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Mandated 1-hour sepsis care protocol lowers mortality in children

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Sepsis bundle completion may not be only reason for improved mortality

The data published by Evans et al support a protocol approach to sepsis management in children as well as prompt delivery of the components outlined in the New York state mandate, according to an accompanying editorial written by Robert J. Vinci, MD, of Boston Medical Center, and Elliot Melendez, MD, of Johns Hopkins All Children’s Hospital, St. Petersburg, Fla. However, it cannot be determined from this study whether it is prompt delivery of these three mandated components or a more rigorous approach to pediatric sepsis management that deserves the most credit for the mortality benefit.

“Organizations that undertake quality improvement initiatives may have systems of care that promote the bundle completion, which then leads to improved outcomes,” they wrote. As a result, bundle completion may be a marker of expertise in managing critically ill children. They agreed that the data support the tested protocol, but they questioned whether this is sufficient.

“Organizations should be cautious about merely adopting a bundle of care without ensuring they have a universal culture of safety and quality that is adopted and supported from front-line clinical caregivers to organizational leaders and administrators,” they stated.

Dr. Vinci and Dr. Melendez had no disclosures to report.

SOURCE: JAMA. 2018;320(4):345-346. doi:10.1001/jama.2018.9183.



A bundle of blood cultures, broad-spectrum antibiotics, and intravenous fluid replacement reduces risk of in-hospital mortality among children with sepsis if all three forms of management are initiated within an hour, according to a cohort study published in JAMA.

Sepsis invisioner/Thinkstock

Although published guidelines already recommend prompt initiation of these three elements of care, a mandate created in New York in 2013 called for these interventions to be initiated in children within 1 hour of sepsis recognition. The newly published cohort study shows a mortality benefit when this is done.

In the study, which evaluated the impact of the bundle as well as each of the components in 1,179 pediatric patients with sepsis treated at 54 hospitals, the risk-adjusted odds ratio of in-hospital mortality was 0.59 (P = .02) among patients receiving the mandated protocol, compared with those who did not.

When provided within 1 hour, none of the individual components of the bundles were associated with a significant reduction of risk-adjusted, in-hospital mortality by themselves. However, there were trends for benefit with blood cultures (OR, 0.73; P = .1) and broad-spectrum antibiotics (OR, 0.78; P = .18). There was no trend for administration of intravenous fluids (OR, 0.88; P = .56), for which the mandate specified 20 mL/kg.

Although 46.5% of patients received intravenous fluids, 62.8% received broad-spectrum antibiotics, and blood cultures were obtained in 67.7% of the children within 1 hour, only 24.9% were managed with the entire sepsis bundle. Across hospitals, the proportion of children completing the bundle ranged from 7.3% to 46.1%.

Bundle completion was more common in hospitals already treating a relatively high volume of pediatric patients and in those with pediatric specialty services, but the study authors noted that this was not a linear relationship. Rather, they called this association “hypothesis generating” and speculated that other factors might also be important.

The children in this cohort ranged in age from under 1 month to 17 years. Slightly more than half were aged 6 years or older and nearly one-third were older than 12 years. Nearly 45% had no comorbidities. Slightly more than one-third had a malignancy or were immunosuppressed.

None of the study authors reported any relevant financial relationships with industry.

SOURCE: Evans IVR et al. JAMA. 2018 Jul 24. doi:10.1001/jama.2018.9071.

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