ED admission, the authors found that “each hour of time to the completion of the 3-hour bundle” was associated with higher risk-adjusted in-hospital mortality (odds ratio, 1.04 per hour; P<0.001). In all, patients who had the bundle completed during hours 3 through 12 following admission had a 14% higher risk for in-hospital death than patients who received the bundle within 3 hours. The researchers also noted a higher risk-adjusted in-hospital mortality for patients in whom the initiation of antibiotic treatment was delayed (odds ratio, 1.04; P<0.001), as patients who received antibiotics in hours 3 through 12 following admission had a 14% higher risk for in-hospital death than those who received antibiotics within 3 hours of admission.

Interestingly, they found that the associations between time to treatment and mortality seemed to be “stronger” in patients who received vasopressors. Overall, on average, the completion of the 3-hour bundle at 6 hours was associated with a 3% higher risk for mortality than completion of the bundle within the first hour of ED admission, the authors concluded.

Although it’s clear the protocols mandated by Rory’s Regulations have had a positive impact, there is still some concern within the medical community as to whether it’s appropriate for state and/or national governments to legislate these clinical practices. Dr. Seymour told Contagion^® that to understand the true scope of the role Rory’s Regulations has played in changing outcomes requires additional research—studies comparing sepsis management and outcomes in New York State prior to the institution of the law with present-day statistics, as well as additional analyses of sepsis outcomes data from surrounding states.

“Like everything in medicine, it’s not black and white,” he said. “At the time of Rory’s death there was a great need to do something and move forward. Whether these regulations are the right approach, we’re still learning about that. However, in the main, I think improving awareness of sepsis in the general public and the earlier administration of antimicrobial therapy in the appropriate patients are good steps.”

Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous healthcare-related publications. He is the former editor of Infectious Disease Special Edition.