Sepsis Survival Higher in Kids With Quick Bundle Completion

Veronica Hackethal, MD

July 24, 2018

Completing a pediatric sepsis care bundle within 1 hour decreased the risk for death by 40% and improved other outcomes as well, a study has found.

"No child should die from a treatable infection. This is the best evidence to date that prompt identification and treatment of sepsis leads to better outcomes in children," senior author Christopher W. Seymour, MD, said in a news release. Dr Seymour is an associate professor at the University of Pittsburgh School of Medicine, Pennsylvania.

The study is the largest analysis of its kind and supports current recommendations from the American College of Critical Care Medicine, the authors write.

Results were published online July 24 in JAMA.

Recent research suggests that about 8% of children who develop sepsis die from their illness. The condition can be particularly difficult to recognize in children, who may initially appear healthy but deteriorate quickly. Some may need life support within hours.

In 2013, New York State implemented Rory's Regulation, a statewide pediatric sepsis bundle, along with mandatory hospital reporting on compliance and sepsis outcomes. The mandate followed the death of 12-year old Rory Staunton, who died from undiagnosed sepsis after developing an infection from a scrape. The bundle requires completion of blood cultures, broad-spectrum antibiotics, and 20 mL/kg intravenous fluid bolus within 1 hour of sepsis recognition.

However, questions have arisen about whether all elements of the bundle need to be completed within 1 hour to improve sepsis care.

To answer that question, researchers analyzed sepsis data reported to the New York State Department of Health database between April 2014 and December 2016. Data came from multiple locations, including emergency departments, inpatient units, and hospital intensive care units in both community and pediatric specialized hospitals. It included 1179 children for whom the sepsis protocol had been triggered at 54 hospitals across New York State. Included children had a mean age of 7.2 years, and 44.5% were previously healthy.

Results showed that 11.8% (n = 139) of children with sepsis died in this study.

Despite the mandate, only 24.9% (n = 294) of children had the entire sepsis bundle completed in 1 hour.

Completion of the entire bundle within 1 hour was linked to 41% lower odds of in-hospital death (odds ratio [OR], 0.59 [95% confidence interval (CI), 0.38 - 0.93; P = .02]; predicted risk difference [RD], 4.0% [95% CI, 0.9% - 7.0%]), regardless of age, location, presence of shock, or care at a hospital or pediatric intensive care unit (P < .05). Mean predicted hospital death increased by 2% for each 1-hour delay in completion of the care bundle.

However, completing individual bundle elements within 1 hour did not lead to significantly lower risk for death (blood culture: OR, 0.73 [95% CI, 0.51 - 1.06; P = .10]; RD, 2.6% [95% CI, −0.5% to 5.7%]; antibiotics: OR, 0.78 [95% CI, 0.55 - 1.12; P = .18]; RD, 2.1% [95% CI, −1.1% to 5.2%], and fluid bolus: OR, 0.88 [95% CI, 0.56 - 1.37; P = .56]; RD, 1.1% [95% CI, −2.6% to 4.8%]).

The authors discuss several possibilities for these results.

"[T]he mechanism of benefit still requires more study. Does each element of the protocol contribute to specific biologic or physiologic changes that, when combined, improve outcomes? Or is it that completion within an hour may simply be an indication of greater awareness by doctors and nurses caring for the child? Or could it be something else entirely?" first author Idris V.R. Evans, MD, assistant professor at the University of Pittsburgh School of Medicine, Pennsylvania, said in a news release.

The authors noted that conducting a randomized trial on this issue would be ethically problematic. It would require assigning some children to care that leaves out certain parts of the protocol and does not conform to the current standard of care.

However, results from this study may encourage other states to adopt similar sepsis bundles and mandated reporting. If so, that could expand the evidence base for this issue.

"The report...demonstrates the clear and significant benefits of bundled care and adds needed evidence of the importance of early recognition and treatment of presumed sepsis in children," Robert J Vinci, MD, from Boston University School of Medicine, Massachusetts, and Eliot Melendez, MD, from Johns Hopkins All Children's Hospital, St. Petersburg, Florida, write in a linked editorial.

However, the study also leaves unanswered questions. Noting a two- to threefold variation between hospitals, such as a larger percentage of specialized hospitals that see a large volume of pediatric patients completed the bundle within 1 hour, they asked whether timely bundle completion is an indication of hospital expertise with critically ill children. Also, some hospitals have strong safety and quality improvement programs, which could have led to better outcomes. Answering such questions may help explain why the entire bundle, and not individual elements, made the difference in improving outcomes.

"[A]s organizations develop robust patient safety programs, the data from the study by Evans et al, including the implementation of the 1-hour bundle, may prove helpful to drive much needed change in the early recognition and treatment of acutely ill children with suspected sepsis," the editorialists conclude.

The study was funded by the National Institutes of Health and the National Institute of General Medical Sciences. Angus is associate editor of JAMA, but was not involved in the review or acceptance of the manuscript. One or more authors reports grants and/or personal fees from one or more of the following: National Institutes of Health, IPRO, National Institute of General Medical Sciences, Beckman Coulter, and Edwards Inc. Vinci and Melendez have disclosed no relevant financial relationships.

JAMA. Published online July 24, 2018. Article abstract, Editorial extract

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