May 26, 2017
2 min read

Mandated rapid sepsis care reduces in-hospital mortality risk

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A New York state-mandated protocol for emergency treatment of sepsis in hospitals reduced patients’ risk for death, according to researchers.

In particular, rapid care and delivery of antibiotics in accordance with the mandate, dubbed “Rory’s Regulations,” were associated with decreased mortality risk, the researchers wrote in a study presented at the American Thoracic Society’s International Conference and simultaneously published in The New England Journal of Medicine.

“There is considerable controversy about how rapidly sepsis must be treated,” study researcher Christopher W. Seymour, MD, MSc, an assistant professor of critical care medicine and emergency medicine at the University of Pittsburgh and a member of the university’s Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center, said in a news release. “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 were named for 12-year-old hospital patient Rory Staunton, whose death in 2012 from undiagnosed sepsis led to the New York law.

Although clinicians are allowed flexibility in following the state protocol, they are required to take a blood culture to detect infection; measure blood lactate, which suggests tissue stress; and administer antibiotics, all within 3 hours of a diagnosis of sepsis — a measure known as the “3-hour bundle.”

To test how important timeliness of care was in sepsis, the study researchers reviewed data from patients with sepsis and septic shock reported in New York between April 1, 2014, and June 30, 2016. They included 49,331 patients treated at 149 hospitals.

The researchers found that the 3-hour bundle was completed within the mandated time frame for 40,696 (82.5%) patients. The bundle was completed in a mean of 1.30 hours, antibiotics were administered in a median of 0.95 hours and fluid tests were completed in a median of 2.56 hours.

For patients whose 3-hour bundles were completed within 12 hours, longer time to bundle completion was associated with greater odds of in-hospital mortality (OR = 1.04 per hour; 95% CI, 1.02-1.05; P < .001). A longer wait for antibiotics, too, was associated with greater odds of mortality (OR = 1.04; 95% CI, 1.03-1.06; P < .001).

A longer time to completion of fluid tests, however, was not associated with increased odds of mortality, the researchers said (OR =1.01; 95% CI, 0.99-1.02; P = .21).

Several previous clinical trials found no advantage in sepsis treatment protocol compared with sound clinical practice. However, Mitchell Levy, MD, a professor of medicine at Brown University’s Warren Alpert Medical School and a researcher on Seymour’s study team, said more than 75% of the patients in those trials had already received portions of the 3-hour bundle before arriving at ICUs.

“When the patient is newly diagnosed and possibly still in the emergency department is when it is most important to check the boxes of the 3-hour bundle,” Levy said in the news release. “Minutes matter, and it is critical to perform the correct tests and get the patient antibiotics as fast as possible.” – by Joe Green


Seymour CW, et al. Abstract A7580. Presented at: American Thoracic Society International Conference; May 19-24, 2017; Washington, D.C.

Seymour CW, et al. N Engl J Med. 2017;doi:10.1056/NEJMoa1703058.

Disclosure: Seymour reports receiving a grant from the NIH for this study. Please see the full study for a list of all other authors’ relevant financial disclosures.