In 2012, Rory Staunton, a middle schooler in New York, experienced a fatal case of sepsis that was not recognized and treated by doctors. Before sepsis onset, Rory had only a cut that he had gotten from a game of basketball. The day after the game, Rory visited his primary care physician after having leg pain, nausea and a fever of 104˚F. Suspecting that Rory was dehydrated and had an upset stomach, the primary care physician requested that Rory be taken to the emergency department and be treated with fluids to get rehydrated. Upon admission to the hospital, Rory had blood samples drawn and was given intravenous fluids and an anti-nausea drug, Zofran. Seeing that Rory’s condition was improving with fluid administration, hospital physicians discharged Rory and recommended rest and medication. However, after discharge, Rory’s symptoms worsened and soon he was unable to walk. Portions of his body also turned blue. Rory died after being readmitted the next day.
When Rory was first admitted to the hospital, he had displayed signs of infection, which physicians were unable to recognize until Rory’s was readmitted and his condition had significantly deteriorated. Rory’s case soon swept through the media with the New York Times chronicling his story and bringing attention to the issue of sepsis. In 2013, the governor of New York, Andrew Cuomo, signed a legislation called the Rory Regulations to change sepsis management in hospitals. Under these regulations, New York hospitals are required to implement sepsis protocols that include evidence-based methods to properly recognize and treat sepsis. These regulations also require physicians to track and properly document sepsis cases.
Such regulations have proven to be very successful. In a 2015 New York report on sepsis quality improvement measures, it was found that “the odds of dying are 21% less for adult patients who receive protocol driven treatments compared to patients who do not receive protocol driven treatments”. In a 2017 study published in the New England Journal of Medicine (NEJM), it was found that there is a relationship between the timing of treatment administration and sepsis-related outcomes. This retrospective study took place after implementation of the Rory Regulations and included 49,931 sepsis patients from 185 hospitals in New York from April 1, 2014 to June 30, 2016. Sepsis patients for the study were identified based on Sepsis-2 definitions and initiation of sepsis protocol within 6 hours of hospital admissions. Sepsis-3 definitions were not used in this study, as these newer definitions only came out after sepsis protocol implementation in hospitals. The study primarily focused on time to completion of the sepsis 3-hour bundle. Time to completion of antibiotic and fluid administration was also studied.
What is unique about this study is that it focused on the efficacy of individual bundle elements in addition to the bundle as a whole. In this sense, this study is able to set itself apart from other studies that solely focus on the bundle as a whole. The study found that 82.5% of patients completed the 3-hour bundle within 3 hours and that the median time to completion was 1.30 hours. It was also found that the median time to completion for antibiotic and fluid administration were 0.95 hours and 2.56 hours, respectively.
Patients who completed the bundle well after three hours, between 3-12 hours, had 14% higher risk of mortality than those those who completed the bundle within 3 hours. Similar results were found when studying time to antibiotic administration. Interestingly, the timing of fluid administration seemed to have no effect, as patients who received fluid therapy after six hours had the same risk of mortality. Overall, it was found that earlier completion of the 3-hour bundle was associated with better patient outcomes.
The authors of the study explain that earlier administration of antibiotics can reduce the effect of pathogens and can reduce the dysregulated immune response that is characteristic of sepsis. The authors also state that earlier completion of the bundle could lead to faster identification and treatment of patients who are undergoing septic shock. It is also important to note that the authors don’t recommend removing fluid administration from the protocol. They suggest that the fluid therapy results may be due to the fact that sicker patients, who are more likely to die, receive early treatment and that there could be negative effects associated with rapid fluid administration. The topic of fluid therapy and administration has recently sparked a great deal of interest within the medical community as some believe that it should be abandoned, while others point to studies showing its efficacy when administered early. To learn more, check out our previous post.
Limitations of this study include possible biased results due to the fact that it was a retrospective study and not a randomized trial, lack of information on proper antibiotic administration and related mortality, and the fact that the study was only conducted in the state of New York. In spite of these limitations, this study still proves to be useful as it informs us about the efficacy of regulations, such as the Rory regulations, and indicates areas of sepsis management where more research needs to be done.